FDA Approves Adjuvant Alectinib for ALK+ Early-Stage NSCLC


The FDA has approved alectinib as adjuvant treatment in select patients with ALK-positive non–small cell lung cancer.



The FDA has approved alectinib (Alecensa) for use as adjuvant treatment following tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC) whose tumors are at least 4 cm or node positive, as detected by an FDA-approved test.1

The regulatory decision was supported by data from the phase 3 ALINA trial (NCT03456076), which showed that alectinib reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC (HR, 0.24; 95% CI, 0.13-0.43, P < .0001). At a median follow-up of 27.8 months for alectinib and 28.4 months for chemotherapy in the intent-to-treat population comprising patients with stage IB to IIIA disease, alectinib (n = 130) elicited a median disease-free survival (DFS) that was not reached (NR) vs 41.3 months (95% CI, 28.5–not evaluable [NE]) for those given chemotherapy (n = 127).

Furthermore, patients with stage II to IIIA treated with alectinib (n = 116) experienced a median DFS that was NR vs 44.4 months (95% CI, 27.8-NE) for patients given chemotherapy (n = 115; HR, 0.24; 955 CI, 0.13-0.45; P <.0001).2

“With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, [alectinib] significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, stated in a news release.1 “At Genentech, 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.”

ALINA was a randomized, active-controlled, multicenter, open-label study that evaluated the efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy in patients with resected stage IB to IIIA, ALK-positive NSCLC.

Patients were required to have an ECOG performance status of 0 or 1; be eligible for platinum-based chemotherapy; and have adequate end-organ function. No prior systemic cancer therapy was permitted.2

Investigators randomly assigned 1:1 to receive 600 mg of alectinib twice per day for 2 years, or platinum-based chemotherapy every 3 weeks for 4 cycles. Chemotherapy options consisted of cisplatin plus pemetrexed, cisplatin plus vinorelbine, or cisplatin plus gemcitabine. In the case of intolerability, cisplatin could be switched to carboplatin.

Stratification factors included stage (IB vs II vs IIIA) and race (Asian vs non-Asian).

Investigator-assessed DFS was the primary end point, and key secondary end points included central nervous system (CNS) DFS, overall survival, and safety.

Additional data showed the DFS benefit was consistent across prespecified subgroups.

A benefit was also observed for alectinib for CNS DFS (HR, 0.22; 905% CI, 0.08-0.58). The 24- and 36-month CNS DFS rates for alectinib were 98.4% and 95.5%, respectively. Those respective rates for chemotherapy were 85.8% and 79.7%.

Any-grade adverse effects (AEs) occurred in 98% of patients treated with alectinib (n = 128) and 93% of patients treated with chemotherapy (n = 120). In the alectinib arm, the rates of grade 3/4 AEs, grade 5 AEs, and serious AEs were 30%, 0%, and 13%, respectively. In the chemotherapy arm, those respective rates were 31%, 0%, and 8%. Serious treatment-related AEs occurred in 2% and 7% of patients in the experimental and control arms, respectively.

In the alectinib arm, AEs leading to dose reduction, dose interruption, and treatment withdrawal occurred in 26%, 27%, and 5% of patients, respectively. Those respective rates in the chemotherapy arm were 10%, 18%, and 13%.

The most common any-grade AEs reported in at least 15% of patients in the experimental arm included increased blood creatine phosphokinase, constipation, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood bilirubin, COVID-19, myalgia, increased blood alkaline phosphatase, and anemia. Notably, rates of any-grade asthenia, nausea, vomiting, decreased appetite, decreased neutrophil count, neutropenia, and decreased white blood cell count were all higher in the chemotherapy arm.


  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 18, 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

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