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Foreword "Focus on innovative research and lead the original future"-The 24th National Conference on Clinical Oncology and the 2021 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting will be combined online and offline on September 25-29 Grandly held
.
In this CSCO conference, the results of many clinical trials were announced, especially the research on cancer targets.
In recent years, it has become a research hotspot for oncologists in China
.
Professor Li Jin from Dongfang Hospital of Tongji University participated in the conference as the chairperson of the special session on gastrointestinal tumors, and published the title "Evaluation of Recombinant Humanized Anti-HER2 Mab-MMAE Conjugate for Injection (MRG002) in Patients with HER2+ Advanced Solid Tumors An important report on the safety, tolerability of dose escalation and expansion of clinical studies into the group"
.
After the meeting, Yimaitong was fortunate to invite Professor Li Jin to deeply interpret the clinical data report of MRG002 Phase I study and share the current progress of tumor immunotherapy in China for readers
.
Professor Li Jin, Chief Physician, Doctoral Supervisor, Chief Physician, Department of Oncology, Oriental Hospital Affiliated to Tongji University, Chairman, Asian Oncology Alliance (FACO), Former Chairman, Chinese Society of Clinical Oncology (CSCO), Former Chairman, CSCO, Committee of Drug Safety Experts, Beijing Hesco Clinical Oncology Research Foundation Chairman, Chinese Medical Doctor Association, Colorectal Cancer Professional Committee, Vice Chairman, Chinese Society for Continuing Medical Education, Abdominal Tumor Committee, and the Vice Chairman of the Abdominal Tumor Committee of the Chinese Society of Medical Continuing Education.
China's contribution"
.
Professor Li Jin said that the expert group of the organizing committee of this conference, from the perspective of whether the submission concept is innovative, selected several unique studies that can represent the innovative strength of Chinese oncologists, and invited experts to report at the conference
.
A randomized, double-blind, double-simulated phase Ⅲ clinical study of acute hepatocellular carcinoma with poor prognosis in the first-line treatment of acoladine versus cinocabine reported by Professor Qin Shukui: tumor marker enrichment design, overall survival, quality of life and safety 》And Professor Zhou Caicun’s report on the research of small-molecule targeted anti-lung cancer drugs, etc.
, which are impressive.
The research results of the application of MRG002 in the treatment of patients with HER2+ advanced solid tumors are also attracting attention
.
What attracted the most attention of Professor Li Jin was the "Phase III Double-blind, Controlled Study of the Decision-Making System of Artificial Intelligence (CSCO AI) Comparing Doctors' Decisions in Breast Cancer Diagnosis and Treatment" reported by Professor Jiang Zefei
.
The results of the study show that compared with the clinical decisions made by doctors, the decision made by the CSCO AI-assisted intelligent decision-making system has a higher agreement rate with the CSCO guidelines.
The data shows that the agreement rate between the two can be as high as 95.
8%.
The coincidence rate of the CSCO guidelines is 90%
.
Professor Li Jin said: "The phase III clinical trial reported by Professor Jiang Zefei has attracted widespread attention.
The use of artificial intelligence system AI as a breast cancer decision-making system can reduce the burden of Chinese doctors and improve the level of diagnosis and treatment of doctors in primary hospitals and remote areas
.
This It is a huge innovation that has created a precedent in the field of Chinese tumor research
.
"The stomach" is expected: MRG002 handed over an amazing answer sheet.
In recent years, antibody-conjugated drugs (ADC) have gradually become the treatment of patients with HER2+ advanced solid tumors.
New choice
.
MRG002 is an emerging ADC drug independently developed by China, which can specifically bind to the HER2 target on the surface of tumor cells, and mediate cell endocytosis through surface receptors into the cell and release methyl auristatin E (MMAE) through degradation to achieve anti-tumor effects.
Effect
.
Figure 1 MRG002 molecular structure and mechanism of action At the meeting, Professor Li Jin announced the progress of MRG002's phase I clinical research: as of July 30, 2021, 76 patients were enrolled in the trial, divided into dose escalation (Ia) and dose Expansion (Ⅰb) two stages
.
In the phase Ia test group, 22 patients can be evaluated, and the covered tumor types are breast cancer, parotid gland cancer and gastric cancer
.
The test results showed that the overall objective response rate (ORR) of patients was 45%, the disease control rate (DCR) was 82%, and the median progression-free survival (PFS) was 7.
4 months
.
Figure 2 Group Ia test results A total of 51 patients with HER2-positive advanced solid tumors were enrolled in stage Ib, covering breast cancer, gastric cancer and colorectal cancer
.
The test results showed that the overall ORR of the patient was 51%, and the DCR was 93%
.
Figure 3 Group Ib test results Professor Li Jin said that the average number of treatment lines for the patients in the study was the fifth line, that is, after the patients failed the 1-4 lines of treatment, and then received MRG002 treatment, the patients with tumor regression still exceeded 50%, the result is shocking, which is equivalent to DS8201, which has the best curative effect in the current international reports.
This is undoubtedly an encouraging research result
.
In addition, Professor Li Jin said that the reason why the study can be recommended to the CSCO conference is not only due to its excellent efficacy in the fifth-line treatment, but also due to its safety
.
It is well known that ADC drugs are prone to severe toxic and side effects of interstitial pneumonia, but in this study, as of July 30, 2021, subjects had not found interstitial pneumonia and obvious ocular toxicity.
The overall safety of the drug Good
.
The study is still in the phase I research stage.
Professor Li Jin mentioned that the phase II study of the MRG002 clinical trial is about to start, especially the phase II study for gastric cancer
.
He believes that in the future research process, MRG002 can be combined with PD-1 monoclonal antibody, or combined with other small molecule targeted drugs, and hopefully used in HER2- tumor patients, which undoubtedly provides a broader scope for clinical exploration Space for exploration
.
In the ascendant: Gastric cancer has entered a new era of immunotherapy.
The heterogeneity of gastric cancer is strong, and the progress of immunotherapy has been relatively slow.
With the recent appearance of immunotherapy results, Professor Li Jin said that in addition to ADC drugs, immunotherapy is a milestone in the 21st century The development of cancer therapy is a symbol of the cross-age of cancer treatment
.
In the past, chemotherapy and radiotherapy for cancer patients had obvious toxicity, and the curative effect was also very limited—the treatment strategies of different cancer types could not be shared
.
In immunotherapy, almost 80% of tumors have a common mechanism.
Therefore, therapies such as PD-1/PD-L1 monoclonal antibody can achieve the purpose of treating different diseases with the same treatment
.
The CheckMate-649 study confirmed that the addition of PD-1 monoclonal antibody to chemotherapy can significantly prolong the overall survival (OS) and PFS of patients with unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer, regardless of PD-L1 Patients with positive expression and combined positive score (CPS) ≥5 and CPS ≥1, or all random populations, have observed OS and PFS benefits
.
Professor Li Jin believes that this is a historic breakthrough, and immunotherapy can bring spring to gastric cancer patients
.
At the end of the interview, Professor Li Jin said that based on current clinical trials, gastric cancer treatments in the future will usher in earth-shaking changes, and gastric cancer patients in China will also "rebirth"
.
.
In this CSCO conference, the results of many clinical trials were announced, especially the research on cancer targets.
In recent years, it has become a research hotspot for oncologists in China
.
Professor Li Jin from Dongfang Hospital of Tongji University participated in the conference as the chairperson of the special session on gastrointestinal tumors, and published the title "Evaluation of Recombinant Humanized Anti-HER2 Mab-MMAE Conjugate for Injection (MRG002) in Patients with HER2+ Advanced Solid Tumors An important report on the safety, tolerability of dose escalation and expansion of clinical studies into the group"
.
After the meeting, Yimaitong was fortunate to invite Professor Li Jin to deeply interpret the clinical data report of MRG002 Phase I study and share the current progress of tumor immunotherapy in China for readers
.
Professor Li Jin, Chief Physician, Doctoral Supervisor, Chief Physician, Department of Oncology, Oriental Hospital Affiliated to Tongji University, Chairman, Asian Oncology Alliance (FACO), Former Chairman, Chinese Society of Clinical Oncology (CSCO), Former Chairman, CSCO, Committee of Drug Safety Experts, Beijing Hesco Clinical Oncology Research Foundation Chairman, Chinese Medical Doctor Association, Colorectal Cancer Professional Committee, Vice Chairman, Chinese Society for Continuing Medical Education, Abdominal Tumor Committee, and the Vice Chairman of the Abdominal Tumor Committee of the Chinese Society of Medical Continuing Education.
China's contribution"
.
Professor Li Jin said that the expert group of the organizing committee of this conference, from the perspective of whether the submission concept is innovative, selected several unique studies that can represent the innovative strength of Chinese oncologists, and invited experts to report at the conference
.
A randomized, double-blind, double-simulated phase Ⅲ clinical study of acute hepatocellular carcinoma with poor prognosis in the first-line treatment of acoladine versus cinocabine reported by Professor Qin Shukui: tumor marker enrichment design, overall survival, quality of life and safety 》And Professor Zhou Caicun’s report on the research of small-molecule targeted anti-lung cancer drugs, etc.
, which are impressive.
The research results of the application of MRG002 in the treatment of patients with HER2+ advanced solid tumors are also attracting attention
.
What attracted the most attention of Professor Li Jin was the "Phase III Double-blind, Controlled Study of the Decision-Making System of Artificial Intelligence (CSCO AI) Comparing Doctors' Decisions in Breast Cancer Diagnosis and Treatment" reported by Professor Jiang Zefei
.
The results of the study show that compared with the clinical decisions made by doctors, the decision made by the CSCO AI-assisted intelligent decision-making system has a higher agreement rate with the CSCO guidelines.
The data shows that the agreement rate between the two can be as high as 95.
8%.
The coincidence rate of the CSCO guidelines is 90%
.
Professor Li Jin said: "The phase III clinical trial reported by Professor Jiang Zefei has attracted widespread attention.
The use of artificial intelligence system AI as a breast cancer decision-making system can reduce the burden of Chinese doctors and improve the level of diagnosis and treatment of doctors in primary hospitals and remote areas
.
This It is a huge innovation that has created a precedent in the field of Chinese tumor research
.
"The stomach" is expected: MRG002 handed over an amazing answer sheet.
In recent years, antibody-conjugated drugs (ADC) have gradually become the treatment of patients with HER2+ advanced solid tumors.
New choice
.
MRG002 is an emerging ADC drug independently developed by China, which can specifically bind to the HER2 target on the surface of tumor cells, and mediate cell endocytosis through surface receptors into the cell and release methyl auristatin E (MMAE) through degradation to achieve anti-tumor effects.
Effect
.
Figure 1 MRG002 molecular structure and mechanism of action At the meeting, Professor Li Jin announced the progress of MRG002's phase I clinical research: as of July 30, 2021, 76 patients were enrolled in the trial, divided into dose escalation (Ia) and dose Expansion (Ⅰb) two stages
.
In the phase Ia test group, 22 patients can be evaluated, and the covered tumor types are breast cancer, parotid gland cancer and gastric cancer
.
The test results showed that the overall objective response rate (ORR) of patients was 45%, the disease control rate (DCR) was 82%, and the median progression-free survival (PFS) was 7.
4 months
.
Figure 2 Group Ia test results A total of 51 patients with HER2-positive advanced solid tumors were enrolled in stage Ib, covering breast cancer, gastric cancer and colorectal cancer
.
The test results showed that the overall ORR of the patient was 51%, and the DCR was 93%
.
Figure 3 Group Ib test results Professor Li Jin said that the average number of treatment lines for the patients in the study was the fifth line, that is, after the patients failed the 1-4 lines of treatment, and then received MRG002 treatment, the patients with tumor regression still exceeded 50%, the result is shocking, which is equivalent to DS8201, which has the best curative effect in the current international reports.
This is undoubtedly an encouraging research result
.
In addition, Professor Li Jin said that the reason why the study can be recommended to the CSCO conference is not only due to its excellent efficacy in the fifth-line treatment, but also due to its safety
.
It is well known that ADC drugs are prone to severe toxic and side effects of interstitial pneumonia, but in this study, as of July 30, 2021, subjects had not found interstitial pneumonia and obvious ocular toxicity.
The overall safety of the drug Good
.
The study is still in the phase I research stage.
Professor Li Jin mentioned that the phase II study of the MRG002 clinical trial is about to start, especially the phase II study for gastric cancer
.
He believes that in the future research process, MRG002 can be combined with PD-1 monoclonal antibody, or combined with other small molecule targeted drugs, and hopefully used in HER2- tumor patients, which undoubtedly provides a broader scope for clinical exploration Space for exploration
.
In the ascendant: Gastric cancer has entered a new era of immunotherapy.
The heterogeneity of gastric cancer is strong, and the progress of immunotherapy has been relatively slow.
With the recent appearance of immunotherapy results, Professor Li Jin said that in addition to ADC drugs, immunotherapy is a milestone in the 21st century The development of cancer therapy is a symbol of the cross-age of cancer treatment
.
In the past, chemotherapy and radiotherapy for cancer patients had obvious toxicity, and the curative effect was also very limited—the treatment strategies of different cancer types could not be shared
.
In immunotherapy, almost 80% of tumors have a common mechanism.
Therefore, therapies such as PD-1/PD-L1 monoclonal antibody can achieve the purpose of treating different diseases with the same treatment
.
The CheckMate-649 study confirmed that the addition of PD-1 monoclonal antibody to chemotherapy can significantly prolong the overall survival (OS) and PFS of patients with unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer, regardless of PD-L1 Patients with positive expression and combined positive score (CPS) ≥5 and CPS ≥1, or all random populations, have observed OS and PFS benefits
.
Professor Li Jin believes that this is a historic breakthrough, and immunotherapy can bring spring to gastric cancer patients
.
At the end of the interview, Professor Li Jin said that based on current clinical trials, gastric cancer treatments in the future will usher in earth-shaking changes, and gastric cancer patients in China will also "rebirth"
.