Camrelizumab Combo Extends Survival in Metastatic Cervical Cancer

Camrelizumab in combination with famitinib produced superior progression-free survival (PFS) outcomes versus platinum-based chemotherapy for the frontline treatment of patients with recurrent or metastatic cervical cancer, according to data from a phase 3 trial presented during the 2025 ESMO Congress.

At the June 10, 2025, data cutoff, at a median follow-up of 19.3 months, the median progression-free survival (PFS) per blinded independent central review (BICR) was 11.1 months in the combination arm (220 patients) compared with 7.5 months in the chemotherapy arm (223 patients). The median PFS values per investigator assessment were 11.3 months and 7.7 months, respectively.

“The chemotherapy-free regimen of camrelizumab/famitinib significantly prolonged PFS and overall survival [OS] compared with platinum-based chemotherapy with or without bevacizumab [Avastin] as first-line treatment in recurrent/metastatic cervical cancer,” Dr. Xiaohua Wu, chief physician, professor and supervisor of oncology, as well as the chairman and chief expert in the Department of Gynecologic Oncology at Fudan University Shanghai Cancer Center in China, said during the presentation. “This regimen met the dual primary end points at interim analysis.”

How was the phase 3 trial designed and what were the baseline characteristics?

The open-label, controlled, multicenter study enrolled patients with histopathologically confirmed, recurrent or metastatic squamous cell carcinoma of the cervix. Patients were required to not be amenable to curative therapy, surgery, radiotherapy or chemoradiotherapy and could not have received prior systemic therapy for recurrent or metastatic disease. Other key inclusion criteria included having at least one measurable tumor lesion according to RECIST 1.1 criteria and an ECOG performance status of 0 or 1.

Patients were randomly assigned one-to-one to receive intravenous (IV) camrelizumab at 200 milligrams (mg) every three weeks for up to 35 cycles plus oral famitinib at 20 milligrams daily, or platinum-based chemotherapy every three weeks for up to 6 cycles with or without IV bevacizumab at 15 milligrams per square meter every three weeks. Stratification was performed by PD-L1 combined positive score (CPS; greater than or equal to 1 versus less than 1) and prior use of platinum (yes versus no).

The dual primary end points were BICR-assessed PFS per RECIST 1.1 criteria and overall survival (OS). Secondary end points included investigator-assessed PFS, overall response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR) and safety.

At baseline, the median ages in the combination and chemotherapy arms were 55 years and 54 years, respectively. Most patients in these respective arms had a PD-L1 CPS of at least 1 (93.2% versus 92.8%), had metastatic disease (97.7% versus 97.3%), had received prior platinum-containing therapy (70.9% versus 70%) and had received prior therapy (95.5% versus 96%). At diagnosis, patients had stage 1 (15.9% versus 13.9%), 2 (32.7% versus 35.4%), 3 (38.2% versus 37.2%), 4A (0.5% versus 1.8%), 4B (8.2% versus 8.1%) or unknown (4.5% versus 3.6%) disease. Prior therapies included surgery (48.2% versus 44.8%), radiotherapy (85.5% versus 88.3%) and systemic anticancer treatment (86.8% versus 85.7%); 30.9% of patients in the chemotherapy arm received bevacizumab during the study.

What were the additional efficacy data and safety profile of the combination?

The median OS in the combination arm was 34.4 months compared with 23.4 months in the chemotherapy arm. Findings from a subgroup analysis revealed that the PFS benefit in favor of the combination arm was reported in all prespecified subgroups except for the subgroup of patients with a PD-L1 CPS of less than 1. The OS benefit with the combination was reported in all prespecified subgroups.

The BICR-assessed confirmed ORR in the combination arm was 52.3% versus 46.6% in the chemotherapy arm, including respective complete response rates of 10.9% and 8.5%. The confirmed DCRs were 81.8% and 77.6%, respectively. The median DORs were 17.9 months and 8.3 months, respectively, and the respective median TTRs were 2.2 months and 2.1 months.

In terms of safety, any-grade treatment-emergent side effects occurred in 99.5% of patients in the combination arm and 99.1% of patients in the chemotherapy arm. Patients in both arms experienced grade 3 to 5 treatment-related side effects (87.3% versus 67.1%), serious treatment-related side effects (34.5% versus 19.2%), as well as side effects leading to treatment discontinuation (13.6% versus 6.6%), dose interruption (83.6% versus 37.6%) and dose reduction (65% versus 12.2%). Patients in the combination arm experienced any-grade immune-related (38.2%) and grade 3 to 5 immune-related (7.3%) side effects; no such events were reported in the chemotherapy arm.

The most common any-grade side effects in the combination arm included decreased white blood cell count (79.5%), decreased neutrophil count (75%) and anemia (70%). These were also the most common any-grade side effects in the chemotherapy arm, occurring at respective rates of 73.7%, 70% and 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 said in his conclusion.

References

1. “Phase 3 study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer” by Dr. Xiaohua Wu, et al., ESMO Congress.
2. “Camrelizumab combined with famitinib malate for treatment of recurrent/metastatic cervical cancer” by Dr. Xiaohua Wu, et al., ClinicalTrials.gov.

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