China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its New Drug Application (NDA) filing for the combination of its anti-PD-L1 monoclonal antibody (mAb) TQB2450 and anlotinib has been accepted for review by the Center for Drug Evaluation (CDE). The Phase III study for this combination in first-line small cell lung cancer (SCLC) has reached its pre-set endpoints and completed interim analysis, marking a significant step forward in the treatment of this aggressive cancer.
Small Cell Lung Cancer: A Challenging Landscape
Small cell lung cancer (SCLC) accounts for 15-20% of all lung cancers and is distinct from non-small cell lung cancer (NSCLC) in terms of tissue origin, biological characteristics, treatment response, and prognosis. SCLC is highly invasive, with a poor prognosis and a five-year survival rate of less than 5%. This underscores the urgent need for new and effective therapies to improve patient outcomes.
Mechanism and Clinical Progress of Anlotinib
Anlotinib is an oral multi-target kinase inhibitor that acts against VEGFR, PDGFR, FGFR, and c-Kit, generating anti-angiogenic effects and inhibiting tumor growth. The drug received marketing approval in China in August 2019 for the treatment of SCLC patients who had previously received at least two systemic chemotherapies. Over 20 Phase II and III clinical studies are currently underway, further exploring the potential of anlotinib in various cancer types.
Synergistic Potential of TQB2450-Anlotinib Combination
Early exploratory studies have demonstrated that the combination of TQB2450 and anlotinib exhibits a synergistic effect in multiple tumor types, including NSCLC, soft tissue sarcoma, renal cell carcinoma, endometrial carcinoma, ovarian cancer, hepatocellular carcinoma, and cholangiocarcinoma. This combination therapy aims to enhance treatment efficacy by leveraging the complementary mechanisms of action of both drugs.
Implications for Future Cancer Treatments
The acceptance of the NDA filing by the CDE highlights Sino Biopharmaceutical’s commitment to advancing innovative cancer therapies. If approved, the TQB2450-anlotinib combination could offer a new treatment option for patients with SCLC, addressing significant unmet needs in this challenging disease area. The ongoing clinical studies will continue to provide valuable insights into the potential applications of this combination across multiple cancer types.-Fineline Info & Tech
