NMPA Accepts Kelun-Biotech's Third NDA for TROP2-ADC SKB264 in EGFR-mutant NSCLC

CHENGDU, China, October 31, 2024 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that its new drug application (NDA) for sacituzumab tirumotecan (sac-TMT), based on favorable phase III trial results, has been accepted by China's National Medical Products Administration (NMPA) for patients with epidermal growth factor receptor (EGFR)-mutant advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed following EGFR-tyrosine kinase inhibitor (TKI) therapy.

The phase III study, known as OptiTROP-Lung04, is a multi-center, randomized trial evaluating the efficacy and safety of sacituzumab tirumotecan as a monotherapy compared to the combination of pemetrexed and platinum-based chemotherapy in patients with EGFR-mutant NSCLC who have previously been treated with EGFR-TKI therapy. Interim analysis results revealed that sacituzumab tirumotecan demonstrated a significant improvement in progression-free survival (PFS), which was measured by a blinded independent review committee, compared to the chemotherapy combination. Furthermore, the safety profile of sacituzumab tirumotecan was found to be manageable with no unforeseen safety concerns.

This marks the third NDA for sacituzumab tirumotecan accepted by the NMPA. The application has also been slated for priority review and approval, as announced on the CDE website on October 25, 2024. Prior NDAs for sacituzumab tirumotecan include treatments for locally advanced or metastatic triple-negative breast cancer (TNBC) and for EGFR-mutant NSCLC in patients who have progressed following EGFR-TKI and platinum-based chemotherapy.

Sacituzumab tirumotecan is a novel antibody-drug conjugate (ADC) targeting advanced solid tumors such as NSCLC, breast cancer, gastric cancer, and gynecological tumors. It is developed with a proprietary linker that attaches the drug payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody ratio (DAR) of 7.4. The ADC identifies TROP2 on the surface of tumor cells using recombinant anti-TROP2 humanized monoclonal antibodies, which allows it to be endocytosed by tumor cells and release the active compound KL610023. As a topoisomerase I inhibitor, KL610023 induces DNA damage, causing tumor cell cycle arrest and apoptosis. Additionally, it releases KL610023 in the tumor microenvironment, enabling a bystander effect that kills adjacent tumor cells.

In May 2022, the company licensed exclusive rights to Merck & Co., Inc. (MSD) to develop, manufacture, and commercialize sacituzumab tirumotecan outside Greater China, encompassing Mainland China, Hong Kong, Macau, and Taiwan.

Dr. Micheal Ge, CEO of Kelun-Biotech, emphasized the significance of sacituzumab tirumotecan receiving its third NDA, highlighting the company's dedication to addressing unmet clinical needs through original innovation. He expressed confidence in the potential of sacituzumab tirumotecan to make significant contributions to the field of oncology and global health.

Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, focuses on the research, development, manufacturing, and global collaboration of innovative biological and small molecule drugs. The company’s primary areas of focus include solid tumors, autoimmune, inflammatory, and metabolic diseases. Kelun-Biotech aims to build a global platform for drug development and industrialization to meet medical needs both in China and internationally. The company currently manages over 30 innovative projects across major disease areas, including more than 10 in the clinical stage and four at the NDA stage. Their proprietary ADC platform, OptiDC™, is considered one of the world’s leading platforms, with multiple ADC projects in various stages of development.