Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed). The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies. A full evaluation of the data from this study
393 Results Found
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYLYNK-008 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3). At the interim analysis 3, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus LYNPARZA did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, compared to KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus placebo. The study’s other dual primary endpoint, progression-free survival (PFS), was not statistically significant at the second interim analysis, but there was a numerical improvement compared to the
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCA m mCRPC patients, recommending against approval beyond this patient population. In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence . The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for use of LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committee’s guidance but takes its advice into consideration. The ODAC Meeting is scheduled for April 28, 2023. AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC. The sNDA is based on the results of the Phase 3 PROpel trial. Results from PROpel,
Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial Results showed KEYTRUDA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy in these patients, regardless of mismatch repair status Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024. The sBLA is based on data from the Phase 3 NRG-GY018 trial. Results from the study, presented at the 2023 Society of
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival 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. Results 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
KEYTRUDA plus CRT is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in OS in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) met its primary endpoint of overall survival (OS) for the treatment of newly diagnosed patients with high-risk locally advanced cervical cancer. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared
Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer. The sBLA is based on data from the KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, in which KEYTRUDA plus concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)
KEYTRUDA plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurrent chemoradiotherapy alone KEYNOTE-A18 is the first Phase 3 study in which an immunotherapy regimen has demonstrated a significant PFS improvement in locally advanced cervical cancer compared to concurrent chemoradiotherapy alone Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) for newly diagnosed patients with high-risk locally advanced cervical cancer (stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease). Results from the trial showed that KEYTRUDA in combination with concurrent
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has informed AstraZeneca that the agency will extend by three months the Prescription Drug User Fee Act (PDUFA) date for the pending supplemental new drug application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The purpose of the extension is to provide further time for the full review of the submission. The companies will continue to work with the FDA to facilitate the completion of the agency’s review. The sNDA for LYNPARZA in combination with abiraterone and prednisone or prednisolone is based on the Phase 3 PROpel trial, results of which were published in NEJM Evidence in June 2022. The application was granted priority review, and AstraZeneca and Merck are committed to working with the FDA to