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SAFFRON-104: a phase Ib/II study of sitravatinib alone or with tislelizumab in advanced hepatocellular carcinoma and gastric cancer/gastroesophageal junction cancer.
Li, Jin; Bai, Yuxian; Chen, Zhendong; Ying, Jieer; Guo, Yabing; Fang, Weijia; Zhang, Feng; Xiong, Jianping; Zhang, Tao; Meng, Zhiqiang; Zhang, Jingdong; Ren, Zhenggang; Hao, Chunyi; Chen, Yajin; Lin, Xiaoyan; Pan, Hongming; Zhou, Fuxiang; Li, Xin; Yu, Fan; Zhang, Juan; Zhang, Zhang; Qin, Shukui.
Afiliación
  • Li J; Department of Oncology, Shanghai East Hospital, Tongji University, Shanghai, China.
  • Bai Y; Department of Gastroenterology, Harbin Medical University Cancer Hospital, Harbin, China.
  • Chen Z; Department of Oncology, The Second Hospital of Anhui Medical Hospital, Hefei, China.
  • Ying J; Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
  • Guo Y; Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
  • Fang W; Department of Medical Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
  • Zhang F; Department of Hepatic & Biliary & Pancreatic Surgery, Hubei Cancer Hospital, Wuhan, China.
  • Xiong J; Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
  • Zhang T; Department of Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • Meng Z; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China.
  • Zhang J; Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang, China.
  • Ren Z; Department of Hepatic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Hao C; Department of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Beijing, China.
  • Chen Y; Department of Hepatobiliary Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
  • Lin X; Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, China.
  • Pan H; Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
  • Zhou F; Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.
  • Li X; BeiGene (Beijing) Co., Ltd., Beijing, China.
  • Yu F; BeiGene (Shanghai) Co., Ltd., Shanghai, China.
  • Zhang J; BeiGene (Beijing) Co., Ltd., Beijing, China.
  • Zhang Z; BeiGene (Beijing) Co., Ltd., Beijing, China.
  • Qin S; GI Cancer Center, Nanjing Tianyinshan Hospital of China Pharmaceutical University, Gulou, Nanjing, Jiangsu, China. qinsk@csco.org.cn.
Cancer Immunol Immunother ; 73(11): 219, 2024 Sep 05.
Article en En | MEDLINE | ID: mdl-39235596
ABSTRACT

BACKGROUND:

Sitravatinib is a spectrum-selective tyrosine kinase inhibitor targeting TAM (TYRO3, AXL, MER), VEGFR-2, KIT, and MET. SAFFRON-104 (NCT03941873) was a multicohort phase Ib/II study investigating sitravatinib with/without tislelizumab, an anti-programmed cell death protein 1 (PD-1) antibody, in patients with advanced hepatocellular carcinoma (HCC) or gastric cancer/gastroesophageal junction cancer (GC/GEJC).

METHODS:

Eligible patients had histologically/cytologically confirmed advanced HCC or GC/GEJC. Phase I determined the recommended phase II dose (RP2D) of sitravatinib with/without tislelizumab. Phase II evaluated sitravatinib monotherapy in patients with pretreated HCC, and sitravatinib plus tislelizumab in anti-PD-(L)1-naïve or -treated HCC and anti-PD-(L)1-naïve GC/GEJC. Primary endpoints were safety/tolerability (phase I) and objective response rate (ORR) (phase II).

RESULTS:

At data cutoff (March 31, 2023), 111 patients were enrolled; 102 were efficacy-evaluable (median study follow-up 9.1 months [range 0.7-36.9]). The RP2D of sitravatinib was determined as 120 mg orally once daily. In patients receiving sitravatinib monotherapy and sitravatinib in combination with tislelizumab, grade ≥ 3 treatment-related adverse events occurred in 14 (51.9%) and 42 (50.0%) patients, respectively. The ORR was 25% (95% confidence interval [CI] 8.7-49.1) in patients with pretreated HCC receiving sitravatinib monotherapy. In patients receiving sitravatinib with tislelizumab, the ORR was 11.5% (95% CI 2.4-30.2) with anti-PD-(L)1-naïve HCC, 9.5% (95% CI 1.2-30.4) with anti-PD-(L)1-treated HCC, and 16.1% (95% CI 5.5-33.7) in patients with anti-PD-(L)1-naïve GC/GEJC.

CONCLUSIONS:

Sitravatinib with/without tislelizumab was generally well tolerated and showed preliminary antitumor activity in patients with advanced HCC and GC/GEJC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Carcinoma Hepatocelular / Unión Esofagogástrica / Anticuerpos Monoclonales Humanizados / Neoplasias Hepáticas Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Cancer Immunol Immunother Asunto de la revista: ALERGIA E IMUNOLOGIA / NEOPLASIAS / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Alemania
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Carcinoma Hepatocelular / Unión Esofagogástrica / Anticuerpos Monoclonales Humanizados / Neoplasias Hepáticas Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Cancer Immunol Immunother Asunto de la revista: ALERGIA E IMUNOLOGIA / NEOPLASIAS / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Alemania