Roche Alecensa gets European Commission nod as targeted adjuvant treatment for ALK-positive early-stage lung cancer

“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.

Alecensa is the preferred treatment option for patients with advanced ALK-positive NSCLC and has transformed outcomes for people with this disease. Approved in more than 100 countries as a first- and second-line treatment, more than 94,000 patients with advanced disease have been treated with Alecensa in clinical practice. Following its approval in the adjuvant treatment setting, Alecensa could for the first time play a pivotal role in ALK-positive resectable disease, where there is a significant unmet medical need. The approval in Europe follows the April 2024 U.S. Food and Drug Administration (FDA) approval of Alecensa as adjuvant treatment following tumour resection for patients with ALK-positive NSCLC (tumours ≥ 4 cm or node positive), as detected by an FDA-approved test. Submissions to additional health authorities worldwide are ongoing to bring this much-needed new treatment option to as many patients as possible.

To support clinicians’ decision-making, routine testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and select IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines).