The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC).
Primary objective:
● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2.
Secondary objectives:
* To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2
* To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response;
* To evaluate the safety of abemaciclib and giredestrant.
Exploratory objectives:
* To evaluate the mechanisms of response and resistance to therapy;
* To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction;
* To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

Start Date27 Jan 2025

Sponsor / Collaborator-

CTRI/2024/03/064777

/ Not yet recruitingPhase 3

A phase III, randomized, open-label study evaluating efficacy and safety of Giredestrant compared with Fulvestrant, both combined with a CDK4/6 inhibitor, in patients with estrogen receptor-positive, HER2-negative advanced breast cancer with resistance to prior adjuvant endocrine therapy - PionERA

Start Date15 May 2024

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+1]

NCT05708235

/ Active, not recruitingPhase 2

A Proof of Concept Study to Evaluate Treatments' Efficacy by Monitoring Minimal Residual Disease Using ctDNA in HR-positive/HER2-negative Early Breast Cancer Population

This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease.
The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase).
After informed consent is obtained, a total of1,260 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature).
At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy:
Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10)
If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.

Start Date01 Apr 2024

Sponsor / Collaborator

Medica Scientia Innovation Research SL

100 Clinical Results associated with Giredestrant

100 Translational Medicine associated with Giredestrant

100 Patents (Medical) associated with Giredestrant

Literatures (Medical) associated with Giredestrant

27 Jan 2025·Annual Review of Medicine

New Oral Selective Estrogen Receptor Degraders Redefine Management of Estrogen Receptor–Positive Breast Cancer

Review

Author: Pathak, Neha ; Oliveira, Mafalda

Oral selective estrogen receptor degraders (SERDs) are pure estrogen receptor antagonists that have the potential to overcome common resistance mechanisms to endocrine therapy in estrogen receptor–positive breast cancer. There are currently five oral SERDs in published and ongoing clinical trials—elacestrant, camizestrant, giredestrant, imlunestrant, and amcenestrant—with more in development. They offer a reasonably well-tolerated oral therapy option with low discontinuation rates in studies. This review summarizes the currently available literature on this new class of drugs.

12 Dec 2024·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of Thiochroman Derivatives as Potent, Oral Selective Estrogen Receptor Degraders and Antagonists for the Treatment of Endocrine-Resistant Breast Cancer

Article

Author: Hu, Wenhao ; Yang, Yushe ; Meng, Xin ; Zhang, Dan ; Lu, Zhengyu ; Leng, Xin-Yu ; Lei, Xiang ; He, Yongqi ; Sun, Lulu ; Kong, Deyu

Selective estrogen receptor degraders (SERDs) deplete the ER signaling pathway via antagonism and degradation of ERα and represent a promising strategy to tackle endocrine resistance. Here, we report a new class of SERDs by pharmacological evolution of a selective estrogen receptor modulator, lasofoxifene. The structure-activity relationship study and efforts to circumvent the issue of human ether-a-go-go-related gene led to the identification of compounds 51. This bifunctional compound displayed broad activity across a vast array of cell backgrounds and was capable of effectively degrading and antagonizing wild-type ERα and clinically relevant ERα mutants. 51 exhibited favorable pharmacokinetic properties and good brain penetration, with a brain/plasma ratio of 3.05, and significantly suppressed the growth of tumor in a tamoxifen-resistant MCF-7 Tam1 xenograft model. Overall, the study demonstrates 51 as a highly potent, oral, and brain penetrant ER degrader and pure antagonist, showing a good potential in overcoming endocrine resistance.

01 Nov 2024·JOURNAL OF PHARMACEUTICAL SCIENCES

Use of differential scanning calorimetry as a rapid, effective in-process check method for impurity quantitation of an early clinical batch of Giredestrant (GDC-9545)

Article

Author: Nagapudi, Karthik ; Chakravarty, Paroma

Giredestrant (GDC-9545) is a selective estrogen receptor degrader (SERD) that was developed for treatment of ER+/HER2- metastatic breast cancer. An anhydrous crystalline tartrate salt was identified as the solid form suitable for clinical development. An early clinical batch of the active pharmaceutical ingredient (API)/drug substance failed to pass the GMP purity specifications owing to the presence of a substantial amount of high molecular weight impurities (oligomers), as determined by size exclusion chromatography. Several trial rework batches were manufactured using various re-slurry and recrystallization conditions to purge impurities in the drug substance to adhere to purity specifications. Based on the melting point depression of the API in presence of oligomers in these rework batches, a differential scanning calorimetry method was developed to quantify impurity content as a function of melting point onset of the API. This thermal analysis method was used as a surrogate for chromatography as a rapid, effective in-process check method for impurity quantitation to enable the timely release of the final reworked clinical batch. Post release, the % w/w oligomer value determined by calorimetry was in excellent agreement to that obtained by size exclusion chromatography.

News (Medical) associated with Giredestrant

13 Mar 2025

·www.prnewswire.com

VERZENIO's Market Potential Soars as Demand for CDK4/6 Inhibitors Grows | DelveInsight

As VERZENIO gains traction in early-stage treatments and broadens its approved uses, its revenue is expected to keep growing. While the global CDK4/6 inhibitor market remains highly competitive, VERZENIO's distinct clinical advantages and ongoing studies could contribute to further market expansion. LAS VEGAS, March 13, 2025 /PRNewswire/ -- DelveInsight's " VERZENIO Market Size, Forecast, and Market Insight Report" highlights the details around VERZENIO, which is a targeted treatment known as a CDK4/6 inhibitor. The drug is a non-chemotherapy oral tablet. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of VERZENIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Eli Lilly and Company's VERZENIO (abemaciclib) Overview VERZENIO (abemaciclib) is a prescription medication used to treat adults with HR-positive, HER2-negative breast cancer that has metastasized (spread to other parts of the body). It is administered orally and is prescribed in combination with an aromatase inhibitor as an initial endocrine-based therapy. Additionally, the drug is being developed for the treatment of prostate cancer. VERZENIO is approved for the following indications: In combination with endocrine therapy for the adjuvant treatment of adults with HR+/HER2-, node-positive, early-stage breast cancer at high risk of recurrence. In combination with an aromatase inhibitor as the initial endocrine-based therapy for adults with HR+/HER2- advanced or metastatic breast cancer. In combination with fulvestrant for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed after prior endocrine therapy. As monotherapy for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed following endocrine therapy and prior chemotherapy in the metastatic setting. Learn more about VERZENIO projected market size for breast cancer @ VERZENIO Market Potential HR+/HER2- breast cancer is the most common subtype of breast cancer, defined by the presence of estrogen and progesterone hormone receptors but lacking HER2 overexpression. This form of breast cancer generally has a favorable prognosis and is primarily managed with hormone therapy to suppress hormone-driven tumor growth. According to DelveInsight's estimates, around 211,000 new cases of HR+/HER2− breast cancer were reported in the US in 2024. Over the past decade, endocrine therapy has remained the cornerstone of treatment, including for cases with visceral involvement. The current preferred approach involves combining endocrine therapy—using aromatase inhibitors or fulvestrant—with CDK4/6 inhibitors. The approval of CDK4/6 inhibitors has significantly transformed the treatment landscape for HR+/HER2− breast cancer. Currently, five selective CDK4/6 inhibitors— ENHERTU, DATROWAY, IBRANCE, KISQALI, and VERZENIO—are used in combination with endocrine therapy. In November 2023, the FDA approved TRUQAP (capivasertib) in combination with FASLODEX for patients with advanced HR+/HER2− breast cancer harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN). The NCCN Guidelines have designated KISQALI as the only Category 1 Preferred CDK4/6 inhibitor for first-line treatment in combination with an aromatase inhibitor, strengthening its position in the U.S. market. This led to KISQALI recovering its lost market share, with its U.S. revenue contribution rebounding to 50%, following declines to 46% in 2020, 36% in 2021, and 38% in 2022. In January 2025, the FDA approved DATROWAY for patients with unresectable or metastatic HR+/HER2- breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) who had previously received endocrine-based therapy and chemotherapy. Additionally, ENHERTU was approved for patients with unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that had progressed after at least one prior endocrine therapy in the metastatic setting. Also, in January 2025, Roche reported positive topline results from its Phase III INAVO120 trial, assessing ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2−, endocrine-resistant, locally advanced, or metastatic breast cancer. Among the seven major markets, the US accounted for the largest market share in HR+/HER2− breast cancer, generating USD 7.5 billion in revenue in 2023. The market is expected to experience substantial growth from 2025 to 2034, driven by the introduction of novel therapeutic options. Discover more about the breast cancer market in detail @ Metastatic HR+/HER2- Breast Cancer Market Report Emerging Competitors of VERZENIO Some of the competing emerging key players in HR+/HER2- breast cancer market are, Merck (KEYTRUDA), Arvinas (ARV-471 (vepdegestrant)), Olema Pharmaceuticals (OP1250 (palazestrant)), Celcuity (Gedatolisib), Roche (Giredestrant (RG6171, GDC-9545); Inavolisib), AstraZeneca and Daiichi Sankyo (Datopotamab Deruxtecan (Dato-DXd)), AstraZeneca (Camizestrant (AZD9833); Capivasertib), Eli Lilly (LY3484356/Imlunestrant), Sermonix Pharmaceuticals (Lasofoxifene), Veru Pharma (Enobosarm), DualityBio/BioNtech (DB-1303), Evgen Pharma (SFX-01), Carrick Therapeutics (Samuraciclib (CT-7001)), EQRx/G1 Therapeutics (Lerociclib), Immutep (Eftilagimod Alpha (LAG-3lg/IMP321)), and others. To know more about the number of competing drugs in development, visit @ VERZENIO Market Positioning Compared to Other Drugs Key Milestones of VERZENIO In 2024, Phase III trials did not meet primary endpoints or were terminated for futility. Negative Phase III CYCLONE-2 results, in which VERZENIO added to abiraterone did not meet the primary endpoint of improved radiographic progression-free survival (rPFS) in men with metastatic castration-resistant prostate cancer (mCRPC). In December 2023, Eli Lilly and Company presented results from the MONARCH 3 clinical trial at the 2023 San Antonio Breast Cancer Symposium (SABCS). Results from MONARCH 3 show a numerical improvement in overall survival (OS) of 13.1 months for women with HR+, HER2- metastatic breast cancer treated with VERZENIO plus an aromatase inhibitor in the intent-to-treat population and 14.9 months for women with visceral disease. In March 2023, the US FDA approved an expanded indication for VERZENIO in combination with endocrine therapy for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer (EBC) at a high risk of recurrence. This expanded adjuvant indication removes the Ki-67 score requirement for patient selection. In February 2022, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product VERZENIO. VERZENIO, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with HR+/HER2− negative, node-positive early breast cancer at high risk of recurrence. In October 2021, the US FDA approved VERZENIO, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. In September 2018, VERZENIO was approved in Europe for treating advanced HR+ breast cancer in women if the cancer has already spread to other parts of the body or is locally advanced. In September 2018, VERZENIO was approved for the treatment of patients with HR+/HER2− unresectable or recurrent breast cancer in combination with fulvestrant or an aromatase inhibitor (AI) in Japan. In February 2018, the US FDA approved VERZENIO in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer In September 2017, the US FDA approved VERZENIO in combination with an endocrine therapy to treat adult patients who have HR+/HER2− advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones (endocrine therapy). In October 2015, the US FDA granted Breakthrough Therapy Designation to abemaciclib for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer Discover how VERZENIO is shaping the breast cancer treatment landscape @ VERZENIO Breast Cancer VERZENIO Market Dynamics The oral administration of VERZENIO enhances patient convenience, while its expanded approval for the adjuvant treatment of adult patients with HR+/HER2- early breast cancer highlights its role as a differentiated CDK4/6 inhibitor in reducing the risk of recurrence. The rising prevalence of HR+/HER2- breast cancer is driving market demand for effective treatments like VERZENIO. Additionally, its demonstrated efficacy in combination with endocrine therapy and its ability to penetrate the central nervous system further strengthen its market position. Favorable reimbursement policies and increasing awareness among healthcare providers also contribute to its adoption. However, its adoption may be hindered by regulatory hurdles and potential side effects, including severe or life-threatening lung inflammation and serious liver problems. High treatment costs and access disparities in certain regions could also limit market penetration. Competition from other CDK4/6 inhibitors such as IBRANCE and KISQALI poses a challenge, along with concerns over long-term safety data. Additionally, the Phase III CYCLONE-2 trial failed to meet primary endpoints in mCRPC, which may impact its broader clinical prospects and investor confidence. Dive deeper to get more insight into VERZENIO's strengths & weaknesses relative to competitors @ VERZENIO Market Drug Report Table of Contents Related Reports CDK4/6 Inhibitor Market CDK4/6 Inhibitor Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies including Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, among others. Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies including Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche, Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies, including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultBreakthrough TherapyASCO

26 Feb 2025

·www.fiercebiotech.com

AstraZeneca, eyeing $5B peak sales, reports phase 3 breast cancer win for oral SERD

AstraZeneca plans to share interim phase 3 data on camizestrant with global regulatory authorities.\n AstraZeneca has advanced its push to make camizestrant a blockbuster, reporting a phase 3 win for the oral SERD at an interim analysis. The trial hit on progression-free survival (PFS), its primary endpoint, but is yet to show patients live longer on the drug candidate.Racing rivals including Eli Lilly and Roche, AstraZeneca is striving to establish the endocrine therapy as a backbone drug in hormone receptor-positive, HER2-negative breast cancer. AstraZeneca’s rivals have similar ambitions, with multiple companies claiming their molecules could be best in class, and the field is now nearing the publication of the hard evidence that will help settle the debate.AstraZeneca landed an early blow Wednesday. At a planned interim phase 3 analysis, the drugmaker found PFS improved when breast cancer patients switched from a standard-of-care aromatase inhibitor to camizestrant.The study has a novel design that reflects an unmet need in the indication. All patients received an aromatase inhibitor and a CDK4/6 inhibitor—either Lilly’s Verzenio, Novartis’ Kisqali or Pfizer’s Ibrance—as their first-line treatment. Physicians monitored circulating tumour DNA to spot ESR1 mutations. If a mutation was found before disease progression, patients switched to camizestrant and stayed on the CDK4/6 drug. ESR1 mutations are found in about 5% of patients at the time of metastatic diagnosis, Susan Galbraith, Ph.D., executive vice president of oncology R&D at AstraZeneca, said on an earnings call this month. The figure rises to around 40% by the time of disease progression at the end of first-line treatment. AstraZeneca designed the trial to show whether camizestrant can extend the benefit of first-line therapy for those patients.The primary endpoint hit suggests that goal is within reach, but questions remain. The data on time to second disease progression (PFS2) and overall survival (OS) were immature at the time of the interim analysis. AstraZeneca noted a trend toward improvement in PFS2 but made no further comment on its OS data. No new safety concerns were seen, and discontinuations were very low, AstraZeneca said.The PFS endpoint is the first of a series of milestones for the program. AstraZeneca is running another trial in a broader first-line population and two adjuvant studies. Through the program, the company is aiming to establish camizestrant as a new backbone therapy and hit a peak sales target that AstraZeneca CEO Pascal Soriot has set at more than $5 billion.AstraZeneca could face competition. Lilly reported phase 3 data on its oral SERD imlunestrant in patients who progressed on an aromatase inhibitor late last year. Roche is aiming to have data on giredestrant, its challenger for the market, sometime from mid-2025 onward. AstraZeneca sees the safety profile of its candidate and ability to combine it with a range of other drugs as differentiators. “The safety profile that we\'re seeing with camizestrant leads to an extremely low discontinuation rate, very low rates of these GI side effects, which I think is important, particularly when you go into the earlier lines of therapy. People want to stay on the drug for a long period of time,” Galbraith said. “I think the overall profile that we have with this drug is really looking best in class from our perspective.”AstraZeneca plans to share the interim phase 3 data with global regulatory authorities.

Phase 3Clinical Result

30 Jan 2025

·www.fiercepharma.com

Vabysmo crosses $4B mark, Polivy joins blockbuster club as Roche preps for key readouts

Roche CEO Thomas Schinecker highlighted 12 key pivotal trial readouts, including from four new molecular entities, that could happen in 2025. After repeatedly wowing investors, Roche’s star eye med Vabysmo collected more than $4 billion in sales during its third year on the market. Still, questions continue to swirl about an evolving market showdown with Regeneron’s rival drug.Vabysmo has supplanted cancer immunotherapy Tecentriq to take the No. 3 spot on Roche’s annual sales ranking. The bispecific eye injection brought in 3.86 billion Swiss francs ($4.3 billion), including 1.05 billion Swiss francs in the fourth quarter.Despite 43% year-over-year growth, Vabysmo’s fourth-quarter sales missed analyst expectations by 2%, according to Intron Health. The performance came after several quarters of Street-beating sales for the drug.During an investor call Thursday, Roche’s pharma chief Teresa Graham suggested that the fourth-quarter haul was affected by a “spend-down” and “significant channel filling” right after the launch of a more convenient prefilled syringe version of Vabysmo, which was approved by the FDA in July and EU in December.Starting in January, Roche is seeing “a strong trajectory” for Vabysmo sales, Graham said, assuring investors of continued strong growth and further market-share expansion in 2025.Vabysmo’s market share in the U.S. in the fourth quarter was 31% in neovascular age-related macular degeneration, 22% in diabetic macular edema and 23% in retinal vein occlusion. The numbers were 30%, 22% and 20%, respectively, in the third quarter.Graham stressed that Vabysmo’s fourth-quarter share numbers were not directly comparable to previous quarters because a data aggregator recently issued a “restatement” of third-quarter share figures. If analyzed by prior metrics, Vabysmo expanded by roughly three percentage points across each of the three indications, she said.Lately, the competition between Vabysmo and a high-dose version of Regeneron’s Eylea has been the focus of industry watchers. In September, European regulators also approved a prefilled syringe of Eylea HD. Nevertheless, Roche is “really not seeing any impact in any part of the world” from the arrival of Eylea HD, Graham said.The Roche exec highlighted how the two products’ syringes are “materially different,” as the Vabysmo product offers one-hand administration, she said. “When you think about it, if you’re doing […] 100 shots a day, having that real ease of administration is super important,” she added. “I would say we definitely have device preference going on our side.” As for Tecentriq, sales of the PD-L1 inhibitor declined by 3.3%—or remained flat at constant exchange rates—last year.“We do believe, as we have mentioned previously, that Tecentriq is getting close to peak, and we expect sales growth to be in the zero to low-single-digit range going forward,” Graham said.In 2024, Roche welcomed antibody-drug conjugate Polivy to the blockbuster club. With full-year sales of 1.12 billion Swiss francs, the drug ranked 16th on the company’s list of top meds.Although Polivy’s fourth-quarter sales, at 304 million Swiss francs, were flat over the prior quarter and came in 6% below Wall Street’s estimates, the drug expanded its U.S. market share in the key first-line diffuse large B-cell lymphoma indication to 29%, according to Graham.Roche has increasingly been leaning on new drugs like Vabysmo for growth. In 2024, a “young portfolio” of drugs contributed to 56% of Roche’s 46.2 billion Swiss francs of pharma sales, up from 51% in 2023. On Thursday’s call, Roche CEO Thomas Schinecker highlighted 12 key pivotal trial readouts, including from four new molecular entities, that could happen in 2025.One of the key assets is giredestrant. The oral SERD is nearing phase 3 readouts from the persevERA and evERA trials in HR-positive, HER2-negative breast cancer, around the middle or the second half of 2025, according to Roche. Schinecker has put the drug’s peak sales potential across multiple indications at above $3 billion.The other three new meds with pivotal readouts expected in 2025 are astegolimab in COPD, fenebrutinib in multiple sclerosis and vamikibart in uveitic macular edema.

Drug ApprovalPhase 3ADCBiosimilar

100 Deals associated with Giredestrant

External Link

KEGG	Wiki	ATC	Drug Bank
D11961	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	Phase 3	United States	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Japan	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Argentina	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Germany	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Greece	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Italy	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Singapore	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	South Africa	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Spain	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	Taiwan Province	Genentech, Inc.	03 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04802759 (MORPHEUS- BREAST CANCER, ESMO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer HER2 Negative \| ER Positive	33	Giredestrant 30 mg PO daily	heikbmwjbn(ivkhuafzpe) = sxkzvbjipq nemdnuyicm (ofvqrprfyg ) View more	Positive	16 Sep 2024
				Giredestrant 30 mg PO daily + Samuraciclib 360 mg PO daily	heikbmwjbn(ivkhuafzpe) = aotwzyfofm nemdnuyicm (ofvqrprfyg ) View more
NCT04576455 (acelERA BC, Pubmed) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Estrogen Receptor-Positive \| HER2-Negative	303	Giredestrant	nrtwbhptss(xqtxbuzhqt): HR = 0.81 (95% CI, 0.6 - 1.1), P-Value = 0.1757 View more	Positive	20 Jun 2024
				fulvestrant choice of endocrine monotherapy
NCT04802759 (ASCO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer HER2 Negative	15	Giredestrant (G) + Everolimus (EVERO)	lcfcipkasr(rebyapwnfb) = uxkyccqkbl uzjeuvbnrn (lrbbxvkiqo ) View more	Positive	24 May 2024
NCT03332797 (GO39932, Pubmed)	Phase 1	ER-positive/HER2-negative Breast Cancer ER+ \| HER2-negative \| ESR1-mutated tumors	175	Giredestrant 10 mg	ognzhegnhx(luobcpuuko) = rwayeehiwa pujuvcxbtr (ilspmovwia )	Positive	23 Jan 2024
				Giredestrant 30 mg	ognzhegnhx(luobcpuuko) = izxgiygngl pujuvcxbtr (ilspmovwia )
NCT03332797 (phase Ia/Ib dose-escalation/-expansion study, Pubmed)	Phase 1	Advanced breast cancer	-	Giredestrant 10 mg	aqwjdbhehl(pdkbnifipf) = hhrvghmgab trdxizyhqb (mwrratuqio )	Positive	15 Dec 2023
				Giredestrant 30 mg	aqwjdbhehl(pdkbnifipf) = obiznlksee trdxizyhqb (mwrratuqio )
NCT04436744 (coopERA Breast Cancer, Pubmed \| Lancet Oncol)	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant oestrogen receptor-positive \| HER2-negative \| Ki67 score	221	Giredestrant 30 mg	dsbwxqknmp(ecmpuffhhe) = sqyxokcujq sedihpgvbj (cgfazkboes, -80 to -70)	Positive	01 Sep 2023
				Anastrozole 1 mg	dsbwxqknmp(ecmpuffhhe) = ncdcbvwmcg sedihpgvbj (cgfazkboes, -73 to -59)
NCT04802759 (MORPHEUS BC, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER Positive \| HER2 Negative	40	Abemaciclib+Giredestrant	ykeedvwmuv(mpvbzreaaj) = katsygnybu vqrlgrszdx (vhjztwssyo ) View more	Positive	26 May 2023
				ribociclib +Giredestrant	ykeedvwmuv(mpvbzreaaj) = htkazwevjn vqrlgrszdx (vhjztwssyo ) View more
NCT04436744 (coopERA BC, ASCO 12023 \| ASCO 22023) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant ER Positive \| HER2 Negative	-	Palbociclib+Giredestrant	emggpxpxij(njhrfysfci) = pvvgnwcwja dcuiatvnwj (fapxsenomk ) View more	Positive	26 May 2023
				Palbociclib+anastrozole	emggpxpxij(njhrfysfci) = lbhvjipivw dcuiatvnwj (fapxsenomk ) View more
NCT03916744 (CTgov)	Phase 1	Estrogen receptor positive breast cancer	75	Surgery+Giredestrant (Giredestrant 10 mg)	arjrynhkts(ewpscnqhyd) = dsxohxmphw dhniopikmv (zwhlwzmeek, tfgvmdejjg - kwdhquibaf) View more	-	10 Mar 2023
				Surgery+Giredestrant (Giredestrant 30 mg)	arjrynhkts(ewpscnqhyd) = bvhhdowkuw dhniopikmv (zwhlwzmeek, tqqwqiaeuz - sxmtdobwsp) View more
NCT04576455 (acelERA Breast Cancer, SABCS2023)	Phase 2	Advanced breast cancer Third line ESR1 mutations	303	Giredestrant (30 mg oral daily)	tgiccafucf(fboqqvgzgl) = nvpundatrf xgnvlarzok (vochlghfxn ) View more	Positive	01 Mar 2023
				Physician’s choice of endocrine therapy (PCET)	tgiccafucf(fboqqvgzgl) = sukyppxtao xgnvlarzok (vochlghfxn ) View more

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