Phase III ILLUMINATE-301 trial of IMO 2125 + Yervoy fails to meet primary endpoint in melanoma.- Idera Pharma

Idera Pharmaceuticals has announced that ILLUMINATE-301, the Company’s phase III pivotal registration trial of IMO 2125 (tilsotolimod) in combination with Yervoy (ipilimumab) versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate (ORR). Idera is evaluating its next steps regarding continuation of the trial toward its overall survival (OS) endpoint, which includes evaluating the full data set when it is available. The Company also plans to continue its ILLUMINATE-206 Phase II study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer (MSS-CRC). Topline results include: ORR of 8.8% for the combination arm and 8.6% for ipilimumab alone. Disease control rate (DCR, defined as stable disease or better) of 34.5% for the combination and 27.2% for ipilimumab alone. Treatment-emergent adverse events (TEAEs) (Grade 3 and above) occurred in 61.1% of patients who received the combination vs. 55.1% of patients who received ipilimumab alone. Immune-related TEAEs (Grade 3 and above) were reported in 37.6% vs. 30.1%, respectively. More detailed results from ILLUMINATE-301 may be submitted for future publication or presentation.