[의학신문·일간보사=김영주 기자]Crystal Genomics has developed a bridging clinical trial plan (IND) to evaluate the efficacy and safety of approval for ‘camrelizumab’, a first-line treatment for non-small cell lung cancer (NSCLC), pemetrexed, and carboplatin in combination therapy for food and drug safety. It was announced on the 4th that it had been submitted to the office.
A bridging study refers to a final stage clinical trial that evaluates and confirms whether there is a difference in ethnic sensitivity among Koreans in order to obtain approval in Korea for a drug approved overseas.
A bridging clinical trial planned for 40 patients with advanced or metastatic non-squamous non-small cell lung cancer was conducted in combination with camrelizumab, pemetrexed, and carboplatin, followed by pharmacokinetics (PK), objective response rate (ORR), and progression-free By analyzing the survival period (PFS), it is evaluated that the drug effects and safety are not significantly different between Koreans and Chinese.
Non-squamous non-small cell lung cancer camrelizumab, pemetrexed, and carboplatin combination therapy already approved in China The objective response rate was 60.5%, and Merck’s Keytruda, pemetrexed, and carboplatin combination therapy showed objective response rate was found to be 48%.
Crystal Genomics has exclusive rights to clinical development and sales of camrelizumab alone or in combination therapy for all cancers including lung cancer, liver cancer and stomach cancer in Korea.
Camrelizumab (trade name: Iruica) is an immune checkpoint inhibitor that targets PD-1 developed by Jiangsu Hengrui Medicine in China. In June 2020, it received approval from the National Drug Administration (NMPA) of China as a first-line treatment for non-small cell lung cancer.
In addition, a total of eight indications, including esophageal cancer, liver cancer, and Hodgkin’s lymphoma, have been approved as first-line or second-line treatment, and the approval process is underway to expand additional indications. According to Hangseo Pharmaceutical, sales of $1.944 billion (about 2.7 trillion won) are expected in 2023.
An official from Crystal Genomics said, “Camrelizumab has already been proven effective in non-squamous non-small cell lung cancer, and we expect approval of camrelizumab as a combination therapy for non-small cell lung cancer through this bridging clinical trial.” “Last year Considering that the domestic market for immune checkpoint inhibitors (including salaries and non-salaries) is about 500 billion won, we aim to increase sales by more than 20% of the market share (about 100 billion won),” he said.