On February 20, 2019 The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, reported the U.S. Food & Drug Administration (FDA) approval of Merck’s pembrolizumab (Keytruda) in the adjuvant setting for melanoma patients with lymph node involvement following complete lymph node resection (Press release, Melanoma Research Alliance, FEB 20, 2019, View Source [SID1234533510]).
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Melanoma, the deadliest skin cancer, is the fifth most common cancer in the U.S. An estimated 9% of new cases have spread to lymph nodes or nearby sites around the tumor— referred to as Stage III disease—with correspondingly high risk of recurrence and death. Reducing the risk of recurrence after surgery represents a major opportunity to eliminate melanoma suffering and death.
"Over the last year we have seen a flurry of drug approvals that help reduce the risk of recurrence for high-risk Stage III melanoma following surgery while reducing treatment-related side effects," said Chief Science Officer Marc Hurlbert, Ph.D. "This is important because it makes more treatment options available to patients and assists in making the decision to start adjuvant therapy that much easier for patients and their doctors."
Pembrolizumab, an anti-PD-1 antibody, works by stimulating the patient’s immune system to attack melanoma by promoting the tumor-killing effectiveness of T cells. It was first approved for the treatment of unresectable or metastatic melanoma in 2014 and has since gained FDA approval to treat multiple cancers, including certain cancers of the lung, bladder and blood.
"Giving patients access to more, better tolerated, treatments to choose from at an earlier stage of disease is critical to achieving our mission of ending suffering and death due to melanoma," said MRA President & CEO Michael Kaplan.
Without adjuvant therapy, about 60% of Stage III melanoma patients will relapse within three years of surgical resection. While adjuvant therapy works to reduce this risk, it does have its own range of side effects. Doctors and patients must work together to weigh the relative benefits of adjuvant therapy.
FDA approval of pembrolizumab in the adjuvant setting is based on results from the KEYNOTE-054 trial. In this phase-three study, pembrolizumab significantly reduced melanoma recurrence/death (26%) compared with patients receiving placebo (43%). The safety of pembrolizumab has been evaluated in 4,948 patients with various cancers and the most commonly reported adverse reactions were fatigue, rash, and nausea.