The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) is held online and in-person from 25th to 29th September 2021. In this meeting, Henlius releases phase 2 study results of serplulimab (HLX10, novel anti-PD-1 antibody), in patients with advanced cervical cancer in an oral presentation. In April, the New Drug Application (NDA) of serplulimab for the treatment of MSI-H solid tumours was accepted by the National Medical Products Administration (NMPA) and granted priority review, which is expected to be approved in the first half of 2022. What's more, the NDA of serplulimab for the treatment of squamous non-small cell lung cancer is also under review.
With the "Combo+Global" strategy, serplulimab has been approved for clinical trials in China, the United States, the European Union, as well as other countries and regions. To evaluate the safety and efficacy of serplulimab, Henlius has conducted 10 immuno-oncology therapy clinical studies covering cancers with high incidence rates, including lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, etc. Up to date, about 2300 patients have been enrolled worldwide, proving that the quality of serplulimab has built trust in foreign markets.
Details of this study are as follows:
Title: Phase 2 study of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) plus albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy (ID: 9943)
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
Form: Oral presentation
Presenter: Jusheng An, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Time: 2021.09.26 15:24–15:30, Parallel Session 5, Cervical and endometrial cancer session
Study design
This single-arm, open-label, multi-centre, phase 2 study aimed to evaluate the clinical efficacy, safety and tolerability of HLX10 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 HLX10 (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
Efficacy-Primary endpoint
By cut-off date of 15 July 2021, 21 patients were enrolled with an average Combined Positive Score (CPS) of 39.3. The median duration of follow-up was 12.5 months (range: 0.2–16.2). The ORR assessed by IRRC and investigators were 57.1% (95% CI: 34.0, 78.2; 2 CR, 10 PR) and 47.6% (95% CI: 25.7, 70.2; 10 PR), respectively.
Efficacy-Secondary endpoints
Secondary efficacy endpoints included ORR assessed by investigators, overall survival (OS), duration of response (DoR), and progression-free survival (PFS). Median PFS assessed by IRRC was 5.7 months (95% CI: 3.0, NR); median DoR and OS have not been reached.
Safety
The results demonstrated that HLX10 was safe and well-tolerated.
Conclusion
The results demonstrated a manageable safety profile and encouraging efficacy of HLX10 plus albumin-bound paclitaxel in advanced cervical cancer patients who have failed to respond to first-line standard chemotherapy.