Camrelizumab-Famitinib Combination Demonstrates Superior Survival Outcomes in Metastatic Cervical Cancer
Key Insights
A phase 3 trial showed that camrelizumab plus famitinib significantly extended progression-free survival to 11.1 months compared to 7.5 months with platinum-based chemotherapy (search) in recurrent or metastatic cervical cancer (search) patients.
The chemotherapy-free combination also improved overall survival to 34.4 months versus 23.4 months with standard treatment, meeting both dual primary endpoints at interim analysis.
The treatment demonstrated a manageable safety profile with higher rates of treatment-related adverse events but provided durable responses with median duration of 17.9 months compared to 8.3 months for chemotherapy.
A chemotherapy-free combination of camrelizumab and famitinib demonstrated superior efficacy compared to platinum-based chemotherapy (search) as first-line treatment for patients with recurrent or metastatic cervical cancer (search), according to phase 3 trial results presented at the 2025 ESMO Congress.
The open-label, controlled, multicenter study enrolled 443 patients with histopathologically confirmed, recurrent or metastatic squamous cell carcinoma (search) of the cervix who were not amenable to curative therapy and had not received prior systemic therapy for recurrent or metastatic disease. At a median follow-up of 19.3 months, the combination met both dual primary endpoints with statistically significant improvements in progression-free survival and overall survival.
Primary Efficacy Outcomes
The median progression-free survival per blinded independent central review was 11.1 months in the combination arm (220 patients) compared with 7.5 months in the chemotherapy arm (223 patients), representing a 32% reduction in risk of disease progression or death (stratified HR, 0.68; 95% CI, 0.53-0.86; P = .0007). Investigator-assessed progression-free survival showed even greater benefit, with median values of 11.3 months versus 7.7 months respectively (stratified HR, 0.62; 95% CI, 0.49-0.79; P < .0001).
"The chemotherapy-free regimen of camrelizumab/famitinib significantly prolonged PFS and overall survival compared with platinum-based chemotherapy (search) with or without bevacizumab as first-line treatment in recurrent/metastatic cervical cancer (search)," said Dr. Xiaohua Wu, chief physician and professor at Fudan University Shanghai Cancer Center in China. "This regimen met the dual primary end points at interim analysis."
The overall survival benefit was substantial, with median overall survival reaching 34.4 months in the combination arm compared to 23.4 months in the chemotherapy arm (stratified HR, 0.65; 95% CI, 0.49-0.86; P = .0012).
Treatment Protocol and Patient Characteristics
Patients were randomly assigned to receive either intravenous camrelizumab at 200 mg every three weeks for up to 35 cycles plus oral famitinib at 20 mg daily, or platinum-based chemotherapy (search) every three weeks for up to 6 cycles with or without intravenous bevacizumab at 15 mg/m² every three weeks. Stratification was performed by PD-L1 (search) combined positive score and prior platinum use.
The study population had a median age of 55 years in the combination arm and 54 years in the chemotherapy arm. Most patients had PD-L1 (search) combined positive scores of at least 1 (93.2% versus 92.8%), metastatic disease (97.7% versus 97.3%), and had received prior platinum-containing therapy (70.9% versus 70%). Approximately 31% of patients in the chemotherapy arm received bevacizumab during the study.
Secondary Efficacy Endpoints
The combination demonstrated superior response rates, with a confirmed overall response rate of 52.3% versus 46.6% in the chemotherapy arm, including complete response rates of 10.9% and 8.5% respectively. Disease control rates were 81.8% and 77.6% respectively.
Notably, the duration of response was substantially longer with the combination therapy, with a median duration of 17.9 months compared to 8.3 months for chemotherapy. Time to response was similar between arms at approximately 2.2 months.
Subgroup analysis revealed that the progression-free survival benefit favored the combination arm in all prespecified subgroups except for patients with PD-L1 (search) combined positive scores less than 1. The overall survival benefit was consistent across all prespecified subgroups.
Safety Profile
The safety profile showed manageable toxicity despite higher rates of treatment-related adverse events in the combination arm. Any-grade treatment-emergent adverse effects occurred in 99.5% of combination patients versus 99.1% of chemotherapy patients. Grade 3 to 5 treatment-related adverse events were more frequent with the combination (87.3% versus 67.1%), as were serious treatment-related adverse events (34.5% versus 19.2%).
Treatment modifications were more common in the combination arm, with higher rates of discontinuation (13.6% versus 6.6%), dose interruption (83.6% versus 37.6%), and dose reduction (65% versus 12.2%). The combination arm experienced immune-related adverse events in 38.2% of patients (any grade) and 7.3% (grade 3-5), while no immune-related events were reported in the chemotherapy arm.
The most common adverse events in both arms included decreased white blood cell count (79.5% combination versus 73.7% chemotherapy), decreased neutrophil count (75% versus 70%), and anemia (70% versus 75.6%).
"The safety profile was manageable. These study findings show that camrelizumab plus famitinib could serve as a novel first-line treatment option for this patient population," Wu concluded.