Background: Anti-programed cell death-1 monotherapy is part of standard therapy for cutaneous melanoma but has low efficacy in mucosal melanoma. We evaluated the efficacy and safety of atezolizumab plus bevacizumab as first-line therapy for advanced mucosal melanoma. Patients and methods: This multicenter, open-label, single-arm, phase II study utilized a Simon’s two-stage design. Atezolizumab (fixed-dose, 1200 mg) and bevacizumab (7.5 mg/kg) were administered by intravenous infusion every 3 weeks. The primary endpoint was objective response rate (ORR), determined per RECIST v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety with adverse events summarized using NCI-CTCAE v5.0. Results: Overall, 43 patients were enrolled, including 20 (46.5%) with unresectable and 23 (53.5%) with metastatic mucosal melanoma. Median follow-up was 13.4 months at data cut-off (July 30, 2021). Forty patients were evaluable for response: ORR was 45.0% (95% confidence interval [CI], 29.3%–61.5%) (one complete response, 17 partial responses). Median PFS was 8.2 months (95% CI, 2.7–9.6); 6- and 12-month PFS rates were 53.4% (95% CI, 36.6%–67.6%) and 28.1% (95% CI, 14.2%–43.9%), respectively. Median OS was not reached (NR) (95% CI, 14.4–NR). Six- and 12-month OS rates were 92.5% (95% CI, 78.5%–97.5%) and 76.0% (95% CI, 57.1%–87.5%), respectively. Median DOR was 12.5 months (95% CI, 5.5–NR). Overall, 90.7% (39/43) of patients experienced treatment-related adverse events; 25.6% (11/43) experienced grade ≥3 events. Conclusion: Atezolizumab in combination with bevacizumab showed promising efficacy and manageable safety in patients with advanced mucosal melanoma.
Supplementary Table from Atezolizumab plus Bevacizumab in Patients with Unresectable or Metastatic Mucosal Melanoma: A Multicenter, Open-Label, Single-Arm Phase II Study
Supplementary Figure from Atezolizumab plus Bevacizumab in Patients with Unresectable or Metastatic Mucosal Melanoma: A Multicenter, Open-Label, Single-Arm Phase II Study
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