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Imjudo, the No. 8 immune anti-cancer drug, landed
by Jun 28, 2023 05:53am
The 8th and 2nd immuno-anticancer drug with CTLA-4 inhibitory mechanism has appeared in Korea. After more than 10 years of development, AstraZeneca created the first immuno-oncology + immuno-oncology combination option in liver cancer. According to the pharmaceutical industry on the 26th, the Ministry of Food and Drug Safety recently granted product approval to AstraZeneca's CTLA-4 immunotherapy Imjudo. Imjudo is used in combination with AstraZeneca's Imfinzi as the first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (liver cancer). Imjudo is the 8th licensed immuno-oncology drug in Korea. Since BMS Yervoy was approved as the first immuno-oncology drug in December 2014, a total of seven immuno-oncology drugs have entered the market, namely Opdivo by Ohno Pharmaceuticals, MSD Keytruda, Roche Tecentriq, Imfinzi by AstraZeneca, Bavencio by Merck, and Jemperli by GSK. With the approval of Imjudo, AstraZeneca has two immuno-oncology drugs. Imjudo is also a CTLA-4 immuno-oncology drug that appeared 9 years after Yervoy. CTLA-4 is a cytotoxic T lymphocyte-associated antigen-4 that is mainly expressed on the surface of T cells to control T cell activity. Imjudo is a mechanism that induces an anti-tumor immune response by activating T cells by selectively blocking the interaction between CTLA-4 and CD80/CD86. It is not an exaggeration to say that immuno-oncology drugs that appeared after Yervoy are all PD-(L)1 series, and PD-(L)1 series is currently holding the immuno-oncology market. Due to their mechanistic characteristics, the CLTA-4 series of immuno-oncology drugs failed to overcome the limitations of relatively low response rates and high side effects of autoimmune diseases. Because of this, Yervoy is limitedly used only in combination therapy with the PD-1 inhibitor Opdivo. Imjudo also suffered from numerous clinical failures during the development process. Imjudo was first developed by Pfizer, and global development rights were acquired by AstraZeneca in 2011. Since then, AstraZeneca has tried combination therapy with Imfinzi for various cancers such as lung cancer, bladder cancer, and head and neck cancer, but it has failed every time in clinical trials. Liver cancer is first cancer that gave the green light for the commercialization of Immudo. The primary endpoint was achieved by minimizing concerns about the toxicity of Imudo and increasing its effectiveness with the STRIDE regimen (first administration of Imjudo followed by administration of Imfinzi at 4-week intervals). AstraZeneca was able to obtain product approval for liver cancer after developing Immu for more than 10 years. According to the results of the HIMALAYA phase 3 conducted by AstraZeneca, Imjudo + Imfinzi STRIDE therapy recorded a median overall survival (mOS) of 16.4 months, reducing the risk of death by 22% compared to standard treatment Nexavar. At the time of the 36-month follow-up, the OS arrival rates of the Imfinzi + tremelimumab and Nexavar groups were 30.7% and 20.2%, respectively, confirming the long-term survival benefit of the combination therapy. Subsequently, in the results of the Asian sub-analysis, Imjudo + Imfinzi therapy proved a consistent effect with the global one. With the advent of Imjudo, changes are expected in the liver cancer treatment environment. In liver cancer, which has been the center of targeted anticancer drugs, the number of immunotherapeutic options is increasing. Roche's Tecentriq is the first immuno-oncology drug to be named for the first-line treatment of liver cancer. Tecentriq demonstrated excellent effects in combination with the targeted anti-cancer drug 'Avastin'. The overall survival period was increased by 6 months compared to Nexavar, the risk of death was reduced by 42% compared to Nexavar, and the response rate was more than twice as high as Nexavar. Following immuno-oncology + targeted anti-cancer drug, immuno-oncology + immuno-oncology combination represented by Imjudo + Imfinzi also appeared. It has the advantage of avoiding various side effects that reduce the quality of life, such as skin-related diseases such as hand-foot syndrome and diarrhea, which can be caused by targeted anticancer drugs. As the efficacy of immuno-anticancer drugs has been proven, immuno-anticancer drugs have come to the fore in domestic liver cancer treatment guidelines. According to the '2022 Hepatocellular Carcinoma Treatment Guidelines' announced by the National Cancer Center last year by the Korean Liver Cancer Society, 'Tecentriq + Avastin' and 'Imudo + Imfinzi' therapies were recommended (A1) as the first systemic treatment. For the first time this year, an immuno-oncology drug was recommended first, overtaking Nexavar, which had been the standard treatment for liver cancer for a long time. Kim Bo-hyun, professor of gastroenterology at the National Cancer Center, said in an interview with Daily Pharm at the time, "It was proven that the combination of Tecentriq + Avastin showed better effects than existing treatments, so it served as the basis for the decision to consider immuno-oncology therapy before Nexavar." “Imudo+Imfinzi therapy also showed a statistically significant effect of prolonging survival compared to Nexavar, so it was judged that it can be recommended as a first-line treatment.”