Alectinib is the first and only ALK inhibitor to demonstrate a reduction in disease recurrence among patients with early-stage ALK-positive non–small cell lung cancer, based on data from the phase 3 ALINA study.
Alectinib (Alecensa) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival compared with platinum-based chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC), meeting the primary end point of the phase 3 ALINA study (NCT03456076) at a prespecified interim analysis.1
At the time of this analysis, the overall survival (OS) data were immature and no unexpected safety signals were seen.
These data will be submitted to health authorities globally and presented at an upcoming medical meeting.
“[Alectinib] 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,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, in a press release. “If approved, [alectinib] has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure, which is our ultimate goal at Genentech. We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”
In a phase 3 trial, alectinib is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death for patients with early-stage ALK-positive NSCLC.
The randomized, active-controlled, multicenter, open-label, phase 3 ALINA study is evaluating the efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy in patients with completely resected stage IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.
A total of 257 patients were included in the study and randomized to receive either the treatment with alectinib in the investigational arm or chemotherapy in the control treatment arm.
In the experimental arm, patients will receive alectinib 600 mg orally twice daily taken with food for 24 months while patients in the control arm will receive 1 of the protocol specified platinum-based chemotherapy regimens for 4 cycles.
Once treatment is completed, patients will be followed up for their disease until disease recurrence where they will enter a survival follow-up until death, withdrawal of consent, or study closure.
Eligible patients are those aged 18 years and older with documented ALK-positive disease who are eligible to receive a platinum-based chemotherapy regimen, have an ECOG performance status of 0-1, and adequate hematologic and renal function. Women of childbearing potential must agree to remain abstinent or use contraceptive methods during the treatment period and for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy, and men must also remain abstinent or use contraceptive measures, and agree to not donate sperm during this same time period.
Aside from the primary end point of DFS, investigators are assessing overall survival and the percentage of patients with adverse events as secondary end points..