EXTON, PA — Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced preliminary data from the first 10 patients in the safety cohort of ILLUMINATE-206, a Phase 2, open-label, multi-center study to evaluate tilsotolimod in combination with Opdivo® (nivolumab) and Yervoy®* (ipilimumab) in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC) patients. Based on data to date, the Company plans to expand the study to further evaluate this triplet combination in MSS-CRC.
To investigate the safety profile of this triplet combination, ILLUMINATE-206 was designed with a stepwise approach to Yervoy® dosage. Patients in this initial safety cohort of the study, many of whom were heavily pre-treated and rapidly progressing, received 8 mg of intratumoral tilsotolimod and 3 mg/kg of intravenous (IV) Opdivo® every 2 weeks, along with 1 mg/kg of IV Yervoy® every 8 weeks.
This regimen was generally well tolerated; no patients discontinued treatment due to adverse events (AEs) and none experienced Grade 4 or 5 AEs. One patient experienced stable disease per RECIST v1.1 criteria, and 9 patients progressed as defined by RECIST v1.1. Investigators reported that 6 of the progressing patients had stability or reduction in size of injected lesions and 6 had stability or reduction in overall size of uninjected lesions.
Based on these results, the Company plans to enroll additional patients in this MSS-CRC cohort of ILLUMINATE-206. Planned changes in the study design intended to improve potential outcomes in this patient population include increasing the frequency of Yervoy® dosing and limiting the number of allowed prior lines of treatment to two or fewer. Enrollment of the next 10 patients is targeted to begin in the fourth quarter of 2020, with data anticipated in the second quarter of 2021. Pending data from those patients, the trial may be expanded further.
“We are encouraged by the initial safety profile of this first-time triplet combination,” stated Elizabeth A. Tarka, M.D., Idera’s Chief Medical Officer. “We look forward to continuing to explore the potential clinical benefit of tilsotolimod in combination with ipilimumab and nivolumab in MSS-CRC, possibly yielding a treatment alternative for these patients with few current options.”
For more information about ILLUMINATE-206, visit www.ClinicalTrials.gov.
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