(Health Korea News / Lee Chung-man) The efficacy of Boryeong’s new small cell lung cancer anticancer drug ‘Zepzelca’ (ingredient name: lurbinectedin) will be tested in pancreatic cancer, which is notoriously difficult to treat.
On the 19th, the Ministry of Food and Drug Safety approved the investigator clinical trial plan (IND) for ‘Zepzelka’ applied by the National Cancer Center. The trial is a single-group clinical trial to evaluate the efficacy of ‘Zepzelka’ in second-line chemotherapy for patients with high-grade pancreatic neuroendocrine tumors.
The indication for ‘Zepzelka’ is the treatment of metastatic small cell lung cancer that has failed first-line platinum-based chemotherapy. Approximately 15% of all lung cancer patients are small cell lung cancer, and this type of cancer is characterized by rapid proliferation and spread throughout the body.
The standard treatment for small cell lung cancer is chemotherapy and radiotherapy. However, small cell lung cancer is generally highly malignant, so it is extremely rare for the first-line treatment alone to achieve remission, and the response rate of the second-line treatment used previously was only about 10%, so the demand for new drugs was high.
‘Zepzelka’ is a new anticancer drug that has emerged to solve these limitations. This drug is a chemotherapy agent that binds to a specific part of the DNA of cancer cells, bends the entire DNA structure, and induces cancer cell death based on DNA damage. The Ministry of Food and Drug Safety of Korea approved ‘Zepzelka’ in September 2022.
For reference, ‘Zepzelka’ was developed by Spain’s PharmaMar, and in Korea, Borung has had exclusive sales and distribution rights for ‘Zepzelka’ since 2017.
According to the research results published in Lancet Oncology, the objective response rate (OS) for the entire patient group was 35%, and the average duration of response was 5.3 months. It was evaluated to be more effective than existing drugs due to clinical benefits such as ease of administration (administered once every three weeks) and manageable side effects.
Based on this, the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines recommend ‘Zepzelka’ as a second-line treatment for small cell lung cancer.
Meanwhile, the possibility of ‘Zepzelka’ being effective in pancreatic cancer, which has a high unmet medical need, is being explored.
Pancreatic cancer is notorious for its very low survival rate, due to its rapid metastasis and the fact that there is currently no effective treatment. The most effective treatment for pancreatic cancer is surgical resection, but it is known that surgery is only possible for about 20% of all patients.
For unresectable pancreatic cancer, radiation therapy after chemotherapy is sometimes considered. However, the 5-year survival rate for patients with unresectable pancreatic cancer is only 6%. This shows the background of pancreatic cancer being recognized as an incurable disease.
In addition, chemoradiation therapy tends not to be actively implemented because it exponentially reduces the quality of life of patients due to cytotoxic side effects. Since patients will not survive long-term anyway, the focus is on suppressing the progression of cancer to a certain extent, improving the patient’s symptoms, and improving the quality of life.
These characteristics of pancreatic cancer are similar to the treatment environment for small bowel cancer before the introduction of ‘Zepzelka’. Accordingly, the National Cancer Center is interpreted as attempting to establish a new pancreatic cancer treatment option through the clinical trial of ‘Zepzelka’ researchers for pancreatic cancer.
The type of pancreatic cancer targeted in this clinical trial is high-grade pancreatic neuroendocrine tumor. This type is a cancer that arises from endocrine (hormonal) and nervous system cells in the pancreas, and accounts for 1-2% of all pancreatic cancers. Among them, high-grade is a subtype that proliferates very quickly.
Therefore, if ‘Zepzelka’ proves a significant therapeutic effect in high-grade pancreatic neuroendocrine tumors, it is expected to be an alternative treatment option for pancreatic cancer patients who do not respond to existing treatments.
However, since this clinical trial is a researcher clinical trial independently conducted by the National Cancer Center, it is not expected to be used as direct evidence for expanding the indications for ‘Zepzelka’.
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Source: www.hkn24.com
