Methods: To formally compare the efficacy and safety of pembro dosing schedules of 10 mg/kg Q3W and 10 mg/kg Q2W, an additional 244 pts were enrolled in KEYNOTE-001 and randomized 1:1 to treatment with pembro 10 mg/kg Q3W (n = 121) or 10 mg/kg Q2W (n = 123). Ipilimumab-naive (IPI-N) pts received ≤2 prior systemic therapies; IPI-treated (IPI-T) pts were not restricted by prior therapy. Response was assessed every 12 wk. Primary end point was objective response rate (ORR) per RECIST v1.1 by independent central review.
Results: As of Feb 2014, median follow-up was approximately 35 wk, and all pts had ≥26 wk follow-up. Arms were balanced for known prognostic factors. Median treatment duration was 21 wk for the Q3W arm and 22 wk for the Q2W arm. Among the 224 pts evaluable for ORR (n = 108 at Q3W, 116 at Q2W), no significant difference was observed between schedules (28% at Q3W [n = 1 complete response, 29 partial responses] vs 33% at Q2W [n = 4 complete response, 34 partial responses]; P = .419). Across schedules, confirmed ORR was 33% in IPI-N (n = 115) and 28% in IPI-T (n = 109) pts. Disease control rate was 44% at Q3W and 50% at Q2W (P = .4064). 24-wk progression-free survival (PFS) rates were 43% at Q3W and 47% at Q2W, and there was no significant difference in PFS between schedules (HR, 1.19; 95% CI, 0.85–1.66; P = .298). The safety profile was similar for both schedules, with grade 3–4 treatment-related adverse events (AEs) observed in 12% of pts at Q3W and 15% at Q2W, discontinuations due to treatment-related AEs in 1% at Q3W and 3% at Q2W, and no treatment-related deaths.
Conclusions: Overall, pembro showed similar efficacy and safety at 10 mg/kg Q2W and 10 mg/kg Q3W in pts with advanced MEL. Considering previous randomized data showing no significant difference in efficacy and safety between pembro doses of 10 mg/kg Q3W and 2 mg/kg Q3W, the recommended pembro dose and schedule is 2 mg/kg Q3W.
|Number of pages||1|
|Journal||Annals of Oncology|
|Issue number||Supplement 4|
|Publication status||Published - 29 Sep 2014|
|Event||39th ESMO Congress (ESMO) - Madrid, Spain|
Duration: 26 Sep 2014 → 30 Sep 2014