Eli Lilly received approval for a new indication for Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck received accelerated approval for the combination of pembrolizumab with Alimta and carboplatin in May 2017. This is the first and only combination of chemotherapy and immunotherapy to earn FDA approval for the first-line treatment of metastatic nonsquamous NSCLC. This indication, now included in the Alimta prescribing information, is based on data from Merck’s KEYNOTE-021 study, Cohort G1.
“Lung cancer is the leading cause of cancer death in the U.S., and this approval represents the power of rational combinations and collaborations in bringing new treatments to these patients,” said Sue Mahony, Ph.D., senior vice president and president of Lilly Oncology. “Almita has been a long-standing, first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer. This combination with pembrolizumab continues to build on the robust body of evidence for Almita in lung cancer.”
The KEYNOTE-021, Part 2, Cohort G1, study included 123 previously untreated patients with locally advanced or metastatic nonsquamous NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations and irrespective of PD-L1 expression status. The triplet combination of Alimta and carboplatin with pembrolizumab (n=60) demonstrated a statistically significant improvement in objective response rate (ORR) versus Alimta plus carboplatin alone (n=63) (55 percent vs 29 percent; all responses were partial) (estimated difference, 26 percent; 95 percent confidence interval [CI], range of 42-68 for triplet and range of 18-41 for Alimta plus carboplatin; P=0.0032), and PFS (HR=0.53; 95 percent CI, 0.31-0.91, P=0.0205). Median PFS was 13.0 months for triplet and 8.9 months for Alimta plus carboplatin (range of 8.3-NE for triplet and 4.4-10.3 for Alimta plus carboplatin).
(Source: Eli Lilly and Company)
Filed Under: Drug Discovery