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The future of cancer therapy

  Right now, how to balance better efficacy and fewer side effects is a big problem. The next stage of tumor treatment is to turn the tumor into a controllable disease, like diabetes and hypertension, so that cancer patients can survive with the disease for a long time.
  At present, there are more than 1,000 qualified clinical trial institutions in China, and most of them are top three hospitals in central cities. These hospitals undertake tens of thousands of clinical trials every year, of which more than half of them are new cancer drug projects.
  Nowadays, it is the choice of more and more cancer patients to use iterative drugs to gain more survival time. This also puts forward new requirements for drug development – decent survival is also more important than complete cure.
  Compared with the traditional treatment methods mainly based on chemotherapy, BTK
  inhibitors have obvious advantages in the treatment of tumors.
  Zhu Jun, director of the Lymphoma Department of Peking University Cancer Hospital, participated in the clinical trial of ibrutinib (a BTK inhibitor from the United States) in China, but he always wanted to be the Chinese people’s own BTK inhibitor.
  At the end of 2016, at the annual meeting of the American Society of Hematology (ASH), Wang Lai, vice president of BeiGene, an innovative biopharmaceutical company, threw an olive branch to Zhu Jun. He intends to bring zanubrutinib, which has conducted phase one clinical trials in Australia, back to China for phase two clinical trials. Zhu Jun, who has participated in clinical trials of ibrutinib, is the most suitable candidate. Zhu Jun quickly accepted Wang Lai’s invitation and became the national chief lead of the Phase II clinical trial project of zanubrutinib and the principal investigator of Beijing Cancer Hospital, commonly known as PI in the clinical field.
  In February 2017, Peking University Cancer Hospital became the first batch of research centers in China to officially start clinical trials of zanubrutinib. By September 2017, 86 patients had been enrolled.
  In December 2018, at the ASH annual meeting, Zhu Jun’s team reported the results of the Phase II clinical study of zanubrutinib.
  In August 2019, zanubrutinib began to apply for listing in the United States. Before the approval of the U.S. Food and Drug Administration (FDA), the U.S. sent inspectors to China’s clinical trial center to verify the authenticity and scientificity of the test data, and praised Zhu Jun’s team after the inspection. This is also the first time that China’s clinical trial center has accepted on-site inspection by the FDA, breaking the international stereotype that China’s clinical trial data is “irregular and of poor quality”.
  On November 15 of the same year, zanubrutinib was approved by the FDA, becoming the first new anti-cancer drug that was completely independently developed in China and approved by the FDA for marketing, achieving a “zero breakthrough” in China’s original research drugs going overseas. In June 2020, zanubrutinib was also officially approved in China.
  Adjusting the ideas of treatment and research and development
  With the advent of the era of innovative drugs, domestic clinicians have more and more opportunities to participate in drug clinical research and development.
  Zhou Caicun is the director of the oncology department of Shanghai Pulmonary Hospital and has been dealing with lung cancer for decades. In the past two years, he has been engaged in the Phase III clinical research of KN046. KN046 is a dual anti-cancer drug, and like zanubrutinib, it is also in a phase I clinical trial in Australia.
  In recent years, the treatment of lung cancer is changing.
  Shen Shuhong, director of the Department of Hematology and Oncology at Shanghai Children’s Medical Center, said: “The concept and goal of treatment of hematological tumors in children are generally different from those in adults. Because children have better tolerance to drugs than adults and recover faster, we first consider cure. The process of choosing a treatment plan will also be more aggressive, and the requirements for efficacy will be higher.”
  Right now, how to strike a balance between better efficacy and fewer side effects is a big problem. Considering that the basic population of tumor patients is still the middle-aged and the elderly, Xu Ting, chairman of Corning & Jereh, believes that the next stage of tumor treatment is to improve the quality of life of patients from prolonging the survival period of patients to focusing on the safety of drugs. In the future, turning tumors into a controllable disease, like diabetes and hypertension, will enable cancer patients to survive with the disease for a long time.
  At the same time, doctors also began to re-examine and weigh the efficacy and side effects of treatment options. “We have to consider not only acute side effects, but also long-term and chronic side effects.” Zhou Caicun said, “In addition, if complications such as brain metastases, bone metastases, and liver metastases are not properly handled, the patient’s primary tumor may be affected. No matter how good the control is, the treatment effect is still very poor. Therefore, this puts forward new requirements for clinical trials-to evaluate the efficacy of a new drug, but also to see whether it is effective against various complications.”   A
  new drug behind the “clumping phenomenon”
The research and development of the company requires not only the investment of enterprises, but also the participation of many subjects. In the past, patients and their families often thought that participating in clinical trials was acting as a “guinea pig”, and their willingness to participate has not been high. However, in recent years, many patients will take the initiative to ask whether there is a clinical trial project to participate in. Especially for those patients who have failed treatment, participating in the trial drug is often their last straw.
  Liu Chunguang, secretary general of the CRO branch of the China Pharmaceutical Quality Management Association, said that China has a large base of cancer patients, which is conducive to the research and development of new drugs, but this advantage has not yet been brought into play. This is because cancer patients are crowded in big tertiary hospitals in big cities, and pharmaceutical companies are trying their best to find big experts in big hospitals to do PI. But there are very few big experts, and the doctors below are already very busy with their daily diagnosis and treatment work. They have very little time to devote to clinical research, and objectively increase the cost of clinical research. In the past five years, the cost of clinical trials has increased two or three times, and the cost of oncology programs has even increased four or five times.
  According to Xu Ting, at present, the first to third phase clinical trials generally take several years, and the overall trial cost is at least 200 to 300 million yuan. But even in the third phase of clinical trials, the risk of failure is still not small. From the point of view of the progress of medicine as a whole, it is still necessary to avoid group competition.

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