Merck’s Keytruda approved by FDA for non-small cell lung cancer treatment

Merck announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB, II, or IIIA non-small cell lung cancer, or NSCLC. The approval is based on data from the pivotal Phase 3 KEYNOTE-091 trial. The major efficacy outcome measure was investigator-assessed disease-free survival. In patients who received adjuvant platinum-based chemotherapy following surgical resection, Keytruda reduced the risk of disease recurrence or death by 27% versus placebo regardless of PD-L1 expression. The median DFS in patients regardless of PD-L1 expression who received adjuvant platinum-based chemotherapy following surgical resection was nearly five years for the Keytruda arm versus nearly three years for the placebo arm, translating to a nearly two-year DFS improvement versus placebo. The adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving Keytruda as a single agent, with the exception of hypothyroidism, hyperthyroidism and pneumonitis. Two fatal adverse reactions of myocarditis occurred. With this approval, Keytruda is the only immunotherapy with an approved option for NSCLC regardless of PD-L1 expression in both the adjuvant and metastatic settings.