SIHUAN PHARM (00460): Xuanzhu Biotech (02575) will present the Phase III clinical research data of Loratretinib as first-line treatment for ALK-positive advanced non-small cell lung cancer at the AACR in 2026.

SIHUAN PHARM (00460) announced that its non-wholly owned subsidiary: Xuanzhu Biotech (02575) presented the results of the Phase III clinical study (DIAMOND-2) on the first-line treatment of ALK-positive advanced non-small cell lung cancer (NSCLC) with lorlatinib at the American Association for Cancer Research Annual Meeting (AACR) in 2026 from April 17 to April 22, 2026 in the form of an oral presentation. The DIAMOND-2 study (NCT05204628) is a multicenter, randomized, open-label Phase III clinical study conducted in China, with lorlatinib as the control, aiming to evaluate the efficacy and safety of lorlatinib compared to crizotinib in the first-line treatment of ALK-positive advanced NSCLC patients. A total of 275 subjects were enrolled in this study, with a 1:1 random allocation to receive lorlatinib (500mg once daily) or crizotinib (250mg twice daily) treatment. The primary endpoint was investigator-assessed progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), duration of response (DoR), intracranial objective response rate (IC-ORR), and safety. The data presented at the 2026 AACR showed that lorlatinib demonstrated statistically and clinically significant efficacy advantages in first-line treatment of ALK-positive advanced NSCLC. In the modified intention-to-treat (mITT) population, the median PFS assessed by investigators was 31.3 months for lorlatinib, significantly better than 12.9 months for the control group, with a 53% reduction in disease progression risk (HR=0.47, P<0.0001). Additionally, the ORR for the lorlatinib group was 88.5%, with a median DoR of 32.10 months and a disease control rate (DCR) of 95.4%, showing significantly better tumor response depth and durability compared to the control group. In patients with measurable intracranial lesions at baseline, lorlatinib exhibited significant intracranial anti-tumor activity with an IC-ORR of 91.7% compared to 11.1% in the control group. Lorlatinib also significantly extended intracranial PFS and reduced the risk of intracranial disease progression by 55% (HR=0.45, P=0.0003). In terms of safety, lorlatinib showed good overall tolerability, with mainly grade 1-2 gastrointestinal adverse events being the most common. The percentage of patients who discontinued treatment due to lorlatinib-related adverse events was only 1.5%, indicating a favorable safety profile for clinical use.