FDA Approves Expanded Keytruda Monotherapy Label for First-Line NSCLC

Officials with the FDA have approved an expanded monotherapy indication for pembrolizumab (Keytruda, Merck) for the first-line treatment of non-small cell lung cancer (NSCLC), according to a Merck press release.

Pembrolizumab monotherapy is now approved for the first-line treatment of patients with stage 3 NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (TPS ³1%) with no EGFR or ALK genomic tumor aberrations.

The approval is based on clinical data from the phase 3 KEYNOTE-042 trial, which showed that pembrolizumab monotherapy demonstrated a statistically significant improvement in overall survival (OS) compared with chemotherapy.

The study included 1274 patients who had not received prior systemic treatment and who were randomized to receive either pembrolizumab 200 mg intravenously for 3 weeks or investigator’s choice of either of the following chemotherapy regimens:

• Pemetrexed 500 mg/m2 every 3 weeks and carboplatin AUC 5 to 6 mg/mL/min every 3 weeks on day 1 for a maximum of 6 cycles followed by optional pemetrexed 500 mg/m2 every 3 weeks for patients with nonsquamous histologies.
• Paclitaxel 200 mg/m2 every 3 weeks and carboplatin AUC 5 to 6 mg/mL/min every 3 weeks on day 1 for a maximum of 6 cycles followed by optional pemetrexed 500 mg/m2 every 3 weeks for patients with nonsquamous histologies.

RELATED

Pembrolizumab Granted FDA Approval for Adjuvant Treatment of Stage 3 Melanoma

Pembrolizumab, Axitinib Combo for Advanced Kidney Cancer Granted Priority Review Designation

Overall, the study results demonstrated a statistically significant improvement in OS in patients whose tumors expressed PD-L1 with a TPS ³50%, with a TPS ³20%, and then in the entire study population (TPS ³1%).

Additionally, efficacy outcomes measures were progression-free survival and overall response rate in the subgroup of patients with TPS ³50% NSCLC, TPS ³20% NSCLC, and the overall population with TPS ³11% NSCLC.

“The KEYNOTE-042 trial demonstrated a survival benefit with Keytruda monotherapy across histologies in certain patients with stage 3 or metastatic non-small cell lung cancer whose tumors expressed PD-L1 in at least 1% of tumor cells,” Gilberto Lopes, associate director for global oncology at the Sylvester Comprehensive Cancer Center at the University of Miami, said in a statement. “As a practicing oncologist, having additional options available for patients is important in the rapidly evolving treatment landscape for lung cancer, which remains the leading cause of cancer death in the United States.”

The recommended pembrolizumab dose for NSCLC is 200 mg as an intravenous infusion over 30 minutes every 3 weeks.

Reference

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) [news release]. Merck. https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-expanded-monotherapy-label-mercks-keytruda-pemb. Accessed April 12, 2019.