On June 17, Simcere Pharmaceutical Group Limited (2096.HK) announced that the clinical trial application for Envafolimab in combination with Lenvatinib Mesylate in treating advanced malignant solid tumors, has been approved by the National Medical Products Administration (NMPA). This came as part of a strategic partnership with 3D Medicines Inc. and Alphamab Oncology (9966.HK).
The multicenter, open-label, Phase Ib/II clinical study aims to evaluate the effectiveness of Envafolimab, in combination with Lenvatinib, in treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) but are resistant to treatment with other PD-1/PD-L1 inhibitors. It can also be applied to patients with locally advanced or metastatic RCC, who have not previously received systemic treatment for advanced disease.
Envafolimab is a novel fusion protein of a humanized single-domain PD-L1 antibody and human immunoglobulin IgG1 Fc fragment. As the first expected single-domain PD-L1 antibody formulated for subcutaneous injection, Envafolimab has already submitted NDA application to the NMPA, for indications of microsatellite instability (MSI-H)/deficient MisMatch Repair (dMMR) advanced colorectal cancer, gastric cancer, and other advanced solid malignancies that have previously failed in standard treatments.
Lenvatinib Mesylate is a generic small-molecule anti-angiogenic drug developed by Simcere. The ANDA application for treatment of hepatocellular carcinoma with Lenvatinib Mesylate has been submitted and is expected to obtain approval in the near future. As an oral multikinase inhibitor, Lenvatinib is highly selective in inhibiting the kinase activity of vascular endothelial growth factor (VEGF) receptors and other receptor tyrosine kinases (RTKs) associated with angiogenesis and carcinogenic pathways, including fibroblast growth factor (FGF) receptor, platelet-derived growth factor (PDGF) receptor, etc.
Results of preclinical studies have shown that Envafolimab, when combined with Lenvatinib, has a synergistic anti-tumor effect. In a humanized mouse MC38-hPD-L1 xenograft model， monotherapy treatment with either Envafolimab or Lenvatinib, and the combination of both compound have displayed remarkable anti-tumor effects，though the most significant anti-tumor effect was observed in the combination group. No significant increase in toxicity was observed.
The latest approval marks the world's first clinical study of the combination of subcutaneously injected PD-L1 antibody and anti-angiogenic targeted therapy drug. In terms of drug administration, Envafolimab is more stable and convenient to use than other intravenously administered PD-1/PD-L1 inhibitors that have been approved to be available in the market，thus resulting in high patient compliance. This also enables the realization of better tumor chronic care management for cancer patients.
Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.