Professor Song Yuqin 76.8%!

In order to promote academic exchanges and scientific and technological cooperation in the field of clinical oncology in China, and actively promote the development of the discipline, the 24th session is hosted by the Chinese Society of Clinical Oncology (CSCO), Beijing Hisco Clinical Oncology Research Foundation, and the Cancer Hospital of the Chinese Academy of Medical Sciences The National Clinical Oncology Conference and the 2021 CSCO Annual Conference will be held online from September 25th to 29th, 2021
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With the theme of "Focus on Innovative Research, Leading the Original Future", this year's National Clinical Oncology Conference brought together well-known experts at home and abroad, focused on the clinical frontiers of oncology, and presented a gluttonous academic feast
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On this occasion, Yimaitong sincerely invites Professor Song Yuqin from Peking University Cancer Hospital to accept an interview to interpret the results of the one-year follow-up of the RELIANCE study and share clinical experience
.

Prof.
Song Yuqin, Deputy Director, Chief Physician, and Doctoral Supervisor, Lymphoma Department, Peking University Cancer Hospital, Director, Chinese Society of Clinical Oncology (CSCO), Secretary-General, Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance, Chairman, Beijing Anti-Cancer Association, Lymphhaematological Oncology Committee Deputy Chairman of the Lymphoma and Hematological Oncology Committee of the Chinese Society of Geriatric Oncology, Vice Chairman of the Lymphoma Professional Committee of the Chinese Geriatric Health Association, Member of the Standing Committee and Secretary of the Oncology Committee of the Beijing Medical Association.
Numerous clinical studies have been carried out.
The RELIANCE study is the first CD19 CAR-T clinical trial approved by the IND in China.
As the main investigator of this study, you originally chose Ruiji Orenza injection (Benoda®) to carry out CAR -What is the original intention of the registration study? Professor Song Yuqin, Peking University Cancer Hospital, including the Lymphoma Department, conducts clinical research, not only out of interest in scientific research, but also on the basis of benefiting the enrolled patients, but also hoping to promote product launches through research to benefit more patients
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In recent years, CAR-T has been a hot research field in China, and CAR-T-related clinical trials need to consider two requirements
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On the one hand, it is to use new technologies and new methods to conduct research in accordance with the regulations of the National Health Commission, but it is not certain whether the product can be successfully marketed after the research is completed; The process is strictly implemented in accordance with the examination and approval standards, and there is hope that the product will pass the inspection of the State Drug Administration and go on the market smoothly
.

At that time, WuXi Junuo had the courage to carry out IND registration research when the prospects for product development and marketing were uncertain
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The original intention of Peking University Cancer Hospital to carry out this clinical trial is the same as that of WuXi Junuo.
They all hope to conduct clinical trials in accordance with the IND registration research standards stipulated by the National Medical Products Administration, and promote the launch of CAR-T products in accordance with the relevant procedures
.

Facts have proved that our decision to carry out this study is correct.
The registered clinical trial of Liso-cel of Junuo Medical* is almost carried out at the same time as the RELIANCE study.
There is no significant difference in the efficacy and safety data of the two studies, and the study data After being submitted to the State Drug Administration for verification, satisfactory results were also obtained
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After the product is approved for marketing, more patients in the real world will be able to use and benefit from Recchio Lunza injection
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Yimaitong: When evaluating an excellent CAR-T product in the clinic, which efficacy evaluation indicators are the main considerations? Is it a short-term efficacy index (such as overall remission rate, duration of remission, progression-free survival, etc.
) or a long-term efficacy index (such as overall survival, etc.
)? What are the significance of these indicators for doctors and patients? For Professor Song Yuqin, effective tumor control is the primary problem for cancer patients, so the primary goal of treatment is effectiveness
.

For patients whose treatment is effective, especially those who are more aggressive, achieving complete remission is the next treatment goal, because complete remission means that the patient’s remission lasts longer
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For patients who have achieved complete remission, it is hoped that the remission process can continue, so progression-free survival (PFS) is the next stage of treatment goal
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For all cancer patients, the overall survival (OS) benefit is the ultimate goal of treatment
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As clinicians, in the process of treatment, we hope that patients will be relieved first, and then survive disease-free and finally achieve long-term survival
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Patients who survive long-term disease-free will eventually be cured, which is what clinicians are most eagerly looking forward to
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Yimaitong: The one-year follow-up data of the RELIANCE study released during the 2021 CSCO shows that the patient's 12-month overall survival (OS) rate is as high as 76.
8%.
Compared with the key CAR-T research data that has been published so far, Ruiji Orenza The OS rate of injection is the highest.
What factors do you think is related to it? In the process of Professor Song Yuqin's RELIANCE study, we did not expect that the patient's one-year OS rate will be as high as 76.
8%.
This is a surprising result
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As a clinician, our ideal goal is to achieve long-term overall survival for patients
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This result is related to the following factors: The high quality of Ruiji Orenxel injection products ensures that the one-year OS rate of patients with high curative effects can reach 76.
8%, and the structural design and supply platform of CAR-T The quality control is closely related
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The RELIANCE Research Institute uses more than 100 quality control and inspection procedures from the original and auxiliary materials to the release of the final product, ensuring that its production success rate reaches 99%
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WuXi Genuo's robust process control is embodied in every production step, so as to ensure the consistency and stable quality of the final product, thereby ensuring the patient's treatment effect
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Clinical research institutions and researchers pay attention to patients and ensure survival benefits.
In the research process, researchers fully assess the patient’s treatment risk and promptly deal with adverse events during the treatment process to reduce the patient’s risk of death and obtain continuous gains in overall survival.
Benefit
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The researcher's attention to patients is of vital importance to the survival and benefit of patients.
I would also like to thank all the researchers from the ten centers who participated in the study
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Yimaitong: In addition to the above factors, is the higher OS rate shown in the one-year follow-up data of the RELIANCE study related to the structure of CAR-T? What are the differences in efficacy and safety of CAR-T products with different costimulation domains? The one-year OS rate of Professor Song Yuqin's patients can be as high as 76.
8%, which is definitely inseparable from the CAR-T product itself.
Among them, the costimulation domain of CAR-T is also related to its product characteristics
.

All currently approved CAR structures use costimulatory domains: CD28 or 4-1BB
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The costimulatory domain of the world's first marketed CAR-T product is CD28, and the costimulatory domains of several subsequent marketed products are all 4-1BB, which is the mainstream CAR structure of the current commercialized CAR-T
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The CAR-T expansion of the CD28 costimulatory domain is relatively fast, and adverse events such as cytokine release syndrome (CRS) and neurotoxicity (NT) will increase accordingly
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However, through the use of clinical research and clinical practice in recent years, doctors have accumulated experience in the treatment of CRS and neurotoxicity, so they have a certain degree of control over their safety during use
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In terms of the long-term survival of CAR-T cells in the body, 4-1BB CAR-T cells account for a high proportion of central memory T cells in the body, and their survival time in the body is significantly longer than that of CD28 CAR-T cells, so 4 The effective duration of -1BB CAR-T cells will be longer
.

Due to the lack of head-to-head research results, the efficacy and safety of different CAR-T products cannot be compared at present, but in general, the use of CAR-T treatment can bring long-term survival benefits to patients
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Yimaitong: The one-year follow-up data of the RELIANCE study showed that the 12-month OS rate of patients was as high as 76.
8%
.

What is the clinical significance and value of this data for doctors and patients? Professor Song Yuqin's disease-free survival for one, two years or even longer is the goal pursued by doctors and patients.
Therefore, the RELIANCE study shows that the patient's one-year OS rate reaches 76.
8%, which is a very satisfactory result for doctors and patients
.

Compared with the global CAR-T research data, the one-year OS rate of the RELIANCE study is the highest, which proves the long-term survival benefits of the use of Recchio Lunsai injection and brings hope to the treatment of hematological tumors
.

After the market of Ruiji Orensai injection, through early intervention, the OS rate may be further improved, and at the same time, it can benefit more patients and accumulate more clinical treatment experience
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References: [1] Jun Zhu, Zhitao Ying, Yuqin Song, et al.
Clinical Response of CD19 CAR-T Cells (relmacabtagene autoleucel, relma-cel) in Adults with Heavily-Pre-Treated Relapsed /Refractory (r/r) Large B-Cell Lymphoma in China.
Blood 2020; 136 (Supplement 1): 39-40.
*Recommended reading by RECOMMEND, a Bristol-Myers Squibb company 1.
Professor Jin JieDLBCL has entered a new era of precision therapy, CAR-T therapy Bring new hope, stamp "read the original text", we will make progress together