“The U.S. Food and Drug Administration is currently examining pembrolizumab for the adjuvant treatment of stage IIB and IIC melanoma; if approved, we would be introducing immunotherapy earlier in the patient journey,” commented invited discussant Omid Hamid, MD (@OmidHamidMD), who was an investigator involved in KEYNOTE-716. “This has the potential to spare patients the morbidity and mortality of recurrence and metastases. It is important to note that the trial included not just adults, but also children and adolescents aged 12 years and older.” Dr. Hamid is Chair of the melanoma and other skin cancers track for the European Society for Medical Oncology (ESMO) Congress and Co-Director of the Cutaneous Oncology Program at The Angeles Clinic and Research Institute, a Cedars-Sinai affiliate.
“The KEYNOTE-716 trial creates new answers and raises new questions about stage IIB and IIC melanoma,” Dr. Hamid continued.
Part 2 of the trial will explore crossover to pembrolizumab at recurrence and rechallenge with pembrolizumab; thus, it should provide evidence about the ability to reintroduce pembrolizumab. The question of whether adjuvant pembrolizumab is beneficial in children could not be answered by KEYNOTE-716; accrual of patients between the ages of 12 and 17 was too low to assess the benefit of pembrolizumab in that subset of patients.
Omid Hamid, MD
“The study provides an early look at recurrence-free survival, showing a 7.4% benefit for pembrolizumab in these patients who tend to recur early,” Dr. Hamid continued. “There is also a benefit in terms of distant recurrence, and this is enough to push this therapy forward for the right patients,” he stated.
“Better biomarkers, including the use of circulating tumor DNA, may allow earlier use of pembrolizumab,” Dr. Hamid proposed. “We have no understanding of what to do for poor-risk patients with stage I or IIA disease.”
It may be possible to give less pembrolizumab, but future trials will have to address this. Adjuvant trials of combination therapy are opening in melanoma and are expected to provide evidence related to the use of combinations with immunotherapy. “We await long-term overall survival data from KEYNOTE-716,” added Dr. Hamid.
DISCLOSURE: Dr. Hamid has received honoraria from Array BioPharma, Bristol-Myers Squibb, Novartis, and Sanofi/Regeneron; has served as a consultant or advisor to Aduro, Akeso Biopharma, Amgen, Array BioPharma, BeiGene, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Immunocore, Incyte, Janssen, Merck, NextCure, Novartis, Regeneron, Roche, Sanofi, Seattle Genetics, Tempus, and Zelluna; has participated in a speakers bureau for Array BioPharma, Bristol-Myers Squibb, Novartis, and Sanofi/Regeneron; has received institutional research funding from Aduro Biotech, Akeso Biopharma, Amgen, Arcus Biosciences, Array BioPharma, AstraZeneca, Bristol-Myers Squibb, CytomX Therapeutics, Exelixis, Genentech, GlaxoSmithKline, Immunocore, Incyte, Iovance Biotherapeutics, MedImmune, Merck, Merck Serono, Moderna Therapeutics, NextCure, Novartis, Pfizer, Regeneron, Roche, Sanofi, Seattle Genetics, Torque, and Zelluna.
Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...