Kelun-Biotech's Lunbotinib Shows Strong Phase II Results in RET-Positive NSCLC
Event summary
- Kelun-Biotech presented pivotal Phase II data for lunbotinib fumarate at the 2026 ASCO Annual Meeting, showing an 81.3% ORR in treatment-naïve patients and 87.1% in pre-treated patients with RET fusion-positive NSCLC.
- The NDA for lunbotinib fumarate has been accepted by China's NMPA for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC.
- The study demonstrated favorable CNS efficacy with a 30% intracranial complete response rate in patients with measurable baseline CNS metastases.
- Lunbotinib fumarate was well tolerated, with a 1.2% rate of permanent discontinuation due to treatment-related adverse events and no treatment-related deaths reported.
The big picture
Kelun-Biotech's lunbotinib fumarate represents a next-generation selective RET inhibitor, addressing a significant unmet need in RET fusion-positive NSCLC. The strong Phase II results position the drug as a potential new treatment option, with favorable CNS efficacy and a manageable safety profile. The acceptance of the NDA by the NMPA marks a critical milestone in the drug's development, while the ongoing Phase II trial in international markets highlights the company's strategic focus on global expansion.
What we're watching
- Regulatory Approval
- Whether the NMPA will approve lunbotinib fumarate based on the Phase II data and the pace of potential approval.
- Global Expansion
- How the exclusive license agreement with Ellipses Pharma will impact the global commercialization of lunbotinib fumarate.
- Clinical Development
- The progress of the Phase II clinical trial in the U.S., U.K., Europe, and UAE, and the potential for combination therapy with chemotherapy.
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