EXTON, PA — Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) announced final topline data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist.
ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in patients with anti-PD-1 refractory advanced melanoma. The phase 1 portion of the trial tested the safety and efficacy of increasing doses of tilsotolimod in combination with either Yervoy®* (ipilimumab) or Keytruda®± (pembrolizumab).
The phase 2 expansion of the trial enrolled additional patients at the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy®, which is the treatment regimen being evaluated for the same indication in the Company’s registrational trial, ILLUMINATE-301.
“The clinical benefit suggested for these anti-PD-1 refractory melanoma patients with limited treatment options includes stabilization of disease and even responses, which is creating hope that this combination might be of benefit to patients in the PD-1 refractory setting,” stated Joseph Markowitz, M.D., Ph.D., from the H. Lee Moffitt Cancer Center & Research Center in Tampa, Florida. “We eagerly await the outcome of the ongoing phase 3 trial to see whether this combination treatment with ipilimumab will represent an additional option for patients with advanced melanoma.”
ILLUMINATE-204 Key Findings:
The study included 52 patients treated with 8 mg of tilsotolimod in combination with Yervoy®.
- 49 patients were evaluable for efficacy.
- Median overall survival (OS) was 21.0 months (95% confidence interval (CI): 9.8 months-not reached (NR)).
- The overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was 22.4%, including 2 complete responses (95% CI: 11.8-36.6%).
– The disease control rate (stable disease or better) was 71.4% (95% CI: 56.7%-83.4%).
– Median duration of response was 11.4 months (95% CI: 3.3 months-NR).
– 7 of 11 RECIST v1.1 responses were durable for greater than 6 months.
– Tumor reduction was observed in both injected and noninjected tumors.
- The combination regimen was generally well tolerated among the 62 patients receiving tilsotolimod at any dose in combination with Yervoy®.
– 48% of patients reported a maximum Grade 3 or 4 treatment emergent adverse event (TEAE).
– The most common serious TEAEs were autoimmune hepatitis, hyponatremia, and hypophysitis (n=2 for each).
– 26% of patients reported immune-related toxicities, suggesting that tilsotolimod + Yervoy® does not add immune-related toxicity versus Yervoy® alone.
– There were no TEAEs leading to discontinuation or death.
Final data from ILLUMINATE-204 is planned for submission to a medical meeting in the second half of 2020.
“The outcomes from this study encourage our belief that the combination of tilsotolimod and ipilimumab may provide a much-needed treatment option for advanced melanoma patients who have limited available therapies,” stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. “We are looking forward to completing our registrational trial for this indication, ILLUMINATE-301, where a comparator arm is included, and moving this potential therapy one step closer to patients in need.”
Continued Dr. Tarka, “As with many of our peers, we are intently monitoring the COVID-19 pandemic and its potential effect on the ILLUMINATE-301 trial. We are working closely with our investigators and partners and taking proactive steps to help protect the safety of our study participants and clinical trial staff while also ensuring the scientific integrity of the trial data. Based on what we know today, and while recognizing the environment could rapidly change, we currently expect to achieve our target of sharing key topline data from the trial in the first quarter of 2021.”
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