Serplulimab combined with bevacizumab and chemotherapy as first-line treatment for recurrent or metastatic cervical cancer (ASTRUM-CC01): a phase II trial

Background Cervical cancer is one of the leading causes of cancer-related mortality among women worldwide. While immune checkpoint inhibitors combined with bevacizumab and chemotherapy are emerging as the standard first-line therapy for recurrent or metastatic (R/M) cervical cancer, substantial unmet needs remain. Methods ASTRUM-CC01 (NCT05444374) is a multicenter, single-arm, phase II trial. Eligible patients were aged 18–75 and had no prior systemic treatment. Patients received 4–6 cycles of serplulimab and bevacizumab combined with cisplatin and paclitaxel, followed by maintenance serplulimab and bevacizumab. The primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety. Results A total of 48 patients were enrolled; 43 were evaluable for efficacy. The ORR was 75.00% (95% CI, 60.40-86.36), and the disease control rate (DCR) was 89.58% (95% CI, 77.34-96.53) in the overall population. The median PFS was 21.23 months (95% CI: 14.43-NR); OS data were immature, with an estimated 12-month OS rate of 83.97% (95% CI: 73.66-95.72). Subgroup analysis indicated that high baseline clinical stage at initial diagnosis was a risk factor for PFS (HR = 3.01, P = 0.023); other baseline characteristics, including PD-L1 expression levels and the location of recurrence, did not significantly correlate with survival. No new safety signals were observed. Grade ≥r adverse events occurred in 21 patients (43.75%), including fistula events in 5 patients (10.42%). Conclusion First-line treatment with serplulimab in combination with bevacizumab and chemotherapy demonstrated promising antitumor activity and acceptable safety in R/M cervical cancer. These findings support further evaluation in phase III trials.