• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC


Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive non–small cell lung cancer.

Image credit: Crystal light | stock.adobe.com

Image credit: Crystal light | stock.adobe.com

Roche’s Alecensa (alectinib) has been approved by the FDA as an adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) with tumors that are at least 4 cm or node positive, as detected by an FDA-approved test.1 In the Phase III ALINA trial (NCT03456076), which was the basis for the FDA approval, Alecensa was found to lower the risk of disease recurrence or death by 76% in comparison with platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive NSCLC.

“With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, MD, PhD, Roche Chief Medical Officer and head of Global Product Development, said in a press release. “At Roche, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”1

Alecensa is an oral, highly selective, central nervous system (CNS)-active therapy indicated patients with NSCLC whose tumors have been identified as ALK-positive. The drug has been approved in more than 100 countries as a first-line treatment for ALK-positive metastatic NSCLC.

The randomized, active-controlled, multicenter, open-label ALINA trial compared the efficacy and safety of adjuvant Alecensa versus platinum-based chemotherapy in patients with resected stage IB to IIIA, ALK-positive NSCLC. Enrollment criteria included an ECOG performance status of 0 or 1; eligibility for platinum-based chemotherapy; adequate end-organ function; and no prior systemic cancer treatment.2

Patients were randomly assigned at a 1:1 ratio to receive 600 mg of alectinib twice per day for two years or platinum-based chemotherapy—comprised of cisplatin plus pemetrexed, cisplatin plus vinorelbine, or cisplatin plus gemcitabine—every three weeks for four cycles. The trial’s primary endpoint was investigator-assessed disease-free survival (DFS), with key secondary endpoints that included CNS DFS, overall survival, and safety.

Among the intent-to-treat population consisting of patients with stage IB to IIIA disease, at a median follow-up of 27.8 months, median DFS was not yet reached (NR) in those administered Alecensa (n = 130); whereas at 28.4 months in the chemotherapy cohort (n = 127), median DFS was 41.3 months. The 24- and 36-month CNS DFS rates for alectinib were 98.4% and 95.5%, respectively, compared with 85.8% and 79.7%, respectively, in patients administered chemotherapy.

In terms of safety, any-grade adverse effects (AEs) were reported in 98% of patients administered Alecensa and 93% of patients administered chemotherapy. Serious treatment-related AEs were reported by 2% of patients administered Alecensa compared with 7% of patients administered chemotherapy.

The most frequently reported any-grade AEs occurring in at least 15% of patients administered Alecensa included elevated blood creatine phosphokinase, constipation, elevated aspartate aminotransferase, elevated alanine aminotransferase, elevated blood bilirubin, COVID-19, myalgia, elevated blood alkaline phosphatase, and anemia.

“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. 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,” said Ken Culver, director of Research and Clinical Affairs at ALK Positive, Inc, in a press release. “Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”1


1. FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer. News release. Genentech. April 18, 2024. Accessed April 19, 2024. https://www.gene.com/media/press-releases/15023/2024-04-18/fda-approves-genentechs-alecensa-as-firs

2. Solomon BJ, Ahn JS, Dziadziuszko R, et al. ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC). Ann Oncol. 2023;34(suppl 2):S1295-S1296. doi:10.1016/j.annonc.2023.10.051

Related Videos
Ashley Gaines
Related Content