Alimta Labeling Updated to Include Combo Treatment for NSCLC

Merck initially gained accelerated approval for Keytruda with Alimta and carboplatin in May 2017.

Eli Lilly announced that the Food and Drug Administration (FDA) has approved the use of Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab; Merck) for first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression status.

This accelerated FDA approval was based on tumor response rate and progression-free survival (PFS) data. Continued approval may be based upon verification and description of clinical benefit in confirmatory trials. 

Merck initially gained accelerated approval for Keytruda with Alimta and carboplatin in May 2017 as the first combination chemotherapy for use as first-line treatment of metastatic nonsquamous NSCLC. This indication, which is now included in the labeling for Alimta, was supported by results from the KEYNOTE-021 study, Cohort G1.

The Phase 2 KEYNOTE-021, Part 2, Cohort G1 (N=123) included treatment-naive patients with locally advanced or metastatic nonsquamous NSCLC with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations and irrespective of PD-L1 status. Patients who received the triple therapy (Alimta + carboplatin + Keytruda) showed a statistically significant improvement in objective response rate (ORR) vs Alimta + carboplatin alone (55% vs 29%, estimated difference 26%; P =.0032). 

PFS was also statistically and significantly improved among patients who received the triple therapy (hazard ratio [HR] 0.53, 95% CI, 0.31-0.91; P =.0205). Median PFS in the triple therapy arm was 13.0 months compared with 8.9 months in the Alimta + carboplatin arm. 

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Alimta, a folate analog metabolic inhibitor, is available as 100mg or 500mg lyophilized powder in single-dose vials. Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, is available as 50mg lyophilized powder and 25mg/mL solution for intravenous (IV) infusion. Carboplatin, a platinum coordination complex, is available as 10mg/mL solution for IV infusion. 

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