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

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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

References

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