PT  - JOURNAL ARTICLE
AU  - Yuan-Yuan Qu
AU  - Zhongquan Sun
AU  - Weiqing Han
AU  - Qing Zou
AU  - Nianzeng Xing
AU  - Hong Luo
AU  - Xuepei Zhang
AU  - Chaohong He
AU  - Xiao-Jie Bian
AU  - Jinling Cai
AU  - Chunxia Chen
AU  - Quanren Wang
AU  - Ding-Wei Ye
TI  - Camrelizumab plus famitinib for advanced or metastatic urothelial carcinoma after platinum-based therapy: data from a multicohort phase 2 study
AID  - 10.1136/jitc-2021-004427
DP  - 2022 May 01
TA  - Journal for ImmunoTherapy of Cancer
PG  - e004427
VI  - 10
IP  - 5
4099  - http://jitc.bmj.com/content/10/5/e004427.short
4100  - http://jitc.bmj.com/content/10/5/e004427.full
SO  - J Immunother Cancer2022 May 01; 10
AB  - Background Dual blockade of immune checkpoint and angiogenesis is an effective strategy for multiple cancers. Camrelizumab is a monoclonal antibody against PD-1, and famitinib is a multitargeted receptor tyrosine kinase inhibitor with antiangiogenesis and antiproliferation activities against tumor cells. We conducted an open-label, multicenter phase 2 basket study of camrelizumab and famitinib in eight cohorts of genitourinary or gynecological cancers. Here, findings in cohort of advanced or metastatic urothelial carcinoma with platinum-progressive disease (cohort 2) are presented.Methods Patients who had progressed after platinum-based chemotherapy for advanced or metastatic disease or had progressed within 12 months after completion of platinum-based (neo)adjuvant therapy were given camrelizumab (200 mg intravenously every 3 weeks) plus famitinib (20 mg orally once daily). Primary endpoint was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1.Results Totally, 36 patients were recruited. With a median duration from enrollment to data cut-off of 11.9 months (range 6.1–28.5), ORR was 30.6% (95% CI 16.3% to 48.1%). Median duration of response (DoR) was 6.3 months (95% CI 2.1 to not reached). Median progression-free survival (PFS) was 4.1 months (95% CI 2.2 to 8.2), and median overall survival (OS) was 12.9 months (95% CI 8.8 to not reached). Patients with bladder cancer (n=18) had numerically better outcomes, with an ORR of 38.9% (95% CI 17.3% to 64.3%) and a median PFS of 8.3 months (95% CI 4.1 to not reached). Median DoR and OS in this subpopulation had not been reached with lower limit of 95% CI of 4.2 months for DoR and 11.3 months for OS, respectively. Of 36 patients, 22 (61.1%) had grade 3 or 4 treatment-related adverse events, mainly decreased platelet count and hypertension.Conclusions Camrelizumab plus famitinib showed potent antitumor activity in advanced or metastatic urothelial carcinoma patients after platinum-based chemotherapy. Patients with bladder cancer seemed to have better response to this combination.Trial registration number NCT03827837.Data are available on reasonable request. Data are available on reasonable request. The data that support the findings of this study are available from the corresponding author on reasonable request.