Boryung (former Boryung Pharmaceutical) said Friday it plans to release in Korea Zepzelca (lurbinectedin), a new small cell lung cancer (SCLC) treatment developed by Spanish company PharmaMar S.A., in March.
Expectations are high for expanding treatment options amid limited secondary treatments for small cell lung cancer in Korea, it said.
Boryung added that it has owned the right to develop and sell the drug in Korea exclusively since 2017.
The Korean company is stepping up preparations for the domestic launch of Zepzelca. Last September, it won the item permit for the drug from the Ministry of Food and Drug Safety. Earlier, the treatment got the designation as a rare drug. Its domestically approved indication is to treat “metastatic SCLC that failed in platinum-based chemotherapy as the primary therapy.”
In the U.S., the drug was released in July 2020 after winning conditional fast-track approval from the Food and Drug Administration a month earlier. The phase 2 trial, the basis for the FDA approval, was conducted on 105 patients with progressive SCLC after receiving treatment with platinum-based chemotherapy.
According to data from the phase 2 clinical trial published in the May 2020 issue of the Lancet Oncology, as a result of the independent review committee’s measuring at 5.1 months, Zepzelca showed overall survival (OS) of 35 percent and the duration of response (DoR) of 5.3 months.
Besides, Boryung believes Zepzelca has excellent ease of administration as it has only to be administered once every 21 days, injecting 3.2 mg/m2 intravenously over an hour.
SCLC is known to have a faster initial metastasis than non-small cell lung cancer (NSCLC) and a higher recurrence rate even after treatment. Therefore, platinum-based chemotherapy is a typical treatment for small-cell lung cancer. However, there are few secondary treatments for resistant or recurrence patients.
According to the National Cancer Information Center, there were 29,960 lung cancer patients in 2019, and 3,169 were SCLC patients.
“In the case of expansionary-phase SCLC, the standard primary treatment is the combined therapy of platinum-based therapy and immunotherapy,” said Professor Lim Sun-min of the Oncology Department at Yonsei University Cancer Hospital. ‘However, the mOS (median overall survival) in this case hovers around one year.”
Professor Lim added that there are also points to consider when administering Zepzelca.
"Zepzelca has a limitation in that it is highly hematologically toxic. Leukopenia and thrombocytopenia are severe. In addition, as many as 40 percent of patients showed side effects of moderate or higher symptoms. Therefore, we should actively consider reducing the dose,” Professor Lim said.
He said, “Nevertheless, in recent guidelines, Zepzelca has emerged as an option in the event of a platinum-based chemotherapy failure. We are looking forward to it because it is a new drug in treating small cell lung cancer."