A multicenter phase 2 trial of camrelizumab plus famitinib for women with recurrent or metastatic cervical squamous cell carcinoma

Abstract

This phase 2 study assesses the efficacy and safety of camrelizumab (an anti-PD-1 antibody) plus famitinib (anti-angiogenic agent) in women with pretreated recurrent or metastatic cervical cancer (ClinicalTrials.gov NCT03827837). Patients with histologically or cytologically confirmed cervical squamous cell carcinoma experiencing relapse or progression during or after 1-2 lines of systemic therapy for recurrent or metastatic disease are enrolled. Eligible patients receive camrelizumab 200 mg intravenously on day 1 of each 3-week cycle plus famitinib 20 mg orally once daily. The primary endpoint is the objective response rate. Secondary endpoints are duration of response, disease control rate, time to response, progression-free survival, overall survival, and safety. The trial has met pre-specified endpoint. Thirty-three patients are enrolled; median follow-up lasts for 13.6 months (interquartile range: 10.0-23.6). Objective responses are observed in 13 (39.4%, 95% confidence interval [CI]: 22.9-57.9) patients; the 12-month duration of response rate is 74.1% (95% CI: 39.1-90.9). Median progression-free survival is 10.3 months (95% CI: 3.5-not reached) and the 12-month overall survival rate is 77.7% (95% CI: 58.9-88.7). All patients experience treatment-related adverse events; grade ≥3 events occur in 26 (78.8%) patients. Treatment-related serious adverse events and deaths are observed in 9 (27.3%) and 2 (6.1%) patients, respectively. Camrelizumab plus famitinib shows promising antitumor activity with a manageable and tolerable safety profile in patients with pretreated recurrent or metastatic cervical squamous cell carcinoma. This combination may represent a treatment option for this population.

Fig. 1. Tumor responses after camrelizumab plus famitinib treatment.

a Waterfall plot demonstrating the best percentage change from baseline in target tumor lesion size. Each bar represents a patient. The dashes indicate a 20% increase or 30% reduction. b Spider plot presenting the percentage change from baseline in target tumor lesion size over time. The waterfall and spider diagrams showed the tumor responses in 29 patients who had at least one post-baseline scan of target lesion. In one patient, the target lesion had not been measured at post-baseline but a new lesion appeared during treatment. This patient was determined to have progressive disease and was not included in the waterfall and spider diagrams.

Fig. 2. Duration of response.

a Kaplan–Meier curve of duration of response. Data are for the 13 patients with confirmed objective responses. b Swimming plot demonstrating the treatment exposure and duration of tumor response in the full analysis population. Two patients who did not have tumor evaluation results at post-baseline and did not die during the study treatment were not included in the swimming plot. The length of the bars corresponds with time from treatment initiation to the last tumor assessment or death.

Fig. 3. Kaplan–Meier curves of progression-free survival and overall survival.

a Progression-free survival. b Overall survival. Data are for the full analysis population (N = 33).