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Single-arm study of camrelizumab plus apatinib for patients with advanced mucosal melanoma.
Zhao, Lianjun; Ren, Yu; Zhang, Guiying; Zheng, Kelin; Wang, Jiayu; Sha, Huizi; Zhao, Mengke; Huang, Rong; Kang, Donglin; Su, Xinyu; Wu, Yirong; Zhang, Wangling; Lai, Ruihe; Li, Lin; Mei, Rui; Wang, Yitao; Tian, You; Wang, Fufeng; Liu, Baorui; Zou, Zhengyun.
Afiliação
  • Zhao L; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Ren Y; Clinical Cancer Institute of Nanjing University, Nanjing, China.
  • Zhang G; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Zheng K; Clinical Cancer Institute of Nanjing University, Nanjing, China.
  • Wang J; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
  • Sha H; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
  • Zhao M; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
  • Huang R; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Kang D; Clinical Cancer Institute of Nanjing University, Nanjing, China.
  • Su X; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China.
  • Wu Y; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Zhang W; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China.
  • Lai R; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Li L; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Mei R; The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Wang Y; Department of Nuclear Medicine of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Tian Y; Department of Pathology of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
  • Wang F; Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
  • Liu B; Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
  • Zou Z; Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
J Immunother Cancer ; 12(6)2024 Jun 21.
Article em En | MEDLINE | ID: mdl-38908858
ABSTRACT

BACKGROUND:

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.

METHODS:

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).

RESULTS:

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.

CONCLUSION:

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. TRIAL REGISTRATION NUMBER Chinese Clinical Trial Registry, ChiCTR1900023277.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piridinas / Protocolos de Quimioterapia Combinada Antineoplásica / Anticorpos Monoclonais Humanizados / Melanoma Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piridinas / Protocolos de Quimioterapia Combinada Antineoplásica / Anticorpos Monoclonais Humanizados / Melanoma Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article