Tilsotolimod Provides No Added Benefit in Advanced Melanoma
Source: Cancer Therapy Advisor, March 2025
The combination of tilsotolimod and ipilimumab does not improve response rates or survival outcomes over ipilimumab alone in patients with advanced melanoma, according to phase 3 trial results published in the Journal of Clinical Oncology.
This trial, ILLUMIATE-301 (NCT03445533), included 481 adults with unresectable, stage III-IV melanoma who had at least 1 measurable lesion accessible for injection and had confirmed progression during or after treatment with a PD-1 inhibitor.
The patients were randomly assigned to receive tilsotolimod plus ipilimumab (n=238) or ipilimumab alone (n=243). Tilsotolimod was given as 9 injections to a single designated lesion over 24 weeks. Ipilimumab was administered at 3 mg/kg once every 3 weeks for 10 weeks, starting in week 2 in the tilsotolimod arm and week 1 in the ipilimumab arm.