Significantly improved risk of central nervous system disease recurrence and death
The scope of use of the targeted anticancer drug ‘Alecenza’ (ingredient name: alectinib) has expanded as a treatment for patients with early-stage non-small cell lung cancer with a risk of recurrence of up to 55% after surgery.
On the 27th, Roche Korea announced that Alecensa, a treatment for Anaplastic Lymphoma Kinase (ALK)-positive lung cancer, received approval from the Ministry of Food and Drug Safety on the 26th as an adjuvant treatment after complete tumor resection in patients with ALK-positive non-small cell lung cancer.
With this approval, the scope of application has been expanded to not only patients with ALK-positive locally advanced or metastatic non-small cell lung cancer, but also patients with early-stage lung cancer. Alecensa is the first tyrosine kinase in Korea that can be used as adjuvant therapy after surgery for patients with ALK-positive early-stage non-small cell lung cancer. It has been established as a Tyrosine Kinase Inhibitor (TKI).
Approximately 30-55% of patients with early-stage non-small cell lung cancer experience recurrence even after surgery and can lead to death, so it is important to lower the risk of recurrence through appropriate treatment options from the beginning. For this reason, the latest global treatment guidelines also recommend adjuvant therapy after surgery as a way to reduce the possibility of recurrence after surgery and increase patient survival rate.
This approval was based on the ‘ALINA study’ conducted on 257 patients with stage 1B to 3A ALK-positive non-small cell lung cancer. A study comparing chemotherapy and Alecensa as adjuvant treatment after surgery for completely resected ALK-positive non-small cell lung cancer. Alecensa reduced the risk of disease recurrence or death by 76% compared to platinum-based chemotherapy, showing clinically meaningful improvement. Confirmed.
In addition, Alecensa lowered the risk of disease recurrence or death in the central nervous system (CNS) by 78%. Safety was consistent with previous clinical trials in metastatic patients, and no new safety issues were identified.
These clinical benefits were also confirmed in Asian patients, including Korea. As a result of a sub-analysis of the ‘ALINA study’ on 140 Asian patients including Korea, China, Japan, Taiwan, and Thailand, Alecenza reduced the risk of disease recurrence or death by 61% compared to platinum-based chemotherapy, and the risk of central nervous system disease recurrence or death was lower than that of platinum-based chemotherapy. It showed a tendency to decrease by 76%.
Professor Ahn Jin-seok of the Department of Hematology and Oncology at Samsung Medical Center said, “Compared to other non-small cell lung cancers, ALK-positive lung cancer, which develops at a relatively young age, has a high risk of central nervous system metastasis in case of recurrence, making it more difficult to cure and placing a greater burden on patients.” As it has been confirmed to effectively lower the risk of recurrence and death in patients when used as adjuvant therapy after surgery for ALK-positive mutant lung cancer, this first approval is significant and is expected to bring positive changes to the domestic non-small cell lung cancer treatment environment in the future. “I look forward to it,” he said.
Meanwhile, Alecensa is the first TKI recommended by the National Comprehensive Cancer Network (NCCN) as adjuvant therapy (Category 1) for the treatment of completely resected stage 2~3A and 3B (T3, N2) ALK-positive non-small cell lung cancer patients. . Additionally, a clinically significant improvement was confirmed in the 5-year overall survival rate of patients suffering from stage 3B and 4 non-small cell lung cancer.
Source: kormedi.com
