FDA Approves Keytruda in Combination with Gemcitabine and Cisplatin for Sixth Gastrointestinal Cancer Indication

▎WuXi

Edited by Kant Content Team

MSD announced today that the U.S. FDA has approved its重磅 PD-1 inhibitor Keytruda (pembrolizumab) for use in combination with gemcitabine and cisplatin.Used to treat patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). According to the press release, this is the sixth indication for Keytruda in the treatment of gastrointestinal cancers.

This approval by the FDA is mainly based on the positive results from the Phase 3 clinical trial KEYNOTE-966. The analysis showed that the combination of Keytruda and chemotherapy demonstrated a statistically significant improvement in the primary endpoint of the trial—overall survival (OS). Specifically,Compared with chemotherapy alone, the combination therapy significantly reduced the risk of death by 17% in the pre-specified final OS analysis of the trial (HR=0.83, 95% CI: 0.72-0.95, one-sided p=0.0034).In addition,The median OS for patients receiving Keytruda plus chemotherapy was 12.7 months (95% CI: 11.5-13.6), compared to 10.9 months (95% CI: 9.9-11.6) for patients in the chemotherapy-alone group.

Compared with the placebo + chemotherapy group, adverse reactions with a difference ≥5% in patients receiving Keytruda and chemotherapy include fever (26% vs. 20%), rash (21% vs. 13%), pruritus (15% vs. 10%), and hypothyroidism (9% vs. 2.6%).

Keytruda is a humanized anti-PD-1 monoclonal antibody that blocks the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating T lymphocytes.This effect may enhance the ability of the immune system in the body to detect and combat tumor cells. In September 2014, Keytruda was first approved by the FDA for the treatment of advanced melanoma, and was subsequently approved as a first-line therapy for patients with metastatic NSCLC. In China, Keytruda has also been approved for multiple indications, covering melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, colorectal cancer, esophageal cancer, liver cancer, and more.