What's Happening?
Kelun-Biotech presented pivotal Phase II data for its next-generation selective RET inhibitor, lunbotinib fumarate, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The study focused on patients with RET fusion-positive non-small
cell lung cancer (NSCLC). The trial included both treatment-naïve and pre-treated patients, showing high objective response rates of 81.3% and 87.1%, respectively. The drug demonstrated robust and durable clinical activity, with favorable central nervous system efficacy in patients with baseline metastases. The safety profile was manageable, with no unexpected safety signals.
Why It's Important?
The results are significant as they offer a new potential treatment for patients with RET fusion-positive NSCLC, a group with limited options and poor prognosis. The high response rates and manageable safety profile suggest that lunbotinib fumarate could become a valuable addition to the treatment landscape for this type of lung cancer. The drug's efficacy in patients with central nervous system metastases is particularly noteworthy, as these patients often have limited treatment options.
What's Next?
Kelun-Biotech's New Drug Application for lunbotinib fumarate has been accepted by China's National Medical Products Administration. The company is also conducting further clinical trials in the U.S. and other regions to evaluate the drug's efficacy as a monotherapy and in combination with chemotherapy. These efforts could lead to broader regulatory approvals and expanded use of lunbotinib fumarate in treating RET fusion-positive NSCLC.
