Recurrent or metastatic cervical cancer (RMCC) remains one of the most challenging malignancies to treat, with median overall survival rarely exceeding 13 to 17 months despite recent advances. Since the landmark KEYNOTE-826 study, Merck & Co’s Keytruda (pembrolizumab) in combination with platinum-based chemotherapy with or without Roche’s Avastin (bevacizumab) has become the global first-line standard delivering sustained overall survival (OS) and progression-free survival benefits in PD-L1 positive populations. However, continued reliance on cytotoxic chemotherapy limits tolerability and access, particularly in regions where infusion-based treatment poses logistical and economic barriers.
This has driven clinical interest in chemotherapy-sparing strategies that maintain efficacy while improving quality of life and treatment convenience. At the 2025 European Society for Medical Oncology (ESMO) Congress 2025, held between 17 October and 21 October in Berlin, Germany, results from the Phase III (NCT04906993) study were presented, evaluating Jiangsu Hengrui Pharmaceuticals’ camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for RMCC. Conducted across multiple centres in China, this randomised, open-label study examined whether simultaneous inhibition of PD-1 and VEGF signalling could produce comparable outcomes to chemotherapy with reduced toxicity.
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Camrelizumab, a PD-1 inhibitor, and famitinib, an oral multikinase inhibitor of VEGFR/PDGFR/c-Kit, form a biologically synergistic combination. By blocking VEGF-mediated immunosuppression, famitinib can normalise tumour vasculature [the arrangement of blood vessels] and enhance T-cell infiltration, augmenting the anti-tumour effects of PD-1 blockade. Earlier phase II data in pretreated cervical cancer showed an objective response rate of 55% and a manageable safety profile supporting progression to phase III testing.
At a median follow-up of 19.3 months, camrelizumab plus famitinib significantly improved PFS compared with chemotherapy (11.1 vs 7.5 months; HR 0.68; 95% CI, 0.53-0.86; one-sided p=0.0007) and achieved a notable OS benefit (34.4 vs 23.4 months; HR 0.65; 95% CI, 0.49-0.86; one-sided p=0.0012). The combination demonstrated consistent efficacy across PD-L1-positive and -negative subgroups, with 93% of patients having a PD-L1 combined positive score (CPS) ≥1. Safety findings were consistent with the known profiles of PD-1 and VEGF inhibitors. Grade ≥3 treatment-related adverse events occurred in 87.3% vs 67.1% of patients, while discontinuation rates were 13.6% vs 6.6% for the experimental and control arms, respectively. Hypertension, proteinuria and hand-foot syndrome were the most frequent toxicities, though cytopenias and gastrointestinal effects were lower than with chemotherapy and were generally manageable through dose adjustments and supportive care.
These results suggest the potential for a chemo-free regimen offering durable disease control and outpatient convenience. While the trial met its primary endpoint, direct comparisons with global standards such as KEYNOTE-826 should be made carefully. Differences in patient populations, including higher proportions of locally advanced or previously untreated metastatic disease in the Chinese cohort, may limit generalisability. The open-label design also raises the potential for investigator bias in PFS assessment.
Dr Domenica Larusso, director of the gynaecological oncology unit at Humanitas Hospital San Pio X, noted limitations in the control arm as there was a low use of Avastin of 30% and the absence of immunotherapy. However, consistent efficacy across PD-L1 subgroups supports a distinct biologic mechanism, reinforcing the rationale for targeting VEGF-mediated immune suppression in cervical cancer. The dual immune-angiogenic strategy may also extend to tumours resistant to prior immune checkpoint blockade.
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By GlobalDataCamrelizumab is already approved in China across multiple indications, while famitinib holds approval for RMCC. If the study results translate into regulatory approval, the regimen could gain rapid adoption across China and other Asia-Pacific markets where oral and outpatient therapies are favoured. International uptake will depend on comparative durability, tolerability with chronic VEGF inhibition and pricing advantages over imported agents. According to GlobalData’s analyst consensus forecast, camrelizumab and famitinib are projected to achieve global annual sales of $463 million and $108 million by 2031, respectively. This is supported by continued label expansions and novel combination strategies. Should survival data mature positively, the camrelizumab and famitinib regimen could emerge as a highly validated chemo-free immune-antiangiogenic option for RMCC, offering a meaningful advance in both treatment accessibility and therapeutic innovation.
