Chugai Pharmaceutical Announces Approval of Alecensa® in Japan
Thursday, August 29, 2024
Chugai Pharmaceutical has secured approval for an additional indication of Alecensa® (alectinib), its ALK inhibitor and antineoplastic agent, for use as adjuvant therapy in ALK fusion gene-positive non-small cell lung cancer (NSCLC).
This approval is grounded in findings from the ALINA study, the first global Phase III clinical trial focused on early-stage ALK-positive resected NSCLC. The study demonstrated that Alecensa reduced the risk of disease recurrence or death by 76%, marking a significant advancement in the treatment of this condition.
This approval addresses a critical unmet need, as approximately half of individuals with early-stage NSCLC experience disease recurrence after surgery, despite undergoing adjuvant chemotherapy. In Japan, the new indication is expected to significantly reduce the risk of postoperative recurrence, offering hope for a complete cure and long-term survival for patients with ALK-positive NSCLC, thereby improving their quality of life.
The ALINA study, a Phase III randomized, active-controlled, multicenter, open-label trial, evaluated the efficacy and safety of adjuvant Alecensa compared to platinum-based chemotherapy in patients with resected Stage IB (tumors ≥ 4 cm) to IIIA ALK-positive NSCLC.
The trial involved 257 patients, randomly assigned to either the Alecensa or chemotherapy treatment arms. Alecensa showed a 76% reduction in the risk of disease recurrence or death (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared to platinum-based chemotherapy. The safety and tolerability profile of Alecensa in the ALINA trial was consistent with previous studies conducted in the metastatic setting, with no unexpected safety concerns.
Lung cancer remains one of the leading causes of cancer-related deaths globally, with 1.8 million fatalities annually. In Japan, lung cancer affected 127,000 individuals in 2019. Non-small cell lung cancer (NSCLC) is the most common type, comprising approximately 85% of all lung cancer cases. Despite advances in treatment, 45-76% of patients with early-stage lung cancer still experience recurrence after surgery, underscoring the importance of early treatment to prevent disease return and improve chances of a cure
Source: chugai-pharm.co.jp
