The FDA has given the novel agent NVL-655 a breakthrough therapy designation for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer.
3D rendered medical illustration of male anatomy with lung cancer: © Sebastian Kaulitzki- stock.adobe.com
The FDA has granted a breakthrough therapy designation to NVL-655, a novel brain-penetrant ALK-selective TKI for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have received 2 or more ALK TKIs.1
"Today's announcement of FDA breakthrough therapy designation for NVL-655 marks another important milestone for our ALK program and the second breakthrough designation granted to our pipeline of novel kinase inhibitors this year," said Darlene Noci, ALM, chief development officer at Nuvalent, in a press release. "Our team is committed to expeditiously advancing NVL-655 in recognition of the continued need for innovation for patients with ALK-positive NSCLC who have exhausted available therapies. We expect to provide an update from the ALKOVE-1 trial of NVL-655 at a medical meeting in the second half of this year."
The designation is supported by preliminary safety and activity findings of NVL-655 in the intent-to-treat population from the phase 1 portion of the ALKOVE-1 trial.
ALKOVE-1 is a phase 1/2 dose-escalation and -expansion study with an estimated enrollment of 470 patients with NSCLC and other ALK-mutated solid tumors.2 The primary end points of phase 1 are dose-limiting toxicities and recommended phase 2 dose, and primary end points for phase 2 are objective response rate and incidence of treatment-emergent adverse events. Secondary end points include pharmacokinetics, duration of response, clinical benefit rate, time to response, progression-free survival, overall survival, and quality of life.
In phase 1, patients are receiving NVL-655 delivered orally daily. In phase 2, there are 6 cohorts:
Enrollment in the phase 2 portion is ongoing,1 and the estimated study completion date is March 2026.2
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