NMPA approves Hansizhuang for extensive stage small cell lung cancer
Shanghai Henlius Biotech announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) Hansizhuang (serplulimab injection), in combination with carboplatin and etoposide for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC), has been approved by the National Medical Products Administration (NMPA), making it the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC)
Hansizhuang had already been approved for the treatment of Microsatellite Instability-High (MSI-H) solid tumors and squamous non-small cell lung cancer (sqNSCLC).
The approval was primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-center phase III clinical study. The study has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. The results of ASTRUM-005 were presented in oral for the first time at the 2022 ASCO annual meeting and the results were updated at the 2022 European Society for Medical Oncology Asia (ESMO Asia) Congress in December 2022. In September 2022, the results of ASTRUM-005 had been published in The Journal of the American Medical Association (JAMA, impact factor of 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, demonstrating the high level of academic acclaim on a global scale.
According to the study analysis, the median OS was significantly longer in the serplulimab group (15.8 months) than in the placebo group (11.1 months), and a 38% reduction in risk of death was observed in the serplulimab group compared with the placebo group. The Asians subgroup also showed a 4.8 months longer median OS in the serplulimab group. Median PFS assessed by the independent radiology review committee per RECIST v1.1 was prolonged with the addition of serplulimab (5.8 vs. 4.3 months). The results indicated that Hansizhuang (serplulimab injection) in combination with chemotherapy (Carboplatin-Etoposide) could bring significant benefits against chemotherapy (Carboplatin-Etoposide) in the treatment of previously untreated patients with ES-SCLC, met the pre-defined primary endpoint criteria, and had good safety and tolerability. Hansizhuang could potentially bring more significant benefits to Asian patients.
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