ASCO 2015: Nivo plus ipi vs ipi alone. Results of the CheckMate 069 melanoma study.

Clinical response, progression-free survival, and safety in patients with advanced melanoma receiving nivolumab combined with ipilimumab vs ipi monotherapy in CheckMate 069 study.  ASCO J Clin Oncol 33, 2015.  Hodi, Postow, Chesney, Pavlick, Robert, Wolchok, et al.

Combined blockade of T cell checkpoints by Nivo and Ipi demonstrate a high objective response rate, promising overall survival, and manageable safety profile in a phase 1 study, based on which an appropriate dose was selected for registrational trials.  142 patients with metastatic and unresectable melanoma, including patients with poor prognostic factors were randomized 2:1 to receive IPI 3 mg/kg combined with either Nivo 1mg/kg or placebo every 3 weeks X 4, followed by Nivo 3mg/kg or placebo every 2 wks until disease progression or unacceptable toxicity.  Results:  In BRAF wild type (n=109) overall response rate was 60% (43/72) for Nivo plus ipi; 11% (4/37) for ipi alone. Complete responses were reported in 12 (17%) for the combo and 0 for ipi alone.  Higher overall response rate was observed for nivo plus ipi vs ipi in predefined subgroups such as:  elevated baseline LDH (53 vs 0%) M1c stage disease (62 vs 25%).  Similar results were found in 33 BRAF mutation positive patients.  Grade 3/4 AE's were reported in 51% of patients given the Nivo/ipi combo vs 20% for ipi alone and was similar across all groups.  Most resolved with immunosuppressive meds (more than 83%) with the exception of endocrinopathies.

Not really news at this point.  The ipi/nivo combo provides better results than ipi alone.  The combo causes more adverse reactions as well....  What'cha gonna do???  Hang in there, ratties!!! - c