The following article features coverage from the European Society for Medical Oncology (ESMO) 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Next-generation sequencing (NGS) blood tests can identify actionable gene mutations such as ALK fusions in circulating tumor DNA shed by non-small cell lung cancer (NSCLC) to guide treatment decision making without invasive biopsy, suggested study findings presented at the European Society of Medical Oncology (ESMO) Congress 2019 in Spain (ClinicalTrials.gov Identifier: NCT03178552).1

“We showed that liquid biopsy could be used to detect a complex type of driver mutation, called ALK, in patients with NSCLC,” said study author Shirish Gadgeel, MBBS, of the University of Michigan’s Rogel Cancer Center in Ann Arbor, in an ESMO press release.2

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The study authors screened 2219 adult patients with stage IIIB/IV NSCLC. Blood-based NGS yielded results for 2188 of them, among whom 119 patients (5.4%) with ALK-positive disease. TP53 mutations were detected in 38 patients.

Of the 199 patients with ALK-positive NSCLC, 87 received oral alectinib (600 mg twice daily) and 8-week restaging and brain scans. Alectinib targets the ALK mutation.

At a median follow-up of 12.6 months (range, 2.6–18.7 months), the investigator-confirmed overall response rate (ORR) was 87% and the independent review facility-confirmed ORR was 92%. At 12 months, 75.9% of patients had not experienced disease progression. Median progression-free duration (PFD) was not reached. Safety data were “consistent with alectinib’s safety profile,” Dr Gadgeel reported.

ALK gene rearrangements can be difficult to detect, making the findings “an important advance,” commented Alberto Bardelli, PhD, of the University of Turin in Italy, in the release.2

“At present the technology is quite expensive but as it becomes more widely used, the cost is likely to come down so that testing becomes more affordable and available in daily practice,” Dr Bardelli predicted.

Blood-based detection of ALK fusions resulted in “high ORR and clinical benefit in patients receiving alectinib,” concluded Dr Gadgeel. “These data validate the clinical utility of blood-based NGS as an additional method to inform clinical decision making in ALK+ NSCLC.”

Disclosure: The study was funded by F. Hoffman-La Roche, Ltd. For a full list of author disclosures, please refer to the abstract.

Read more of Cancer Therapy Advisor‘s coverage of the ESMO annual meeting by visiting the conference page.

References

  1. Gadgeel M, Mok TSK, Alexander JAA, et al. Phase II/III blood-first assay screening trial (BFAST) in treatment-naive NSCLC: initial results from the ALK+ cohort. Presented at: European Society of Medical Oncology (ESMO) Congress 2019; September 27-October 1, 2019: Barcelona, Spain. Abstract LBA81_PR.
  2. European Society of Medical Oncology (ESMO). Blood test can replace invasive biopsy for more patients with lung cancer. Published September 30, 2019.