NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Wednesday recommended Genentech's ALK inhibitor Alecensa (alectinib) as an adjuvant therapy option for certain ALK-positive, early-stage non-small cell lung cancer patients.
In its final draft guidance, based on results from the Phase III ALINA trial, the agency recommended Alecensa as a treatment option for ALK-positive NSCLC patients with stage Ib to IIIa disease following complete tumor resection. In that trial, Alecensa improved disease-free survival in patients with fully resected stage Ib to IIIa ALK-positive NSCLC versus chemotherapy. At three years, 89 percent of patients on Alecensa had not experienced disease recurrence compared to 54 percent of those on chemo.
NICE noted that the trial has not been going on long enough to gauge differences in overall survival but said that, despite the uncertainty, the cost-effectiveness estimates fall in the range it considers an acceptable use of National Health Service resources.
According to the agency, this is the first time NICE has recommended a targeted treatment option for ALK-positive NSCLC to reduce the risk of cancer returning after surgery. It estimated that nearly 100 patients in England would be eligible for the treatment.
The US Food and Drug Administration approved Alecensa in this setting in April, and the European Commission approved it in June.
NICE, meanwhile, also recommended treatment with Merck's Keytruda (pembrolizumab) in combination with chemotherapy prior to surgery and then alone as an adjuvant therapy for resectable NSCLC.
"I am delighted that we have been able to recommend these two lung cancer treatments," said Helen Knight, director of medicines evaluation at NICE, in a statement. "Both treatments are designed to reduce the risk of cancer returning after surgery and demonstrate NICE's commitment to getting the best care to patients fast and ensuring value for the taxpayer."