Professor Ma Jun & Zhu Jun: relma-cel new indications have been approved in China, bringing the dawn of cure for r/r FL patients!

Follicular lymphoma (FL) is a common type of non-Hodgkin lymphoma, and in recent years, the development of new drugs and the application of new drug combinations have significantly improved the prognosis of FL patients, but it is still an incurable malignant lymphoma, and patients eventually face multiple recurrences/refractory dilemmas
.
RECENTLY, BASED ON THE RESULTS OF RELIANCE, THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) OF CHINA OFFICIALLY APPROVED THE MARKETING AUTHORIZATION APPLICATION FOR RELMA-CEL FOR THE TREATMENT OF REFRACTORY OR RELAPSED FOLLICULAR LYMPHOMA (R/R FLA)
IN ADULTS WHO HAVE UNDERGONE SECOND-LINE OR ABOVE SYSTEMIC THERAPY.
This is the second indication approved for relma-cel after its approval in September last year, making it the first cellular immunotherapy product approved in China for the treatment of r/r FL, bringing new treatment options
to Chinese FL patients.
On this occasion, Professor Ma Jun, Director of Harbin Institute of Hematology and Oncology, and Professor Zhu Jun, Director of the Department of Internal Medicine and Director of the Department of Lymphoma, Peking University Cancer Hospital, were interviewed to share the treatment status of FL and the application prospects
of relma-cel.

Video of Professor Ma Jun's interview

Video of Professor Zhu Jun's interview

Yimaitong: Lymphoma is one of the top ten most common malignant tumors in China, it is reported that the 5-year overall survival (OS) rate of lymphoma patients in China is only 38.
4%, far lower than that of European and American countries, can you please talk about the current status and future development direction of lymphoma treatment in China?

Lymphoma is a malignant tumor originating from the lymphatic hematopoietic system, according to statistics, the incidence of lymphoma in China is about 6.
9-12/100,000, of which the incidence of lymphoma in Beijing is about 10.
23/100,000, and the statistical accuracy rate can reach about 92%, that is, China's annual new lymphoma cases are as high as 150,000-200,000, ranking first in the incidence of hematological tumors in China, followed by leukemia, multiple myeloma, myelodysplastic syndrome
.
With the aging of China's population, the incidence of lymphoma is also increasing
year by year.
People aged 60-90 are a group with a high incidence of lymphoma, of which the incidence of 80-90 years old people can reach about 30/100,000, and by 2030, the incidence of lymphoma in China may approach the level of Japan and European and American countries, reaching about
25/100,000.

Lymphoma can be divided into B-cell, T-cell, and NK-cell lymphomas
.
In addition to hair and nails, lymphoma
can occur in all parts of the body.
Lymphoma is highly heterogeneous, and the R-CHOP (rituximab + cyclophosphamide + vincristine + doxorubicin + prednisone) regimen is the "gold standard" for first-line treatment of diffuse large B-cell lymphoma, significantly improving the 5-year OS rate of patients and making it possible for about 70% of patients to achieve clinical cure; Although indolent lymphoma is difficult to cure, treatments such as Chemo-free have enabled many patients to achieve long-term survival; Relatively speaking, the prognosis of patients with multiple T-cell lymphomas, including extranodal NK/T-cell lymphoma, is still poor
.
To achieve clinical cure for more lymphoma patients, we need more new weapons
.

With the development of chemotherapy, targeted therapy and immunotherapy in the past 20 years, monoclonal antibodies, bispecific antibodies, antibody conjugates, PD-1/PD-L1 inhibitors and chimeric antigen receptor T (CAR-T) cells and other therapeutic methods have emerged one after
another.
Hodgkin lymphoma mortality has been reduced by about 27 percent due to the advent of drugs that target PD-1 and CD30, but the reduction in B-cell lymphoma and T-cell lymphoma mortality is still small
.
Therefore, we "want one medicine, one doctor and one patient", and work together to help lymphoma patients achieve longer survival and higher clinical cure rates
.

Yimaitong: As a common indolent non-Hodgkin lymphoma, the incidence of FL in China is increasing year by year, can you please talk about the current treatment status of FL?

Compared with European and American countries, the incidence of FL in China is low, but in the past 20 years, especially in recent years, the diagnosis rate of FL in China has increased significantly, the faster the aging process in China, the number of FL patients in China is increasing
year by year.
At present, FL treatment is mainly immunochemotherapy, using CD20 monoclonal antibody combined with chemotherapy, and then appropriate combination of radiotherapy, which can achieve effective disease control
.
However, FL is difficult to cure, and patients are prone to repeated recurrence and even disease progression
after the disease resolves.
Some patients with disease progression (POD24) within 24 months of the first treatment have a poor survival prognosis, and clinicians are actively trying to apply various new drugs and therapies or recommend enrollment in clinical trials to better meet the clinical needs
of these patients.
CAR-T therapy has received more and more attention in recent years, and more and more
research results on CAR-T cell therapy FL at home and abroad.
We believe that in the process of standardized diagnosis and treatment, the application of CAR-T cells and more new drugs will bring new opportunities
to FL patients.

Yimaitong: FL is difficult to cure, some patients may still recur repeatedly after the disease is relieved, at present, many clinical trials are exploring the application of new drugs in r/r FL, can you please talk about the current r/r FL treatment what are the most promising treatment options?

FL is common in people over 65 years old, but there is a trend
towards younger people in China.
FL therapy often combines immunotherapy with chemotherapy and uses small molecule drugs for maintenance therapy, which can lead to long-term survival, but some patients may still face relapse, and subsequent treatment options for relapsed patients are limited
.
And FL patients may face early disease progression and disease transformation, that is, POD24 or transformation into more aggressive diffuse large B-cell lymphoma, which also has a poor prognosis and the response of existing treatment options is not
good.
CAR-T cell therapy targeting CD19 has brought new opportunities
to patients with relapsed/refractory lymphomas, including some highly aggressive lymphomas.
relma-cel was approved last year for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) in adults after second-line or more systemic therapy, and a new indication for r/r FL was approved this year based on the results of the RELIANCE study
.
The RELIANCE study showed that relma-cel treated patients with r/r FL with 3-month complete response rates and objective response rates of 85.
2% and 100%, showing good and sustained responses
.
We look forward to real-world research results from relma-cel in Chinese populations to validate its long-term survival benefits for patients with r/r FL and to assess whether patients have a 5-year OS rate, a 10-year OS rate, or clinical cure
can be achieved.
" We also look forward to researchers and companies working together to advance clinical research and real-world research, and strive for longer survival and even cure for patients with indolent lymphoma
.

Yimaitong: The new indication of relma-cel has been approved for marketing, bringing new life to more Chinese FL patients, can you please talk about your feelings about the approval of relma-cel for the new indication in China? What kind of new era of treatment will r/r FL patients usher in in the future?

In the era of new drugs, in the era of cell drugs widely used in the clinic, the CAR-T product targeting CD19 relma-cel provides clinicians with a new weapon
.
We look forward to real-world practice exploring whether it can lead to longer survival
for patients with r/r FL.
" We also hope that enterprises can consider the burden of medical expenses and allow more r/r FL patients to benefit from CAR-T treatment
under the multi-party protection of medical insurance, Huimin Insurance and commercial insurance.
With the wide application of bispecific antibodies, antibody conjugate drugs, PI3K inhibitors, small molecule drugs, CAR-T cells and more new drugs, more treatment options
will be provided for r/r FL patients.

As a new type of treatment, CAR-T cell therapy has been supported by more and more clinical data in aggressive B-cell lymphoma, especially diffuse large B-cell lymphoma, and a series of domestic and foreign data obtained in patients who have failed previous first-line treatment and second-line/third-line CAR-T cell therapy have proved the considerable efficacy
of CAR-T cell therapy products.
Subsequently, it was explored in FL, and when selecting indications and rationally applying CAR-T, it will bring new choices, new hopes, and even greatly improve the possibility
of cure for FL patients.