More exciting news in the adjuvant melanoma world! The KEYNOTE-054 trial is a large (1019 patients) phase III trial which compared adjuvant pembrolizumab to placebo in patients with resected high risk melanoma (IIIA with > 1mm metastasis, IIIB and IIIC). Pembrolizumab 200 mg or placebo was given IV every three weeks for up to one year. Pembrolizumab reduced the risk of recurrence by 43% in the study population compared to placebo. There were no new safety concerns noted, meaning the usual immune related toxicities for pembro were seen. The study is ongoing and data on overall survival, distant metastases-free survival and outcome measures specifically for PD-L1 positive patients will also be reported. Full results are to be shared at an upcoming medical meeting. I look forward to hearing the additional results! It is wonderful to have so much to talk about in the melanoma world.
An additional point- a more general one for PD-1 inhibitors, since so many changes are occurring so rapidly, checking the PI information on the manufacturers web site will provide the most up to date prescrbing and administration guidelines, and more changes are slated ahead!
It is such an amazing time for melanoma therapies and cancer therapies in general. As many of these therapies receive approvals in multiple cancer types, it is essential to review the PI for specifics around the approvals as well as for nuances in toxicity profiles from one tumor type to another. For many of our colleagues who don’t specialize in a single tumor type, this is even more important.