European Commission approves Roche’s Alecensa for people with ALK-positive early-stage lung cancer

The European Commission has approved Roche’s Alecensa (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [≥4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).

Data from the Phase III ALINA trial, where Alecensa demonstrated a 76% reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application.

“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,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This is a landmark approval for people who have historically faced a high risk of their cancer returning after surgery. We are now able to bring the transformational benefits of Alecensa to even more people with ALK-positive lung cancer.”

“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,” said Professor Fabrice Barlesi, thoracic oncologist, Paris Saclay University and chief executive officer of Gustave Roussy Institute. “The magnitude of disease-free survival 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, Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. In an exploratory analysis, an improvement of central nervous system disease-free survival was observed (HR=0.22; 95% CI: 0.08-0.58). This is of particular importance for people with ALK-positive NSCLC, who are at greater risk of developing brain metastases than those with other types of NSCLC. The safety and tolerability of Alecensa in the ALINA trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed. These data were published in the New England Journal of Medicine in April 2024.

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