Bristol-Myers reports safety data for Phase 1 lirilumab studies
Bristol-Myers Squibb and Innate Pharma announced safety data for two Phase I studies conducted by Bristol-Myers testing lirilumab in combination with nivolumab or ipilimumab, respectively, in patients with advanced refractory solid tumors. Lirilumab was licensed by Innate to Bristol-Myers. The safety profile of the combination of lirilumab and nivolumab therapy was similar to that of nivolumab monotherapy, with the exception of an increased frequency of low grade infusion-related reactions in patients treated with the lirilumab combinations. These reactions were clinically managed and similar to those seen with lirilumab alone. In the limited population -- 22 patients -- studied for the combination of lirilumab and ipilimumab, there did not appear to be additional safety concerns compared to ipilimumab monotherapy. Specifically, the CA223-001 study of lirilumab-nivolumab, no dose-limiting toxicities were reported. The overall rate of treatment-related adverse events was reported as 71.7 percent and the rate of Grade 1-2 TRAEs was 56.6 percent. The rate of Grade 3-4 TRAEs was 15.1 percent. Discontinuations due to TRAEs occurred in 7.5 percent, with only treatment related pneumonitis and diarrhea occurring in more than one patient. In the CA223-002 trial of lirilumab-ipilimumab, the overall rate of treatment-related adverse events was reported as 68.2 percent and the rate of Grade 1-2 TRAEs was 59.1 percent. The rate of Grade 3-4 TRAEs was 9.1 percent and included erythematous rash and pruritus and hypopituitarism. This study is complete and the combination of lirilumab with ipilimumab is no longer being evaluated. "Based on these data, further evaluation of lirilumab in combination with nivolumab is warranted. Efficacy data from the lirilumab and nivolumab combination study will be reported separately," the company said.