The Merkel market.

The options for PD-1 axis inhibition for the treatment of advanced Merkel cell carcinoma (MCC) just doubled. The FDA approved pembrolizumab for this indication based on results of the single-arm phase 2 KEYNOTE-017. Among 50 patients receiving first-line pembro for recurrent or metastatic MCC, over half had a response and over half of those remained without progression at one year. Most remarkably, one-quarter achieved a complete response, and median progression-free survival was 4x that seen historically with cytotoxic chemo. To dial it back a notch, we’ll remind you: “The accelerated approval of pembro in this setting is contingent on the results of a confirmatory trial.” TBL: Both pembro and avelumab are FDA-approved for the systemic treatment of MCC based on exciting phase 2 results, but we cautiously await larger-scale data. | NCI 2019