Alectinib “First of Many Approvals” In ALK+ NSCLC
D. Ross Camidge, MD, PhD, spoke about how the approval of alectinib is the beginning of multiple other approvals for patients with ALK-positive NSCLC.
D. Ross Camidge, MD, PhD, discussed the recent FDA approval of alectinib (Alecensa) as adjuvant treatment for patients with ALK-positive non–small cell lung cancer of which tumors are at least 4 cm or node-positive.1
Camidge, director of the Thoracic Oncology Clinical and Clinical Research programs at the University of Colorado Health, further expressed how this approval may be a stepping stone for the approvals of other agents in this population.
Results for the approval were based on the phase 3 ALINA trial (NCT0346076), which investigated alectinib vs chemotherapy.2 When patients received alectinib, the risk of death or recurrence was reduced by 76% compared with chemotherapy (HR, 0.24; 95% CI, 0.13-0.43; P <.0001). Of note, the disease-free survival rate improved with alectinib when analyzed in an exploratory analysis (HR, 0.22; 95% CI, 0.08-0.58).
The safety and tolerability of alectinib in the ALINA trial was comparable with prior reports of the agent in the metastatic setting.
In the press release of the study, it was noted that the design of alectinib was to help prevent lung cancer recurrence after it has been removed by surgery or to treat those with metastasized tumors.
Of the 257 patients enrolled, 130 patients were given alectinib and 127 were given chemotherapy.
Transcript:
The recent approval of adjuvant alectinib is going to push open a door. People with targetable abnormalities found in the early-stage setting are likely to go on to a well-tolerated treatment to suppress their disease. I don’t know that anyone knows if it’s a cure, or whether we’re just kicking the can down the road. But it’s the beginning of probably multiple approvals in that setting. The key thing is it’s going to be well tolerated. These are [patients] who might be cured. You don’t want them to spend 2 or 3 years on a treatment; that is no fun at all.
References
- FDA approves Genentech’s Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer. News release. Genentech. April 18, 2024. Accessed April 29, 2024. https://shorturl.at/zSV29
- Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med. 2024;390(14):1265-1276. doi:10.1056/NEJMoa2310532
These data support less restrictive clinical trial eligibility criteria for those with metastatic NSCLC. This is especially true regarding both targeted therapy and immunotherapy treatment regimens.
