EU Approves Roche’s Alecensa as First Adjuvant Therapy for ALK+ Early-Stage Lung Cancer

The European Commission has approved Alecensa® (alectinib) monotherapy as an adjuvant treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who are at high risk of recurrence (Stage IB [≥4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]) following tumor resection. This decision is based on data from the Phase III ALINA trial, where Alecensa showed a remarkable 76% reduction in the risk of disease recurrence or death in patients with resected ALK-positive NSCLC.

“For the first time, people in Europe who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, significantly reducing 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 approval is a landmark for people historically facing high recurrence risks post-surgery. Alecensa’s benefits can now reach more ALK-positive lung cancer patients.”

Professor Fabrice Barlesi, thoracic oncologist at Paris Saclay University and CEO of Gustave Roussy Institute, added, “Surgery alone often isn’t enough for early-stage ALK-positive NSCLC due to high recurrence risks. The ALINA study’s unprecedented disease-free survival benefit was consistent across all stages. Early ALK testing will identify patients who can benefit from this new treatment.”

In the ALINA study, Alecensa reduced the risk of disease recurrence or death by 76% (HR=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in patients with completely resected IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. An exploratory analysis showed an improvement in central nervous system disease-free survival (HR=0.22; 95% CI: 0.08-0.58), which is crucial for ALK-positive NSCLC patients who are more prone to brain metastases. The safety profile of Alecensa in the ALINA trial was consistent with previous trials, with no unexpected safety issues. These results were published in the New England Journal of Medicine in April 2024.

Alecensa, already a preferred treatment for advanced ALK-positive NSCLC, has transformed outcomes for many patients. It is approved in over 100 countries as a first- and second-line treatment, with more than 94,000 patients treated worldwide. This new adjuvant approval marks Alecensa’s potential pivotal role in treating resectable ALK-positive disease, addressing a significant unmet need. This European approval follows the U.S. FDA’s April 2024 approval of Alecensa for adjuvant treatment post-tumor resection in ALK-positive NSCLC (tumors ≥ 4 cm or node positive). Ongoing submissions to health authorities globally aim to make this treatment available to more patients.

To aid clinicians, international guidelines recommend routine ALK, EGFR, and PD-L1 biomarker testing of resected surgical tissue or biopsy in patients with stage IB to IIIA and select IIIB (UICC/AJCC 8th edition) NSCLC, alongside advanced-stage testing, as per the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology.

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