%0 Journal Article
%T Single-arm study of camrelizumab plus apatinib for patients with advanced mucosal melanoma.
%A Zhao L
%A Ren Y
%A Zhang G
%A Zheng K
%A Wang J
%A Sha H
%A Zhao M
%A Huang R
%A Kang D
%A Su X
%A Wu Y
%A Zhang W
%A Lai R
%A Li L
%A Mei R
%A Wang Y
%A Tian Y
%A Wang F
%A Liu B
%A Zou Z
%J J Immunother Cancer
%V 12
%N 6
%D 2024 Jun 21
%M 38908858
%F 12.469
%R 10.1136/jitc-2023-008611
%X <B>BACKGROUND: </B>Previous studies have suggested the potential synergistic antitumor activity when combining immune checkpoint inhibitors with anti-angiogenic agents in various solid tumors. We aimed to assess the efficacy and safety of camrelizumab (a humanized programmed cell death-1 antibody) plus apatinib (a vascular endothelial growth factor receptor tyrosine kinase inhibitor) for patients with advanced mucosal melanoma (MM), and explore-related biomarkers.<BR><B>METHODS: </B>We conducted a single-center, open-label, single-arm, phase II study. Patients with unresectable or recurrent/metastatic MM received camrelizumab and apatinib. The primary endpoint was the confirmed objective response rate (ORR).<BR><B>RESULTS: </B>Between April 2019 and June 2022, 32 patients were enrolled, with 50.0% previously received systemic therapy. Among 28 patients with evaluable response, the confirmed ORR was 42.9%, the disease control rate was 82.1%, and the median progression-free survival (PFS) was 8.05 months. The confirmed ORR was 42.9% (6/14) in both treatment-naïve and previously treated patients. Notably, treatment-naïve patients had a median PFS of 11.89 months, and those with prior treatment had a median PFS of 6.47 months. Grade 3 treatment-related adverse events were transaminase elevation, rash, hyperbilirubinemia, proteinuria, hypertension, thrombocytopenia, hand-foot syndrome and diarrhea. No treatment-related deaths were observed. Higher tumor mutation burden (TMB), increased T-cell receptor (TCR) diversity, and altered receptor tyrosine kinase (RTK)/RAS pathway correlated with better tumor response.<BR><B>CONCLUSIONS: </B>Camrelizumab plus apatinib provided promising antitumor activity with acceptable toxicity in patients with advanced MM. TMB, TCR diversity and RTK/RAS pathway genes were identified as potential predictive biomarkers and warrant further validation.<BR><B>BACKGROUND: </B>Chinese Clinical Trial Registry, ChiCTR1900023277.