Mar 10, 2023: Keytruda (Pembrolizumab, IV)/ Metastatic malignant pleural mesothelioma / Merck: Phase 2/3 IND.227/KEYNOTE-483 study met its primary endpoint
Merck announced that the KEYNOTE-483 study, evaluating Keytruda with chemotherapy met its primary endpoint of overall survival in patients with metastatic malignant pleural mesothelioma.
Study details: NCT02784171; Phase 2/3; n=520; Patients With Advanced Malignant Pleural Mesothelioma; Active, not recruiting; Pembrolizumab (200mg) with Cisplatin (75 mg/m2) & Pemetrexed (500 mg/m2); PO: Progression-free survival & overall survival hormone-sensitive prostate cancer)
Statistically significant and clinically meaningful improvement in Overall Survival compared to chemotherapy alone.
Safety profile of Keytruda was consistent with previously reported studies.
Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.
“.. Patients are in need of new treatments that can improve survival outcomes, and these positive results support the potential of KEYTRUDA in combination with chemotherapy as a first-line treatment for patients with the most common form of malignant mesothelioma.” said Dr. Eliav Barr, Sr. VP & CMO of Merck Research Laboratories