Merck says Phase 2/3 CCTG IND.227/KEYNOTE-483 trial met primary endpoint

Merck and the Canadian Cancer Trials Group announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. IND.227 was sponsored by CCTG, in collaboration with investigators in Italy, and France. Merck provided KEYTRUDA and support for the trial. At the final analysis of the study, KEYTRUDA plus chemotherapy showed a statistically significant and clinically meaningful improvement in OS compared to chemotherapy alone in these patients. The safety profile of KEYTRUDA in combination with chemotherapy in this study was consistent with previously reported studies. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities worldwide.