Expanded Indication for Pemetrexed in Combination Treatment of Metastatic NSCLC
Posted: Thursday, June 14, 2018
On June 6, 2018, the U.S. Food and Drug Administration (FDA) granted approval for a new indication for pemetrexed (Alimta) in combination with carboplatin and pembrolizumab (Keytruda) for the initial treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), irrespective of the status of PD-L1 expression. This expanded indication is based on data from the KEYNOTE-021 study, Cohort G1. Accelerated approval of the combination of pembrolizumab with pemetrexed and carboplatin was granted in May 2017.
The KEYNOTE-021, 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 the status of PD-L1 expression. The triplet combination of pemetrexed and carboplatin with pembrolizumab (n = 60) demonstrated a statistically significant improvement in objective response rate versus pemetrexed plus carboplatin alone (n = 63), with response rates of 55% and 29%, respectively. The median progression-free survival was 13.0 months in the triplet combination arm and 8.9 months in the pemetrexed/carboplatin arm.
Adverse reactions leading to interruption of pemetrexed treatment occurred in 36% of patients. The most common adverse events were fatigue (9%), neutrophil count decreased (9%), anemia (7%), dyspnea (3.4%), and pneumonitis (3.4%).
