FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic NSCLC

The US Food and Drug Administration has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

The efficacy of ensartinib was evaluated in eXALT3, an open-label, randomized, active-controlled, multicenter trial that included 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients were randomized 1:1 to receive either ensartinib or crizotinib.

The main efficacy outcome measure was progression-free survival (PFS) as evaluated by a blinded independent central review. The key secondary efficacy outcome measure was overall survival (OS).

Ensartinib showed a statistically significant PFS improvement compared to crizotinib with a median PFS of 25.8 months (95% CI, 21.8 to not estimable) compared with a median PFS of 12.7 months in patients receiving crizotinib (95% CI, 9.2 to 16.6), with a hazard ratio (HR) of 0.56 (95% CI, 0.40-0.79; P = .0007).

The most common adverse reactions, occurring in at least 20% of patients, were rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue. The recommended ensartinib dose is 225 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Source: FDA