Standard of Care Shift in ALK-Positive Lung Cancer

A second-generation inhibitor delays anaplastic lymphoma kinase (ALK)-positive lung cancer growth for a median of 15 months longer and causes fewer adverse events than the current standard of care, according to a new study presented at the 2017 ASCO Annual Meeting (June 2-6, 2017; Chicago, IL).


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Alectinib, an ALK inhibitor, has shown efficacy in crizotinib-naïve or resistant ALK-positive non-small cell lung cancer (NSCLC) in early trials. The inhibitor was initially approved in 2015 for use in patients with advanced NSCLC that progressed after crizotinib treatment.

Alice T Shaw, MD, PhD, director of thoracic oncology, Massachusetts General Hospital Cancer Center (Boston, MA) and colleagues conducted an open-label, multicenter, phase III trial to further assess the safety and efficacy of alectinib in patients with NSCLC. Researchers randomly assigned 303 patients with stage IIIb or IV, ALK-positive NSCLC to receive alectinib (600 mg twice daily, orally) or crizotinib (250 mg twice daily, orally). Patients did not receive any prior systemic therapies for their cancer.

Results of a 1-year follow-up period showed that alectinib met its primary endpoint of increasing progression-free survival (PFS) compared with crizotinib. The ALK-inhibitor reduced the risk of progression by 53% compared with the standard-of-care and more than doubled the median PFS (25.7 months vs 10.4 months, respectively).

Additionally, alectinib was found to significantly delay disease progression in the brain. Twelve-month cumulative incidence of central nervous system progression was 9.4% with alectinib compared with 41.4% with crizotinib.

Serious adverse events were less common with alectinib (41% of patients) than with crizotinib (50% of patients).

“The efficacy and safety results establish alectinib as the new standard of care for patients with advanced, previously untreated ALK-positive NSCLC,” said Dr Shaw in a press briefing (June 9, 2017).

Further research is currently underway to assess long-term survival of patients treated with alectinib or crizotinib in the first-line setting.—Zachary Bessette