Overview
- In the ALKOVE‑1 primary analysis of 253 heavily TKI‑pretreated patients, neladalkib achieved a 31% objective response rate with responses ongoing in 76% at 6 months, 64% at 12 months, and 53% at 18 months.
- Median duration of response had not been reached after 11.3 months of follow‑up, and activity was observed across pretreated subgroups.
- Nuvalent selected 150 mg once daily as the recommended Phase 2 dose based on Phase 1 dose escalation.
- Preliminary Phase 2 data in 44 TKI‑naïve patients showed an 86% objective response rate with 9% complete responses and DOR rates of at least 6 and 12 months in 91% of responders.
- In nine patients with measurable brain lesions, intracranial ORR was 78% with a 44% intracranial CR rate and no CNS progression among responders, while the ALKAZAR Phase 3 trial is enrolling globally and NUVL shares rose about 16% on the news.