Advancements in fighting lung cancer benefit ALK patients


Companion diagnostics are essential in realizing the value of targeted therapies.

January 18, 2024


Targeted therapies for non-small cell lung cancer (NSCLC) patients harboring ALK or EGFR gene alternations and immunotherapies for PD-L1 positive  NSCLC continue to bring better quality of life and longevity to patients. Specifically, advances in therapies and biomarker tests targeting ALK are bringing new hope to patients with ALK-positive cancer.

New data on Alecensa® (alectinib), a drug targeting the ALK-gene rearrangement in non-small cell lung cancer, was released in October 2023, at the European Society of Medical Oncology Congress, showing improvement in disease-free survival in early-stage, non-small cell lung cancer (NSCLC). 

Alecensa reduces the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected Stage IB to IIIA, according to an interim analysis of the ALINA trial.1 Alecensa is a kinase inhibitor indicated for the treatment of patients with ALK-positive metastatic NSCLC, as detected by an FDA-approved test.

Sanam Rashidi, Pharm.D., Roche Diagnostics’ disease area partner for medical and scientific affairs, discusses what the news could mean for diagnostics.


Why is this news so important?

For clinicians and pathologists, it’s practice changing – a real paradigm shift in how lung cancer can be managed. It’s more important than ever to discover whether a patient is positive for the ALK gene rearrangement as early as possible in the diagnosis. These findings can potentially make an incredible difference for ALK-positive patients who won’t be expected to respond well to therapies developed for patients with different subtypes of lung cancer. Now, there’s potential for an existing drug to help at an earlier stage of lung cancer.


Is the profile of a patient with ALK-based cancer different from a patient with other types of lung cancer?

Yes, ALK-positive patients often have a different patient profile. About 30% of lung cancer patients who are under 40 years old are ALK-positive.2 About 50% are under 50 years old.3 Also, ALK-positive patients have typically never smoked or smoked lightly. They also are at higher risk of developing brain metastases than those with other types of NSCLC.4


Who is eligible for ALK testing?

Tumor molecular testing is recommended for ALK rearrangements at the time of initial diagnosis and prior to initiation of therapy. Medical guidelines were updated in early 2023 to recommend testing for PD-L1 status, EGFR mutations and ALK rearrangements in early-stage NSCLC patients (Stage IB-IIIA, IIIB [T3,N2]).2

About one in two people with early-stage NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy.5 Now that existing therapies to treat ALK are showing efficacy in earlier stages of NSCLC, it’s critical that patients are properly matched with the therapy that is targeted for their type of cancer.


What are the guidelines used in determining lung cancer testing?

The National Comprehensive Cancer Network has guidelines for all cancer types, including lung cancer. The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology have published their Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors. Both guidelines provide support and recommendations for ALK testing. 


Are there other advantages to ALK testing today? 

Another advancement is that ALK tests today are available as immunohistochemistry (IHC) tests, when historically, they were available as fluorescence in-situ hybridization (FISH) or next-generation sequencing (NGS) tests, among other types. 

Advancements in testing have allowed for ALK gene rearrangements to be tested using various methodologies. FDA-approved IHC can be used as a diagnostic assay and does not require confirmation by FISH.


What is next in ALK testing?

Although testing for ALK rearrangements has increased over time, an unmet need for comprehensive and timely biomarker testing remains to ensure necessary molecular data is available for therapeutic planning and informed treatment decision-making in patients with ALK+ NSCLC. Utilization of broad molecular panels and development of testing algorithms is likely to become the standard of practice in both initial and subsequent treatment phases. The future direction in managing ALK+ NSCLC may involve understanding and preventing resistance development to next-generation ALK inhibitors through a combined targeting approach, with liquid biopsies playing a role in identifying newly acquired emerging resistance mechanisms.


  1. Last accessed Oct. 30, 2023.
  2. Last accessed Oct. 30, 2023.
  3. Last accessed Oct. 30, 2023.
  4. Griesinger F, et al. Brain metastases in ALK-positive NSCLC – time to adjust current treatment algorithms. Oncotarget. 2018:9(80);35181-35194.
  5. Pignon JP, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.