Xuanzhu Biopharma's DiLuoAke Demonstrates Superior Efficacy Over Crizotinib in Phase III ALK-Positive NSCLC Trial
核心洞察
Xuanzhu Biopharma-B (搜索) presented Phase III DIAMOND-2 trial results at the 2026 AACR Annual Meeting, showing DiLuoAke (搜索) achieved statistically significant and clinically meaningful efficacy advantages over crizotinib in first-line ALK (搜索)-positive advanced NSCLC treatment.
The multicenter, randomized, open-label Phase III study enrolled 275 patients in China, comparing DiLuoAke (搜索) (500mg once daily) against crizotinib (250mg twice daily) as first-line therapy for ALK (搜索)-positive advanced non-small cell lung cancer.
DiLuoAke (搜索) is a next-generation oral ALK (搜索) inhibitor independently developed by Xuanzhu Biopharma, specifically designed for treating ALK-rearranged advanced non-small cell lung cancer patients.
Xuanzhu Biopharma-B (搜索) has announced positive Phase III clinical trial results for DiLuoAke (搜索) (Diruketinib (搜索)), demonstrating statistically significant and clinically meaningful efficacy advantages over crizotinib in the first-line treatment of anaplastic lymphoma kinase (搜索) (ALK (搜索))-positive advanced non-small cell lung cancer (NSCLC). The results were presented in an oral session at the 2026 American Association for Cancer Research (AACR) Annual Meeting held from April 17 to April 22, 2026.
DIAMOND-2 Trial Design and Patient Population
The DIAMOND-2 study (NCT05204628) represents a multicenter, randomized, open-label Phase III clinical trial conducted in China. The study enrolled 275 subjects who were randomly assigned at a 1:1 ratio to receive either DiLuoAke (搜索) at 500mg once daily or crizotinib at 250mg twice daily as first-line treatment for ALK (搜索)-positive advanced NSCLC.
The trial was designed to evaluate head-to-head efficacy and safety of DiLuoAke (搜索) compared with crizotinib, establishing a direct comparison between the next-generation ALK (搜索) inhibitor and the current standard of care.
Primary and Secondary Endpoints
The study's primary endpoint focused on investigator-assessed progression-free survival (PFS), a critical measure of treatment efficacy in advanced lung cancer. Secondary endpoints included objective response rate (ORR), duration of response (DoR), intracranial objective response rate (IC-ORR), and comprehensive safety assessments.
Drug Profile and Development
DiLuoAke (搜索) tablets, marketed under the brand name Xuan Fei Ning, represent a next-generation oral ALK (搜索) inhibitor independently developed by Xuanzhu Biopharma. The drug has been specifically designed for the treatment of ALK-rearranged advanced non-small cell lung cancer, addressing the clinical need for improved therapeutic options in this patient population.
The positive Phase III results mark a significant milestone for Xuanzhu Biopharma-B (搜索), demonstrating the potential of their proprietary ALK (搜索) inhibitor to provide superior clinical outcomes compared to existing first-line treatments for ALK-positive advanced NSCLC patients.