Intratumoural tilsotolimod shows no benefit for advanced refractory melanoma

In the phase 3 ILLUMINATE-301 trial, adding tilsotolimod to ipilimumab did not improve the response or survival of patients with PD-1-inhibitor-refractory advanced melanoma.

Limited treatment options are available for advanced melanoma that has progressed during or after immune checkpoint inhibitor therapy. Previously, the phase 1/2 ILLUMINATE-204 trial showed promising results for ipilimumab plus tilsotolimod, a toll-like receptor 9 agonist [1]. The phase 3 ILLUMINATE-301 trial (NCT03445533) evaluated tilsotolimod with or without ipilimumab in patients with PD-1-inhibitor-refractory advanced melanoma. Prof. Caroline Robert (Gustave Roussy, France) presented the results [2].

A total of 454 ipilimumab-naïve participants with stage III/IV, unresectable melanoma who had progression on or after anti-PD-1 therapy were 1:1 randomised to receive 24 weeks of tilsotolimod plus ipilimumab (4 cycles, 3 mg/kg) or 10 weeks of ipilimumab alone. Tilsotolimod was administered by 9 intratumoural injections in a single designated lesion, over 24 weeks.

Adding tilsotolimod did not improve the median progression-free survival (2.9 vs 2.7 months) or the median overall survival (11.6 vs 10.0 months). The objective response rate was also not different between arms (8.8% vs 8.6%).

“Adding tilsotolimod to ipilimumab did not improve response or survival in patients with PD-1-inhibitor-refractory advanced melanoma. However, the results represent the largest prospective dataset reported to date on the use of ipilimumab in this setting and are a valuable addition to the knowledge base,” concluded Prof. Robert.

1. Haymaker C, et al. Cancer Discov. 2021;11:1996-2013.
2. Robert C, et al. Phase III randomized trial evaluating tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with advanced refractory melanoma (ILLUMINATE 301). Abstract LBA9516, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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Posted on 18 July 202418 July 2024