Professor Song Yuqin welcomes the hope of cure for 200 patients with Benoda®, and jointly hopes for the 2-year OS survival rate

According to statistics, there were 75,400 new cases of lymphoma and 40,500 deaths in China in 2016, of which 68,500 new cases and 37,600 deaths were non-Hodgkin lymphoma (NHL)1, the most common NHL in adults The type is diffuse large B-cell lymphoma (DLBCL) 2
.

It has been more than half a year since Benoda® (Rigiorenza injection) was approved in China for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or above systemic therapy.
As of April 2022, 200 Chinese patients have successfully completed the reinfusion treatment of Ruikiorenza injection (including clinical research and commercialization stages), and have obtained hope of cure
.

On this occasion, Yimaitong sincerely invites Professor Song Yuqin of Peking University Cancer Hospital for an interview to share the research progress and clinical experience of CAR-T
.

Professor Song Yuqin Deputy Director, Chief Physician and Doctoral Supervisor of the Lymphoma Department of Peking University Cancer Hospital Director of the Chinese Society of Clinical Oncology (CSCO) Secretary General of the Anti-Lymphoma Expert Committee of the Chinese Society of Clinical Oncology (CSCO) Director of the Lymphoma and Hematology Committee of the Beijing Anti-Cancer Association Member, National Health Commission Capacity Building and Continuing Education Center-Lymphoma Specialist Construction Project Expert Group Consultant and Secretary General Chairman of the Lymphoma Professional Committee of the Chinese Association for the Promotion of Human Health The Ministry of Medicine conducts post-doctoral basic research work and studies lymphoma clinical diagnosis and treatment in the United States.
He has undertaken 5 projects of the National Natural Science Foundation of China Youth Fund and general projects, major special sub-projects of the Ministry of Science and Technology, provincial outstanding young and middle-aged scientists fund and Beijing Natural Science Foundation projects.
Published more than 50 SCI papers, and translated 3 academic monographs Yimaitong: In 2021, Benoda® (Rigiorenza injection) will be approved for marketing in China, please talk about Ruikioren The current application status of Sai injection in China? And how can commercialized CAR-T products better avoid treatment risks and serve patients? Professor Song Yuqin's Ruiki Orenza injection is currently marketed in China for r/r LBCL in adult patients after second-line or above systemic therapy, including DLBCL, high-grade B-cell lymphoma (HGBL) and follicular lymphoma (FL) Converted DLBCL et al
.

After its launch, the latest data as of April 25th show that more than 60 patients have received commercialized cell reinfusion, and more than 40 patients have undergone one-month efficacy evaluation, plus part of the FL and kits enrolled in the RELIANCE study.
There are currently more than 200 patients in China who have received reinfusion of Rekiorenza injections for patients with MCL
.

Reiki Orenza injection is also the product that has benefited the most Chinese patients from registration research to commercial use among the CD19-targeting CAR-T products marketed in China
.

Clinicians should fully consider how to better use commercial CAR-T products in the clinic and manage patients throughout the process
.

For patients with particularly high tumor burden, central nervous system invasion, poor general condition, or underlying diseases, commercial CAR-T products should be used with caution, and the patient's past medical history, the effects of concomitant medications, and tumor status, should be fully evaluated.
General condition and organ function tolerance,
etc.

In addition, if the patient has recently used drugs that affect hematopoietic stem cell function or lymphocyte function, it is necessary to appropriately avoid recent cell collection
.

What is more noteworthy is that when choosing commercialized CAR-T products for relapsed or refractory patients, clinicians need to reasonably arrange the treatment sequence of patients
.

Yimaitong: As the principal investigator of the RELIANCE study, can you talk about the survival benefits that RELIANCE injection can bring to patients based on the latest research progress? Professor Song Yuqin So far, the largest and most successful CAR-T registration study in China is the RELIANCE study
.

Judging from the current data of the RELIANCE study, no matter in terms of study design, safety, efficacy and other data, it is comparable to similar foreign registered studies, and even the research quality is better than foreign studies
.

Special thanks go to the investigators and staff of all centers involved in this study
.

Data presented at the 2021 ASH meeting showed3.
The RELIANCE study included 59 patients with r/r LBCL.
After a median follow-up of 17.
9 months, the best objective response rate (ORR) was 77.
6%, and the best complete response (CR) The rate was 51.
7%, the median progression-free survival (PFS) was 7.
0 months, and the 1-year overall survival (OS) rate was as high as 76.
8%.
The safety data were consistent with previous data and no adverse events were added
.

The long-term follow-up data of the RELIANCE study showed that RELIANCE injection brought sustained remission and long-term survival to patients with good safety
.

At the upcoming 2022 ASCO meeting, the 2-year follow-up data of the RELIANCE study will be announced.
I hope this can help you to better understand the mid- and long-term efficacy and safety of RELIANCE injection, and enhance your confidence in clinical use.
Looking forward to your attention
.

Yimaitong: Could you please talk about the difference between the real-world application of Ruiki Aureenzae injection and clinical research? Are there major differences in efficacy and safety? Among the real-world data of Professor Song Yuqin, one is the efficacy and safety of longer-term follow-up of patients in the registration study, and the other is whether the real-world data can replicate the long-term efficacy and safety of the registration study
.

CAR-T products can be paid attention to from the following perspectives: First, whether the patient's preparation success rate in the post-marketing real-world study is high, such as whether the patient's previous treatment drugs will affect the collection of cells; second, the production method needs to be considered.
preparation capacity
.

Regardless of whether it is in the whole country or at Peking University Cancer Hospital, according to statistics, the success rate of commercialized Ruiki Orenza injection has been maintained at 100%.
, the national counterparts have reported that its preparation platform is very powerful
.

Because Ruiki Orenza injection has not been on the market for a long time, all real-world data has not been aggregated so far, and currently only some data from Peking University Cancer Hospital can be provided for your reference
.

As of March 31, 2022, 90 patients at Peking University Cancer Hospital have chosen to use Ruiki Aurenzai injection for treatment, of which 82 patients have completed apheresis, and 58 patients have completed CAR-T cell reinfusion.
Data from clinical trials in the current year and real-world data after commercialization
.

Some patients treated with commercialized CAR-T cells in the real world had significantly higher disease severity than patients enrolled in clinical studies, and all patients in the real-world study had an expected survival of less than 3 months
.

However, about 1.
5 months after the reinfusion, Rekiorenza injection also showed good safety in patients with extremely high tumor burden, and the incidence of ≥ grade 3 cytokine release syndrome (CRS) was 3%.
, lower than 5.
1% in clinical trials, and the incidence of grade ≥3 neurotoxicity was also 3%, consistent with the data in clinical trials; although patients in the real world were more severely ill, patients in the real world were significantly different from clinical Efficacy across studies was consistent, with an ORR of 76%
.

Because Peking University Cancer Hospital has accumulated a lot of experience in the use of CAR-T products and has a good understanding of the product characteristics, it is more convenient in the process of clinical use
.

Although the disease severity of the patients in the real world is higher, the RELIANCE injection still shows good efficacy and safety, and there is no significant difference compared with the data of the RELIANCE study, and even the data of Peking University Cancer Hospital is better than Results of the RELIANCE study
.

I hope that in the future, all the data in the real world will be aggregated to provide you with more complete information
.

Yimaitong: In recent years, Peking University Cancer Hospital has accumulated rich clinical experience in the application of CAR-T therapy.
Could you please talk about your experience in diagnosis and treatment? Professor Song Yuqin This is also a question that my colleagues across the country keep asking me
.

The RELIANCE study has to meet the requirements of the State Drug Administration, and the patient entry and exclusion criteria are very strict, but the disease severity of the patients in the real world is significantly higher than that of the patients enrolled in the clinical study and accompanied by a variety of other diseases, such as plasma Membranous effusion, infection, respiratory failure, cardiac failure, renal failure, hemophagy, central nervous system invasion, extremely high tumor burden, etc.
, face more clinical challenges
.

The registration study is led by Peking University Cancer Hospital, and we have a greater responsibility to our peers and patients across the country
.

Therefore, after the commercialization of CAR-T, it is hoped that the experience accumulated during use can be shared with peers across the country through real-time broadcasting, and patients themselves or their families can also learn about their conditions online.

.

References: 1.
Liu W, Liu J, Song Y, et al.
Burden of lymphoma in China, 2006-2016: an analysis of the Global Burden of Disease Study 2016.
J Hematol Oncol.
2019 Nov 19;12(1) :115.
2.
Harris LJ, Patel K, Martin M.
Novel Therapies for Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Int J Mol Sci.
2020 Nov 13;21(22):8553.
3.
Song YQ, Ying ZT, Yang HY, et al.
Relmacabtagene Autoleucel CD19 CART Therapy for Adults with Heavily-Pretreated Relapsed/Refractory Large B-Cell Lymphoma in China.
ASH 2021.
Poster 3557.
Edit: May Typesetting: Wenting Execution: Quinta pokes "read the original text", we progress together