Abstract 840P
Background
Famitinib malate (F) is an oral tyrosine kinase inhibitor against VEGFR-2, PDGFR, c-kit. Camrelizumab (C) is a humanised anti-PD-1 monoclonal antibody. We initiated an open-label, multicenter phase II study to assess F plus C in patients (pts) with advanced genitourinary and gynecological cancers. Herein, we report the preliminary results from the advanced cervical cancer (CC) and recurrent platinum-resistant epithelial ovarian/fallopian tube/peritoneal cancer (OC) cohorts.
Methods
Pts with histologically confirmed CC that had progressed after at least one line of systemic chemotherapy for metastatic, recurrent or persistent CC or epithelial OC that had disease recurrence <6 months (mos) of last platinum-based therapy were given C 200 mg Q3W IV plus F 20 mg QD PO. Primary endpoint was the objective response rate (ORR) per RECIST v1.1.
Results
From Apr 4, 2019 to Mar 20, 2020, 19 CC pts were enrolled. Median follow-up was 10.0 mos. Of 15 pts with at least one post-baseline efficacy evaluation, Seven pts achieved confirmed partial response (PR), with two additional unconfirmed PR. The ORR was 46.7% (7/15, 95% CI 21.3-73.4) and DCR was 80.0% (12/15, 95% CI 51.9-95.7). Responses were ongoing in 6 of the 7 responders, and median duration of response (mDoR) was not reached. From Apr 19, 2019 to Mar 20, 2020, 32 OC pts were enrolled. Median follow-up was 9.3 mos. Of 31 pts with at least one post-baseline efficacy evaluation, Seven pts achieved confirmed PR, with three additional unconfirmed PR. The ORR was 22.6% (7/31, 95% CI 9.6-58.9). DCR was 61.3% (19/31, 95% CI 42.2-78.2). The mDoR was 4.1 mos. Most common grade 3-4 treatment-related AEs (TRAEs) were hypertension (17/51, 33.3%), neutropenia (12/51, 23.5%), thrombocytopenia (5/51, 9.8%), hand-foot syndrome (4/51, 7.8%), and hypertriglyceridemia (4/51, 7.8%). No pts discontinued the treatment due to TRAEs. One CC pt with recurrent pelvic lesion died due to severe vaginal bleeding.
Conclusions
F plus C appeared to show encouraging activity in recurrent platinum-resistant OC and advanced CC with manageable safety profile, representing a novel potential treatment option that warranted further investigation.
Clinical trial identification
NCT03827837.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Medicine Co., Ltd.
Funding
Jiangsu Hengrui Medicine Co., Ltd.
Disclosure
X. Wang, Q. Wang: Full/Part-time employment: Jiangsu Hengrui Medicine Co., Ltd. All other authors have declared no conflicts of interest.