Neladalkib (NVL-655) has shown strong results in patients with ALK-positive solid tumors, according to new data from the phase 1/2 ALKOVE-1 study. The drug achieved a 44% overall response rate among 34 patients, including 69% in those who had never received an ALK inhibitor and 29% in those previously treated with one. Responses appeared quickly, with a median time of 6.1 weeks, and were durable—80% of patients remained on treatment without disease progression at the time of analysis. One patient achieved a complete response in the brain.
Neladalkib was generally well tolerated, with only 8.8% of patients requiring dose reductions and no severe (Grade 4 or 5) treatment-related side effects. No one discontinued therapy because of side effects.
The drug targets a range of ALK alterations, including resistance mutations and brain metastases, while minimizing neurological toxicity. It received FDA Breakthrough Therapy Designation in 2024 for ALK-positive non–small cell lung cancer after multiple prior ALK inhibitor treatments.