Alecensa for Stage I-III ALK+ NSCLC

Alecensa the new standard treatment of ALK mutated early stage NSCLC – gets FDA approval.

Charles H. Weaver, MD
3–5 minutes
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Results of the ALINA clinical trial confirm the superiority of Alecensa over chemotherapy for the initial treatment of ALK mutated early stage NSCLC leading to US Food and Drug Administration approval in April 2023,7 and highlight that ALL individuals with NSCLC should undergo molecular testing for ALK, EGFR, PDL-1 and other biomarkers. 

Approximately 5% of all Non-Small Cell Lung Cancer’s (NSCLC) have a mutation of the anaplastic lymphoma kinase (ALK) gene. The ALK mutation is responsible for initiating and driving cancer growth. Individuals with ALK+ lung cancer tend to be non-smokers or former light smokers; younger in age and are a type of NSCLC referred to as adenocarcinoma (based upon the cells affected). ALK + NSCLC tends to respond poorly to standard chemotherapy regimens but can be effectively treated with precision cancer medicines.1-5

Alecensa is the current standard of care for the initial treatment of patients with advanced ALK-positive NSCLC and recently released clinical trial results at the 2023 European Society for Medical Oncology meeting in Madrid Spain have established Alecensa as the new standard initial treatment for patients with early-stage NSCLC with an ALK mutation.6

About Alecensa (alectinib)

Alecensa was initially approved for treatment of patients with the ALK driver mutation in NSCLC in December 2015 based on research showing that 38% – 44% of patients intolerant to or failing Xalkori responded to Alecensa treatment. Of interest 81% of patients with central nervous system involvement responded longer to Alcensa treatment compared to Xalkori.3

Other Precision Cancer Medicines Targeting ALK.

Alecensa became the current standard of care for the initial treatment of patients with advanced ALK-positive lung cancer3-7 because Alecensa provides longer symptom improvement, improves progression-free and overall survival, and delays the time to CNS progression when directly compared to Xalkori – the previous standard of care.

The ALINA Clinical Trial

The ALINA study [NCT03456076] is a Phase III, randomized, multi-center study designed to evaluate whether the use of adjuvant Alecensa® in earlier stages of NSCLC would also be superior to platinum-based chemotherapy. The study enrolled 257 people with completely resected early stage IB to IIIA ALK positive NSCLC. The study results showed that Alecensa® treatment was well tolerated and reduced the risk of disease recurrence or death by 76%. The average survival duration was not yet reached for the Alecensa treated patients compared with 41 months for those treated with chemotherapy.

Overall survival data are still immature, follow-up is ongoing, and a mature survival estimate will be reported in the future. However 88% of Alecensa treated patients survive cancer free compared to 53% of those treated only with chemotherapy. “These potentially practice-changing data reinforce the potential of Alecensa as a new standard of care in the ALK-positive early lung cancer setting where treatment options are currently extremely limited,” said Professor Benjamin Solomon, Medical Oncologist, Peter MacCallum Cancer Centre, Australia. “The magnitude of disease-free survival observed in this study could represent a paradigm shift in the way we manage early-stage ALK-positive lung cancer.” All newly diagnosed lung cancer patients should undergo NGS-biomarker testing of both tissue and blood to determine optimal treatment.

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References

  1. N Engl J Med. 2017 Jun 6. doi: 10.1056/NEJMoa1704795.
  2. Shaw AT, Kim DW, Mehra R, et al: Ceritinib in ALK-rearranged non–small-cell lung cancer. New England Journal of Medicine. 2014; 370: 1189-1197.
  3. Peters S, Camidge DR, Shaw AT, et al. Alcensa versus Xalkori in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377(9):829–838. doi: 10.1056/NEJMoa1704795.
  4. news.cancerconnect.com/alecensa-superior-xalkori-treatment-lung-cancer/
  5. Abstract 138PD_PR “Patient-reported outcomes (PROs) in ALEX: A phase III study of Alcensa (ALEC) vs Xalkori (CRIZ) in non-small-cell lung cancer (NSCLC)” presented by Maurice Pérol during the Poster Discussion session “Immunotherapy and next-generation TKIs: from second to frontline treatment” on Thursday 12 April, 07:45 to 09:00 (CEST) in Room A. Journal of Thoracic Oncology, Volume 13, Issue 4, Supplement, April 2018.
  6. https://news.cancerconnect.com/lung-cancer/understand-alk-inhibitor-treatment-of-alk-positive-lung-cancer
  7. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery
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