In a Chinese phase II trial reported in the Journal of Clinical Oncology, Xia et al compared objective response rates seen with camrelizumab plus famitinib vs camrelizumab alone in previously treated patients with recurrent or metastatic cervical cancer.
Study Details
In the multicenter, open-label trial, patients enrolled between April 2021 and October 2022 were randomly assigned 2:1:2 to receive camrelizumab at 200 mg every 3 weeks plus famitinib at 20 mg once daily; camrelizumab alone; or investigator choice of chemotherapy. Enrollment in the chemotherapy group was stopped early on the basis of external findings, with the intent-to-treat study population thus consisting of 195 patients in the camrelizumab plus famitinib group, 54 in the camrelizumab alone group, and 35 in the chemotherapy group. The primary outcome measure was objective response rate on blinded independent central review for camrelizumab plus famitinib vs camrelizumab alone.
Key Findings
As of April 2023, objective response rates per blinded independent central review were 41.0% (95% confidence interval [CI] = 31.5%–51.0%) in the camrelizumab plus famitinib group vs 24.1% (95% CI = 13.5%–37.6%) in the camrelizumab group (difference = 16.9%, 95% CI = 2.1%–31.7%, P = .0181).
On investigator assessment, objective response rates were 42.9% in the camrelizumab plus famitinib group, 22.2% in the camrelizumab alone group, and 14.3% in the chemotherapy group.
Median progression-free survival on investigator assessment was 8.1 months (95% CI = 6.2–12.4 months) in the camrelizumab plus famitinib group vs 4.1 months (95% CI = 2.1–5.1 months) in the camrelizumab alone group and 2.9 months (95% CI = 2.0–6.2 months) in the chemotherapy group. As of October 2023, median overall survival was 20.2 months (95% CI = 15.3 months to not reached) with camrelizumab plus famitinib, 14.9 months (95% CI = 12.6 months to not reached) with camrelizumab alone, and 13.9 months (95% CI = 7.4–20.0 months) with chemotherapy.
Grade ≥ 3 treatment-related adverse events occurred in 84.8% of the camrelizumab plus famitinib group, 15.1% of the camrelizumab alone group, and 60.0% of the chemotherapy group. The most common events included decreased neutrophils (23.8%), hypertension (22.9%), decreased white blood cells (20.0%), and anemia (20.0%) in the camrelizumab plus famitinib group and increased alanine transaminase (3.8%) in the camrelizumab alone group; grade ≥ 3 immune-related adverse events occurred in 4.8% vs 5.7% of patients.
The investigators concluded: “Camrelizumab plus famitinib improved antitumor activity while exhibiting a manageable safety profile in patients with pretreated [recurrent or metastatic cervical cancer], potentially offering a novel treatment option.”
Xiaohua Wu, MD, PhD, of the Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Jiangsu Hengrui Pharmaceuticals Co, Ltd. For full disclosures of all study authors, visit ascopubs.org.
