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.