Merck's Keytruda Achieves Additional Clinical Endpoints in Early-Stage Melanoma, Demonstrating Significant Improvement in Distant Metastasis-Free Survival

Today, MSD announced another positive development in its key immunotherapy, Keytruda. In the clinical trial as an adjuvant treatment for resectable stage IIB and IIC melanoma, the therapy achieved a key secondary clinical endpoint.

Melanoma is one of the most serious types of skin cancer, characterized by uncontrolled growth of pigment-producing cells. Early-stage melanoma can be treated with surgical removal, but the recurrence rate after removal is relatively high: for patients in stages IIB and IIC, the recurrence rate is 32-46%; for stage III patients, the recurrence rate is 39-74%. The five-year survival rate for patients in these three stages is approximately 80% to 90%.

MSD’s Early Cancer Treatment Program Indicates Early Intervention Can Improve Long-Term Survival Rates, with Keytruda at Its Core. In a Phase 3 clinical trial named KEYNOTE-716, researchers recruited patients with resectable melanoma in stages IIB and IIC. The interim analysis showed that the treatment improved recurrence-free survival (RFS) compared to placebo. Previously, this trial had already met its primary endpoint for RFS (HR=0.65 [95% CI, 0.46-0.92]; p=0.00658), leading the FDA to expand Keytruda's indications based on these data. Today's results further demonstrate that the therapy, as an adjuvant treatment, can statistically significantly improve distant metastasis-free survival (DMFS) without presenting new safety signals. MSD plans to release more data at upcoming medical conferences.

(Original text has been abridged)

References:

[1] Merck’s KEYTRUDA^® (pembrolizumab) Demonstrated Significant Improvement in Distant Metastasis-Free Survival (DMFS) Compared to Placebo as Adjuvant Therapy for Patients With Resected Stage IIB and IIC Melanoma in Phase 3 KEYNOTE-716 Trial, Retrieved March 7, 2022, from https://www.merck.com/news/mercks-keytruda-pembrolizumab-demonstrated-significant-improvement-in-distant-metastasis-free-survival-dmfs-compared-to-placebo-as-adjuvant-therapy-for-patients-with-resected-stage/

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