A randomized controlled comparison of pembrolizumab and chemotherapy in patients with ipilimumab-refractory melanoma
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ORAL PRESENTATION
Open Access
A randomized controlled comparison of pembrolizumab and chemotherapy in patients with ipilimumab-refractory melanoma Reinhard Dummer1*, Adil Daud2, Igor Puzanov3, Omid Hamid4, Dirk Schadendorf5, Caroline Robert6, Jacob Schachter7, Anna Pavlick8, Rene Gonzalez9, F Stephen Hodi10, Lee D. Cranmer11, Christian Blank12, Steven J. O’Day13, Paolo A. Ascierto14, April K.S. Salama15, Nicole Xiaoyun Li16, Wei Zhou16, Joy Lis16, Scot Ebbinghaus16, Peter S. Kang16, Antoni Ribas17 From Melanoma Bridge Meeting 2014 Naples, Italy. 03-06 December 2014 Background Pembrolizumab blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby inducing an antitumor immune response. In a phase I study, pembrolizumab demonstrated promising antitumor activity and acceptable safety in patients with ipilimumab-treated melanoma, leading to accelerated approval in the US. Materials and methods KEYNOTE-002 is a randomized phase 2 study in patients with ipilimumab-refractory melanoma (ie, confirmed PD in the 24 weeks following ≥2 ipilimumab doses) and, if BRAF mutant, previously treated with a BRAF inhibitor. Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg Q3W or investigator-choice chemotherapy (carboplatin + paclitaxel, carboplatin, paclitaxel, dacarbazine, or temozolomide). Patients with PD confirmed by independent central review could cross over to pembrolizumab treatment after the first 3-month assessment. Primary objective of the interim analysis prespecified to occur after ≥ 270 PFS events (RECIST v1.1, independent central review) was to evaluate the superiority of either pembrolizumab dose over control for PFS at a 1-sided 0.25% significance level (estimated HR 0.66). Results From Nov 2012 to Nov 2013, 540 patients from 12 countries enrolled. Based on central review of a total of 410 PFS events, the HR was 0.57 and 0.50 for pembrolizumab
2 and 10 mg/kg Q3W, respectively, over control (P
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