Merck Finds Keytruda to Be Effective Treatment for Stage 2 Melanoma


Phase 3 trial results show that the drug reduced the risk of death or reoccurrence by 35% for individuals with high-risk disease compared with the placebo.

The KEYNOTE-716 phase 3 trial showed that Keytruda (pembrolizumab), an anti-PD-1 therapy, showed clinically meaningful and statistically significant improvement in recurrence-free survival (RFS) compared with the placebo for individuals with resected high-risk stage 2 melanoma, Merck said in a statement.

“These findings of a significant 35% reduction in the risk of disease recurrence or death compared to placebo support earlier intervention with Keytruda. We are pleased that these findings have been accepted for priority review by the FDA, and we are grateful to the investigators and patients for their involvement in this important study,” Roy Baynes, MD, PHD, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in the statement.

At the 14.4-month mark, just 11.1% of individuals with melanoma who were treated with Keytruda died or had a recurrence compared with 16.8% who were treated with a placebo.

“Patients diagnosed with stage IIB and IIC melanoma have a high risk of recurrence after complete resection and similar 5-year survival outcomes as those with stage IIIA and IIIB disease, but because there are no systemic treatment options available, the standard of care is observation,” Jason Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center, said in the statement.

“The encouraging results from KEYNOTE-716 show that adjuvant treatment with pembrolizumab was associated with a significant reduction in disease recurrence or death versus placebo for patients with resected high-risk stage II melanoma and, if approved, may offer these patients a new treatment option,” Luke said.

The safety profile remained consistent with previous studies with treatment-related adverse events in 79.9% of individuals who received Keytruda compared with 60.9% of those treated with the placebo. Grade 3 or 4 treatment-related adverse events were observed in 16.1% and 4.3%, respectively.

The research was presented at the European Society for Medical Oncology (ESMO) and was featured as part of the ESMO press program.


Merck’s KEYTRUDA (pembrolizumab) demonstrated superior recurrence-free survival (RFS) in patients with resected high-risk stage II melanoma compared to placebo in the adjuvant setting. Merck. News release. September 18, 2021. Accessed September 20, 2021.

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