Tilsotolimod (IMO-2125) Program
|Anti-PD-1 Refractory Advanced Melanoma||
|Microsatellite-Stable Colorectal Cancer||
|Resistant Solid Tumors||
|Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma||
A randomized, multicenter phase 3 trial to compare the efficacy of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma.
This study enrolled approximately 480 patients, with key topline data reported in March 2021. For more information on ILLUMINATE-301, please refer to ClinicalTrials.gov.
A phase 1/2 trial that tested the safety and efficacy of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with anti-PD-1 refractory metastatic melanoma.
Tilsotolimod in combination with ipilimumab has shown promising efficacy, including complete responses, and has been generally well tolerated. Topline data from the study were reported in 2020, with final data to be published in 2021. For more information on ILLUMINATE-204, please refer to ClinicalTrials.gov.
A phase 2, open-label, multi-cohort, multicenter study to test the safety and efficacy of tilsotolimod in combination with ipilimumab and nivolumab for the treatment of solid tumors.
Though checkpoint inhibitors are approved for use in microsatellite instability-high colorectal cancer (CRC), patients with microsatellite-stable (MSS) CRC do not appear likely to respond to these regimens. We’re examining the efficacy of the triple combination of tilsotolimod, ipilimumab, and nivolumab in MSS-CRC with the goal of extending the option of immunotherapy to these patients and the physicians treating them. For more information on ILLUMINATE-206, please refer to ClinicalTrials.gov.
A phase 1b study of the safety, efficacy, and immune effects of intratumoral tilsotolimod in patients with refractory solid tumors.
Tilsotolimod was generally well tolerated and, in alignment with pre-clinical findings, induced alterations in the tumor microenvironment, including immune checkpoint upregulation, activation of dendritic cells, and induction of Type-I IFN signaling. Final data from the study were reported in April 2020. For more information on ILLUMINATE-101, please refer to ClinicalTrials.gov.
A study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-368 plus tilsotolimod and other therapy combinations in patients with recurrent/metastatic head and neck squamous cell carcinoma. AbbVie is solely responsible for the conduct of the study. For more information on this study, please refer to ClinicalTrials.gov.