Phase 1 study of KHK2455, a long-acting, potent and selective IDO1 inhibitor, in combination with avelumab in patients with locally advanced or metastatic urothelial carcinoma.
J Immunother CancerSep 21, 2026 (epub)
Clinical ResearchOncology (Medical)
Yousef Zakharia, Bernard Doger de Spéville, Rafael Morales-Barrera et al.
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In 30 seconds
This Phase 1 multicenter study assessed the safety and preliminary efficacy of KHK2455, an IDO1 inhibitor, combined with avelumab in adults with locally advanced or metastatic urothelial carcinoma. Among 16 enrolled subjects, one achieved a complete response and one a partial response, indicating potential antitumor activity.
Key findings
- One subject in the KHK2455 30 mg cohort achieved a complete response.
- One subject in the KHK2455 200 mg cohort achieved a partial response.
- 57.1% of patients with disease control expressed PD-L1 at high levels.
- The subject with complete response had the highest Tumor Inflammation Signature score of 9.06.
Why it matters
The combination of KHK2455 and avelumab shows promise in enhancing antitumor responses in urothelial carcinoma, suggesting a potential new therapeutic strategy for this challenging cancer type.