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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

Published: 2022-03-07 11:45:00 ET

New Results Build on Previously Reported Significant Recurrence-Free Survival (RFS) Benefit Seen in These Patients

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-716 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with resected stage IIB and IIC melanoma met its key secondary endpoint of distant metastasis-free survival (DMFS) at a pre-specified interim analysis. In the trial, adjuvant treatment with KEYTRUDA demonstrated a statistically significant improvement in the endpoint of DMFS compared to placebo in these patients. No new safety signals were observed.

At this interim analysis, treatment with KEYTRUDA also continued to show an improvement in recurrence-free survival (RFS) compared to placebo. As previously reported, KEYNOTE-716 met the primary endpoint of RFS at the first interim analysis (HR=0.65 [95% CI, 0.46-0.92]; p=0.00658), which supported U.S. Food and Drug Administration approval for this indication in December 2021. Full results from this analysis of KEYNOTE-716 will be presented at an upcoming medical meeting.

“Patients with melanoma that has spread to distant sites have a significantly worse prognosis and the goal of adjuvant therapy is to delay disease recurrence, especially distant metastases,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “In KEYNOTE-716, adjuvant treatment with KEYTRUDA first showed a significant improvement in recurrence-free survival and has now demonstrated a significant improvement in the time until the first diagnosis of a distant metastasis compared to placebo. The distant metastasis-free survival data from KEYNOTE-716 reinforce the evidence for KEYTRUDA as adjuvant therapy in stage IIB and IIC melanoma.”

To date, KEYTRUDA has shown significant improvements in RFS and DMFS compared to placebo across resected stage IIB and stage IIC (KEYNOTE-716) and stage III melanoma (EORTC1325/KEYNOTE-054: RFS HR=0.57 [95% CI, 0.46, 0.70] p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.