BioCentury
ARTICLE | Clinical News

Keytruda pembrolizumab: Additional Phase III data

October 17, 2016 7:00 AM UTC

Additional data from the open-label, crossover, international Phase III KEYNOTE-024 trial in 305 patients with previously untreated stage IV NSCLC and >=50% PD-L1 expression showed that 200 mg IV Keytruda every 3 weeks led to a median PFS, the primary endpoint, of 10.3 months vs. 6 months for investigator’s choice of 1 of 5 platinum-based chemotherapy regimens (HR=0.5, 95% CI: 0.37, 0.68, p<0.001). Keytruda led to an ORR of 44.8%, including 6 complete responses, vs. 27.8%, including 1 complete response, for chemotherapy. Median OS was not reached in either treatment arm. Keytruda led to an estimated 6-month OS rate of 80.2% vs. 72.4% for chemotherapy (HR=0.6, 95% CI: 0.41, 0.89, p=0.005). Patients received Keytruda or investigator’s choice of Alimta pemetrexed plus carboplatin or cisplatin, gemcitabine plus carboplatin or cisplatin, or carboplatin plus paclitaxel. Data were presented at the European Society for Medical Oncology meeting in Copenhagen and published in The New England Journal of Medicine. Merck previously reported that KEYNOTE-024 was stopped early after top-line data showed that Keytruda met the primary endpoint of improving PFS and the secondary endpoint of improving OS vs. chemotherapy (see BioCentury, June 20). ...