{"id":54005,"date":"2023-02-16T16:04:23","date_gmt":"2023-02-16T15:04:23","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/merck-and-astrazeneca-present-final-results-of-key-secondary-overall-survival-endpoint-from-phase-3-propel-trial-at-2023-american-society-of-clinical-oncology-genitourinary-cancers-symposium\/"},"modified":"2023-02-16T16:04:23","modified_gmt":"2023-02-16T15:04:23","slug":"merck-and-astrazeneca-present-final-results-of-key-secondary-overall-survival-endpoint-from-phase-3-propel-trial-at-2023-american-society-of-clinical-oncology-genitourinary-cancers-symposium","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/merck-and-astrazeneca-present-final-results-of-key-secondary-overall-survival-endpoint-from-phase-3-propel-trial-at-2023-american-society-of-clinical-oncology-genitourinary-cancers-symposium\/","title":{"rendered":"Merck and AstraZeneca Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium"},"content":{"rendered":"
\n

\nData build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival<\/b>\n<\/p>\n

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK<\/a> #MRK<\/a>–AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the final analysis of the key secondary endpoint of overall survival (OS) from the Phase 3 PROpel trial evaluating LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi\/pred), compared to placebo plus abi\/pred. Median OS was 42.1 months for the LYNPARZA plus abi\/pred arm versus 34.7 months for the placebo plus abi\/pred arm, representing a 7.4-month absolute difference in median OS versus a standard of care (at 47.9% maturity, HR=0.81 [95% CI, 0.67-1.00]; p=0.0544). This OS trend did not reach statistical significance.\n<\/p>\n

<\/a><\/p>\n

\nResults from the primary endpoint of investigator-assessed radiographic progression-free survival (rPFS), which showed that LYNPARZA in combination with abi\/pred significantly reduced the risk of disease progression or death by 34% compared to placebo plus abi\/pred (median rPFS 24.8 months versus 16.6 months, respectively, HR=0.66 [95% CI, 0.54-0.81]; p<0.0001), were previously presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium and published in NEJM Evidence<\/i>.\n<\/p>\n

\nThe final OS results from PROpel will be presented today at ASCO GU 2023 (abstract LBA16).\n<\/p>\n

\nIn this updated analysis, the most common adverse events (AEs) (\u226520%) were anemia (49.7%), fatigue (38.7%), nausea (30.7%), back pain (21.6%) and diarrhea (20.6%). Grade \u22653 AEs were anemia (16.1%), hypertension (3.8%), urinary tract infection (2.5%), fatigue (2.5%), vomiting (1.5%), diarrhea (1.3%), decreased appetite (1%), back pain (1%) and nausea (0.3%). Approximately 17% of patients who received LYNPARZA <\/i>in combination with abi\/pred discontinued treatment due to an AE.\n<\/p>\n

\nNoel Clarke, urological surgeon and professor of urological oncology at Manchester\u2019s Christie\/Salford Royal Hospitals and Manchester University, and a senior investigator in the PROpel trial, said, \u201cFrom the primary radiographic progression-free survival analysis presented at ASCO GU last year to the updated overall survival data presented today, the data reinforce the therapeutic potential of olaparib plus abiraterone and prednisone for patients with metastatic castration-resistant prostate cancer in the overall trial population and across subgroups. The results of PROpel are important for patients and the oncology community alike, providing support for this combination as a potential and critically needed new treatment option in metastatic castration-resistant prostate cancer.\u201d\n<\/p>\n

\nSusan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, \u201cBoth PARP, the target of LYNPARZA, and the androgen receptor are important for providing DNA repair in prostate cancer. The results in the overall trial population from PROpel illustrate how the combination of LYNPARZA and abiraterone can exploit the dependency of the androgen receptor\u2019s role in DNA repair on PARP to provide greater anticancer activity than abiraterone alone. Based on the totality of the data, it is notable to see this combination delivering a meaningful benefit in a broad population of patients in this setting, which is further underscored by the recent indication approved in the European Union.\u201d\n<\/p>\n

\nDr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, \u201cProstate cancer is the second most commonly diagnosed cancer in patients assigned male at birth, and mortality is estimated to almost double over the next 20 years. With limited treatment options for these patients, we recognize the critical need for therapies that can delay disease progression. We are proud of our collaboration with AstraZeneca, as we work together to advance pending regulatory reviews and bring a new treatment option to the prostate cancer community.\u201d\n<\/p>\n

\nSummary of final results of key secondary OS endpoint across subgroups<\/b>\n<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nLYNPARZA + abi\/pred\n<\/p>\n<\/td>\n

\n

\nPlacebo + abi\/pred\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nIntention-to-Treat (ITT)\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients (n)\n<\/p>\n<\/td>\n

\n

\n399\n<\/p>\n<\/td>\n

\n

\n397\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian OS in months\n<\/p>\n<\/td>\n

\n

\n42.1\n<\/p>\n<\/td>\n

\n

\n34.7\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)\n<\/p>\n<\/td>\n

\n

\n0.81 (0.67, 1.00)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHomologous recombination repair-mutated (HRRm)\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients (n)\n<\/p>\n<\/td>\n

\n

\n111\n<\/p>\n<\/td>\n

\n

\n115\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian OS in months\n<\/p>\n<\/td>\n

\n

\nNR\n<\/p>\n<\/td>\n

\n

\n28.5\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)\n<\/p>\n<\/td>\n

\n

\n0.66 (0.45, 0.95)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNon-HRRm\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients (n)\n<\/p>\n<\/td>\n

\n

\n279\n<\/p>\n<\/td>\n

\n

\n273\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian OS in months\n<\/p>\n<\/td>\n

\n

\n42.1\n<\/p>\n<\/td>\n

\n

\n38.9\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)\n<\/p>\n<\/td>\n

\n

\n0.89 (0.70, 1.14)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nBRCA<\/i>m\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients (n)\n<\/p>\n<\/td>\n

\n

\n47\n<\/p>\n<\/td>\n

\n

\n38\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian OS in months\n<\/p>\n<\/td>\n

\n

\nNR\n<\/p>\n<\/td>\n

\n

\n23.0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)\n<\/p>\n<\/td>\n

\n

\n0.29 (0.14, 0.56)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNon-BRCA<\/i>m\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients (n)\n<\/p>\n<\/td>\n

\n

\n343\n<\/p>\n<\/td>\n

\n

\n350\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian OS in months\n<\/p>\n<\/td>\n

\n

\n39.6\n<\/p>\n<\/td>\n

\n

\n38.0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)\n<\/p>\n<\/td>\n

\n

\n0.91 (0.73, 1.13)\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\n*18 patients with unknown HRRm status were excluded from subgroup analysis. NR, not reached.<\/i>\n<\/p>\n

\nLYNPARZA <\/i>in combination with abi\/pred was approved by the European Commission in December 2022 for the treatment of mCRPC in adult men for whom chemotherapy is not clinically indicated and is currently undergoing regulatory review by the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency for this indication.\n<\/p>\n

\nLYNPARZA is currently approved in the U.S. for patients with HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone, based on the Phase 3 PROfound trial. For this indication, patients are selected for therapy based on an FDA approved companion diagnostic for LYNPARZA.\n<\/p>\n

\nAbout PROpel<\/b>\n<\/p>\n

\nPROpel is a randomized, double-blind Phase 3 trial testing the efficacy, safety and tolerability of LYNPARZA versus placebo when given in addition to abiraterone and prednisone or prednisolone in patients with mCRPC who had not received prior chemotherapy or new hormonal agents in the mCRPC setting. The major efficacy outcome was rPFS as assessed by investigator per RECIST v1.1 and Prostate Cancer Working Group (bone) criteria. OS was an additional efficacy outcome measure.\n<\/p>\n

\nAbout prostate cancer<\/b>\n<\/p>\n

\nProstate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men globally, with an estimated 1.4 million cases and 375,000 deaths in 2020. Approximately 10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at least 84% of these patients presenting with metastases at the time of CRPC diagnosis. Patients diagnosed with advanced prostate cancer have a particularly poor prognosis, with a five-year relative survival rate of about 30%, compared to patients diagnosed with earlier stages of the disease, with a five-year relative survival rate of more than 99%.\n<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/b>\n<\/p>\n

\nCONTRAINDICATIONS<\/b>\n<\/p>\n

\nThere are no contraindications for LYNPARZA.\n<\/p>\n

\nWARNINGS AND PRECAUTIONS<\/b>\n<\/p>\n

\nMyelodysplastic Syndrome\/Acute Myeloid Leukemia (MDS\/AML): <\/b>Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS\/AML was 2 years (range: <6 months to >10 years). All of these patients had previous chemotherapy with platinum agents and\/or other DNA-damaging agents, including radiotherapy.\n<\/p>\n

\nDo not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (\u2264Grade 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.\n<\/p>\n

\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.\n<\/p>\n

\nPneumonitis: <\/b>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.\n<\/p>\n

\nVenous Thromboembolic Events (VTE):<\/b> Including severe or fatal pulmonary embolism (PE) occurred in patients treated with LYNPARZA. VTE occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. 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.\n<\/p>\n

\nEmbryo-Fetal Toxicity: <\/b>Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.\n<\/p>\n

\nFemales<\/i>\n<\/p>\n

\nAdvise 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.\n<\/p>\n

\nMales<\/i>\n<\/p>\n

\nAdvise 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.\n<\/p>\n

\nADVERSE REACTIONS\u2014First-Line Maintenance BRCA<\/i>m Advanced Ovarian Cancer<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226510% of patients who received LYNPARZA in the first-line maintenance setting<\/b> for SOLO-1 <\/b>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%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in \u226525% of patients who received LYNPARZA in the first-line maintenance setting <\/b>for SOLO-1<\/b> 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%).\n<\/p>\n

\nADVERSE REACTIONS\u2014First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226510% of patients treated with LYNPARZA\/bevacizumab and at a \u22655% frequency compared to placebo\/bevacizumab in the first-line maintenance setting<\/b> for PAOLA-1<\/b> were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). In addition, the most common adverse reactions (\u226510%) 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%).\n<\/p>\n

\nIn addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA\/bevacizumab (5%) than in those receiving placebo\/bevacizumab (1.9%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in \u226525% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting<\/b> for PAOLA-1<\/b> 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%).\n<\/p>\n

\nADVERSE REACTIONS\u2014Maintenance Recurrent Ovarian Cancer<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226520% of patients who received LYNPARZA in the maintenance setting <\/b>for SOLO-2<\/b> 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%).\n<\/p>\n

\nStudy 19: <\/b>nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in \u226525% of patients who received LYNPARZA in the maintenance setting (SOLO-2\/Study 19<\/b>) were: increase in mean corpuscular volume (89%\/82%), decrease in hemoglobin (83%\/82%), decrease in leukocytes (69%\/58%), decrease in lymphocytes (67%\/52%), decrease in absolute neutrophil count (51%\/47%), increase in serum creatinine (44%\/45%), and decrease in platelets (42%\/36%).\n<\/p>\n

\nADVERSE REACTIONS\u2014Adjuvant Treatment of gBRCA<\/i>m, HER2-Negative, High-Risk Early Breast Cancer<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226510% of patients who received LYNPARZA in the adjuvant setting<\/b> for OlympiA<\/b> 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%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in \u226525% of patients who received LYNPARZA in the adjuvant setting <\/b>for OlympiA<\/b> 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%).\n<\/p>\n

\nADVERSE REACTIONS\u2014gBRCA<\/i>m, HER2-Negative Metastatic Breast Cancer<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226520% of patients who received LYNPARZA in the metastatic setting<\/b> for OlympiAD<\/b> were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in ><\/span>25% of patients who received LYNPARZA in the metastatic setting<\/b> for OlympiAD <\/b>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%).\n<\/p>\n

\nADVERSE REACTIONS\u2014First-Line Maintenance gBRCA<\/i>m Metastatic Pancreatic Adenocarcinoma<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226510% of patients who received LYNPARZA in the first-line maintenance setting<\/b> for POLO <\/b>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%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in \u226525% of patients who received LYNPARZA in the first-line maintenance setting<\/b> for POLO<\/b> 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%).\n<\/p>\n

\nADVERSE REACTIONS\u2014HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer<\/b>\n<\/p>\n

\nMost common adverse reactions (Grades 1-4) in \u226510% of patients who received LYNPARZA for PROfound<\/b> were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).\n<\/p>\n

\nMost common laboratory abnormalities (Grades 1-4) in \u226525% of patients who received LYNPARZA for PROfound<\/b> were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).\n<\/p>\n

\nDRUG INTERACTIONS<\/b>\n<\/p>\n

\nAnticancer Agents: <\/b>Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.\n<\/p>\n

\nCYP3A Inhibitors: <\/b>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.\n<\/p>\n

\nCYP3A Inducers: <\/b>Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.\n<\/p>\n

\nUSE IN SPECIFIC POPULATIONS<\/b>\n<\/p>\n

\nLactation: <\/b>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.\n<\/p>\n

\nPediatric Use: <\/b>The safety and efficacy of LYNPARZA have not been established in pediatric patients.\n<\/p>\n

\nHepatic Impairment: <\/b>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).\n<\/p>\n

\nRenal Impairment: <\/b>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 \u226430 mL\/min).\n<\/p>\n

\nINDICATIONS<\/b>\n<\/p>\n

\nLYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:\n<\/p>\n

\nFirst-Line Maintenance BRCA<\/i>m Advanced Ovarian Cancer<\/b>\n<\/p>\n

\nFor the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA<\/i>-mutated (gBRCA<\/i>m or sBRCA<\/i>m) 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.\n<\/p>\n

\nFirst-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab<\/b>\n<\/p>\n

\nIn 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<\/p>\n