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Last update 23 Aug 2025

Goserelin Acetate

Last update 23 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Goserelin, Goserelin acetate (JAN/USP), Goserelin Acetate Sustained-Release Depot

+ [23]

Target

GnRHR

Action

agonists

Mechanism

GnRHR agonists(Gonadotropin-releasing hormone receptor agonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

Estrogen receptor positive breast cancerMetrorrhagiaUterine Hemorrhage+ [5]

Inactive Indication

Adenocarcinoma of prostateAdvanced breast cancerEarly Stage Breast Carcinoma+ [6]

Originator Organization

AstraZeneca PLC

Active Organization

TerSera Therapeutics LLC

Nanjing Hencer Pharmacy Co. Ltd.

Mithra Pharmaceuticals SA

+ [2]

Inactive Organization

Luye Pharma Group Ltd.

Jiangxi Jemincare Group Co., Ltd.

JAMP Pharma Corp.

+ [1]

License Organization

AstraZeneca PLC

TerSera Therapeutics LLC

Drug Highest PhaseApproved

First Approval Date

United States (29 Dec 1989),

Breast CancerEndometriosisProstatic Cancer

Regulation-

Structure/Sequence

Molecular FormulaC59H84N18O14.C2H4O2

InChIKeyIKDXDQDKCZPQSZ-JHYYTBFNSA-N

CAS Registry145781-92-6

Sequence Code 21723901

303

Clinical Trials associated with Goserelin Acetate

NCT06348134

/ Not yet recruitingPhase 2IIT

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT07097259

/ Not yet recruitingPhase 1

A Phase 1, Open Label, Randomized, 2-sequence, 2-period, Cross-over, Single Center Study to Assess the Bioequivalence of Follitropin Alfa Solution for Injection in Prefilled Pen (Test) and Follitropin Alfa Powder and Diluent for Solution for Injection in Vial (Reference) in Healthy Downregulated Male Participants

The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and 2. At the end of the first Downregulation period (DR1), eligible participants will be randomly assigned to 1 of the 2 treatment sequences:
Sequence 1: Test - Reference Sequence 2: Reference - Test Where, Test = follitropin alfa (solution for injection in prefilled pen), and Reference = follitropin alfa (powder and diluent for solution for injection in vial).
The total duration of the study will be up to approximately 9 weeks.

Start Date21 Jul 2025

Sponsor / Collaborator

EMD Serono Research & Development Institute, Inc.

[+1]

NCT06953882

/ RecruitingPhase 2IIT

SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy

This is a Phase II Trial to assess the impact of omitting adjuvant chemotherapy based on patient's selection on treatment persistence of CDK4/6 inhibitor, ribociclib (Kisqali), in a well-defined subgroup of patients with resected estrogen receptor (ER)-positive, HER2-negative, lymph node-positive breast cancer, but whose tumor profiling indicates a less aggressive biological nature (OncotypeDx 21-gene recurrence score RS 0-25).

Start Date09 Jul 2025

Sponsor / Collaborator

Yale University

[+2]

100 Clinical Results associated with Goserelin Acetate

100 Translational Medicine associated with Goserelin Acetate

100 Patents (Medical) associated with Goserelin Acetate

2,254

Literatures (Medical) associated with Goserelin Acetate

01 Oct 2025·THERIOGENOLOGY

Supplementation of boar semen extender with 5 μg of buserelin improves litter size and birth weight in gilts raised under tropical field conditions

Article

Author: Adi, Yosua Kristian ; Knox, Robert V ; Lin, Hongyao ; Tummaruk, Padet ; Sang-Gassanee, Kridtasak ; Collell, Miquel ; Suwimonteerabutr, Junpen ; Taechamaeteekul, Preechaphon

Administering exogenous GnRH at the onset of standing estrus induces ovulation within ∼37.5 ± 3.3 h by stimulating LH secretion, narrowing the optimal insemination window. This study evaluated the effects of supplementing extended boar semen with a GnRH analog (buserelin) for fixed-time AI on conception rate, farrowing rate, and litter size under tropical field conditions. A total of 741 French Landrace × Yorkshire females (319 gilts, 422 sows) were used across nine replicates. After estrus detection, females were randomly assigned to four groups: control (n = 191), 10-IM (n = 183; 10 μg buserelin i.m.), 5-S (n = 181; semen + 5 μg), and 10-S (n = 186; semen + 10 μg). Gilts were inseminated at 0, 12, and 24 h; sows at 12, 24, and 36 h post-estrus. Litter data were collected from 223 farrowings: control (29 gilts, 34 sows), 10-IM (16 gilts, 35 sows), 5-S (29 gilts, 25 sows), and 10-S (27 gilts, 28 sows). Across groups, average farrowing rate was 88.9 %, with total number of piglets born per litter (TB) 17.0 ± 4.0, number of piglets born alive per litter (BA) 15.2 ± 3.5, stillborn 1.0 ± 1.5, and mummified fetuses 0.5 ± 1.2. No significant differences in conception or farrowing rates were found. The 5-S group had a significantly higher litter weight than the control group (24.5 ± 2.0 kg vs. 19.4 ± 0.7 kg; P = 0.018). Gilts receiving 5 μg buserelin in semen had significantly higher TB, BA, and litter weight (P < 0.05), while 10 μg increased litter weight without affecting TB. In sows, no significant improvements were observed. These results suggest that supplementing semen with low-dose GnRH analog can improve gilt productivity under tropical conditions and merits further investigation.

11 Aug 2025·JOURNAL OF CLINICAL ONCOLOGY

US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting.

Article

Author: Hou, Sherry ; Gao, Jennifer J ; Gao, Tingting ; Bhatnagar, Vishal ; Yang, Yuching ; Fiero, Mallorie ; Pierce, William F ; Kolhatkar, Rohit ; Raghavachari, Ramesh ; Green, Francis ; Yu, Jingyu ; Prowell, Tatiana M ; Bulatao, Ilynn ; Cheng, Joyce ; Ching-Jey Chang, George ; Grimstein, Manuela ; Osgood, Christy ; Tu, Chi-Ming ; Leach, Courtney ; Akinboro, Oladimeji ; Tang, Shenghui ; Wu, Huali ; Fuller, Barbara ; Kim, Tamy ; Woods, Stacie ; Redwood, Susan ; Gittleman, Haley ; Liu, Qi ; Narayan, Preeti ; Ricks, Tiffany K ; Griffiths, LaShawn ; Shah, Mirat ; Pazdur, Richard ; Rahman, Atiqur ; Ajua-Alemanji, Mispa ; Zhao, Hong ; Kluetz, Paul G ; Gormley, Nicole ; Amiri-Kordestani, Laleh

PURPOSE:

On September 17, 2024, the US Food and Drug Administration (FDA) approved ribociclib in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer (EBC) who are at high risk of recurrence.

PATIENTS AND METHODS:

The FDA approval was based on NATALEE, a randomized (1:1), open-label, multicenter, multinational trial in adults of any sex or menopausal status with hormone receptor-positive, HER2-negative stage II and III EBC who received ribociclib plus an AI (Ribo + AI, n = 2,549) versus an AI (n = 2,552); patients also received goserelin as clinically indicated. Ribociclib was given at 400 mg once daily (3 weeks on/1 week off) for up to 36 months. AI was given per standard of care for at least 5 years. The primary end point was invasive disease-free survival (iDFS), defined according to Standardized Definitions for Efficacy End Points version 1.0 criteria. Overall survival (OS) was a secondary end point.

RESULTS:

iDFS was statistically significant at the third interim analysis (IA3; January 2023; hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]) in the intent-to treat (ITT) population. However, at IA3, there was a large amount of censoring for iDFS as only 20% of patients had completed 3 years of adjuvant therapy and OS was immature. Because of these concerns, FDA requested that NATALEE continue until the final iDFS analysis. At the final iDFS analysis, the iDFS at 36 months was 90.7% (95% CI, 89.3 to 91.8) for Ribo + AI versus 87.6% (95% CI, 86.1 to 88.9) for AI, with a HR of 0.75 (95% CI, 0.63 to 0.89). More patients who received ribociclib experienced all-grade (98% Ribo + AI v 88% AI) and grade ≥3 (64% Ribo + AI v 19% AI) adverse reactions (ARs).

CONCLUSION:

Addition of adjuvant ribociclib to NSAI for adults with high-risk stage II and III hormone receptor-positive, HER2-negative EBC demonstrated a favorable benefit-risk profile with a statistically significant iDFS advantage. OS data remain immature.

11 Aug 2025·ACS Biomaterials Science & Engineering

Rocket-Like Microneedle Patch for Sustained Hormone Therapy in Prostate Cancer.

Article

Author: Yu, Kai-Jie ; Chen, Ying-Tzu ; Chen, Kuan-Ta ; Yang, Hung-Wei ; Pang, See-Tong

Prostate cancer (PCa) remains a significant global health challenge, necessitating the development of advanced therapeutic strategies. This study introduces a rocket-like microneedle patch (RLMNP) as a dual-layer drug delivery system for sustained hormone therapy in PCa. RLMNP integrates a rapid-release layer, employing the pH-responsive zeolitic imidazolate framework-8 (ZIF-8) to encapsulate bicalutamide (CDX), and a sustained-release layer comprising an alginate-tyramine (Alg-Tyr) hydrogel loaded with goserelin. The dual mechanism synergistically targets PCa by blocking androgen receptor signaling and suppressing androgen synthesis. RLMNP demonstrates robust mechanical properties, efficient skin penetration, and controlled drug release profiles. In vivo studies highlight its remarkable efficacy in reducing tumor volume, extending survival (from 34 to 46 days), and mitigating side effects in PCa models. Furthermore, this painless, self-administered platform addresses key limitations of current hormone therapies, including low patient compliance and treatment-associated discomfort. By combining state-of-the-art microneedle technology and a dual-action therapeutic approach, RLMNP establishes a promising paradigm for PCa management. This innovation not only improves therapeutic outcomes but also sets the stage for broader applications of microneedle-based transdermal drug delivery in oncology.

News (Medical) associated with Goserelin Acetate

05 Jun 2025

·www.globenewswire.com

Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis

33% reduction in relative risk of invasive disease observed in pre-menopausal early breast cancer (EBC) patients receiving Kisqali in 1-year post-treatment analysis1 Tolerability remained consistent, with fewer treatment discontinuations due to adverse events among pre-menopausal patients1 Rising breast cancer diagnosis rates and more aggressive disease in younger women underscore importance of early detection and care with effective and tolerable treatments that help prevent cancer recurrence2 Separate real-world analysis presented at ASCO demonstrates differences in treatment outcomes that underscore critical need to improve care for Black patients with EBC3 June 1, 2025 – Novartis is announcing data from a new subgroup analysis of the Phase III NATALEE trial evaluating the efficacy and safety of Kisqali® (ribociclib) plus endocrine therapy (ET, a non-steroidal aromatase inhibitor) in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence across age and menopausal status1. The data will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Results at median follow-up of 44.2 months show that patients receiving Kisqali continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status1. In this one-year post-treatment analysis, pre-menopausal and younger patients, who often present with more aggressive disease characteristics, experienced greater reductions in risk of recurrence and fewer treatment discontinuations due to adverse events (AEs) than post-menopausal patients1. “As the incidence of early onset breast cancer increases, it is encouraging to see that ribociclib continues to deliver durable risk reduction for a broad population of patients with EBC, including younger patients,” said Dr. Kevin Kalinsky, Division Director of Medical Oncology and Director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University. “Coupled with the lower rates of discontinuation due to AEs seen in this subgroup, these data reinforce the benefit of three-year adjuvant treatment with ribociclib as a well-tolerated intervention for patients seeking to reduce the likelihood of their cancer coming back.” A separate real-world analysis of EBC patients who met the NATALEE trial eligibility criteria and received ET monotherapy found that Black patients were more likely to be younger, pre-menopausal, have stage III tumors, and have more extensive nodal involvement than white patients. After adjusting for these factors, Black patients also had worse RFS, DDFS, and overall survival than their white counterparts. These findings reinforce the critical need to improve care for Black patients with the addition of a CDK4/6 inhibitor to their adjuvant treatment3. Novartis is continuing to add to the body of evidence on the efficacy and safety of Kisqali in different patient populations. Trial design details will be presented at ASCO for the Adjuvant WIDER study, which is enrolling patients that closely reflect the population seen in clinical practice, including more patients from racial and ethnic minority groups4. “There is an undeniable and urgent need to improve outcomes for vulnerable patient populations, including younger and Black patients, who often face more aggressive forms of breast cancer and remain at high risk of recurrence," said Reshema Kemps-Polanco, Executive Vice President and Chief Commercial Officer, Novartis US. "With Kisqali, we have the opportunity to reduce the risk of recurrence for these patients with early breast cancer, while we continue to offer significant survival benefit to patients living with metastatic disease.” NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO5,6. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable5,6. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria5,6. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial5,6. Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Kisqali has been approved as a treatment for breast cancer by regulatory authorities in 99 countries worldwide, including the U.S. FDA and the European Commission7,8. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET7. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression8. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist7,8. In EBC, ribociclib (Kisqali) is the only CDK4/6 inhibitor recommended by the NCCN Guidelines® for breast cancer for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 39. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration10. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials11-21. The NCCN Guidelines® also recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI9, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC. In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC22; and has the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer23. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line24. For more than 30 years, Novartis has been at the forefront of driving scientific advancements for people touched by breast cancer and improving clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in the discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease. Beyond medicines, Novartis is leading efforts to encourage early detection and working to remove access barriers faced by patients along their care journey. Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. References Kalinsky K et al. Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age. Presented at the American Society of Clinical Oncology Annual Meeting, June 1, 2025. Chicago, USA. American Cancer Society. Cancer Facts & Figures 2025. American Cancer Society. 2025. Available from: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed May 2025. Abdou Y et al. Real-world (RW) analysis of characteristics and risk of recurrence (ROR) in Black patients (pts) with HR+/HER2- early breast cancer (EBC) eligible for NATALEE. Presented at the American Society of Clinical Oncology Annual Meeting, June 2, 2025. Chicago, USA. Graff SL et al. Adjuvant WIDER: A phase 3b trial of ribociclib (RIB) + endocrine therapy (ET) as adjuvant treatment (tx) in a close-to-clinical-practice patient (pt) population with HR+/HER2− early breast cancer (EBC). Presented at the American Society of Clinical Oncology Annual Meeting. June 2, 2025. Chicago, USA. Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024;390(12):1080-1091. doi:10.1056/NEJMoa2305488 Clinicaltrials.gov. NCT03701334. A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/ HER2- Early Breast Cancer (NATALEE). Available from: https://clinicaltrials.gov/study/NCT03701334. Accessed May 2025. Kisqali. Prescribing Information (US FDA). Novartis Pharmaceuticals Corporation; 2017. Accessed May 2025. https://www.novartis.com/us-en/sites/novartis_us/files/kisqali.pdf Kisqali. Summary of product characteristics (SmPC). Novartis Europharm Limited; 2017. Accessed May 2025. https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Accessed May 2025. https://www.nccn.org National Medical Products Administration. Drug Evaluation Information Disclosure: Drug Evaluation Approval Results. National Medical Products Administration. Published May 21, 2025. Accessed May 28, 2025. https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250521151427103.html Yardley DA et al. Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials. Poster presented at the European Society of Medical Oncology Congress. September 9-13, 2022. Paris, France. Neven P et al. Updated overall survival (OS) results from the first-line (1L) population in the Phase III MONALEESA-3 trial of postmenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at the European Society for Medical Oncology Breast Cancer Congress. May 4, 2022. Paris, France. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663 Hortobagyi GN et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. LBA 17. Proffered paper presented at the European Society of Medical Oncology Congress, September 16-21, 2021. Lugano, Switzerland. Im SA, Lu YS, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. doi:10.1056/NEJMoa1903765 Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-524. doi:10.1056/NEJMoa1911149 Slamon DJ et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). LBA7_PR. Presented at the European Society of Medical Oncology Congress, September 29, 2019. Barcelona, Spain. Slamon DJ et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the American Society of Clinical Oncology Annual Meeting, June 5, 2021. Chicago, USA. Tripathy D et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium, December 9, 2020. Texas, USA. Yardley D et al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology Annual Meeting, June 2020. Chicago, USA. O’Shaughnessy J et al. Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with HR+/HER2− advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Texas, USA. European Society of Medical Oncology (ESMO). ESMO MCBS scorecards; NATALEE. Accessed May 2025. https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards/scorecard-468-1 European Society for Medical Oncology. Magnitude of Clinical Benefit Scale Scorecard. Accessed May 2025. https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=158-1 European Society for Medical Oncology. Magnitude of Clinical Benefit Scale Scorecard. Accessed May 2025. https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=9-1 The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCODrug Approval

02 Jun 2025

·pipelinereview.com

ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial

AstraZeneca and Daiichi Sankyo’s ENHERTU plus pertuzumab showed a median progression-free survival greater than three years First trial in more than a decade to demonstrate an improvement in outcomes in the 1st-line setting for a broad population of patients with HER2-positive metastatic breast cancer WILMINGTON, DE, USA J June 02, 2025 I Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU ® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer. Results will be presented today during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (abstract #LBA1008). In a prespecified interim analysis, ENHERTU plus pertuzumab reduced the risk of disease progression or death by 44% versus THP (based on a hazard ratio [HR] of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.00001). Median PFS was 40.7 months with ENHERTUplus pertuzumab compared to 26.9 months for THP, as assessed by blinded independent central review (BICR). The PFS benefit for ENHERTU plus pertuzumab versus THP was consistent across subgroups, including for the prespecified stratification factors of de novo or recurrent disease, hormone receptor status and PIK3CA mutation status. Investigator-assessed PFS demonstrated a median PFS of 40.7 months for ENHERTU plus pertuzumab compared to 20.7 months for THP (HR 0.49; 95% CI 0.39-0.61; nominal p-value <0.00001). Confirmed objective response rate (ORR) with ENHERTU plus pertuzumab was 85.1% versus 78.6% with THP. There were 58 complete responses (CRs) with ENHERTU plus pertuzumab compared to 33 with THP. Median duration of response (DOR) for ENHERTU plus pertuzumab exceeded three years (39.2 months) versus 26.4 months with THP. Overall survival (OS) was not mature at the time of the interim analysis (16% maturity at data cut-off); however, interim OS data showed an early trend favoring the ENHERTU combination compared to THP (HR 0.84; 95% CI 0.59-1.19). Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute and principal investigator in the trial, said: “Patients with HER2-positive metastatic breast cancer often experience disease progression around two years after initiating standard-of-care first-line treatment. With a median progression-free survival of more than three years, the DESTINY-Breast09 results show trastuzumab deruxtecan combined with pertuzumab has the potential to become a new first-line standard of care for these patients.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Bringing ENHERTU earlier in the treatment of HER2-positive metastatic breast cancer may represent an important advancement for patients. The DESTINY-Breast09 trial showed the combination of ENHERTUand pertuzumab in the first-line setting substantially increased the amount of time before a patient’s cancer progressed compared to standard of care and nearly doubled the number of patients showing no signs of disease on imaging. Establishing a strong therapeutic response as soon as metastatic disease is diagnosed is critical given that about one in three patients do not receive further treatment after progressing in the first-line setting.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “ENHERTU continues to transform the treatment of metastatic breast cancer with the first new data in more than a decade to demonstrate improved outcomes for a broad population of patients with HER2-positive disease compared to THP in the first-line setting. DESTINY-Breast09 shows that initiating treatment with ENHERTU in combination with pertuzumab at the time of metastatic diagnosis can delay disease progression.” Summary of DESTINY-Breast09 interim analysis results Median duration of follow-up was nearly 2.5 years (29.2 months). As of the data cut-off, 302 (39.6%) patients remained on treatment, 174 in the ENHERTUplus pertuzumab arm and 128 in the THP arm. The safety profile of ENHERTU in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual therapy with no new safety concerns identified. Interstitial lung disease (ILD)/pneumonitis occurred in 12.1% of patients treated with ENHERTU in combination with pertuzumab, as determined by an independent adjudication committee. The majority of ILD events were low Grade (Grade 1 [n=17; 4.5%] or Grade 2 [n=27; 7.1%]). There were no Grade 3 or Grade 4 ILD events. There were two Grade 5 (0.5%) ILD events in the ENHERTU plus pertuzumab arm. An additional investigational arm of the trial assessing ENHERTUmonotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. ENHERTU is already approved in more than 80 countries as 2nd-line treatment for patients with HER2-positive breast cancer based on the results from the DESTINY-Breast03trial. Indications and Important Safety Information Indications ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Please see accompanying full Prescribing Information , including Boxed WARNINGS, and Medication Guide . Notes HER2-positive metastatic breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer. 3 HER2 protein overexpression may occur as a result of HER2 gene amplification. 4 HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer. 5,6 Approximately 23,000 patientsare treated each year in the 1st-line HER2-positive setting across G7 countries alone. 7 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade. 4,8-10 Further, approximately one in three patients do not go on to receive treatment following 1st-line therapy due to disease progression or death. 11,12 DESTINY-Breast09 DESTINY-Breast09 is a global, multicenter, randomized, open-label, Phase III trial evaluating the efficacy and safety of ENHERTU(5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a 1st-line treatment in patients with HER2-positive metastatic breast cancer. Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment ( de novo metastatic disease versus progression from early-stage disease), hormone receptor status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include OS, ORR, DOR, investigator-assessed PFS and PFS2 and safety. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov . ENHERTU ENHERTU is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridization [ISH]+) breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4mg/kg) is approved in more than 60 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication will depend on whether a randomized controlled confirmatory clinical trial can demonstrate clinical benefit in this population. ENHERTU (5.4mg/kg) is approved in the US and other countries for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on the results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US is contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU clinical development program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as monotherapy, in combination or sequentially with other anti-cancer therapies across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan-dlnk in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan-dlnk. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment. With ENHERTU, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines fulvestrant and goserelin and aims to reshape the HR-positive space with first-in-class AKT inhibitor, capivasertib, the TROP-2-directed ADC, datopotamab deruxtecan-dlnk and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor olaparib is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with Merck & Co., Inc. (MSD outside the US and Canada) continue to research olaparib in these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA -mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of datopotamab deruxtecan-dlnk alone and in combination with immunotherapy durvalumab. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca . References SOURCE: AstraZeneca

Clinical ResultPhase 3Drug ApprovalASCOImmunotherapy

02 Jun 2025

·www.astrazeneca.com

Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial

Positive results from the DESTINY-Breast09 Phase III trial showed Enhertu (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer. Results will be presented today during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (abstract #LBA1008). In a prespecified interim analysis, Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP (based on a hazard ratio [HR] of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.00001). Median PFS was 40.7 months with Enhertu plus pertuzumab compared to 26.9 months for THP, as assessed by blinded independent central review (BICR). The PFS benefit for Enhertu plus pertuzumab versus THP was consistent across subgroups, including for the prespecified stratification factors of de novo or recurrent disease, hormone receptor status and PIK3CA mutation status. Investigator-assessed PFS demonstrated a median PFS of 40.7 months for Enhertu plus pertuzumab compared to 20.7 months for THP (HR 0.49; 95% CI 0.39-0.61; nominal p-value <0.00001). Confirmed objective response rate (ORR) with Enhertu plus pertuzumab was 85.1% versus 78.6% with THP. There were 58 complete responses (CRs) with Enhertu plus pertuzumab compared to 33 with THP. Median duration of response (DOR) for Enhertu plus pertuzumab exceeded three years (39.2 months) versus 26.4 months with THP. Overall survival (OS) was not mature at the time of the interim analysis (16% maturity at data cut-off); however, interim OS data showed an early trend favouring the Enhertu combination compared to THP (HR 0.84; 95% CI 0.59-1.19). Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute and principal investigator in the trial, said: “Patients with HER2-positive metastatic breast cancer often experience disease progression around two years after initiating standard-of-care first-line treatment. With a median progression-free survival of more than three years, the DESTINY-Breast09 results show trastuzumab deruxtecan combined with pertuzumab has the potential to become a new first-line standard of care for these patients.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Bringing Enhertu earlier in the treatment of HER2-positive metastatic breast cancer may represent an important advancement for patients. The DESTINY-Breast09 trial showed the combination of Enhertu and pertuzumab in the first-line setting substantially increased the amount of time before a patient’s cancer progressed compared to standard of care and nearly doubled the number of patients showing no signs of disease on imaging. Establishing a strong therapeutic response as soon as metastatic disease is diagnosed is critical given that about one in three patients do not receive further treatment after progressing in the first-line setting.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “Enhertu continues to transform the treatment of metastatic breast cancer with the first new data in more than a decade to demonstrate improved outcomes for a broad population of patients with HER2-positive disease compared to THP in the first-line setting. DESTINY-Breast09 shows that initiating treatment with Enhertu in combination with pertuzumab at the time of metastatic diagnosis can delay disease progression.” Summary of DESTINY-Breast09 interim analysis results Efficacy Measure Enhertu (5.4 mg/kg) + pertuzumab (n=383) THP (n=387) PFS by BICRi Median PFS (months) (95% CI) 40.7 (36.5-NC) 26.9 (21.8-NC) Hazard ratio (95% CI) HR 0.56 (0.44-0.71) p-value p<0.00001ii 24-month PFS rate (%) (95% CI) 70.1 (64.8-74.8) 52.1 (46.4-57.5) PFS by investigator Median PFS (months) (95% CI) 40.7 (36.5-NC) 20.7 (17.3-23.5) Hazard ratio (95% CI) HR 0.49 (0.39-0.61) Nominal p-value p<0.00001ii PFS2 by investigatoriii Median PFS2 (months) (95% CI) NC (NC-NC) 36.5 (36.1-NC) Hazard ratio (95% CI) HR 0.60 (0.45-0.79) Nominal p-value 0.00038ii ORR by BICR iv Confirmed ORR(%) (95% CI)v 85.1 (81.2-88.5) 78.6 (74.1-82.5) CR % (n) 15.1 (58) 8.5 (33) PR % (n) 70 (268) 70 (271) SD % (n) 9.9 (38) 14.5 (56) Median DOR in months (95% CI) 39.2 (35.1-NC) 26.4 (22.3-NC) Remaining in response at 24 months (%) 73.3 54.9 THP, taxane, trastuzumab and pertuzumab; PFS, progression-free survival; BICR, blinded independent central review, CI, confidence interval; NC, not calculable; HR, hazard ratio; ORR, objective response rate; CR, complete response; PR, partial response, SD, stable disease; DOR, duration of response i. Interim analysis was based on a data cut-off of 26 Feb 2025; interim analysis criterion for superiority for primary endpoint (P-value <0.00043); ~38% maturity at data cut-off ii. Stratified log-rank test iii. PFS2 was defined by investigators according to local standard clinical practice as the time from randomisation to second progression (earliest progression event following first subsequent therapy) or death iv. ORR is (CR + PR) based on RECIST v1.1 v. Response required confirmation after 4 weeks Median duration of follow-up was nearly 2.5 years (29.2 months). As of the data cut-off, 302 (39.6%) patients remained on treatment, 174 in the Enhertu plus pertuzumab arm and 128 in the THP arm. The safety profile of Enhertu in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual therapy with no new safety concerns identified. Interstitial lung disease (ILD)/pneumonitis occurred in 12.1% of patients treated with Enhertu in combination with pertuzumab, as determined by an independent adjudication committee. The majority of ILD events were low Grade (Grade 1 [n=17; 4.5%] or Grade 2 [n=27; 7.1%]). There were no Grade 3 or Grade 4 ILD events. There were two Grade 5 (0.5%) ILD events in the Enhertu plus pertuzumab arm. An additional investigational arm of the trial assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca. Enhertu is already approved in more than 80 countries as 2nd-line treatment for patients with HER2-positive breast cancer based on the results from the DESTINY-Breast03 trial. Notes HER2-positive metastatic breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.5,6 Approximately 23,000 patientsare treated each year in the 1st-line HER2-positive setting across G7 countries alone.7 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.4,8-10 Further, approximately one in three patients do not go on to receive treatment following 1st-line therapy due to disease progression or death.11,12 DESTINY-Breast09 DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a 1st-line treatment in patients with HER2-positive metastatic breast cancer. Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include OS, ORR, DOR, investigator-assessed PFS and PFS2 and safety. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 60 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population. Enhertu (5.4mg/kg) is approved in the US and other countries for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on the results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US is contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu clinical development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as monotherapy, in combination or sequentially with other anti-cancer therapies across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;10.3322/caac.21834. 2. National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed May 2025. 3. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;852748. 4. Pillai R, et al. HER2 mutations in lung adenocarcinomas: A report from the Lung Cancer Mutation Consortium. Cancer. 2017;1;123(21):4099-4105. 5. Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med. 2019;54(1):34-44. 6. Tarantino P, et al. ESMO expert consensus statements (ECS) on the definition, diagnosis, and management of HER2-low breast cancer. J Ann Onc. 2023;34(8):645-659. 7. AstraZeneca. Investor Relations: Epidemiology. Available at: https://www.astrazeneca.com/content/dam/az/Investor_Relations/Epidemiology-data-2024.xlsx. Accessed May 2025. 8. Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, Phase III study. Lancet Oncol. 2020;21(4):519-530. 9. Blumenthal G, et al. First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer. Clin Can Res. 2013;19(18). 10. Tripathy D, et al. De Novo Versus Recurrent HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from the SystHERs Registry. Oncologist. 2020;25(2):e214-e222. 11. Hall P, et al. Attrition rates from first- to third-line therapy in HER2+ metastatic breast cancer in Europe. Presented at SABCS Annual Meeting 2023. Poster #PO3-16-11. 12. Hartkopt AD, et al. Attrition in the First Three Therapy Lines in Patients with Advanced Breast Cancer in the German Real-World PRAEGNANT Registry. Geburtshilfe Frauenheilkd. 2024;84(5):459–469. Oncology Corporate and financial

Clinical ResultPhase 3ASCODrug ApprovalLicense out/in

100 Deals associated with Goserelin Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D00573	Goserelin Acetate	L02AE03	DB00014

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	Canada	TerSera Therapeutics LLC	07 May 2024
Metrorrhagia	United States	TerSera Therapeutics LLC	27 Jul 1998
Uterine Hemorrhage	United States	TerSera Therapeutics LLC	27 Jun 1997
Premenopausal breast cancer	Japan	AstraZeneca PLC	28 Jun 1991
Breast Cancer	United States	TerSera Therapeutics LLC	29 Dec 1989
Endometriosis	United States	TerSera Therapeutics LLC	29 Dec 1989
Prostatic Cancer	United States	TerSera Therapeutics LLC	29 Dec 1989

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	China	AstraZeneca PLC	31 Mar 2020
Adenocarcinoma of prostate	Phase 3	China	Shandong Luye Pharmaceutical Co., Ltd.	06 Jan 2020
Recurrent Prostate Carcinoma	Phase 3	Canada	AstraZeneca PLC	01 Apr 2007
Early Stage Breast Carcinoma	Phase 3	-	AstraZeneca PLC	01 Dec 1990
Advanced breast cancer	Phase 2	Czechia	AstraZeneca PLC	01 Apr 2006
Advanced breast cancer	Phase 2	Russia	AstraZeneca PLC	01 Apr 2006
Advanced breast cancer	Phase 2	Ukraine	AstraZeneca PLC	01 Apr 2006
Locally advanced breast cancer	Phase 2	France	AstraZeneca PLC	01 Dec 2001
Hormone Receptor Positive Breast Adenocarcinoma	Phase 2	United States	AstraZeneca PLC	01 Oct 2000
Metastatic breast cancer	Phase 2	United States	AstraZeneca PLC	01 Oct 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05184257 (J Natl Cancer Cent) Manual	Not Applicable	Hormone receptor positive breast cancer HR Positive	1,060	Goserelin 10.8-mg	wjjdmhjchw(tukwmsnjtc) = hoheyxnqcx swaalpoois (spqwvegbya, 96.9 - 99.8)	Non-inferior	01 Aug 2025
				Goserelin 3.6-mg	wjjdmhjchw(tukwmsnjtc) = aeuraifmlr swaalpoois (spqwvegbya, 91.0 - 97.6)
Pubmed \| EJNMMI Res	Phase 2	Salivary duct carcinoma prostate-specific membrane antigen (PSMA) \| androgen receptor (AR)	8	Goserelin plus bicalutamide	polumwbgpi(ejbhweouqm) = The FDG SUVmax increased in 35 lesions (44%), remained stable in 39 lesions (49%), and decreased in 6 lesions (8%), with a significant overall median increase of + 0.97 (Wilcoxon signed rank test, p < 0.001). xvmjqamols (pyuxyevxoh ) View more	Positive	15 Jul 2025
NCT02278120 (MONALEESA-7, ESMO_ASIA2024)	Phase 3	Hormone receptor positive breast cancer	672	Ribociclib+Endocrine Therapy	tibhffhhxs(xfwehyutkz) = ecfcnlpxff keanrwwwpn (ujimsqnngc )	Positive	07 Dec 2024
				Placebo+Endocrine Therapy	tibhffhhxs(xfwehyutkz) = glecdwcmfe keanrwwwpn (ujimsqnngc )
NCT06009627 (ESMO2024) Manual	Phase 2	Premenopausal breast cancer Neoadjuvant HER2 Negative \| HR Positive	32	Dalpiciclib, Exemestane, and Goserelin	iiuyufkpwm(qnpavzbtdf) = iukgineqlc wnrjnupszr (ylujepzstd )	Positive	16 Sep 2024
				TAC (docetaxel, doxorubicin, and cyclophosphamide)	iiuyufkpwm(qnpavzbtdf) = mmhwogyept wnrjnupszr (ylujepzstd )
ESMO_BC 12024 \| ESMO_BC 22024 Manual	Not Applicable	Hormone receptor positive breast cancer	590	Goserelin 10.8 mg	buejsjwwpn(ajhhkjbbjo) = ifownbhcce mxhaivoloe (eoboofgfog, 96.9 - 99.8)	Non-inferior	15 May 2024
				Goserelin 3.6 mg	buejsjwwpn(ajhhkjbbjo) = zcrkopdaiu mxhaivoloe (eoboofgfog, 91.0 - 97.6)
NCT00295646 (ABCSG-12, CTgov)	Phase 3	Hormone receptor positive breast cancer	1,803	zoledronic acid+goserelin+anastrozole (AZ (Arimidex+Zoledronate))	oyqglseszr(stdbwwaqkx) = pgbwzssaph whuilpwlqf (rdjyiztjnr, egwodsxujq - lvurtyhwwk) View more	-	15 Mar 2024
				tamoxifen+zoledronic acid+goserelin (TZ (Tamoxifen+Zoledronate))	oyqglseszr(stdbwwaqkx) = xpekytjrkl whuilpwlqf (rdjyiztjnr, thyawvscok - chsgsnpdtd) View more
NCT01674140 (S1207 \| SWOG S1207 \| e3, CTgov)	Phase 3	Hormone receptor positive HER2 negative breast cancer	1,939	placebo+letrozole+tamoxifen citrate+exemestane+leuprolide acetate+goserelin acetate+anastrozole (Placebo)	hlxhxjrzuh = gzdethbymk dnjkfohbwa (lwykyyfpvr, mgyzrxxahv - tgfcxuyccq) View more	-	20 Dec 2023
				Everolimus (Everolimus)	hlxhxjrzuh = gzmjuxvbkn dnjkfohbwa (lwykyyfpvr, pxlqfrfdns - ebmsfanaqt) View more
NCT02003209 (NRG Oncology/NSABP B-52, CTgov)	Phase 3	HER2 Positive Breast Cancer \| Hormone Receptor Positive Breast Adenocarcinoma \| Hormone receptor positive HER2 positive breast cancer ... View more	315	Cytology Specimen Collection Procedure+Trastuzumab+Carboplatin+Pertuzumab+Docetaxel (Arm I (Combination Chemotherapy, Surgery, Radiation))	ovxkebwaib = brdkkjvaes ivzlqxevdx (rnaqicmokz, eajjfcsyeb - eqrwfjhfbg) View more	-	12 Jun 2023
				Aromatase Inhibition Therapy+Trastuzumab+Carboplatin+Pertuzumab+Docetaxel+Goserelin Acetate (Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation))	ovxkebwaib = tzaemsxxgz ivzlqxevdx (rnaqicmokz, wburaqvyoq - fnfhoqktla) View more
NCT02058706 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Castration-sensitive prostate cancer \| Adenocarcinoma of prostate	71	orchiectomy+enzalutamide+leuprolide acetate+goserelin acetate (Arm A (Enzalutamide and LHRH Analogue Therapy))	kznekugvxw = ixllaxtvqd hyuoyizncq (tbcccodpgm, duxvpyvdyt - hpsaexaiww) View more	-	10 May 2023
				orchiectomy+bicalutamide+leuprolide acetate+goserelin acetate (Arm B (Bicalutamide and LHRH Analogue Therapy))	kznekugvxw = kaoiwteape hyuoyizncq (tbcccodpgm, duxwigmaay - gfrottpynk) View more

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