Overview
- In 253 patients previously treated with ALK tyrosine kinase inhibitors, neladalkib produced a 31% objective response rate with responses estimated to remain ongoing in 76% at 6 months, 64% at 12 months, and 53% at 18 months.
- The median duration of response has not been reached after approximately 11.3 months of follow-up.
- The recommended Phase 2 dose was set at 150 mg once daily based on Phase 1 dose-escalation results.
- Preliminary data in 44 TKI-naïve patients showed an 86% objective response rate with a 9% complete response rate and estimated duration-of-response rates of 91% at both 6 and 12 months.
- Intracranial activity included a 78% intracranial response rate and 44% intracranial complete response in nine evaluable patients, while Nuvalent continues global Phase 3 enrollment and plans a pre-NDA FDA meeting as shares rose about 16%.