Chinese and foreign experts discuss new progress in tumor immunotherapy

Chinese and foreign experts discuss new progress in tumor immunotherapy

July 9, 2018 Source: China Pharmaceutical News Author: Wang Yiyi

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Recently, the "2018 China Cancer Immunotherapy Symposium" sponsored by the China Food and Drug International Exchange Center (CCFDIE), the Drug Evaluation Center (CDE), the American Chinese Society of Blood and Oncology Experts (CAHON) and the Tsinghua University School of Medicine was held in Beijing. . Top global experts, officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and experts in the biopharmaceutical community gathered together for basic tumor immunity, immune checkpoint inhibitors, cell therapy, cancer vaccines and a new generation The latest advances in the application of immunotherapy in different types of cancer, sharing their views and experiences, and exploring the significance of new immunotherapy and its clinical development.

In recent years, the use of immunomodulation to regulate or increase the body's immunity to inhibit tumors has become the new favorite of the cancer treatment community. With the increase in indications for tumor immunotherapy, the development of new products in this field is growing stronger. The epoch-making CAR-T cell therapy was approved for marketing, and people are more convinced that tumor immunotherapy has found a way of hope for cancer treatment research. Doctors and patients expect more alternative immunotherapies to cure tumors.

At the seminar, Richard Pazdur, director of the FDA Center for Excellence in Oncology, pointed out that compared with other therapeutic areas, tumor diseases are serious and endanger the lives of patients, and related companies need to accelerate drug delivery. Oncology is one of the active areas of biomedical research. Among them, 50% of the therapies are breakthrough treatments, and the target population needs to be identified through biomarkers. The progress needs to be driven by external forces.

It is reported that the “breakthrough therapy” approval was initiated by the US FDA in July 2012. It is part of the US Food and Drug Administration Safety and Innovation Act (FDASIA), which aims to accelerate the development and review of serious or threatened treatments. A new drug for the disease of life. As a fast-track, accelerated approval, and priority review, the FDA has another new drug review channel, and drug development with “breakthrough drug” certification can be more closely guided by the US FDA's senior drug regulatory officials. Provide patients with new treatment options in the shortest possible time. According to Richard Pazdur, about 50% of the breakthrough therapy applications submitted to the US FDA's Drug Evaluation Center are in the field of oncology, and about one-third of them have been approved.

Dr. Ping Ping, Professor of Immunology, Dermatology and Oncology at Yale University School of Medicine, reviewed the development of tumor immunotherapy, introduced the principles of PD-1 immunotherapy, and some current problems in tumor immunotherapy and corresponding responses. Strategy.

At the seminar, Dong Chen, Dean of Tsinghua University School of Medicine, Guo Jun, Associate Dean of Peking University Cancer Hospital, Zhu Jun, Party Secretary of Peking University Cancer Hospital, Director Han Weidong, Laboratory of Molecular Immunology, General Hospital of PLA, and Wu Yilong, Chief Physician of Guangdong Provincial People's Hospital Qin Shuzhen, deputy director of Nanjing Bayi Hospital, shared their latest achievements in the field of tumor immunotherapy for melanoma, malignant B cell tumor, lung cancer, hepatocellular carcinoma, etc., and put forward viewpoints and experiences from the perspective of clinical research and patient needs.

Taking melanoma immunotherapy as an example, Guo Jun pointed out that in the melanoma diagnosis and treatment guidelines developed by the 2017 Chinese Anticancer Association Clinical Oncology Collaborative Professional Committee (CSCO), PD-1 monoclonal antibody and PD-1 monoclonal antibody + CTLA have been adopted. -4 monoclonal antibody is recommended as an optional strategy. Taking the experimental data as an example, Guo Jun pointed out that the immunotherapy data of non-extremity non-mucosal melanoma in China is similar to that in foreign countries, and the effect of apical and mucosal immunotherapy is slightly worse.

Guo Jun said that melanoma in Asia and Europe is very different. Asian melanoma patients have limited benefits from international breakthroughs. It is especially important to find treatments that are consistent with Asian characteristics in the technological advances where opportunities and challenges coexist.

According to Zhu Jun, at present, 76 of the clinical trials of CAR-T cell therapy registered by clinicaltrials.gov have been carried out in China.

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