PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors), PARP3 inhibitors(Poly (ADP-Ribose) Polymerase 3 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [10]

Active Indication

Advanced Endometrial CarcinomaRecurrent Endometrial CancerBRCA mutation positive Breast Cancer+ [139]

Inactive Indication

Advanced Cervical CarcinomaAdvanced gastric carcinomaAdvanced Lung Non-Small Cell Carcinoma+ [33]

Originator Organization

AstraZeneca PLC

Active Organization

Merck Sharp & Dohme Corp.

AstraZeneca PLCAstraZeneca KK

+ [14]

Inactive Organization

Syndax Pharmaceuticals, Inc.

License Organization

Breast International Group

+ [1]

Drug Highest PhaseApproved

First Approval Date

European Union (16 Dec 2014),

BRCA Mutation Castration-Resistant Prostate CancerBRCA-mutated Fallopian Tube CarcinomaBRCA-mutated Ovarian Cancer+ [12]

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Special Review Project (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Priority Review (United States)

Structure/Sequence

Molecular FormulaC24H23FN4O3

InChIKeyFDLYAMZZIXQODN-UHFFFAOYSA-N

CAS Registry763113-22-0

500

Clinical Trials associated with Olaparib

NCT06856499

/ Not yet recruitingPhase 1IIT

Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer

The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.
If a participant is a good fit for the study, and they enroll in the study, they will:
* Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days.
* Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Colorado Denver

[+2]

NCT05128734

/ Not yet recruitingPhase 2IIT

A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)

This is a randomized phase II study to evaluate the disease control rate (DCR) of patients with metastatic or locally advanced METHYLATED 06-methylguanine-DNA methyltransferase (MGMT) with triple-negative breast cancer (TNBC) treated with Temozolomide ± Olaparib. Patients will be randomized 1:1 to Treatment Arm 1 (temozolomide treatment) or Arm 2 (temozolomide plus olaparib treatment).

Start Date01 Sep 2025

Sponsor / Collaborator

AHS Cancer Control Alberta

NCT06966700

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.
The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:
* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Start Date19 Jun 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Olaparib

100 Translational Medicine associated with Olaparib

100 Patents (Medical) associated with Olaparib

4,808

Literatures (Medical) associated with Olaparib

31 Dec 2025·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Addition of PARP1-inhibition enhances chemoradiotherapy and thermoradiotherapy when treating cervical cancer in an in vivo mouse model

Article

Author: van Bochove, Gregor G. W. ; Rodermond, Hans M. ; Oei, Arlene L. ; Krawczyk, Przemek M. ; Stalpers, Lukas J. A. ; Franken, Nicolaas A. P. ; Scutigliani, Enzo M. ; Mei, Xionge ; Crezee, Johannes ; IJff, Marloes

Background: Efficacy of current treatment options for cervical cancer require improvement. Previous in vitro studies have shown the enhancing effects of the addition of PARP1-inhibitors to chemoradiotherapy and thermoradiotherapy. The aim of our present study was to test efficacy of different combinations of treatment modalities radiotherapy, cisplatin, hyperthermia and PARP1-inhibitors using in vitro tumor models, ex vivo treated patient samples and in vivo tumor models.Materials and Methods: In vitro clonogenic survival curves (0-6 Gy) show that PARP1-i (4-5 M Olaparib) enhances both chemoradiotherapy (0.3-0.5 µM cisplatin) and thermoradiotherapy (42 °C for 1 h) in SiHa, CaSki and HeLa cells. A cervical cancer mouse model and freshly obtained in-house developed patient-derived organoids were used to examine the effects of different treatment combinations. For the in vivo study, human cervical cancer (SiHa) cells were injected in the right hind leg of athymic nude mice. In vivo mouse experiments show that PARP1-i enhances thermoradiotherapy or chemoradiotherapy by reduction of tumor volumes. Five cycles of treatment were applied with the following doses per cycle: irradiation 3 Gy, hyperthermia 1 h at 42 °C, cisplatin at 2 mg/kg, and twice PARP1-i at 50 mg/kg.Results: Quadruple treatment, combining radiotherapy, hyperthermia, cisplatin and PARP1-i, was very effective but also lead to severe side effects causing severe weight loss and death. In contrast, thermoradiotherapy or chemoradiotherapy with addition of PARP1-i, were effective without serious side effects.Conclusion: The triple combinations are promising options for potentially more effective treatment of locally advanced cervical cancer without more toxicity.

31 Dec 2025·ANNALS OF MEDICINE

Haematologic outcomes and associated clinical characteristics among patients receiving Olaparib therapy in the UAE: a retrospective chart review

Article

Author: Akour, Amal ; Nabil, Said ; Ibrahim, Mariam ; Kendakji, Saba ; ZainAlAbdin, Sham ; Aburuz, Salahdein ; Wahba, Lina

BACKGROUND:

Poly ADP ribose polymerase (PARP) inhibitors, such as Olaparib (Lynparza^®), are pivotal in treating certain cancers, particularly those linked to BReast CAncer gene (BRCA) mutations. Despite its established efficacy, Olaparib use is associated with various adverse events (AEs), notably haematologic toxicities, such as anaemia. This retrospective chart review study aimed to examine haematologic outcomes and associated factors in patients treated with Olaparib at a tertiary hospital in the UAE.

METHODS:

We reviewed the medical charts of patients prescribed Olaparib and focused on haematologic indices at a baseline of 1-month, 3-month and 6-month follow-up periods. Data were analysed to determine the AEs frequency, transfusions need and potential associated patients' clinical characteristics.

RESULTS:

This study included all patients who received Olaparib (n = 66). Most patients were females (n = 61; 92.4%) and the vast majority were non-smokers (97%) and free of hepatic disease. Themean age of the patients was 57.03-year-old (SD) = 12.06 years), and body mass index (BMI) was 28.16 (SD = 6.40) kg/m². A high rate of anaemia (70.8%) was detected among the patients during their Olaparib therapy. Approximately, one-third of the patients developed neutropenia and thrombocytopenia. Transfusion was needed in almost half of the patients. Glomerular filtration rate (GFR) and neutropenia were significantly correlated with moderate-severe anaemia (OR = 0.097, 95% CI: 0.011-0.88, p value = .038) and (OR = 9.04, 95% CI: 1.024-79.78, p value = .048), respectively.

CONCLUSIONS:

Our findings highlight the side effects of Olaparib therapy in terms of haematology which could be avoided. Further studies are needed to better understand the therapeutic management of Olaparib and the mitigation of haematologic complications.

01 Oct 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

The drug discovery candidate for targeting PARP1 with Onosma. Dichroantha compounds in triple-negative breast cancer: A virtual screening and molecular dynamic simulation

Article

Author: Mishra, Anurag ; Chandra, Muktesh ; Hamad, Atheer Khdyair ; Jawad, Mahmood Jasem ; Taher, Waam Mohammed ; Kareem, Radhwan Abdul ; Verma, Lokesh ; Prasad, G V Siva ; Alwan, Mariem ; Ahmed, Hanan Hassan ; Saadh, Mohamed J

Triple-negative breast cancer (TNBC) is an aggressive subtype characterized by the overexpression of poly-ADP ribose polymerase 1 (PARP1), a key enzyme in DNA repair. Targeting PARP1 with inhibitors presents a promising therapeutic strategy, particularly given the limited treatment options for TNBC. This study employed in silico methodologies to evaluate the pharmacokinetic and inhibitory potential of FDA-approved drugs and compounds derived from Onosma. dichroantha root extracts against PARP1. Virtual screening and molecular docking identified Midazolam, Olaparib, Beta-sitosterol, and 1-Hexyl-4-nitrobenzene as top candidates, exhibiting strong binding affinities of -10.6 kcal/mol, -9.9 kcal/mol, -6.83 kcal/mol, and -5.53 kcal/mol respectively. Molecular dynamics simulations (MDS) over 100 nanoseconds revealed that Beta-sitosterol formed the most stable complex with PARP1, demonstrating minimal structural deviations and robust hydrogen bonding. The Molecular Mechanics-Poisson-Boltzmann Surface Area (MM-PBSA) analysis further confirmed Beta-Sitosterol and Olaparib superior binding free energy (ΔG_bind= -175.43 kcal/mol and -180.8 kcal/mol respectively), highlighting its potential as a potent PARP1 inhibitor. ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) profiling indicated that Beta-Sitosterol adheres to Lipinski's Rule of Five, with high intestinal absorption (95.88 %) and blood-brain barrier permeability (0.824), despite low water solubility. Protein-protein interaction analysis identified key PARP1-associated proteins, including CASP3, CASP7, and XRCC1, suggesting broader therapeutic implications. These findings underscore the potential of Beta-Sitosterol as a novel PARP1 inhibitor for TNBC treatment, combining computational validation with favorable pharmacokinetic properties. The study also highlights the utility of drug repurposing and plant-derived compounds in developing targeted therapies for TNBC, paving the way for further preclinical and clinical investigations.

665

News (Medical) associated with Olaparib

03 Jun 2025

·www.biopharmadive.com

J&J data support earlier use of combo pill in prostate cancer

CHICAGO A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial.Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncologys meeting in Chicago. They could potentially expand the number of people able to receive J&Js Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga.Akeega, along with hormone therapy, kept men with so-called BRCA mutations from getting sicker for longer than Zytiga and hormone therapy, reducing the relative risk of disease progression by nearly half. The combination also reduced by 56% the risk that BRCA-positive participants in the study experienced symptoms of disease progression.Akeega is already approved for men whose disease stops responding to hormone therapy if they have BRCA mutations, which often signal a more aggressive cancer. This stage of disease, classified as castration resistant, is considered to be advanced.Akeegas constituent drug components target the proteins PARP and CYP17, respectively. Drugs aimed at CYP17 have been used in prostate cancer for more than a decade, while PARP inhibitors are more recent arrivals. However, in prostate cancer, PARP blockers are largely used in the castration-resistant setting, where testosterone suppression no longer keeps the disease in check.Some physicians and drugmakers have explored moving treatment to early-stage disease as a way of helping patients live longer. Amplitude was set up to test that hypothesis.The challenge is that when we use PARP inhibitors as monotherapy at the end of the treatment sequence, resistance rapidly develops, and the median time to radiographic progression-free survival is shorter than 12 months, said Gerhardt Attard, a professor of medical oncology at University College London and lead author of the study, in a press conference presenting the data. This group of patients have poor outcomes, significantly worse outcomes than other patients.Bradley McGregor, a genitourinary specialist with Dana-Farber Cancer Institute, said the study results will help clear up debate over where PARP inhibitors fit into treatment of people with hormone-sensitive disease. This data is quite compelling for the BRCA 1/2 patients where that magnitude of benefit is higher, he said.Amplitude enrolled men with a broader set of mutations to homologous recombination repair, or HRR, genes, of which BRCA is one. The benefit in the overall population was smaller, with Akeega reducing the risk of radiographic progression by 37% and symptomatic progression by half.Akeega is currently approved only for the narrow BRCA-mutated population. Of the PARP inhibitors on the market, only AstraZenecas Lynparza has won clearance for the broader HRR population, but its use is reserved for castration-resistant disease.Mark Wildgust, J&Js global medical affairs vice president for oncology, said the HRR results from Amplitude should stimulate some discussion with the Food and Drug Administration. The company must keep working with regulators to see if there is room or comfort to expand to that broader population, he said.Trial investigators also analyzed results by specific HRR mutations beyond BRCA. With some, like one called PALB2, patients didnt see any benefit, Wildgust said. I think with smaller patient groups, it's a bit more difficult, he added.Physicians will need to be able to identify the patients most likely to benefit, should Akeega gain an expanded approval in earlier-stage prostate cancer. You dont know if you dont test, McGregor said.Akeega first won approval in 2023. Johson & Johnson didnt report annual sales for the drug in 2024.GSK has some rights to Zejula, Akeegas PARP-inhibiting ingredient, by way of its 2019 acquisition of the drug's developer, Tesaro Bio. J&J had previously licensed rights to niraparib in prostate cancer specifically, allowing it to market Akeega. '

Clinical ResultDrug ApprovalAcquisitionPhase 3ASCO

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 Olaparib

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KEGG	Wiki	ATC	Drug Bank
D09730	Olaparib	L01XX46	DB09074

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	European Union	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Iceland	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Liechtenstein	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Norway	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	European Union	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Iceland	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Liechtenstein	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Norway	AstraZeneca AB	15 Aug 2024
BRCA mutation positive Breast Cancer	Japan	AstraZeneca KK	24 Aug 2022
HRD-positive Ovarian Cancer	United States	AstraZeneca Pharmaceuticals LP	19 May 2020
HRR Gene-mutated Castration-Resistant Prostate Cancer	United States	AstraZeneca Pharmaceuticals LP	19 May 2020
Pancreatic Cancer	South Korea	AstraZeneca Pharmaceuticals LP	29 Oct 2019
Prostatic Cancer	South Korea	AstraZeneca Pharmaceuticals LP	29 Oct 2019
Platinum-Sensitive Ovarian Carcinoma	China	AstraZeneca AB	22 Aug 2018
Recurrent HER2-Negative Breast Carcinoma	Japan	AstraZeneca KK	02 Jul 2018
Recurrent HER2-Negative Breast Carcinoma	Japan	MSD KK	02 Jul 2018
Pancreatic adenocarcinoma metastatic	Australia	AstraZeneca Pty Ltd.	23 May 2018
Breast Cancer	Canada	AstraZeneca Canada, Inc.	29 Apr 2016
Ovarian Cancer	Canada	AstraZeneca Canada, Inc.	29 Apr 2016
BRCA Mutation Castration-Resistant Prostate Cancer	European Union	AstraZeneca AB	16 Dec 2014

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	NDA/BLA	United States	AstraZeneca PLC	17 Aug 2022
Endometrial Carcinoma	Phase 3	France	AstraZeneca PLC	26 Jun 2024
Ovarian Serous Adenocarcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	22 Jul 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03991832 (ASCO2025)	Phase 2	Glioma \| Bile Duct Neoplasms TP53 \| ATRX \| ARID1A ... View more	29	Olaparib 300 mg twice daily + Durvalumab 1500 mg IV every 4 weeks	byteomffha(tqohmikyzb) = zpeviylqts eteddkcrjm (dnerfmrxbj, 3.9 - 32)	Positive	30 May 2025
NCT05432791 (Alliance A092104, ASCO2025)	Phase 2/3	Uterine Leiomyosarcoma Homologous recombination deficiency (HRD)	74	Olaparib plus Temozolomide	ycqcggtoxa(igacwcrwgw) = bqewzkoyyu kkxtjvarkz (slbkojbtfb, 2.0 - NE)	Negative	30 May 2025
				Investigator's choice (Trabectedin or Pazopanib)	ycqcggtoxa(igacwcrwgw) = indnijegud kkxtjvarkz (slbkojbtfb, 2.8 - NE)
ABCSG 45 (ASCO2025)	Phase 2	Triple Negative Breast Cancer Neoadjuvant HRD-positive \| BRCA1/2 PV \| BRCA1/2 WT	90	Olaparib/Carboplatin (OC)	knvsjpivme(rcrhhnyekz) = cwazjcxgjf ndwecwlezx (nwolnjqeji )	Positive	30 May 2025
				Docetaxel/Epirubicin/Cyclophosphamide (TAC)	knvsjpivme(rcrhhnyekz) = uevhjxwhhf ndwecwlezx (nwolnjqeji )
NCT04269200 (DUO-E, ASCO2025)	Phase 3	Endometrial Carcinoma First line dMMR \| pMMR	718	Carboplatin/paclitaxel plus Durvalumab	fkbasycxqm(ogzcvhpknw) = shfdvffdmd zajaazmeup (jdwcbtzzdv )	Positive	30 May 2025
				Carboplatin/paclitaxel plus Durvalumab plus Olaparib	fkbasycxqm(ogzcvhpknw) = ikelixtwzg zajaazmeup (jdwcbtzzdv )
ASCO2025	Not Applicable	BRCA-mutated Ovarian Cancer Maintenance homologous recombination deficiency \| BRCA-negative \| HRD-score determined by AmoyDx panel	-	Maintenance Olaparib	szyudsqbqz(sjzhcqszsh) = rshjhfpdun geqwztxnfe (lealtqsqcs ) View more	Positive	30 May 2025
				Bevacizumab or No Maintenance Therapy	szyudsqbqz(sjzhcqszsh) = nnonfkaypa geqwztxnfe (lealtqsqcs ) View more
NCT03212274 (NCI 10129, ASCO2025)	Phase 2	Solid tumor IDH1 \| IDH2	26	Olaparib 300 mg twice daily	vcgpndecpg(yrrjpqibuf) = vkykirwnka rsmckutxzm (gxcxzamgum, 1.3 - 13) View more	Negative	30 May 2025
NCT03317392 (COMRADE, ASCO2025)	Phase 2	Castration-Resistant Prostatic Cancer Homologous recombination repair gene (HRR) mutation status	120	Olaparib + Radium-223	pxfpjtgbrw(zvpfoimssh) = guisdukabh lpsuhrggeb (vhyghxvqid )	Positive	30 May 2025
				Radium-223	pxfpjtgbrw(zvpfoimssh) = wmgaevainf lpsuhrggeb (vhyghxvqid )
OlympiA trial (ASCO2025)	Not Applicable	Early Stage Breast Carcinoma Adjuvant germline BRCA1/2 pathogenic or likely pathogenic variants \| HER2-negative	176	Olaparib	txjxsoneyi(jrwltpcihv) = ldmcsnwzyv tnuduwjjlg (wauncndmvs )	Positive	30 May 2025
N.N. Blokhin NMRCO ovarian cancer (ASCO2025)	Not Applicable	Recurrent ovarian cancer BRCA-mutations	126	Platinum-based chemotherapy	uqtgzgzsig(ennpxdadoh) = iosksmlpnz kvgqjojteu (bkhffdrgnv ) View more	Negative	30 May 2025
				Non-platinum chemotherapy	uqtgzgzsig(ennpxdadoh) = ijnmdaizng kvgqjojteu (bkhffdrgnv ) View more
NCT04417062 (phase II trial of olaparib in combination with ceralasertib, ASCO2025)	Phase 2	Osteosarcoma, Recurrent mutations in genes involved in DDR	38	Olaparib 150mg	uxqesddecd(pmrwowkegi) = jtcmxhppze erialejyur (hpuropniti, 4% - 29%) View more	Negative	30 May 2025
				Ceralasertib 80mg	qikdhrclwf(ppfyjwtbxm) = zaalzclvcz jlfzqxecgd (upzmbxqlnd ) View more

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