Merck’s KEYTRUDA Demonstrates Clinically Meaningful Improvement in Phase 3 Trial

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Merck, on Sunday, announced distant metastasis-free survival (DMFS) results from the Phase 3 KEYNOTE-716 trial investigating Merck’s anti-PD-1 therapy, KEYTRUDA versus placebo as adjuvant therapy for patients with resected stage IIB or IIC melanoma.

With a median follow-up of 27.4 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DMFS versus placebo. The company has also presented the late-breaking data during an oral abstract session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

“Based on survival data, we know that patients with stage IIB and IIC melanoma have similar five-year outcomes as those with stage IIIB melanoma. In KEYNOTE-716, treatment with KEYTRUDA after surgery improved both distant metastasis-free survival and recurrence-free survivalcompared to placebo in patients with stage IIB or IIC melanoma. These data are encouraging for the melanoma community and add to results from six positive pivotal studies for KEYTRUDA-based regimens in earlier stages of cancer.”

Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories

Additionally, at the median 27.4-month follow-up, KEYTRUDA continued to show a reduction in the risk of recurrence versus placebo. According to Kaplan-Meier estimates, 81.2% of patients in the KEYTRUDA arm were recurrence-free at two years compared to 72.8% of patients in the placebo arm.

In the study, the safety profile of KEYTRUDA was consistent with previously reported studies in patients with solid tumors, and no new safety signals were observed at the time of DMFS analysis. 

Treatment-related adverse events Grade 3 or higher were observed in 17% of patients receiving KEYTRUDA versus 5% of patients receiving placebo. Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).

“Patients with stage IIB and IIC melanoma are at risk of seeing their cancer return and spread to distant sites,” said Dr. Georgina Long, co-medical director, Melanoma Institute Australia (MIA), and chair, Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, University of Sydney. “The latest results from KEYNOTE-716 show the potential of pembrolizumab to help reduce distant recurrence in patients with resected stage IIB and IIC melanoma, and further highlight the important role of adjuvant therapy for these patients.”

In addition to KEYNOTE-716, the five other pivotal trials evaluating a KEYTRUDA-based regimen in patients with earlier stages of cancer met their primary endpoints. 


Based on RFS results from KEYNOTE-716, the U.S. Food and Drug Administration approved KEYTRUDA for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection in December 2021. 

With the approval, KEYTRUDA became the first anti-PD-1 adjuvant treatment option for patients (12 years and older) across completely resected stage IIB, IIC and III melanoma. 

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion based on KEYNOTE-716 in May 2022, and the data will be shared with additional health authorities globally.

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