FDA Approves Alectinib to Treat Patients With ALK-Positive NSCLC


With this approval, alectinib is the first anaplastic lymphoma kinase inhibitor to be approved for patients with ALK-positive, early-stage non-small cell lung cancer.

Tumor in lungs -- Image credit: Sebastian Kaulitzki | stock.adobe.com

Image credit: Sebastian Kaulitzki | stock.adobe.com

About the Trial

Trial Name: A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT03456076

Sponsor: Hoffmann-La Roche

Completion Date (Estimated): November 19, 2026

The FDA has approved alectinib (Alecensa; Genentech) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. With this approval, alectinib is the first and only ALK inhibitor that has been approved for patients with ALK-positive early-stage NSCLC who have previously received surgery for tumor removal.1

Alectinib is an oral, highly selective, central nervous system-active drug. Currently, it is approved for both first- and second-line treatment for patients with ALK-positive metastatic NSCLC.1

“The approval of [alectinib] 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

The approval follows positive results from phase 3 ALINA trial (NCT03456076), a randomized, active-controlled, multicenter, open-label study that evaluated the efficacy and safety of adjuvant alectinib compared with platinum-based chemotherapy in patients with stage IB to IIIA ALK-positive NSCLC. A total of 257 patients were randomly assigned to receive either 600 mg of oral alectinib twice per day (alectinib group), or a combination of cisplatin, vinorelbine, gemcitabine, and pemetrexed, as well as carboplatin when there is an unacceptable toxicity with cisplatin (chemotherapy group). The study’s primary end point is disease-free survival (DFS), and the secondary outcome measures include overall survival, central nervous system-DFS, and the proportion of patients who experience adverse events (AEs).1,2

The trial results demonstrated that patients in the alectinib group had a reduced risk of disease recurrence or death by 76% (HR=0.24, 95% CI: 0.13-0.43, p < .001) compared with those in the chemotherapy group. Further, an exploratory analysis showed an improvement in central nervous system-DFS was also present among patients who were treated with alectinib (HR=0.22; 95% CI: 0.08-0.58). Additionally, the safety and tolerability profiles of the drug were generally consistent with what was observed in prior trials in the metastatic setting. No new safety signals were observed, according to the investigators.1,2

Further, the most common AEs reported by patients on alectinib were hepatotoxicity, constipation, myalgia, COVID-19 infection, fatigue, rash, and cough. According to experts, the recommended dose of alectinib is 600 mg administered orally twice per day—the same dosage examined in the ALINA trial—with food.3

“With an unprecedented 76% reduction in the risk of disease recurrence or death vs chemotherapy, [alectinib] significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, MD, PhD, chief medical officer, head of Global Product Development, Roche, in the press release. “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 1 step closer to achieving that mission.”1

1. GlobeNewswire. FDA approves Roche’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer. News release. April 19, 2024. Accessed April 19, 2024. https://kommunikasjon.ntb.no/pressemelding/18068619/fda-approves-roches-alecensa-as-the-first-adjuvant-treatment-for-people-with-alk-positive-early-stage-lung-cancer?publisherId=4954260
2. A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer.ClinicalTrials.gov identifier: NCT03456076. Updated April 3, 2024. Accessed April 19, 2024. https://clinicaltrials.gov/study/NCT03456076
3. US Food & Drug Administration. FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. News release. April 18, 2024. Accessed April 19, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer
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