Keytruda pembrolizumab: Additional Phase I/II data

Data from 123 chemotherapy-naive patients with metastatic, non-squamous EGFR- and anaplastic lymphoma kinase (ALK)-negative NSCLC in cohort G of the Phase II portion of the open-label, crossover, international Phase I/II KEYNOTE-021 trial showed that 200 mg IV Keytruda every 3 weeks plus carboplatin and Alimta pemetrexed led to an ORR of 55%, including 33 partial responses, vs. 29%, including 18 partial responses, for carboplatin plus Alimta (p=0.0016). Median duration of response was not reached in either treatment arm. Keytruda plus carboplatin and Alimta led to a median PFS of 13 months vs. 8.9 months for carboplatin plus Alimta (p=0.0102). Additionally, Keytruda plus carboplatin and Alimta led to 6- and 12-month OS rates of 92% and 75%, respectively, vs. 92% and 72% for carboplatin plus Alimta. In PD-L1-negative (n=44) and -positive (n=79) patients, Keytruda plus carboplatin and Alimta led to ORRs of 57% and 54%, respectively, vs. 13% and 38% for carboplatin plus Alimta. Data were presented at the European Society for Medical Oncology meeting in Copenhagen and published in The Lancet Oncology. Merck has previously reported data from the trial (see BioCentury, May 25, 2015 & May 23, 2016). ...