The Study: In KEYNOTE-040, patients with advanced (mostly metastatic) H&N cancer that progressed on or shortly after platinum chemo were randomized to receive pembrolizumab or dealer’s choice of docetaxel, methotrexate, or cetuximab. In other words, a very similar design to Checkmate-141 that showed improved survival with nivolumab in a similar population. Here pembro improved the primary outcome of overall survival from a median of 7 → over 8 months (it was 5 → 8 with nivo). Survival rate at 12 months improved from 27 → 37% (17→ 36% with nivo). And again, response rate was less than impressive at 15% (13% with nivo). At least the responses were sustained for a median of 18 months. Compared to either immune checkpoint inhibitor, docetaxel fairs pretty well while methotrexate and especially cetuximab do much worse. Let’s not forget that this trial is being published under the looming abstract of KEYNOTE-048, which reported at ESMO that first-line pembro improved survival compared to standard cetuximab with platinum-based chemo.
Bottom Line: Pembrolizumab prolonged overall survival over dealer's choice chemo with a 15% response rate in platinum-refractory advanced H&N cancer. | Cohen, Lancet 2018