FDA Expands Lilly's ALIMTA® (pemetrexed) Label with Combination of KEYTRUDA® (pembrolizumab) and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer
INDIANAPOLIS, Jan. 31, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with KEYTRUDA® (pembrolizumab), developed and marketed by Merck (known as MSD outside the U.S. and Canada), 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. This indication is approved based on data from Merck's Phase 3 KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had dual primary endpoints of overall survival (OS) and progression-free survival (PFS).
ALIMTA in combination with pembrolizumab and carboplatin was first approved in June 2018 under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and PFS data from the Phase 2 study KEYNOTE-021 (Cohort G1). In accordance with the accelerated approval process, continued approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in the KEYNOTE-189 trial and has resulted in the FDA converting the accelerated approval to full (regular) approval.
"KEYNOTE-189 demonstrated an exceptional effect of the ALIMTA-pembrolizumab-platinum chemotherapy combination in the first-line setting, offering significantly improved survival in patients with metastatic nonsquamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations," said Anne White, president, Lilly Oncology. "This new indication reinforces Lilly's continued commitment to providing practice-changing treatment options that can make a meaningful difference for people living with lung cancer."
ALIMTA is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed. See additional Important Safety Information below.
KEYNOTE-189 Trial Results
On August 20, 2018, Merck's pembrolizumab was approved by the FDA for this indication, based on data from the KEYNOTE-189 study, which demonstrated that treatment with ALIMTA in combination with pembrolizumab plus platinum-based chemotherapy resulted in significantly longer OS and PFS than ALIMTA plus platinum chemotherapy with placebo.