Phase 3 ALINA Study of Alectinib Shows DFS Benefit in ALK+ NSCLC


The phase 3 ALINA study of alectinib is the first to show an improvement in its primary end point of disease-free survival among patients with early-stage resected ALK-positive non–small cell lung cancer.

illustration of Lungs, medical concept© yodiyim -

Illustration of Lungs, medical concept© yodiyim -

A statistically significant and clinically meaningful improvement in disease-free survival (DFS) was observed with alectinib (Alecensa) in patients with completely resected stage IB to IIIA ALK-positive non–small cell lung cancer (NSCLC), according to results from the primary analysis of the phase 3 ALINA study (NCT03456076).1

Alectinib reduced the risk of disease recurrence or death by 76% (hazard ratio [HR], 0.24; 95% CI, 0.13-0.43; P <.0001) vs platinum-based chemotherapy in this patient population. Investigators also observed a clinically meaningful improvement of central nervous system (CNS) DFS among patients with ALK-positive NSCLC (HR, 0.22; 95% CI, 0.08-0.58). At the time of this analysis, the overall survival (OS) data were immature. Follow-up is ongoing to report a more mature OS estimate.

In this trial, the safety and tolerability of alectinib were consistent with what has been previously observed of the agent in prior studies in the metastatic setting. No unexpected safety findings were observed.

“By reducing the risk of recurrence or death of ALK-positive early-stage NSCLC by an unprecedented 76%, [alectinib] can potentially alter the course of this disease as we aim to provide the best chance for cure,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at, Genentech, in a press release. “We urgently need to do more to help people with lung cancer, as about half of patients with early-stage NSCLC experience disease recurrence. We’re working with health authorities to bring [alectinib] to patients in this setting as soon as possible.”

In the primary analysis of the ALINA trial, the median DFS was not yet reached for alectinib vs 41.3 months for chemotherapy (95% CI, 28.5- not evaluable.

For safety, grade 3 or 4 adverse events (AEs) were seen in 30% of patients treated with alectinib vs 31% of patients given chemotherapy. No patients experienced a grade 5 AE in either treatment arm. Further, 5.5% vs 12.5% of patients discontinued treatment due to AEs in the alectinib vs chemotherapy arms of the study.

The randomized, active-controlled, multicenter, open-label, phase 3 ALINA study aims to assess the efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy in 257 patients with completely resected stage IB to IIIA ALK-positive NSCLC. Patients were randomized to either the investigational arm with alectinib or the control treatment arm where they received chemotherapy.2

Enrollment in the study was open to patients aged 18 years or older with documented ALK-positive disease, an ECOG performance status of 0-1, and adequate hematologic and renal function. Patients must have been eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines. Women of childbearing potential must have agreed to remain abstinent or use contraceptive methods with a failure rate of < 1% per year 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. Men must have also refrained from donating sperm during this same period.

The primary end point is DFS, and secondary end points are OS and percentage of patients with AEs.

Full results from the ALINA study will be presented as a late-breaking oral at the European Society of Medical Oncology Congress 2023 Presidential Symposium on Saturday, October 21, 2023, and submitted to global health authorities, including the FDA and the European Medicines Agency.1

“These potentially practice-changing data reinforce the potential of [alectinib] as a new standard of care in the ALK-positive early lung cancer setting where treatment options are currently extremely limited,” said Benjamin Solomon, PhD, MBBS, professor, medical oncologist, Peter MacCallum Cancer Centre, Australia, in a press release.1 “The magnitude of disease-free survival observed in this study could represent a paradigm shift in the way we manage early-stage ALK-positive lung cancer.”

1. Genentech’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer. News release. Genentech. October 17, 2023. Accessed October 19, 2023.
2. A study comparing adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with ALK positive non-small cell lung cancer. Clinical Trials. Updated September 21, 2023. Accessed October 19, 2023.

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