Phase II Trial of First-line Axitinib plus Nivolumab in Patients with Advanced Mucosal Melanoma.
Sarah E Lochrin, Hannah L Kalvin, Monica F Chen et al.
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In 30 seconds
This single-center, investigator-initiated phase II trial evaluated first-line nivolumab plus axitinib in patients with untreated unresectable or metastatic mucosal melanoma. Among 20 evaluable patients, the objective response rate was 45% (95% CI, 23-68), including four complete and five partial responses. Median duration of response was 21 months (95% CI, 8.6-Not Reached), while median progression-free survival was 6.4 months (95% CI, 3.5-NR). Grade 3 to 5 treatment-related adverse events occurred in 67%, including two treatment-related deaths. The authors concluded that the combination warrants randomized evaluation.
Key findings
- Objective response rate was 45% (95% CI, 23-68), with 4 complete responses (20%) and 5 partial responses (25%).
- Median duration of response was 21 months (95% CI, 8.6-Not Reached); median progression-free survival was 6.4 months (95% CI, 3.5-NR).
- Grade 3 to 5 treatment-related adverse events occurred in 67%, including two treatment-related deaths.
- Seven patients received ipilimumab or SBRT after progression; no unexpected toxicities were observed.
Why it matters
Mucosal melanoma has comparatively poor immunotherapy outcomes, and this study reports substantial antitumour activity with a VEGF-targeting agent combined with PD-1 blockade. The response duration suggests some responses were sustained, but serious treatment-related toxicity, including deaths, is important when weighing the signal. These findings provide a rationale for further evaluation rather than establishing comparative benefit.
What to keep in mind
The study was single-center and included 20 evaluable patients; it was not randomized, and the authors call for randomized studies.