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The FDA extended indications for alectinib (Alecensa) to include adjuvant treatment for ALK-positive non-small cell lung cancer (NSCLC), the first such approval for an ALK inhibitor.

The stipulates use of alectinib as adjuvant therapy after surgery for tumors ≥4 cm or positive lymph nodes, as detected by an FDA-approved test. Principal support for the new indication came from the randomized, phase III ALINA study, which showed a 76% reduction in the risk of disease recurrence or death with adjuvant alectinib versus chemotherapy.

"The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy," said Ken Culver, MD, of ALK Positive Inc., a patient and caregiver advocacy group, in a from Genentech. "These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC."

"Now, with this significant advance, it is more important than ever that all patients diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them," he added.

Clinical guidelines, including those of the National Comprehensive Cancer Network, recommend routine testing for ALK, EGFR, and PD-L1 in patients with stage IB-IIIA NSCLC and selected patients with stage IIIB, in addition to those with advanced/metastatic disease.

An estimated 30-40% of patients with NSCLC have resectable disease, but almost half of them will have disease recurrence at some point after surgery. About 4-5% of NSCLC is ALK+. Alectinib previously demonstrated superiority over crizotinib (Xalkori) in three randomized trials of patients with advanced ALK+ NSCLC. Approval of the adjuvant indication follows prior FDA approval of alectinib as first- and second-line treatment for ALK+ metastatic NSCLC.

The ALINA trial compared adjuvant alectinib with adjuvant platinum-based chemotherapy in 257 patients with stage II-IIIA ALK+ NSCLC. The primary endpoint was disease-free survival, which was significantly improved with adjuvant alectinib (P<0.0001). Patients randomized to alectinib had an improvement in central nervous system disease-free survival similar to the primary result (HR 0.22). Median DFS was not reached in the alectinib arm as compared with 41.3 months with chemotherapy.

Adverse events occurring in ≥20% of patients treated with alectinib were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.

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