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Envafolimab in Combination with Lenvatinib for the Treatment of Endometrial Cancer Granted Implied License for Clinical Trials

Release time:2021-09-15

On September, 14, Simcere Pharmaceutical Group Limited (2096.HK) announced that the clinical trials application for Envafolimab in combination with Lenvatinib Mesylate in the treatment of endometrial cancer has been granted approval by NMPA(National Medical Products Administrationvia an implied license.  This comes as part of Simcere's strategic partnership with 3D Medicines Inc. and Alphamab Oncology (9966.HK). 

Specifically, the combination treatment will be clinically studied to treat patients with locally advanced endometrial cancers which have previously failed or been intolerant to at least first-line platinum-based chemotherapies. The clinical trial also targets such cancer patients who have conditions unsuitable for radical treatment, or with metastatic or recurrent non-microsatellite highly unstable (non- MSI-H )/non- DNA mismatch repair defect (non-d MMR) disease. This is the second clinical trial approved for this combination treatment following its previous approval towards advanced malignant solid tumors.

Endometrial cancer is the most commonly diagnosed gynecologic cancer. For patients who are diagnosed with advanced stages of the cancer and have very limited treatment options, or those with recurrent or metastasis disease post-treatment, new treatment options are urgently needed to provide second and third-line treatments.

Envafolimab is a novel fusion protein of a humanized single-domain PD-L1 antibody and human immunoglobulin IgG1 Fc fragment. As expected to be the world's first single-domain PD-L1 antibody formulated for subcutaneous injection, Envafolimab has already had its NDA application submitted to the NMPA. Relevant indications of the treatment include microsatellite instability (MSI-H)/deficient MisMatch Repair (dMMR) advanced colorectal cancer, gastric cancer, and other advanced solid tumors that have previously failed standard treatments.

Lenvatinib Mesylate is a generic small-molecule anti-angiogenic drug developed by Simcere. It has been approved for treatment of hepatocellular carcinoma since July 2021. As an oral multi-kinase 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) receptors and platelet-derived growth factor (PDGF) receptors, among others.

Several international clinical studies have shown that combination treatments of anti-angiogenesis targeted drugs and immunotherapy can remarkably improve patient outcomes. The use of Lenvatinib has also been approved in the United States to be used in combination with the PD-1 inhibitor Keytruda for treatment of advanced endometrial cancer. The combination of Lenvatinib, which is administered orally, and Envafolimab which is administered by subcutaneous injection, is more convenient for clinical use compared to other intravenous PD-1 and PD-L1 antibodies. This strategy may further enhance patient compliance, and enable better chronic disease 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.