Pembrolizumab Prolongs Recurrence-Free Survival Compared With Placebo in Stage II Resected High-Risk Melanoma


Pembrolizumab met its primary end point of prolonged recurrence-free survival in the phase 3 KEYNOTE-716 trial for patients with stage II resected high-risk melanoma.

Pembrolizumab (Keytruda) prolonged survival benefit over placebo in a population of patients patients with stage II resected high-risk melanoma in the KEYNOTE-716 trial (NCT03553836), according to a press release from Merck.

During the interim analysis of the study, investigators identified a meaningful improvement in recurrence-free survival (RFS) compared with the placebo, meeting the trial’s primary end point. The full results of KEYNOTE-716 will be presented at an upcoming conference.

“Many patients with stage II melanoma have a high risk of their cancer returning after surgery. This is an important milestone for patients, and we look forward to sharing these results with the medical community as soon as possible. We thank the patients and investigators for their participation in this study,” Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a press release.

The KEYNOTE-716 trial, which investigated the safety and efficacy of pembrolizumab for patients with surgically resected high-risk stage II melanoma, enrolled 954 patients who were 12 years or older.

In the first part of the double-blind study adults in the pembrolizumab group received 200 mg intravenously every 3 weeks for up to 17 cycles. Patients in the placebo group received an intravenous saline infusion on the same schedule as the experimental cohort. Pediatric patients were to receive either pembrolizumab or the placebo intravenously up to 200 mg every 3 weeks for up to 17 cycles.

Part 2 of the study was open-label, and adults and pediatric patients were eligible to receive up to 35 additional cycles of treatment. Patients were only eligible for the second part of the study if they had recurrence after receiving the placebo or completed 17 cycles of pembrolizumab. Patients in the pembrolizumab group who experienced disease recurrence within 6 months of completing the treatment were excluded from part 2 of the study.

The secondary end points included distant metastasis-free survival, overall survival, safety, and quality of life.

“KEYNOTE-716 is the first phase 3 study to evaluate adjuvant therapy solely for stage IIB and IIC melanoma–an area with high unmet need,” Jason Luke, MD, director, Cancer Immunotherapeutics Center at University of Pittsburgh Medical Center Hillman Cancer Center, said in a press release. “By moving immunotherapy with KEYTRUDA to earlier stages of melanoma, we have the opportunity to reduce the risk of recurrence for high-risk stage II patients compared to observation alone following complete resection.”

The FDA has accepted a new supplemental Biologics License Application for pembrolizumab based on the results of the trial. This application is for adults and pediatric patients with stage IIB or IIC melanoma following complete resection. The FDA has previously granted priority review and assigned a Prescription Drug User Fee Act PDUFA for December 2021.


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 KEYNPTE-716 trial. News Release. Merck. August 5, 2021. Accessed August 5, 2021.

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