LYNPARZA® (olaparib) demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase III trial

Business Wire12-11

87.5% of patients treated with LYNPARZA were alive at six years vs. 83.2% in the comparator arm First and only PARP inhibitor to improve survival in early breast cancer WILMINGTON, Del., December 11, ...

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WILMINGTON, Del., December 11, 2024----Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA  demonstrated sustained, clinically meaningful improvements in overall survival , invasive disease-free survival  and distant disease-free survival  at six years for patients with germline BRCA-mutated  HER2-negative high-risk early breast cancer.Eliav Barr, Senior Vice President, Head of Global Clinical Development and C","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4516":"特朗普概念","AZN":"阿斯利康","LU1917777945.USD":"安联专题基金Cl AT Acc","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","BK4225":"医疗保健房地产信托","NCI":"思宏国际","BK4007":"制药","BK4585":"ETF&股票定投概念","OS":"Onestream Inc","BK4203":"医疗保健房地产投资信托","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","BK4114":"综合货品商店","LU2023250843.SGD":"Allianz Thematica Cl AT Acc H2-SGD","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4220":"综合零售","BK4588":"碎股","BK4568":"美国抗疫概念","BK4134":"信息科技咨询与其它服务","LU2106854487.HKD":"ALLIANZ THEMATICA \"AMG\" (HKD) INC","BIG":"必乐透","LU1721428933.USD":"法巴全球经典环境基金RH MD Dis","URI":"联合租赁","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","BK4097":"系统软件","LU1829250122.USD":"高盛欧洲核心股票组合Acc","HR":"医疗保健房地产信托","LU2417539215.USD":"ALLIANZ GLOBAL INCOME \"AMF\" (USD) INC","BK4104":"贸易公司与经销商","LU2456880835.USD":"ALLIANZ GLOBAL INCOME \"AT\" (USD) ACC","BK4202":"服装、服饰与奢侈品","LU2462157665.USD":"ALLIANZ GLOBAL INCOME \"A\" (USD) INC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","III":"信息服务"},"translate_title":"LYNPARZA®（olaparib）在OLYMPIA III期试验中证明了在早期乳腺癌中具有临床意义的延长生存获益","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BIG":1,"URI":1,"OS":1,"NCI":1,"III":1,"HR":1,"AZN":0.9},"content_text":"87.5% of patients treated with LYNPARZA were alive at six years vs. 83.2% in the comparator arm\nFirst and only PARP inhibitor to improve survival in early breast cancer\nWILMINGTON, Del., December 11, 2024--(BUSINESS WIRE)--Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA® (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.\nThese results were presented today at the San Antonio Breast Cancer Symposium 2024 (SABCS) (#GS1-09) and build on the positive primary results published in The New England Journal of Medicine.\nAt a median follow-up of 6.1 years in eligible patients, who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, results showed LYNPARZA reduced the risk of death by 28% (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.56-0.93) versus placebo. In addition, 87.5% of patients treated with LYNPARZA remained alive versus 83.2% of those on placebo.\nLYNPARZA also demonstrated sustained and clinically meaningful improvements in the primary and secondary endpoints of IDFS and DDFS. LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35% (HR 0.65; 95% CI; 0.53-0.78) and reduced the risk of distant disease recurrence or death by 35% (HR 0.65; 95% CI; 0.53-0.81) versus placebo. The benefit with LYNPARZA was consistent across all key subgroups, including patients with high-risk, hormone-receptor-positive disease.\nJudy E. Garber, Chief of the Division of Cancer Genetics and Prevention at Dana-Farber Cancer Institute and co-principal investigator of the trial said: \"These exciting long-term data from OlympiA confirm that adjuvant treatment with olaparib for one year continues to deliver clinically meaningful survival benefit for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer even after six years, with benefit persisting in all subgroups and with toxicity and pregnancy data reassuring for this generally younger group. These data reinforce the importance of germline BRCA testing at the time of diagnosis, so we can identify all eligible patients who may benefit from treatment with olaparib as early as possible.\"\nSusan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: \"Two years ago, LYNPARZA became the first and only PARP inhibitor to demonstrate a survival benefit in germline BRCA-mutated, HER2-negative and high-risk early-stage breast cancer. To see this benefit continue at six years of follow-up is tremendous for patients and reinforces how LYNPARZA is continuing to transform the treatment of BRCA-mutated early-stage breast cancer.\"\nEliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories, said: \"The durable long-term efficacy seen in the OlympiA study reinforces LYNPARZA as an important treatment option for those living with this truly challenging, very aggressive form of the disease.\"\nSummary of results\n\n\n\n\nLYNPARZA(n=921)\nPlacebo(n=915)\n\n\nIDFS (primary endpoint)\n\n\n\nHR (95% CI)\n0.65 (0.53, 0.78)\n\n\nIDFS rates at 6 years\n79.6%\n70.3%\n\n\n\n\n\nDDFS (secondary endpoint)\n\n\n\nHR (95% CI)\n0.65 (0.53, 0.81)\n\n\nDDFS rates at 6 years\n83.5%\n75.7%\n\n\n\n\n\nOS (secondary endpoint)\n\n\n\nHR (95% CI)\n0.72 (0.56, 0.93)\n\n\nOS rates at 6 years\n87.5%\n83.2%\n\n\n\nThe safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials and no new safety signals were identified with longer follow-up. No evidence of an increased risk of myelodysplastic syndrome or acute myeloid leukemia was observed compared to those on placebo.\nThe OlympiA trial is coordinated by the Breast International Group (BIG) in partnership with NRG Oncology, the US National Cancer Institute (NCI), the Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and Merck & Co., Inc.1\nLYNPARZA is approved in the US, EU, Japan, and many other countries for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. LYNPARZA is also approved in the US, EU, Japan, and many other countries for the treatment of patients with gBRCAm, HER2-negative metastatic breast cancer. In the EU, this indication also includes patients with locally advanced breast cancer.\nIMPORTANT SAFETY INFORMATION ABOUT LYNPARZA® (olaparib) tablets\nCONTRAINDICATIONSThere are no contraindications for LYNPARZA.\nWARNINGS AND PRECAUTIONS\nMyelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.2% of patients with various BRCAm, gBRCAm, HRR gene-mutated or HRD-positive cancers who received LYNPARZA as a single agent or as part of a combination regimen, consistent with the approved indications, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was approximately 2 years (range: <6 months to >4 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.\nIn SOLO-1, patients with newly diagnosed advanced BRCAm ovarian cancer, the incidence of MDS/AML was 1.9% (5/260) in patients who received LYNPARZA and 0.8% (1/130) in patients who received placebo based on an updated analysis. In PAOLA-1, of patients with newly diagnosed advanced ovarian cancer with HRD-positive status, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA and 2.3% (3/131) in the control arm.\nIn SOLO-2, patients with BRCAm platinum-sensitive relapsed ovarian cancer, the incidence of MDS/AML was 8% (15/195) in patients who received LYNPARZA and 4% (4/99) in patients who received placebo. The duration of LYNPARZA treatment prior to the diagnosis of MDS/AML ranged from 0.6 years to 4.5 years.\nDo not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.\nIf the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.\nPneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.\nVenous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE) occurred in patients treated with LYNPARZA. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.\nEmbryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating treatment.\nFemalesAdvise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.\nMalesAdvise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.\nADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian CancerMost common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).\nADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with BevacizumabMost common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%).\nIn addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).\nIn addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).\nADVERSE REACTIONS—Maintenance gBRCAm Recurrent Ovarian CancerMost common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: increase in mean corpuscular volume (89%), decrease in hemoglobin (83%), decrease in leukocytes (69%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), increase in serum creatinine (44%), and decrease in platelets (42%).\nADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast CancerMost common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).\nADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast CancerMost common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).\nADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic AdenocarcinomaMost common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).\nADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate CancerMost common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).\nMost common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).\nADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or PrednisoloneMost common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/abiraterone with a difference of ≥5% compared to placebo for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%).\nMost common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%).\nDRUG INTERACTIONSAnticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.\nCYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.\nCYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.\nUSE IN SPECIFIC POPULATIONSLactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.\nPediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.\nHepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).\nRenal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).\nINDICATIONSLYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:\nFirst-Line Maintenance BRCAm Advanced Ovarian CancerFor the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nFirst-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with BevacizumabIn combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:\n\na deleterious or suspected deleterious BRCA mutation, and/or\ngenomic instability\n\nSelect patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nMaintenance BRCA-mutated Recurrent Ovarian CancerFor the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nAdjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast CancerFor the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\ngBRCAm, HER2-Negative Metastatic Breast CancerFor the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nFirst-Line Maintenance gBRCAm Metastatic Pancreatic CancerFor the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nHRR Gene-mutated Metastatic Castration-Resistant Prostate CancerFor the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nBRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or PrednisoloneIn combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.\nNotes\nEarly breast cancerEarly breast cancer is defined as cancer confined to the breast with or without regional lymph node involvement, and the absence of distant metastatic disease.2 In the US, the 5-year survival rate is 99.6% for localized breast cancer (only found in the breast area) and 86.7% for regional breast cancer (cancer that has spread outside the breast to nearby structures or lymph nodes).3 Despite advancements in the treatment of early breast cancer, up to 30% of patients with high-risk clinical and/or pathologic features recur within the first few years and patients with gBRCA mutations are more likely to be diagnosed at a younger age than those without these mutations.4,5\nBreast cancer is one of the most biologically diverse tumor types with various factors fueling its development and progression.6 The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.7\nOlympiAOlympiA is a phase III, double-blind, parallel group, placebo-controlled, multicenter trial evaluating the efficacy and safety of LYNPARZA tablets versus placebo as a 12-month adjuvant treatment for adult patients with gBRCAm HER2-negative early breast cancer, who have completed neoadjuvant or adjuvant chemotherapy.1 The primary endpoint of the trial is invasive disease-free survival defined as time from randomization to date of first loco-regional or distant recurrence or new cancer or death from any cause. Key secondary endpoints include distant disease-free survival and overall survival, which is defined as time from randomization until documented evidence of first distant recurrence of breast cancer or death without distant recurrence.1\nBreast International Group (BIG)BIG is an international not-for-profit organization for academic breast cancer research groups from around the world, based in Brussels, Belgium.\nFounded by leading European opinion leaders in 1999, the organization aims to address fragmentation in breast cancer research and now represents a network of over 50 like-minded research groups affiliated with specialized hospitals, research centers and leading experts across approximately 70 countries on six continents.\nBIG’s research is supported in part by its philanthropy unit, known as BIG against breast cancer, which is used to interact with the general public and donors, and to raise funds for BIG’s purely academic breast cancer trials and research programs.\nFrontier Science & Technology Research Foundation (FSTRF)FSTRF is a non-profit, research organization which supports research networks, pharmaceutical companies and investigators to conduct scientifically meaningful high-quality clinical trials. The OlympiA trial involved research staff in the US and in the Affiliate office in Scotland.\nFSTRF works with scientists and technicians in more than 800 laboratories, universities and medical centers around the world to provide a comprehensive range of research services throughout the clinical trial process including design, analysis and reporting.\nThrough its work, FSTRF aims to advance the application of statistical science and practice and data management techniques in science, healthcare and education.\nNRG OncologyNRG Oncology is a network group funded by the US National Cancer Institute (NCI), a part of the National Institutes of Health. NRG Oncology brings together the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG), with the mission to improve the lives of cancer patients by conducting practice-changing multi-institutional clinical and translational research. NRG Oncology sponsored OlympiA in the US and collaborated with the other adult cancer clinical trials research groups funded by the NCI, Alliance, ECOG/ACRIN and the Southwest Oncology Group. The NCI and AstraZeneca are collaborating under a Cooperative Research and Development Agreement between the parties.\nBRCABRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells.8 When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including LYNPARZA.8-11\nLYNPARZALYNPARZA® (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination-related (HRR) genes, such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as new hormonal agents [NHAs]).\nInhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA may also help enhance immunogenicity and increase the impact of anti-tumor immune responses.\nLYNPARZA is currently approved in a number of countries across multiple tumor types, including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD)-positive advanced ovarian cancer, respectively; for gBRCAm metastatic pancreatic cancer; in combination with abiraterone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) when chemotherapy is not clinically indicated (EU only) and for BRCAm mCRPC (US and Japan); as monotherapy for HRR gene-mutated mCRPC in patients who have progressed on prior NHA treatment (BRCAm only in the EU and Japan); and in combination with durvalumab following durvalumab plus chemotherapy as 1st-line treatment for advanced or recurrent endometrial cancer that is mismatch repair proficient (EU and Japan). In China, LYNPARZA is approved for the treatment of BRCA-mutated mCRPC as well as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer.\nLYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, has been used to treat over 140,000 patients worldwide. LYNPARZA has a broad clinical trial development program, and AstraZeneca and Merck & Co., Inc., are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types. LYNPARZA is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.\nThe AstraZeneca and Merck & Co., Inc., strategic oncology collaborationIn July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and selumetinib, a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.\nWorking together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. The companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines independently.\nAstraZeneca in oncologyAstraZeneca 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.\nThe 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.\nAstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.\nAstraZenecaAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.\nReferences\n\nClinicalTrials.gov. Olaparib as Adjuvant Treatment in Patients with Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA). Available at: https://clinicaltrials.gov/ct2/show/NCT02032823. Accessed December 2024.\nNational Cancer Institute. Early-stage breast cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/early-stage-breast-cancer. Accessed December 2024.\nNational Cancer Institute: Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed December 2024.\nO'Shaughnessy J, et al. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Research. 2020;22(114).\nColleoni M, et al. Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol. 2016 Mar 20; 34(9):927–935.\nYersal O, Barutca S. Biological subtypes of breast cancer: Prognostic and therapeutic implications. World J Clin Oncol. 2014;5(3):412-424.\nRivenbark AG, et al. Molecular and Cellular Heterogeneity in Breast Cancer: Challenges for Personalized Medicine. Am J Pathol. 2013;183:1113-1124.\nRoy R, et al. BRCA1 and BRCA2: different roles in a common pathway of genome protection. Nat Rev Cancer. 2016;12(1):68-78.\nWu J, et al. The role of BRCA1 in DNA damage response. Protein Cell 2010;1(2):117-123.\nGorodetska I, et al. BRCA Genes: The Role in Genome Stability, Cancer Stemness and Therapy Resistance. Journal of Cancer. 2019;10:2109-2127.\nLi H, et al. PARP inhibitor resistance: the underlying mechanisms and clinical implications. Molecular Cancer. 2020;19:1-16.\n\nUS-96561 Last Updated 12/24\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241211215308/en/\nContacts\nMedia Inquiries Brendan McEvoy +1 302 885 2677Jillian Gonzales +1 302 885 2677\nUS Media Mailbox: usmediateam@astrazeneca.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2490866155"}