On October 27, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Alectinib hydrochloride capsules are planned to be included in the breakthrough therapy category, and the proposed indications are for the treatment of anaplastic lymphoma kinase (ALK)-positive patients. Postoperative adjuvant therapy for patients with small cell lung cancer (NSCLC).
Lung cancer is a common cancer in the world, and NSCLC accounts for approximately 85% of lung cancers. For ALK-positive NSCLC patients, especially early-stage patients, delaying disease progression is particularly important. On the one hand, this group is relatively young, about 55 years old; on the other hand, because this group is relatively younger than other types of NSCLC. Brain metastasis is more likely to occur. Once the disease recurs, it usually spreads to other parts of the body, at which point it is generally considered an incurable condition.
Alectinib is a new generation ALK inhibitor. It was previously approved for marketing in China in 2018 for the treatment of ALK-positive locally advanced or metastatic NSCLC. This application to be included in the breakthrough therapy category by CDE is for a new indication: postoperative adjuvant treatment for patients with ALK-positive NSCLC.
It is worth mentioning that on October 18, 2023, Alectinib achieved the primary endpoint in the global phase 3 clinical trial ALINA study. The ALINA study is a phase 3, randomized, active-controlled, multi-center, open-label study designed to evaluate Alectinib in patients with completely resected IB (tumor ≥4 cm) to stage IIIA (UICC/AJCC seventh edition) ALK-positive NSCLC. Efficacy and safety of nil compared with platinum-based chemotherapy in the adjuvant setting. This study enrolled 257 patients. The primary endpoint of the study is disease-free survival (DFS). Secondary endpoints include overall survival (OS), time to central nervous system (CNS) relapse or death, and safety. The research data were announced as an important study in the form of an oral report at the bureau seminar of the 2023 European Society for Medical Oncology (ESMO) Congress.
ALINA study results show that the use of Alectinib as adjuvant treatment for patients with completely resected IB (tumor ≥4 cm) to stage IIIA ALK-positive NSCLC can reduce the risk of disease recurrence or death compared with the platinum-based chemotherapy group. 76%.
At the same time, a clinically meaningful improvement in CNS-DFS was also observed in the current study (HR = 0.22). In this analysis, the median DFS in the Alectinib group has not yet been reached (NE), while the median DFS in the chemotherapy group is 41.3 months; currently, OS data for patients who received adjuvant Alectinib in the ALINA study are not yet mature. , relevant data will be published after longer follow-up.
The safety and tolerability profile of Alectinib in this study 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 with 12.5% in the chemotherapy group.
Professor Wu Yilong from Guangdong Provincial People's Hospital, the principal investigator of the ALINA study, said in a press release: "ALK mutation-positive patients respond better to ALK-TKI treatment and can obtain long-term survival benefits. Therefore, ALK gene mutations are also known as It is a 'diamond mutation'. Although early-stage patients will receive adjuvant chemotherapy after surgery, nearly half of early-stage patients will still relapse. Against this background, scholars around the world have joined hands to carry out the ALINA study, of which China has contributed the second largest amount. The number of patients and the research results are also full of the efforts of Chinese scholars. This study indicates that ALK-TKI treatment has been moved from late stage to early stage, which may completely change the current treatment pattern of ALK-positive early NSCLC groups."