Pemetrexed for injection (Alimtra, Eli Lilly and Company) has received FDA approval for a new indication in combination with pembrolizumab (Keytruda, Merck) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
The approval was based on data from the phase 3 KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had primary endpoints of overall survival (OS) and progression-free survival (PFS).
KEYNOTE-189 demonstrated that Alimta, in combination with pembrolizumab plus platinum-based chemotherapy, resulted in significantly longer OS and PFS than ALIMTA plus platinum chemotherapy with placebo.
Severe adverse reactions occurring in ≥20% of patients included fatigue, diarrhea, dyspnea, vomiting, nausea, rash, decreased appetite, constipation, and pyrexia.
Source: Eli Lilly and Company, January 31, 2019