Adjuvant Alectinib Earns European Approval in Resectable ALK+ NSCLC

The FDA approved adjuvant alectinib for ALK-positive NSCLC in April 2024. Supporting data for the FDA approval came from the phase 3 ALINA study (NCT03456076).

The European Commission has granted approval to adjuvant alectinib (Alecensa) for adults with resected ALK-positive non–small cell lung cancer (NSCLC) at high risk of recurrence, according to a press release from the developer, Roche.¹

Supporting data for the approval of alectinib in the European Union came from the phase 3 ALINA study (NCT03456076), which assessed treatment with alectinib vs platinum-containing chemotherapy among patients with ALK-positive NSCLC.

According to findings published in The New England Journal of Medicine, treatment with alectinib lowered the risk of disease recurrence or death by 76% compared with chemotherapy (HR, 0.24; 95% CI, 0.13-0.45; P <.001).² Additionally, the disease-free survival (DFS) rate at 2 years among patients with stage II or IIIA disease was 93.8% with alectinib vs 63.0% with chemotherapy.

The safety profile of alectinib in the ALINA trial was comparable with prior reports of the agent in the metastatic setting. Adverse effects (AEs) among patients who received alectinib included increased creatine kinase levels (43.0%) and constipation (42.2%). Additionally, 93.8% and 18.0% of patients in the alectinib arm had any-grade treatment-related AEs (TRAEs) and grade 3/4 TRAEs, respectively.

“When it comes to early stage ALK-positive NSCLC, surgery is not always enough as there remains a high risk of recurrence that leaves patients concerned about what’s to come,” Fabrice Barlesi, MD, PhD, a thoracic oncologist at Paris Saclay University and chief executive officer at Gustave Roussy Institute, said in the press release.¹ “The magnitude of [DFS] benefit observed in the ALINA study was unprecedented and consistent across all disease stages. The use of early ALK testing will help to identify all patients that could benefit from this important new treatment option.”

In the ALINA study, 257 patients were assigned to receive either alectinib orally at 600 mg twice daily (n = 130) or platinum-containing chemotherapy intravenously (n = 127). The trial’s primary end point was DFS, and secondary end points included overall survival and safety.

The FDA approved adjuvant alectinib for ALK-positive NSCLC in April 2024.³ Supporting data for the FDA approval came from the ALINA trial.

“For the first time, people in Europe who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, which can significantly reduce the risk of disease recurrence or death. This is a landmark approval for people who have historically [had] a high risk of their cancer returning after surgery. We are now able to bring the transformational benefits of [alectinib] to even more people with ALK-positive lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, concluded.¹

References

1. European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer. News release. Roche. June 10, 2024. Accessed June 10, 2024. https://tinyurl.com/nhc57d2u
2. 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
3. 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 June 10, 2024. https://shorturl.at/zSV29