2021 CSCO | Henlius Publishes Newest Phase II Clinical Data of Novel Anti-PD-1 mAb Serplulimab for Treatment of Advanced Cervical Cancer

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.


  • 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.


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.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDAs) of 3 products accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has proactively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康 (rituximab), the first China-developed biosimilar, 汉曲优 (trastuzumab, Zercepac in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远 (adalimumab), the Company's first product indicated for autoimmune diseases, the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX04 (bevacizumab), HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What's more, Henlius has conducted over 20 clinical studies for 11 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.