Significantly improve patients' "cancer-free survival" period, PD-1 inhibitors are eligible for FDA priority review

On August 5, 2021, Merck & Co.

The approval is based on the positive results of the Phase 3 clinical trial KEYNOTE-716, which reached the primary endpoint of recurrence-free survival (RFS)

Keytruda is a humanized monoclonal antibody that can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes and increasing the body's immune system's ability to detect and fight tumor cells

The randomized, double-blind, open-label Phase 3 KEYNOTE-716 trial enrolled 954 patients with high-risk grade II melanoma aged 12 years and older who had undergone complete resection

Melanoma is the most serious type of skin cancer

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Reference materials:

[1] Merck's Keytruda® (pembrolizumab) Significantly Prolonged Recurrence-Free Survival (RFS) Compared to Placebo as Adjuvant Therapy for Patients With Stage II Resected High-Risk Melanoma in Phase 3 KEYNOTE-716 Trial.