Adjuvant Alectinib Could Aid Disease-Free Survival in ALK-Positive NSCLC


A 76% lower risk was displayed with adjuvant alectinib compared to chemotherapy treatment for non–small cell lung cancer.

New study findings published in The New England Journal of Medicine discovered that adjuvant alectinib (AlecensaGenetech) drastically improved disease-free survival among individuals with stage IB, II, or IIIA resected anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) compared to platinum-based chemotherapy.1

Photomicrograph of fine needle aspiration (FNA) cytology of a pulmonary (lung) nodule showing adenocarcinoma, a type of non small cell carcinoma - Image credit: Saiful52 |

Image credit: Saiful52 |

Alectinib is an oral, highly selective, central nervous system-active targeted therapy ALK inhibitor that can block the activity of mutated ALK proteins. Following, about 5% of NSCLC tumors are ALK positive.2,3 However, the demographic of ALK positive NSCLC individuals are more likely to be younger, nonsmokers, and are high risk for brain metastases, according to study authors.1 Treatment options for respectable individuals is typically surgery and adjuvant chemotherapy.1

Despite this, adjuvant chemotherapy was only connected with meek improvements in patient outcomes, as the disease recurrence remained high after treatment, according to study authors.1

About the Trial ID: NCT03456076

Sponsor: Hoffmann-La Roche

Study Completion (Estimated): November 2026

The FDA recently approved alectinib for adjuvant treatment, following tumor resection among individuals with ALK-positive NSCLC, as detected by an FDA-approved test. The approval was based on results that displayed statistically significant and clinically meaningful improvement of disease-free survival (DFS) among individuals that received alectinib.3

However, data and research of the efficacy and safety of adjuvant alectinib is limited among individuals with resected ALK-positive NSCLC compared to chemotherapy examination to treat individuals with resected ALK-positive NSCLC.1

“We urgently need to do more to help people with lung cancer, as about half of patients with early-stage NSCLC experience disease recurrence,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development, Roche. “Alectinib can potentially alter the course of this disease as we aim to provide the best chance for cure.”4

The researchers conducted the global, phase 3, open-label, randomized ALINA phase 3 trial ( NCT03456076) to assess alectinib in patients with completely resected, ALK-positive NSCLC in stages IB, II, or IIIA. The study authors noted that a total of 257 individuals were included in the study and were randomly assigned to receive 600 mg twice daily of alectinib (130 patients) for 24 months, or intravenous platinum-based chemotherapy (127 patients) in 4, 21-day cycles.1

The results displayed that after 2 years, 93.8% of individuals in the alectinib group were alive and disease free compared to 63.0% in the chemotherapy group among individuals that were diagnosed with stage II or IIIA. Alectinib met the primary endpoint of central nervous system (CNS) DFS, according to study authors.1

“The magnitude of DFS observed in this study could represent a paradigm shift in the way we manage early-stage ALK-positive lung cancer,” said Benjamin Solomon, medical oncologist, Peter MacCallum Cancer Centre, Australia, in the press release, published in Pharmacy Times.4

The most common reported adverse events with alectinib included increased kinase levels, and constipation. The study authors noted that at least 1 event was reported by 98.4% of individuals.1

The findings suggest a 76% lower risk was displayed with adjuvant alectinib, compared to chemotherapy treatment.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,” Solomon said.4

1. Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer. The New England Journal of Medicine. News release. April 10, 2024. Accessed April 23, 2024.
2. FDA Approves Alectinib For Initial Treatment of ALK-Positive Lung Cancer. National Cancer Institute. News release. December 6, 2017. Accessed April 23, 2024.
3. FDA Approves Alectinib to Treat Patients With ALK-Positive NSCLC. Pharmacy Times. News release. April 19, 2024. Accessed April 23, 2024.
4. Novel Oral Medication Reduces Risk of Death by 76% in Patients With ALK-Positive Lung Cancer. Pharmacy Times. News release. October 20, 2023. Accessed April 23, 2024.
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