The Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer is holding on March 18 - 21, in Phoenix, Arizona. SGO is a comprehensive forum for the subspecialty of gynecologic oncology. At the meeting, the Phase 2 clinical trial (HLX10-011-CC201) of serplulimab (novel anti-PD-1 monoclonal antibody) combined with chemotherapy in patients with advanced cervical cancer was selected as an oral presentation. Professor Jusheng An from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, presented the results of HLX10-011-CC201 online, which demonstrated encouraging efficacy and a manageable safety profile of serplulimab in advanced cervical cancer patients.
Serplulimab (novel anti-PD-1 mAb) is the first innovative monoclonal antibody (mAb) developed by Henlius. Up to now, 2 New Drug Applications (NDA) of serplulimab for the treatment of MSI-H solid tumors and squamous non-small cell lung cancer (sqNSCLC) have been accepted by the NMPA and are expected to be approved in 2022. Furthermore, the international multi-center Phase 3 study of serplulimab in combination with chemotherapy in previously untreated extensive small-cell lung cancer (ES-SCLC) met the primary endpoint of overall survival (OS) with remarkable readouts and its NDAs in China and the EU are expected to be submitted in 2022, making serplulimab potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Henlius actively promotes serplulimab synergy with in-house products of the company and innovative therapies, and has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to conduct 10 clinical trials on immuno-oncology therapies of serplulimab, covering a wide range of indications of lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc. Up to date, the company has enrolled more than 2800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs. Serplulimab is one of the anti-PD-1 mAbs with relatively rich international clinical data.
Title: Efficacy and safety of serplulimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy
Form: Oral presentation
Leading PI: Lingying Wu, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Presenter: Jusheng An, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Platform: SGO 2022 Annual Meeting on Women’s Cancer online platform, Scientific Plenary III: Novel Therapeutics
Study Design
This is a single-arm, open-label, multi-centre, phase 2 study, aimed to evaluate the clinical efficacy, safety and tolerability of serplulimab in combination with albumin-bound paclitaxel for the treatment of advanced cervical cancer patients who have failed to respond to the first-line standard chemotherapy. Eligible patients were enrolled and given intravenous infusion of serplulimab (4.5 mg/kg) plus albumin-bound paclitaxel (260 mg/m2) every 3 weeks. The primary endpoints were objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1 and safety.
Results
By cut-off date of 31 December 2021, 21 patients were enrolled with an average Combined Positive Score (CPS) of 39.3. The median duration of follow-up was 14.6 months (range: 0.2–21.7). The ORR assessed by IRRC was 57.1% (95% CI: 34.0, 78.2; 3 CR, 9 PR). The median DoR have not been reached. The median progression-free survival (PFS) assessed by IRRC was 5.7 months (95% CI: 3.0, NA); 12-month PFS rate was 48.2% (95% CI: 23.3, 69.5). The median overall survival (OS) was 15.5 months (95% CI: 10.5, NA); 12-month OS rate was 71.1% (95% CI: 46.6, 85.9). 17 patients experienced grade 3 or worse treatment-emergent adverse events (TEAEs), most commonly neutrophil count decreased (n=7, 33.3%), white blood cell count decreased (n=6, 28.6%), and anaemia (n=5, 23.8%). No TEAEs leading to serplulimab discontinuation were reported during the study.
Conclusion
The results demonstrated a manageable safety profile and encouraging efficacy of serplulimab plus albumin-bound paclitaxel in advanced cervical cancer patients who have failed to respond to first-line standard chemotherapy.