Recently, Henlius’ phase 2 clinical study of HANSIZHUANG (serplulimab, anti-PD-1 monoclonal antibody) plus chemotherapy in previously treated patients with programmed death ligand-1 (PD-L1)–positive advanced cervical cancer, was published in Frontiers in Immunology (impact factor 8.786), a leading journal in the field of immunology. The leading principal investigator of the study, who is also the corresponding author of this paper, is Professor Lingying Wu from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
This single-arm, open-label, multicentre, phase 2 study aimed to evaluate the efficacy and safety of serplulimab plus nanoparticle albumin-bound (nab)-paclitaxel in previously treated patients with PD-L1–positive advanced cervical cancer. Patients diagnosed with PD-L1–positive (combined positive score ≥1) cervical cancer were enrolled and given serplulimab 4.5 mg/kg for up to 2 years (35 dosing cycles) plus nab-paclitaxel 260 mg/m2 for up to six cycles once every 3 weeks. Primary endpoints were safety and objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST version 1.1.
By the data cut-off date of 31 December 2021, 21 patients were enrolled. The median duration of follow-up was 14.6 months. IRRC-assessed ORR was 57.1% (95% confidence interval [CI] 34.0–78.2%); 3 patients achieved complete response and 9 partial response. The median duration of response was not reached. IRRC-assessed median progression-free survival was 5.7 months (95% CI 3.0–NA), and median overall survival was 15.5 months (95% CI 10.5–NA). The safety profile of this combination therapy was manageable, with no new safety signals and no serplulimab discontinuation due to treatment-emergent adverse events. Taken together, in previously treated patients with PD-L1–positive advanced cervical cancer, serplulimab plus nab-paclitaxel provided durable clinical activity and a manageable safety profile.
HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer and extensive-stage small cell lung cancer (ES-SCLC), benefiting more than 20,000 Chinese patients. Henlius actively promotes the layout of HANSIZHUANG synergy with in-house products of the company and innovative therapies and has initiated 14 clinical trials on immuno-oncology combination therapies. What’s more, several clinical data of HANSIZHUANG have been recognized by authoritative international journals. The results of the phase 3 clinical study on extensive-stage small cell lung cancer, ASTRUM-005, were published in the Journal of the American Medical Association (JAMA, IF 157.3), one of the top four medical journals in the world, which made ASTRUM-005 the first study published on JAMA in SCLC immunotherapy. The results of the phase 3 clinical study for the first-line treatment of esophageal squamous cell carcinoma (ESCC), ASTRUM-007, was also published in Nature Medicine (IF 87.241), and the NDA was accepted by the NMPA based on the data.
Looking forward, Henlius will actively focus on unmet medical needs to bring more high-quality and affordable therapies to patients worldwide.
AboutFrontiers in Immunology
Frontiers in Immunology is a leading journal in its field, publishing rigorously peer-reviewed research across basic, translational and clinical immunology. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
Frontiers in Immunology is the official journal of the International Union of Immunological Societies (IUIS). Encompassing the entire field of immunology, this journal welcomes papers that investigate basic mechanisms of immune system development and function, with a particular emphasis given to the description of the clinical and immunological phenotype of human immune disorders, and on the definition of their molecular basis.
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the EMA, respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 14 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,500 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA, IF: 157.3), Nature Medicine (IF: 87.241), and the British Journal of Cancer (IF: 9.075), respectively. On the other hand, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. Furthermore, Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.