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FDA Grants Priority Review to Pembrolizumab Plus Chemotherapy for Advanced Pleural Mesothelioma

The FDA granted priority review to an sBLA seeking the approval of pembrolizumab plus chemotherapy as frontline therapy in malignant pleural mesothelioma. ....

Gregory Lubiniecki , Merck Research Laboratories , Prescription Drug User Fee Act ,

Keytruda-Lynparza combination misses survival targets in phase 3 lung cancer trial

Keytruda-Lynparza combination misses survival targets in phase 3 lung cancer trial
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Bymatthew Shinkle , Gregory Lubiniecki , Merck Research Laboratories ,

Phase 3 Trial of Pembrolizumab with Olaparib Did Not Meet Endpoints Among Individuals with NSCLC

Pembrolizumab in combination with chemotherapy followed by maintenance olaparib did not meet its pre-specified statistical criteria of overall survival or progression free survival. ....

Gregory Lubiniecki , Merck Sharp Dohme , Merck Research Laboratories , Pembrolizumab With Maintenance Olaparib , Maintenance Pemetrexed , Metastatic Nonsquamous Non Small Cell Lung Cancer , Merck Sharp , Provides Update , Plus Maintenance Lynparza ,

Pembrolizumab Plus Lenvatinib Misses Both Survival End Points in Advanced, Recurrent Endometrial Cancer

The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient. ....

Gregory Lubiniecki , Corina Dutcus , Merck Research Laboratories , Global Clinical Development , Oncology Global Clinical Development Lead , Eisai Inc , Gynecologic Oncology , The Phase 3 Leap 001 Trial ,

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United States , Damini Chokshi , Peter Dannenbaum , John Infanti , Gregory Lubiniecki , Julie Cunningham , Corina Dutcus , Global Clinical Development , Merck Co Inc , United States Research Laboratories , Eisai Co Ltd , United States Provide Update , First Line Treatment , Recurrent Endometrial , Vice President , United States Research , Senior Vice President , Oncology Global Clinical Development Lead , Acn Newswire ,