Idera misses primary endpoint in Phase 3 melanoma trial

 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA; the “Company”) today is announcing that ILLUMINATE-301, the Company’s pivotal registration trial of tilsotolimod in combination with 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 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer (MSS-CRC).

ILLUMINATE-301 is a randomized, global, multi-center, open label Phase 3 trial comparing the efficacy of 8 mg intratumoral tilsotolimod in combination with 3 mg/kg ipilimumab versus 3 mg/kg ipilimumab alone in 481 patients with anti-PD-1 refractory advanced melanoma. The trial has a primary endpoint family of ORR per RECIST v1.1 and OS. Although the primary endpoint of ORR was not met, if the study continues and reaches a positive OS outcome, the Company would expect to discuss with regulatory authorities a potential path forward in this indication.

ILLUMINATE-301 Key Findings:
Patients in the study were randomized and treated either with 8 mg of tilsotolimod in combination with ipilimumab or with ipilimumab alone. 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.

“We are surprised and disappointed that the response data from ILLUMINATE-301 do not lead us to an accelerated path to a new and much-needed treatment option for these patients,” stated Vincent Milano, Idera’s Chief Executive Officer. “We would like to extend our deepest gratitude to everyone involved in this study, especially the many courageous patients who participated and continue in follow up.”

Continued Mr. Milano, “Despite today’s news, we are continuing to explore tilsotolimod via our ongoing ILLUMINATE-206 study in order to understand its potential to lead to better outcomes for patients with MSS-CRC.”

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