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Clinical Trial
. 2022 May;10(5):e004427.
doi: 10.1136/jitc-2021-004427.

Camrelizumab plus famitinib for advanced or metastatic urothelial carcinoma after platinum-based therapy: data from a multicohort phase 2 study

Yuan-Yuan Qu  1   2 , Zhongquan Sun  3 , Weiqing Han  4 , Qing Zou  5 , Nianzeng Xing  6 , Hong Luo  7 , Xuepei Zhang  8 , Chaohong He  9 , Xiao-Jie Bian  1   2 , Jinling Cai  10 , Chunxia Chen  10 , Quanren Wang  10 , Ding-Wei Ye  11   2
Affiliations
Clinical Trial

Camrelizumab plus famitinib for advanced or metastatic urothelial carcinoma after platinum-based therapy: data from a multicohort phase 2 study

Yuan-Yuan Qu et al. J Immunother Cancer. 2022 May.

Abstract

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.

Keywords: Immunotherapy; Programmed Cell Death 1 Receptor; Therapies, Investigational; Urinary Bladder Neoplasms; Urologic neoplasms.

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Conflict of interest statement

Competing interests: JC, CC, and QW are employees of Jiangsu Hengrui Pharmaceuticals. No other potential conflicts of interest were reported.

Figures

Figure 1
Figure 1
Clinical activity. (A) Best change in target lesion from baseline in all evaluable patients; (B) tumor responses over time. For the patient who achieved with complete response (CR), the target lesions included pathological lymph nodes, and thus the change in target lesions was not −100%. PR, partial response; SD, stable disease; PD, progressive disease.
Figure 2
Figure 2
Kaplan-Meier estimates of progression-free survival. (A) All patients; (B) subgroup by primary tumor types. NR, not reached.
Figure 3
Figure 3
Kaplan-Meier estimates of overall survival. (A) All patients; (B) subgroup by primary tumor types. NR, not reached.
See this image and copyright information in PMC

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