Adjuvant alectinib extends DFS in ALK-positive early-stage lung cancer
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Adjuvant therapy with alectinib prolonged DFS compared with platinum-based chemotherapy for certain patients with lung cancer, according to the agent’s manufacturer.
Depending on disease stage, half to three-quarters of people with non-small cell lung cancer develop disease recurrence after surgery.
Approximately 5% of people with NSCLC have anaplastic lymphoma kinase (ALK)-positive disease.
Alectinib (Alecensa, Genentech) — an oral small-molecule kinase inhibitor — is approved for treatment of patients with ALK-positive metastatic NSCLC. No ALK inhibitors are approved for treatment of early-stage ALK-positive disease.
The randomized phase 3 ALINA study included 257 patients with completely resected stage IB to stage IIIA ALK-positive NSCLC. Researchers assigned patients to alectinib or platinum-based chemotherapy.
DFS served as the primary endpoint. OS and percentage of adverse events served as secondary outcomes.
A prespecified interim analysis showed longer DFS in the alectinib group. OS data had not matured. Researchers observed no unexpected safety signals.
Full results from the ALINA study will be presented at a medical meeting and shared with health authorities.
“Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a company-issued press release. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure. ... We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”
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