What's Happening?
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced the publication of translational research results on sacituzumab tirumotecan (sac-TMT) in combination with osimertinib for treating advanced epidermal growth factor receptor (EGFR)-mutant
non-small cell lung cancer (NSCLC). The study, published in Cancer Cell, highlights that EGFR-TKIs induce TROP2 upregulation in drug-tolerant persister cells, providing a basis for combining sac-TMT with EGFR-TKI. Sac-TMT, a novel human TROP2 antibody-drug conjugate (ADC), has shown significant progression-free survival (PFS) and overall survival (OS) benefits in TKI-resistant settings. The company is conducting a Phase III study of sac-TMT plus osimertinib as a first-line treatment for advanced EGFR-mutant NSCLC, with patient enrollment completed and the study in the follow-up phase.
Why It's Important?
The development of sac-TMT in combination with osimertinib represents a significant advancement in the treatment of EGFR-mutant NSCLC, a challenging cancer type with limited treatment options. The research underscores the potential of sac-TMT to delay drug resistance, a major hurdle in cancer therapy. This combination therapy could offer a new line of defense for patients who have developed resistance to existing treatments, potentially improving survival rates and quality of life. The approval and ongoing studies of sac-TMT highlight its potential to become a key player in the oncology market, offering hope to patients and healthcare providers seeking more effective treatment options.
What's Next?
Kelun-Biotech is advancing its clinical exploration of sac-TMT for earlier-stage EGFR-mutant NSCLC. A Phase II study is ongoing to evaluate sac-TMT in combination with osimertinib or as monotherapy in the neoadjuvant setting for resectable NSCLC. The company is also pursuing additional indications and has initiated multiple registrational clinical studies in China. Internationally, Merck & Co., Inc. is evaluating sac-TMT in 17 global Phase III clinical studies, potentially expanding its use across various cancer types. These efforts could lead to broader approval and adoption of sac-TMT, further solidifying its role in cancer treatment.













