Kelun-Biotech gains approval for innovative cancer treatment in China

On April 12, 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced the publication of results from a Phase 3 clinical trial evaluating their novel TROP2 antibody drug conjugate, sacituzumab tirumotecan. This study showed the efficacy and safety of sacituzumab tirumotecan compared with standard chemotherapy for patients suffering from locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC). After demonstrating positive outcomes, sacituzumab tirumotecan was approved in China for adult patients with unresectable, locally advanced or metastatic TNBC who had undergone at least two previous systemic therapies, one of which must have been for advanced conditions. The results were also shared at the 2024 American Society of Clinical Oncology Annual Meeting, further highlighting the rising attention of the academic community towards this therapy. The clinical research also indicated sacituzumab tirumotecan's effectiveness against non-small cell lung cancer (NSCLC), particularly in patients with advanced stages who had previously received treatment, and explored the potential mechanisms that may enhance the drug's anti-tumor activity. Findings suggest that mutations in the epidermal growth factor receptor (EGFR) could bolster the effect of the TROP2 ADCs by facilitating their uptake and action within tumor cells. As a result, additional drug mechanisms could also create a bystander effect, allowing adjacent cancer cells to be affected, which broadens its therapeutic efficacy beyond just targeting EGFR mutation-positive cells. The importance of this drug lies not only in its innovative approach but also as it currently stands as the first TROP2 ADC to gain marketing approval for a lung cancer indication. Kelun-Biotech has been proactive in the field, launching 8 registrational clinical studies in China, while MSD is sponsoring 12 ongoing global Phase 3 studies of sacituzumab tirumotecan. These studies aim to investigate the drug as a monotherapy or in combination with other agents like pembrolizumab, exemplifying the commitment of both companies to developing novel cancer treatments. The positive clinical outcomes for sacituzumab tirumotecan underscore the power of targeted therapies in oncological care and the growing recognition of the importance of TROP2 as a therapeutic target. In summary, the recent publication and marketing approval mark a significant milestone for Kelun-Biotech and represent their commitment to innovation in biopharmaceutical development. As they continue their research partnership with MSD, expectations for continued advancements and new therapeutic solutions for challenging cancer types like TNBC and NSCLC are high.