Dr Lee on Disease-Free Survival Outcomes With Alectinib in ALK+ NSCLC

“If we [consider] how we normally treat adjuvantly, these patients [usually receive] chemotherapies and immunotherapies. However, since these [patients with] ALK-positive NSCLC, do not respond to immunotherapy as well, [alectinib] has shown more of a benefit than our standard of care.”

Matthew Lee, MD, an assistant professor in the Department of Medical Oncology and Therapeutics Research at the City of Hope, detailed the effect of alectinib (Alecensa) on disease-free survival (DFS) outcomes in patients with ALK-positive non–small cell lung cancer (NSCLC).

In April 2024, the FDA approved adjuvant alectinib for the treatment of patients with ALK-positive NSCLC; the approval was supported by data from the phase 3 ALINA trial (NCT03456076). Data from the trial demonstrated high DFS rates with alectinib, Lee began. Specifically, in patients with stage II or IIIA disease, the DFS rate at 2 years was 93.8% in the alectinib arm (n = 116) compared with 63.0% in the chemotherapy arm (n = 115). Additionally, the 3-year DFS rates in the respective arms were 88.3% and 53.3% (HR, 0.24; 95% CI, 0.13-0.45; P < .001). Additionally, in the intent-to-treat population, the 2-year DFS rates were 93.6% and 63.7% in the alectinib (n = 130) vs chemotherapy (n = 127) arms, respectively. At 3 years, the DFS rates in the respective arms were 88.7% and 54.0% (HR, 0.24; 95% CI, 0.13-0.43; P < .001).

Considering the typical practice with adjuvant therapy, patients usually receive chemotherapies and immunotherapies, Lee continued. He noted that because patients with ALK-positive NSCLC do not respond well to immunotherapies, they have derived benefit from receiving alectinib compared with standard of care. Furthermore, as long-term data are collected, survival benefits may continue to evolve, he added. In a similar trend to the phase 3 CheckMate trial (NCT02998528), which investigated neoadjuvant nivolumab (Opdivo) plus chemotherapy in resectable NSCLC, the regimen being evaluated in ALINA will likely have similar overall survival benefits, Lee concluded.