Henlius' anti-PD-1 mAb MRCT achieved 15.38 months OS in first-line treatment of SCLC, reducing the risk of death by 38% of the overall population

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20 Dec, 2021, 13:28 GMT

The ASTRUM-005 states that serplulimab combined with carboplatin-etoposide prolonged median OS in both the overall population and the Asian subgroup, the median overall survival (OS) in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, reducing the risk of death by 38% (41% in the Asian subgroup), p <0.001. The 2-year OS rate (OSR) in the two treatment groups were 43.2% and 8.0%, respectively. Serplulimab also has controllable safety.
Serplulimab is expected to become the first anti-PD-1 mAb in first-line small cell lung cancer treatment, providing a new treatment option for patients. No anti-PD-1 mAb approved to treat extensive-stage small cell lung cancer worldwide.
Keytruda and Opdivo, anti-PD-1 monoclonal antibody products, failed in the first-line of SCLC clinical trial. NDAs for related indications were withdrawn.

SHANGHAI, Dec. 20, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) held its Global R&D Day themed "H-evolution: From Biotech to Biopharma", and released its interim analysis results of Phase 3 clinical study (ASTRUM-005) in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) of serplulimab (novel anti-PD-1 mAb). The study states that serplulimab combined with carboplatin-etoposide prolonged median OS in both the overall population and Asian subgroup.

More than 810,000 new cases are reported in lung cancer (LC) in 2020 in China, in which SCLC is the most malignant subtype, comprising 15%-20% of total cases. Most SCLC patients are in extensive-stage when diagnosed. Their clinical condition deteriorates rapidly with a poor prognosis. In the past 20 years, etoposide combined carboplatin/cisplatin was the SoC for ES-SCLC, but almost all patients with ES-SCLC relapse within one year. Currently, anti-PD-L1 mAb combined with chemotherapy has been recommended by NCCN and CSCO guidelines as the first-line treatment for ES-SCLC. Data showed that the median OS of anti-PD-L1 mAb group was 12-13 months while that of the chemotherapy groups was 10 months . However, the application of immunotherapy in ES-SCLC still faces challenges. Several anti-PD-1 mAbs have failed in the area. More effective first-line treatment of PD-1 inhibitors is urgently needed.

ASTRUM-005 is an international multi-center clinical research and its principal investigator is Professor Ying Cheng, Director of Department of Medical Oncology, Jilin Cancer Hospital. This study has set up around 128 sites in China, Poland, Russia, Turkey, Ukraine, Georgia, etc. 585 subjects were enrolled, of which 31.5% were Caucasian. The enrolled patients were randomised 2:1 to receive intravenous infusion of serplulimab or placebo combined with chemotherapy every-3-week. The primary endpoint is OS, and the secondary endpoints include progression-free survival (PFS), safety, etc.

By the cut-off date (10/22/2021), 585 eligible subjects were enrolled with a median follow-up of 12.3 months. The median OS in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, with a hazard ratio (HR) of 0.62, p <0.001. The 2-year OSR in the two treatment groups were 43.2% and 8.0%, respectively. In Asian subgroup, the median OS were 16.03 versus 11.10 months, with a hazard ratio of 0.59, p<0.001. The results demonstrated that serplulimab combined with carboplatin-etoposide as first-line therapy significantly improved OS in ES-SCLC patients with controllable safety. On December 7, the Independent Data Monitoring Committee (IDMC) conducted an interim analysis and suggested that the company can hence communicate with healthy authority.

Henlius will proceed to file the regulatory applications for this indication soon with the promising data. In the future, the company will proactively promote the combination immunotherapy of serplulimab to benefit more patients around the world.