Eli Lilly and Co. said FDA has granted approval for a new indication for Alimta (pemetrexed for injection) in combination with Keytruda (pembrolizumab), developed and marketed by Merck, and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
This indication is approved based on data from Merck’s phase III KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had dual primary endpoints of overall survival and progression-free survival.
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 II 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 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,” Anne White, president, Lilly Oncology, said in a statement. “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.
On Aug. 20, 2018, Merck’s pembrolizumab was approved by 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.
