Gelonghui, May 9 | China Biopharmaceutical (01177.HK) announced that the Group's self-developed, innovative bemosubidumab injection “Benmelstobart (TQB2450)” (trade name: Andevil) has been approved for marketing by the China National Drug Administration and used in combination with anlotinib hydrochloride capsules, carboplatin, and etopogan for first-line treatment of patients with extensive small cell lung cancer (ES-SCLC).
Bemosubimab is a humanized PD-L1 monoclonal antibody independently developed by the Group. It can prevent PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restore activity to T cells, and thereby enhance immune response. A number of early exploratory clinical data proved that bemosubimab combined with anlotinib had a synergistic effect in multiple tumors (such as non-small cell lung cancer, soft tissue sarcoma, renal cell carcinoma, endometrial cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, etc.).
The approval for first-line treatment of small cell lung cancer is based on a randomized, double-blind, placebo-controlled, multicenter, phase III clinical trial (ETER701) of bemosubimab combined with anlotinib, carboplatin, and etopogan for first-line treatment of broad-stage small cell lung cancer.
The results of the ETER701 study were announced at the 2023 World Lung Cancer Conference (WCLC): As of May 14, 2022, the median progression-free survival (mPFs) of bemosubimab combined with anlotinib and chemotherapy and chemotherapy groups was 6.9 months (95% CI: 6.18-8.25) and 4.2 months (95% CI: 4.17-4.24), respectively. The risk of tumor recurrence was reduced by 68%, with significant statistically significant differences. The median overall survival (MoS) of bemosubimab combined with anlotinib and chemotherapy and chemotherapy groups was 19.3 months (95% CI: 14.23-NE) and 11.9 months (95% CI: 10.74-13.37), respectively. The risk of death was reduced by 39%, and the difference was significant statistically significant. In terms of safety, there were no unexpected serious adverse events. Bemosubimab combined with anlotinib and chemotherapy were used in first-line treatment for patients with ES-SCLC, and overall safety was manageable.
Lung cancer is a malignant tumor with a high incidence rate and case fatality rate in China and globally. Among them, small cell lung cancer (SCLC) accounts for 13%-17% of lung cancer [6]. Unlike non-small cell lung cancer, SCLC is more aggressive, has a poor prognosis, and a 5-year survival rate of less than 5% [7], and there is an urgent need for more effective treatment options.