FDA Expands Lilly’s ALIMTA® (pemetrexed) Label to Include Combination with KEYTRUDA® (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression

INDIANAPOLIS, June 5, 2018 /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 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 (known as MSD outside the U.S. and Canada) 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. “ALIMTA 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 ALIMTA 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% vs 29%; all responses were partial) (estimated difference, 26%; 95% 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% 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).

The labeling for ALIMTA contains warnings and precautions for myelosuppression and increased risk of myelosuppression without vitamin supplementation, renal failure, bullous and exfoliative skin toxicity, interstitial pneumonitis, radiation recall, increased risk of toxicity with ibuprofen in patients with renal impairment and also embryo-fetal toxicity. Initiate supplementation with oral folic acid and intramuscular vitamin B12 prior to and for 21 days after the last dose of ALIMTA. Determine creatinine clearance before each dose and periodically monitor renal function during treatment. Withhold ALIMTA in patients with a creatinine clearance of less than 45 mL/minute. The dosage of ALIMTA should be modified according to the full prescribing information when experiencing certain adverse reactions. The dosage of ibuprofen needs to be modified in patients with mild to moderate renal impairment receiving ALIMTA. Advise patients of the potential risk to a fetus and to use effective contraception. Please see Important Safety Information below and full Prescribing Information for more information.