JCSE01.02 The Opportunity of Drugs Development on Immunotherapy in China

Abstract

Immunotherapy gets the breakthrough after almost 100 years of silence. PD1/PD-L1 inhibitors as the representative have been extensively studied in various human malignant tumors and get promising long term response with relatively fewer adverse events. The first PD1 inhibitor indication was approved for melanoma in Japan on July 2014. Up to now, the US Food and Drug Administration had approved several PD-1 pathway blockade treatments including nivolumab, pembrolizumab and atezolizumab using in first line and second line of NSCLC. In China, nivolumab was approved for second line setting for advanced NSCLC and pembrolizumab combined with chemotherapy were approved for first line setting of advanced NSCLC. Two novel PD-1 inhibitors from Chinese pharmaceutical companies were approved for melanoma and lymphoma by National Medical Products Administration (NMPA) of China. And, a lot of clinical trials about domestic novel PD-1 and PD-L1 inhibitors from Chinese pharmaceutical companies are now ongoing. IO arena faces intense in-class competition from both MNC (Multi-National Corporation) and domestic pharmaceutical company in China. Now there are more than 20 IO antibodies from 10 MNCs and 16 pharmaceutical companies in China. Besides PD1/PD-L1 and CTLA4, other hot IO drugs such as IDO or Lag3 et al are also under investigation. Clinical trials about some novel combination, for example, CMET inhibitor plus IO, anti-angiogenesis drugs plus IO, et al, are also ongoing. There are special questions which need to be settled in China. Chinese population has relatively high rates of hepatitis B virus infection and much higher proportion of EGFR mutation. The delightful changing recently is some studies emerging to consider the characteristics of the Chinese or Asian populations. Some clinical trials are trying to answer these questions. Besides clinical trials for advanced NSCLC, Clinical trials focus on local advanced NSCLC, early stage NSCLC and SCLC are also ongoing. New adjuvant and adjuvant IO trials have started in China. Most importantly, some novel combinations overcoming previous IO resistance are now on the way, which will give more interesting results in the near future. Research about Chinese IO treatment remains in their early stage and further efforts are needed to improve the design of future clinical trials and translational research. Meanwhile, the other hot IO drugs and phase I studies need to speed up in China. Immunotherapy, China, Drugs Development