Combined anti-angiogenic chemoradiotherapy with PD-1 monoclonal antibody for Chinese patients with advanced melanoma: A prospective single-arm study.

Abstract

e21522 Background: Malignant melanoma, characterized by its aggressiveness and early metastasis, poses significant challenges in terms of treatment efficacy. Combining nab-paclitaxel, bevacizumab(bev), and immunotherapy has shown promising efficacy across various cancer types. This study investigated the efficacy and safety of this regimen in patients(pts) with advanced melanoma in Chinese pts. Methods: This was a prospective, single-arm study (ChiCTR2200062880). Inoperable stage III-IV melanoma pts with ECOG PS 0-1 were eligible to receive nab-paclitaxel (200mg/m 2 ) plus bev (7.5mg/kg) and toripalimab(tor) (240mg) (Q3W). Maintenance therapy with bev and tor was given after 6 cycles without disease progression or intolerable adverse reactions. Personalized hypofractionated radiotherapy was delivered. The primary endpoint was objective response rate (ORR) and disease control rate (DCR) according to the RECIST V1.1. Results: Between July 2022 and January 2025, a total of 37 patients were enrolled (Table). As of January 2025, 31 patients underwent at least once efficacy evaluation and the median follow-up was 7.8 months. The ORR was 67.7% (95% CI: 48.6-83.3) and DCR was 96.8% (95% CI: 83.3-99.9) with 1(3.2%) confirmed complete response, 15(48.4%) confirmed partial response(PR), 5(16.1%) unconfirmed PR and 9(29.0%) stable disease. The median progression-free survival was 15.9 months (95% CI: 9.2-22.6). Grade≥3 treatment-related adverse events(TRAEs) occurred in 12 (32.4%) pts, included leukopenia (3 [8.1%]), neutropenia (7 [18.9%]) and hypertension (2 [5.4%]). No treatment-related deaths or treatment discontinuation occurred. Conclusions: Toripalimab in combination with chemotherapy, bevacizumab and radiotherapy showed encouraging efficacy in Chinese patients with advanced melanoma, with an acceptable safety profile. Follow-up for survival outcomes is ongoing. Clinical trial information: ChiCTR2200062880 . Baseline characteristics. Characteristics Patients (n=37) Age (years), median (range) 60 (43-78) Sex (male/female) 18/19 Current therapy line (1/≥2) 22/15 Prior therapy chemotherapy/no 7/30 anti-angiogenic therapy/no 6/31 immunotherapy/no 20/17 Primary site (acral/mucosal/cutaneous/unknown) 21/9/6/1 Metastatic site liver/no 8/29 lung/no 14/23 lymph node/no 29/8 bone/no 8/29 Gene mutation (BRAF/C-KIT/NRAS/unknown) 4/5/7/6