Frontline Keytruda Gains Priority Review for Lung Cancer

A Keytruda was recently granted a  priority review to a supplemental biologics license application to treat patients with metastatic or advanced non-small cell lung cancer. 
BY SILAS INMAN @silasinman
PUBLISHED: JANUARY 11, 2017
Keytruda (pembrolizumab) in combination with pemetrexed plus carboplatin was granted a priority review to a supplemental biologics license application (sBLA) by the FDA to treat patients with metastatic or advanced non-small cell lung cancer (NSCLC) without EGFR or ALK mutations and regardless of PD-L1 expression.

The sBLA was based on part 2 of cohort G in the KEYNOTE-021 trial, in which the Keytruda triplet elicited an objective response rate (ORR) of 55 percent compared with 29 percent with the chemotherapy agents alone. The median progression-free survival (PFS) was 13.0 months with the addition of Keytruda versus 8.9 months for chemotherapy alone.

Under the priority review program, the FDA will decide on the sBLA for the Keytruda combination within six months compared with the standard 10-month review. The target action date for the application is May 10, 2017, according to a statement from Merck, the developer of the PD-1 inhibitor.

“Keytruda in combination with chemotherapy has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non–small cell lung cancer, regardless of PD-L1 levels," Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said in a statement. "If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non–small cell lung cancer.”

In the open-label phase 2 KEYNOTE-021 cohort study, 123 patients were randomized to receive pemetrexed and carboplatin alone (63 patients) or in combination with Keytruda (60 patients). In both groups, carboplatin was given at AUC 5 mg/mL per min and pemetrexed was given at 500 mg/m2 every three weeks for four cycles followed by indefinite pemetrexed maintenance. In the investigational arm, Keytruda was continued for 24 months.

The baseline characteristics were balanced between the two arms. The average age of participants was 62.5 years in the Keytruda group versus 63.2 years for the control arm. The ECOG performance status was 0 (40 percent vs 46 percent) and 1 (58 percent and 54 percent) for those in the Keytruda and control arms, respectively. Eighteen percent of those in the Keytruda arm were of non-white ethnic origin compared with 8 percent in the control arm. Additionally, 25 percent of those in the Keytruda arm were never smokers versus 14 percent in the control group.

After 10.6 months of follow-up, 88 percent of those in the Keytruda arm remained alive and progression free compared with 78 percent for the chemotherapy agents alone. The median time to response was 1.5 months with Keytruda compared with 2.7 months for the chemotherapy agents alone. Overall, a response of at least six months was seen for 92 percent of patients in the Keytruda group compared with 81 percent of those in the control arm.



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