Shares of Idera Pharmaceuticals Inc. IDRA plunged more than 62% in the extended session Thursday after the biopharmaceutical company said its lead drug candidate Tilsotolimod failed to meet the primary endpoint in a Phase 3 trial for anti-PD-1 refractory advanced melanoma.
What Happened: Idera Pharmaceuticals said that ILLUMINATE-301 is a Phase 3 trial evaluating tilsotolimod in combination with Bristol-Myers Squibb Company’s BMY Yervoy (ipilimumab) against ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma. The company noted that the trial did not meet its primary endpoint of objective response rate (ORR).
Results from the trial showed an ORR of 8.8% for the combination arm, compared to 8.6% for the ipilimumab alone arm, which is not statistically significant.
Idera said it is evaluating its next steps regarding the continuation of the trial toward its endpoint or overall survival (OS), which includes evaluating the full data set when it is available.
The Pennsylvania-based company plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and another Bristol drug Opdivo (nivolumab), in patients with microsatellite stable colorectal cancer (MSS-CRC).
Why It Matters: Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors.
Idera Pharmaceuticals said in January that the success of Tilsotolimod in the ILLUMINATE-301 trial could yield its lead drug candidate a significant commercial opportunity in melanoma. If approved, the company expects Tilsotolimod to bring in peak sales of $600 million in the U.S. and $350 million in the European Union.
Price Action: Idera Pharmaceuticals shares closed about 1.6% higher on Thursday at $5.21. However, the stock tumbled more 62% in the after-hours session.
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