{
  "abstract": "Background Cervical cancer is one of the leading causes of cancer-related mortality among women worldwide. While recent phase III trials have established PD-1 blockade combined with bevacizumab and chemotherapy as a new standard first-line therapy for recurrent or metastatic cervical cancer, substantial global unmet needs remain. Serplulimab is a multinational marketed anti-PD-1 mAb with broad antitumor activity across multiple tumor types. However, its efficacy in cervical cancer has not been established. Here, we report the pilot phase II trial results, evaluating the preliminary activity of serplulimab in combination with HLX04 (a bevacizumab biosimilar) and chemotherapy as first-line treatment for cervical cancer.Methods ASTRUM-CC01 ( NCT05444374) is a multicenter, single-arm, phase II trial. Eligible patients were aged 18-75, with pathologically confirmed advanced cervical cancer (regardless of PD-L1 status), and no prior systemic treatment for recurrent or metastatic disease. Patients will receive 4-6 cycles of serplulimab and bevacizumab combined with cisplatin and paclitaxel, followed by maintenance serplulimab and bevacizumab (up to 2 years). The primary endpoint is objective response rate (ORR); secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.Results A total of 48 patients received at least one dose of study treatment, with 6 patients (12.5%) had de novo metastatic disease at enrollment. The median follow-up was 19.0 months (range, 0.4-24.1). The median age was 54 years (range, 25-68), with 85.4% (n=41) had squamous cell carcinoma, and PD-L1 negativity was observed in 47.9% (n=23) of patients. The ORR was 75.0% (95% CI, 60.4-86.4), with 36 patients achieving partial response and 7 having stable disease, and the DCR was 89.6% (95% CI, 77.3-96.5). The median PFS was not reached (NR), with a lower 95% CI bound of 15.4 months, and the estimated 12-month PFS rate was 75.2% (95% CI, 62.9-90.0). Subgroup analysis revealed no statistically significant differences in PFS between patients with squamous vs. adenocarcinoma histology, PD-L1-positive vs. negative tumors, or in-field vs. out-of-field recurrence after radiotherapy (all log-rank p > 0.05). OS data were immature, with 11 deaths reported at the time of data cutoff. Treatment-emergent adverse events (TEAEs) occurred in 93.8% (n=45) of patients. Serious adverse events (SAEs) related to serplulimab or bevacizumab (HLX04) were reported in 8 patients (16.7%).Conclusions First-line treatment with serplulimab in combination with bevacizumab and chemotherapy demonstrated promising antitumor activity and acceptable safety in patients with recurrent or metastatic cervical cancer. These findings support further evaluation in phase III trials.Trial Registration NCT05444374Ethics Approval This study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol and all amendments were approved by the institutional ethics committee at each participating site. The trial was registered on ClinicalTrials.gov ( NCT05444374). All patients provided written informed consent before enrollment, including consent for data collection and publication of anonymized data.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.",
  "authors": [
    {
      "affiliations": [
        "Sichuan Cancer Hospital and Institute, Chengdu, China"
      ],
      "name": "Guonan Zhang"
    },
    {
      "affiliations": [
        "Sichuan Cancer Hospital and Institute, Chengdu, China"
      ],
      "name": "Hong Liu"
    },
    {
      "affiliations": [
        "Sichuan Cancer Hospital and Institute, Chengdu, China"
      ],
      "name": "Dengfeng Wang"
    },
    {
      "affiliations": [
        "Hunan Cancer Hospital, Changsha, China"
      ],
      "name": "Jie Tang"
    },
    {
      "affiliations": [
        "Liaoning Cancer Hospital and Institute, Shenyang, China"
      ],
      "name": "Chunyan Wang"
    },
    {
      "affiliations": [
        "Linyi Cancer Hospital, Linyi, China"
      ],
      "name": "Xiumin Li"
    },
    {
      "affiliations": [
        "Harbin Medical University Cancer Hospital, Harbin, China"
      ],
      "name": "Ge Lou"
    }
  ],
  "title": "1349 Serplulimab combined with bevacizumab and chemotherapy as first-line treatment for recurrent or metastatic cervical cancer (ASTRUM-CC01): a phase II trial",
  "uid": "bd486a0e-e3f8-5912-bea9-6d39a0049544"
}