Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has announced that the U.S. Food and Drug Administration (FDA) has given approval for Alecensa® (alectinib), an anaplastic lymphoma kinase (ALK) inhibitor, to be used as an adjuvant treatment subsequent to tumor resection for patients with ALK-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as identified by an FDA-endorsed test. Alecensa is now the sole ALK inhibitor endorsed for individuals with ALK-positive early-stage NSCLC who have undergone tumor removal surgery. This medication is currently under review for the same indication by health authorities in Europe, Japan, and Taiwan.
Dr. Osamu Okuda, President and CEO of Chugai, expressed satisfaction with the FDA’s approval of Alecensa as the primary adjuvant therapy for ALK-positive early-stage NSCLC, highlighting its significant risk reduction of death or recurrence by 76% as evidenced in clinical trials. Dr. Okuda emphasized the potential of this approval to mark a pivotal moment in the treatment of ALK-positive early-stage NSCLC and pledged collaboration with Roche to swiftly provide this treatment to patients worldwide.
The approval is based on compelling outcomes from the Phase III ALINA study, demonstrating Alecensa’s remarkable 76% reduction in the risk of disease recurrence or death compared to platinum-based chemotherapy in individuals with completely resected IB to IIIA ALK-positive NSCLC. Moreover, an exploratory analysis showcased Alecensa’s efficacy in improving central nervous system (CNS)-disease-free survival, with a 78% reduction in the risk of disease recurrence or death compared to platinum-based chemotherapy. The safety and tolerability profile of Alecensa in this trial remained consistent with previous trials in the metastatic setting, with no unexpected safety concerns observed. These findings were presented at the European Society of Medical Oncology Congress 2023 Presidential Symposium and recently published in the New England Journal of Medicine in April 2024.
Alecensa, a kinase inhibitor, is currently approved for both first- and second-line treatment of ALK-positive metastatic NSCLC. Its efficacy, including in patients with CNS metastases, suggests potential benefits for individuals with early-stage NSCLC following this approval. International guidelines, including the NCCN Clinical Practice Guidelines in Oncology, recommend routine testing of resected surgical tissue or biopsy for ALK, EGFR, and PD-L1 biomarkers in patients with stage IB to IIIA NSCLC, supporting clinicians’ decision-making. Approximately 5% of NSCLC cases are ALK-positive, representing about 90,000 individuals worldwide diagnosed annually.
The ALINA study (NCT03456076), a Phase III trial, evaluated Alecensa’s efficacy and safety compared to platinum-based chemotherapy in individuals with completely resected stage IB to IIIA ALK-positive NSCLC. Alecensa, developed by Chugai’s Kamakura Research Laboratories, is a highly selective, central nervous system-active oral medication for NSCLC patients with ALK-positive tumors. It is approved in over 100 countries for initial and second-line treatment of ALK-positive metastatic NSCLC, including Japan where it is also approved for recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.
Lung cancer remains a significant global health concern, with NSCLC accounting for approximately 85% of cases. Despite adjuvant chemotherapy, a considerable number of individuals experience cancer recurrence, underscoring the importance of early treatment to prevent recurrence and improve cure rates.
