May, 2024
May 2024
FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer based on ALINA trial
Apr 19, 2024, 15:52

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer based on ALINA trial

FDA, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with ALK-positive non-small cell lung cancer (NSCLC) on April 18, 2024.

Alectinib is an anaplastic lymphoma kinase (ALK)/tyrosine kinase inhibitor, first approved in Japan in 2014 and by the US Food and Drug Administration in 2015.


ALINA trial / NCT03456076 – global, randomized, open-label phase III trial 

  • Population – ALK-positive NSCLC patients after complete tumor resection (IB-IIIA stages)
  • Study size – 257 patients (1:1)
  • Arms – alectinib 600 mg orally twice daily vs platinum-based chemotherapy
  • Primary outcome measures – disease free survival (DFS)
  • Secondary outcome measures – overall survival (OS); plasma concentration of alectinib; plasma concentration of alectinib metabolite; percentage of participants with adverse event


Median DFS

1 / for stage II-IIIA NSCLC subgroup

  • alectinib arm – not reached (95% CI: not estimable [NE], NE)
  • chemotherapy arm – 44.4 months (95% CI: 27.8, NE)
  • HR 0.24 [95% CI: 0.13, 0.45]; p<0.0001

2 / overall study population

  • alectinib arm – not reached (95% CI: NE, NE)
  • chemotherapy arm – 41.3 months (95% CI: 28.5, NE)
  • HR 0.24 [95% CI: 0.13, 0.43]; p<0.0001

The most common (≥ 20%) adverse reactions for alectinib arm were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.

Read further on the FDA website.
Proceed to the publication in the Journal of Clinical Oncology.

ALINA: A phase III study of alectinib versus chemotherapy as adjuvant therapy in patients with stage IB–IIIA anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) 
Authors: Benjamin J. Solomon, Jin Seok Ahn, Fabrice Barlesi, Rafal Dziadziuszko, Makoto Nishio, Alice Tsang Shaw, Walter Bordogna, Christoph Meyenberg, and Yi-Long Wu

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