ORR 92.86%!

On April 23-24, 2022, the Chinese Society of Clinical Oncology (CSCO) Guidelines Conference was successfully held in Beijing in a combination of online and offline methods
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The conference invited well-known experts and professors in the field of oncology to give us keynote speeches such as guideline release and updated interpretation in several special sessions
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With the joint efforts of experts, the 2022 edition of the "CSCO Lymphoma Diagnosis and Treatment Guidelines" arrived as scheduled
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Lymphoma is one of the most common malignant tumors in China.
Although the standard first-line therapy has greatly improved the survival of patients with classical Hodgkin lymphoma (cHL), some patients are still relapsed/refractory and have poor prognosis.

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There are a large number of patients with relapsed/refractory classical Hodgkin lymphoma (R/R cHL) every year in China, and how to effectively treat it has become the focus of clinicians
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As China's first fully human anti-PD-1 monoclonal antibody independently developed using the international advanced transgenic rat platform (OmniRat®), the first approved indication for relapsed or refractory classical Hodgkin's lymphoma , the effective rate is as high as 92.
86%, and the update of sepalizumab in this CSCO guideline conference is worthy of attention
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On this occasion, Yimaitong specially invited Professor Ma Jun from the Harbin Institute of Hematology and Oncology to interpret the updated highlights of the new "CSCO Lymphoma Diagnosis and Treatment Guidelines" and the application of sapalizumab
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Yi Mai Tong: The CSCO Guideline Conference is held once a year to share the updates and additions of relevant guidelines in the field of oncology.
This year's conference is mainly held online due to the impact of the epidemic.
First of all, could you please share this year's "CSCO" Highlights of the Guidelines for the Diagnosis and Treatment of Lymphoma? In the environment of virus isolation, academic isolation, and love isolation, Professor Ma Jun held this year's CSCO Guideline Conference mainly online.
This conference released 17 new editions of CSCO Cancer Clinical Diagnosis and Treatment Guidelines for clinical work and standardization.
Provide the basis for diagnosis and treatment
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The new version of the "CSCO Lymphoma Diagnosis and Treatment Guidelines" is mainly based on evidence-based medicine and compiled according to the guidelines of the Chinese Society of Clinical Oncology.
The main highlights include: 1) Clinical practicability: the new version of the guidelines combines the updated catalogue of medical insurance and the combination of cutting-edge progress and Accumulate evidence, especially the clinical research data of Chinese people, and update recommendations in a timely manner; 2) Protocol and drug accessibility: In this regard, the new version of the guideline timely includes approved drugs and treatment plans, taking into account large medical centers and primary medical care.
Accessibility of institutions; 3) Whole-process management: While focusing on curative effects, continue to focus on the treatment of toxic and side effects
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The new guideline continues to provide clinicians with the latest academic progress and diagnosis and treatment plans for hematological tumors.
It is an important reference for Chinese clinicians in their daily work and helps to improve the standardization of tumor diagnosis and treatment in China
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Yi Mai Tong: In recent years, the incidence of Hodgkin's lymphoma has increased year by year, and immunotherapy has played a role in it, making the current clinical treatment options more abundant
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Among them, due to its excellent clinical efficacy, sapalimumab was included in the CSCO guidelines before the indication was approved, and this year it was included in the class I recommendation for relapsed and refractory cHL.
Could you please talk about PD-1 monoclonal antibody? Updates in the new guideline and features and benefits of sapalizumab? In the treatment section of R/R cHL that is not suitable for transplantation, Professor Ma Jun, compared with last year's guideline, the new guideline will include sintilimab, tislelizumab, camrelizumab, saparib Monoclonal antibody has been upgraded from "Class II recommendation" to "Class I recommendation", and Piamprimab has also been added to "Class I recommendation"; it is recommended for R/R cHL grade III in suitable and unsuitable transplant conditions , "PD-1 monoclonal antibody + second-line salvage chemotherapy" was added
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Among them, sepalizumab is more worthy of attention.
In August 2021, the China National Medical Products Administration (NMPA) officially approved the marketing of sepalizumab for the treatment of second-line and above cHL
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In view of its outstanding curative effect, it is included in the new guideline to bring a new treatment plan to cancer patients
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Sepalizumab is the world's first fully human anti-PD-1 monoclonal antibody independently developed using the international advanced transgenic rat platform (OmniRat®), which can block PD-1 and PD-L1 in 360 degrees.
The combination is entrusted by Yuheng Bio to be produced by WuXi Biologics certified by China's NMPA, the US FDA and the EU EMA
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As a domestic innovative drug, it has initially demonstrated efficacy higher than other PD-1 antibodies in phase II registration clinical trials: the objective response rate (ORR) is as high as 92.
86% (the latest investigator data), the disease control rate (DCR) ) was as high as 96.
43%, the 1-year overall survival (OS) rate was nearly 100%, and the 1-year progression-free survival (PFS) rate was 74%
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In addition, sepalizumab was well tolerated, with 76% of patients taking it for more than 1 year and 32% of patients taking it for more than 2 years
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Treatment-related adverse events (TRAEs) were observed in 96.
5% of patients, most of which were grade 1-2, and the overall safety was manageable
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It is a new safe and effective treatment for R/R cHL, and we look forward to the further research results of sapalimumab
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Yimaitong: The "Healthy China 2030" Planning Outline proposes to increase the overall cancer 5-year survival rate by 15%, which is inseparable from the research and development of effective anti-tumor drugs
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Based on the performance of PD-1 monoclonal antibody in multiple tumors and the excellent efficacy of sapalizumab in clinical trials, can you talk about which hematological tumor patients can benefit from sapalizumab? Professor Ma Jun, as a fully human PD-1 monoclonal antibody, has shown very good efficacy.
The previous application experience of PD-1 monoclonal antibody suggests that sapalimab combined with other drugs may bring better efficacy The efficacy of single drug and combination drug have also been explored in other hematological tumor fields.
At present, it has accumulated in diffuse large B-cell lymphoma, central nervous system lymphoma, acute myeloid leukemia, and myelodysplastic syndrome.
Some experiences are worth looking forward to
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In addition, it is worth mentioning that the ORR of the second-line monotherapy of sepalizumab for advanced cervical cancer reached 27.
8%, and the breakthrough therapy was obtained and included in the priority review process
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In addition, in terms of combined application, the combination with CAR-T may be the direction of Sepalizumab's future exploration, and it is expected that further exploration of Sepalizumab will bring good news to more tumor patients
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Yimaitong: As mentioned earlier, sepalizumab is of great significance to patients.
What are your prospects for the application of sepalizumab and the development of domestic innovative drugs in the future? Professor Ma Jun In recent years, as China's innovative drug research and development has entered the fast lane, national enterprises have made continuous breakthroughs in the research and development of anti-tumor drugs, which not only provides a powerful weapon for clinical practice, but also brings hope to more patients
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PD-1 monoclonal antibody is a landmark milestone in the history of immunotherapy.
The launch and application of the domestic innovative drug sapalizumab will better promote the improvement of the treatment level of lymphoma
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Life comes first, and life is above everything else.
In order to enable hematological tumor patients to live longer and achieve a higher clinical cure rate, we look forward to the research and development of more domestic innovative drugs to help achieve a 15% increase in the five-year survival rate of tumor patients by 2030.
target
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Professor Ma Jun Director of Harbin Institute of Hematology and Oncology Chairman of the Supervisory Board of the Chinese Society of Clinical Oncology (CSCO) Vice Chairman of the Asian Society of Clinical Oncology Vice Chairman of the Chinese Society of Clinical Oncology Leukemia Expert Committee Chairman of the National Health Commission Capacity Building and Continuing Education Center Lymphoma The leader of the expert group of the construction project, the honorary consultant of the nursing group of the Lymphoma Expert Committee of the Chinese Society of Clinical Oncology, went to the Faculty of Medicine of the University of Tokyo, Japan to study in 1979
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In 1982, the in vitro multipotent hematopoietic progenitor cell culture system was first established in China, filling the domestic gap
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Since 1983, the sequential therapy of retinoic acid and arsenic trioxide has been used to treat more than 1,200 cases of acute promyelocytic leukemia.
The 10-year disease-free survival rate is 85%, reaching the international advanced level.

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He has published more than 200 papers and more than 40 monographs in domestic and foreign journals, and won 20 national, provincial and municipal science and technology awards
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Undertook 8 national 863 major scientific research projects and 25 provincial and municipal scientific research projects
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