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Endometrial and Cervical Cancer Treatments / HER2/EGFR in Cancer Research · Journal article
Frontiers in Immunology · August 18, 2026
Encouraging direction, but not yet definitive.
ASTRUM-CC01 is a single-arm phase II trial demonstrating an ORR of 75% and median PFS of 21.23 months with serplulimab plus bevacizumab and chemotherapy in 43 evaluable patients with recurrent or metastatic cervical cancer. Overall survival data are immature; the 12-month OS rate was 83.97%. These results are encouraging but require phase III confirmation with a control arm before guiding routine practice.
Multicenter, single-arm, phase II trial. Adults aged 18–75 with recurrent or metastatic cervical cancer and no prior systemic therapy. 48 patients enrolled; 43 evaluable for efficacy.. Intervention: Serplulimab combined with bevacizumab, cisplatin, and paclitaxel: 4–6 induction cycles followed by maintenance serplulimab and bevacizumab.. n = 43. Multicenter; specific locations not stated in the source text..
ORR was 75.00% (95% CI, 60.40–86.36) in 43 evaluable patients DCR was 89.58% (95% CI, 77.34–96.53) Median PFS was 21.23 months (95% CI: 14.43–NR)
Fistula incidence of 10.42% is notable and may warrant monitoring; longer follow-up needed for delayed toxicities. Grade ≥3 adverse events in 21 patients (43.75%); fistula in 5 patients (10.42%)
These phase II results are promising but preliminary. Clinicians should await phase III data with a control arm before adopting serplulimab in place of established checkpoint inhibitor regimens. The median PFS of >21 months and ORR of 75% suggest activity, but the single-arm design cannot confirm superiority or establish the optimal role relative to existing options.
Single-arm phase II trial showing encouraging ORR and PFS in a small cohort, but lacks a control arm and mature OS data; results warrant phase III confirmation but do not yet change practice.
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Quoted from the source exactly as published.
These phase II results are promising but preliminary. Clinicians should await phase III data with a control arm before adopting serplulimab in place of established checkpoint inhibitor regimens. The median PFS of >21 months and ORR of 75% suggest activity, but the single-arm design cannot confirm superiority or establish the optimal role relative to existing options.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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.
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