Roche's Alectinib Capsules Nominated for Priority Review in China for Adjuvant Treatment of ALK-Positive NSCLC

On November 7, Roche's Alectinib Capsules were proposed by the CDE to be included in the priority review for adjuvant treatment after complete tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

On September 1 this year, Roche announced that the Phase III ALINA study of alectinib as adjuvant therapy for ALK-positive early-stage NSCLC met its primary endpoint of disease-free survival (DFS) in a pre-planned interim analysis. Alectinib is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death in patients with ALK-positive early-stage NSCLC in a Phase III trial.

Results presented at the 2023 ESMO Congress showed that, compared to platinum-based chemotherapy, adjuvant treatment with alectinib in patients with completely resected IB (tumors ≥4cm) to IIIA stage ALK-positive NSCLC reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001).

At the same time, the current research results also observed a clinically significant improvement in central nervous system (CNS)-DFS (HR=0.22; 95% CI: 0.08-0.58). In this analysis, the median DFS in the alectinib group has not yet been reached (NE), while the median DFS in the chemotherapy group was 41.3 months (95% CI: 28.5, NE); the overall survival (OS) data for patients receiving alectinib as adjuvant therapy in the current ALINA study are not yet mature and relevant data will be released after longer follow-up.

In this study, the safety and tolerability profile of Alectinib was consistent with previous studies, and no new unexpected safety signals were observed. The incidence of Grade 3 or 4 adverse events (AEs) was 30% in the Alectinib group and 31% in the chemotherapy group. No Grade 5 adverse events were observed in either treatment group. In the Alectinib group, 5.5% of patients discontinued treatment due to adverse events, compared to 12.5% in the chemotherapy group.

Currently, about half of the patients with early-stage lung cancer (45%-76%, depending on the stage of the disease) will experience cancer recurrence after surgery despite receiving adjuvant chemotherapy. Recent innovative therapies (including immunotherapy) have improved the prognosis for some patients with early-stage NSCLC; however, there are currently no ALK inhibitors approved for early-stage ALK-positive disease.

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