FDA approved the second PD-L1 inhibitor this year, and domestic innovative drugs did not lose

Recently, the FDA approved the drug durvalumab (trade name: imfinzi) of AstraZeneca for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who developed disease progression after completing or carrying out platinum based standard treatment Imfinzi is also the third FDA approved PD-L1 inhibitor For a long time, PD-L1 inhibitors have been widely recognized as a broad-spectrum anti-tumor drug because of their high specificity and expression, as well as effective treatment for most advanced cancers, especially solid tumors In recent years, major pharmaceutical enterprises and R & D institutions have also increased R & D investment in PD-L1 inhibitors Some organizations predict that the future PD-1 / PD-L1 drug market will reach US $35 billion, so the development competition is very fierce Large pharmaceutical enterprises, including Roche, MSD, Pfizer, AstraZeneca, etc., have joined in the R & D competition So far, there are three PD-L1 inhibitors approved by FDA: 1 Atezolizumab (trade name: tecentriq) tecentriq is the first PD-L1 inhibitor approved by FDA Approved on May 18, 2016, for the treatment of bladder cancer, the most common type of urothelial cancer As the first PD-L1 inhibitor on the market, tecentriq's price is $12500 / month, similar to that of PD-1 inhibitor Experts predict that tecentriq's peak sales will reach US $2.5 billion It is reported that tecentriq has obtained multiple qualifications such as FDA breakthrough drug, accelerated approval, priority approval and so on before being approved for listing, and the approval speed is also quite amazing Roche also intensified the clinical research and development of other indications of tecentriq It is reported that ovarian cancer, renal cell, non-small cell lung cancer, breast cancer and other indications are in the third phase of clinical stage If approved, it will have a great impact on the market of other types of tumor drugs 2 Avelumab (trade name: bavencio) and Merck signed a cooperation agreement of up to US $2.85 billion in November 2014, officially announcing its entry into the field of PD-1 / PD-L1 immunotherapy In less than three years, bavencio, which was jointly developed by two pharmaceutical companies and approved by FDA on March 23, 2017, has been used for the treatment of pediatric and adult metastatic Merkel cell carcinoma (MCMC) over 12 years old, becoming the second PD-L1 inhibitor approved globally after Roche tecentriq Like tecentriq, bavencio has received various "care" from FDA before being approved for listing, including accelerated approval qualification, breakthrough drug qualification, etc This led to the launch of the second PD-L1 inhibitor approved by FDA in half a year At present, bavencio has carried out clinical trials in non-small cell lung cancer, Merkel cell tumor, gastric cancer, ovarian cancer, melanoma and other solid tumors 3 Durvalumab (trade name: imfinzi) FDA seems to be adamant about the superiority of PD-L1 inhibitor for tumor treatment Two months after the approval of the second PD-L1 inhibitor in March, the third PD-L1 inhibitor was approved for marketing In addition to the approved indications for urothelial cancer, imfinzi has also carried out clinical trials for non-small cell lung cancer, head and neck cancer and other indications In addition to the three approved varieties, there are also some PD-L1 inhibitors in clinical research and development In this respect, the research and development of new drugs in China has also been in the first echelon Kn035 is a new generation of PD-L1 monoclonal antibody injection jointly developed by mindI and corningeri It is also the first new generation of PD-L1 humanized monoclonal antibody independently developed in China Its clinical application has passed the formal examination and registration site examination of Jiangsu food and drug administration, and has been reported to the State Food and drug administration Data source: CPM database of China Pharmaceutical Industry Information Center During the research and development of PD-L1 inhibitors, most scientists believe that immunotherapy plus other mechanisms of anticancer drug combination will be the hot spot of anticancer drug treatment in the future At the same time of developing new drugs, pharmaceutical companies are constantly exploring the combination effect of PD-L1 and existing anticancer drugs Taking AstraZeneca as an example, we can see that it has carried out a number of joint drug clinical studies around tecentriq on the product line under development on AstraZeneca's global official website And its combination with tremelimumab (ximumab, a CTLA4 antibody drug that AstraZeneca loves and hates) has reached the third phase of clinical stage Data source: Although PD-L1 inhibitors are two years later than their brothers, they are on the global website of AstraZeneca However, due to its high overall patient response rate, small side effects and advantages significantly higher than PD-1 inhibitors, the golden line of PD-L1 market is very promising in the future At the same time, small side effects mean that more drug combination programs will be developed It is believed that there will soon be a large wave of cancer drugs combined with several PD-L1 inhibitors on the market, which also means that more patients, especially those with advanced cancer, will be given hope for treatment.