Melanoma: Long-term response after discontinuation of therapy
In this morning´s oral abstract session on melanoma, Caroline Robert from the Institut Gustave Roussy in Paris presented an update on the KEYNOTE-006 trial including impressive long-term survival data.
About the study
The randomized, controlled, phase 3 study evaluated pembrolizumab (pembro, 10 mg/kg every 2 or 3 weeks) vs. ipilimumab (ipi, 4 doses of 3 mg/kg every 3 weeks in 834 patients with advanced melanoma who had previously received ≤ 1 systemic treatment. Treatment was continued for 2 years (pembro-group) or until disease progression, intolerable toxicity or patient/investigator decision to discontinue. The trial demonstrated superior PFS and OS of pembro vs. ipi.
Updated results
As of the data cutoff (Nov 3, 2016), median follow up in the total population was 33.9 months. At 33 months, OS-rates were 50% in the pooled pembro-cohorts, and 39 % in the ipi-group; 33-month PFS rates were 31% and 14%, ORR was 42% and 16%, respectively. After a median follow-up of 9.0 mo after completion of pembro, 102 (98%) pts were alive. Responses were durable in pts who completed pembro; 9.7 months after completion of pembro, estimated PFS was 91% in all 104 pts, 95% in pts with complete response, 91% in pts with partial response, and 83% in pts with stable disease. Pembro provides durable efficacy after treatment discontinuation; the risk for progression does not appear to differ by best response.
References:
Robert C et al. abstract 9504: Long-term outcomes in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in the phase 3 KEYNOTE-006 study who completed pembrolizumab (pembro) treatment.