Jalova, a new generation of CD20 monoclonal antibody, was approved for marketing, innovating the first-line treatment standard for follicular lymphoma

A few days ago, Roche Pharmaceuticals China announced that its Jialuohua® (English name: Gazyva®, generic name: otuzumab) has been formally approved by the National Medical Products Administration (NMPA) of China to be used in combination with chemotherapy for initial treatment Adult patients with stage II with giant masses, stage III or IV follicular lymphoma, and patients who achieved at least partial remission were subsequently treated with monotherapy
.

 The approval of Jialuohua®'s first-line treatment program brings new treatment options for patients with follicular lymphoma (FL) in China.
As the world's first glycosylated type II humanized anti-CD20 monoclonal antibody, Austria The innovative structure and mechanism of touzumab can enhance tumor cell lethality, so as to improve the progression-free survival rate of patients
.

Reduce the risk of progression/recurrence and significantly improve the quality of life.
Jia Luohua ® is approved this time based on the global Phase III GALLIUM study
.

This pivotal study aims to compare the efficacy of otuzumab combined with chemotherapy, followed by otuzumab monotherapy for two years, and rituximab combined with chemotherapy, followed by rituximab monotherapy for two years.
And safety
.

A total of 1202 patients with advanced FL (stage II large mass, stage III or IV) were enrolled
.

The results of the study showed that after a median follow-up of 34.
5 months, compared with the standard treatment regimen in the control group, the combination of otuzumab chemotherapy can significantly reduce the risk of progression/recurrence or death by 34%, and a progression-free survival period Significantly prolonged (three-year PFS rate was 80.
0% vs.
73.
3%, HR=0.
66; 95% CI: 0.
51-0.
85; p=0.
0012), reaching the primary study endpoint1
.

In terms of the early progression of follicular lymphoma, otuzumab combined with chemotherapy can significantly reduce the cumulative incidence of disease progression (POD24) within 24 months, and reduce the risk of early progression by 46% (9% vs.
16%) , HR=0.
54; 95% CI: 0.
39-0.
75)2
.

The study also conducted continuous follow-up, and the 5-year long-term data conclusions further confirmed the long-term benefits of otuzumab in reducing the risk of disease recurrence and death (PFS and POD24)
.

In addition, the safety data confirmed that the application of the otuzumab treatment regimen was consistent with the previously known safety data, and no new or unexpected safety signals were found
.

"First-line treatment is an important basis for formulating overall treatment strategies and improving the overall survival benefits of patients
.

Otuzumab combined with chemotherapy has achieved a significant improvement in PFS in patients with newly treated follicular lymphoma, and the disease progressed within 24 months (POD24).
) The proportion of incidents has dropped by nearly half, and the average risk has dropped by 46%2.
The evidence-based data is surprising
.

” Professor Ma Jun, director of the Harbin Institute of Hematology and Oncology, said, “At present, otuzumab has been included in CSCO and NCCN.
The first-line recommendations of many authoritative guidelines around the world, including the guidelines, have become a new standard that is unanimously recognized in the first-line treatment of follicular lymphoma
.

"The needs of patients with acute FL, the first-line tuning brings long-term benefits.
" In the past 20 years, to benefit Tuximab and its based regimens have always been the first-line treatment for patients with follicular lymphoma and have brought significant survival benefits to patients
.

” said Professor Zhu Jun, Party Secretary and Director of the Lymphoma Department of Peking University Cancer Hospital, "In recent years, although the exploration of the first-line treatment of follicular lymphoma has been advancing all the way, the results have always been unsatisfactory; the GALLIUM study is the first clinical exploration to realize the first-line treatment of newly diagnosed FL patients to significantly reduce the risk of disease recurrence and death
.

Based on this, the arrival of otuzumab is not only expected to realize the patient's desire to reduce the risk of recurrence and death, and to have a better life; it can also bring a positive impact on subsequent treatment
.

Therefore, this approval is a landmark for the FL treatment field
.

"Data shows that the incidence of follicular lymphoma in China has been increasing in recent years3, and this type of tumor is usually difficult to cure
.

Statistics show that about 20% of follicular lymphoma patients will start Recurrence occurs within 2 years of treatment.
Such patients with early progression are relatively at higher risk, with a five-year survival rate of only 50%
.

In the process of continuous recurrence, 30%-40% of follicular lymphoma will transform into other aggressive types.
A stronger type of lymphoma, and there are currently no clear markers that can predict the risk of early progression of patients, which makes the treatment more difficult and aggravates the physical and mental stress that affects the treatment
.
In
order to scientifically show the life status of patients with follicular lymphoma, in 2020, lymphoma The Tumor House, the Jockey Club School of Public Health and Primary Medical Care of The Chinese University of Hong Kong, and Beijing New Sunshine Charity Foundation jointly conducted a six-month online survey and released the "White Paper on the Survival Status of Patients with Follicular Lymphoma in China" based on the results of the survey.
(Hereinafter referred to as the "White Paper")
.
The
"White Paper" survey results show that patients with follicular lymphoma are deeply troubled by repeated treatments, have fear of recurrence, and are more difficult to return to normal social life
.

Therefore, the first-line treatment of FL is not only right The survival time is required (longer OS), and the quality of life is tested (longer PFS); further reducing recurrences and obtaining long-term and higher-quality survival are the most urgent hopes for FL patients
.

  Image source: "Follicular in China" The White Paper on the Living Conditions of Lymphoma Patients" Otuzumab can meet this treatment demand is mainly due to its unique mechanism of action
.

As the world’s first humanized type II anti-CD20 monoclonal antibody modified by glycosylation engineering structure, compared with the control group human-mouse chimeric type I anti-CD20 monoclonal antibody, the otuzumab antibody relies on cell mediation.
The guided cytotoxicity (ADCC) and antibody-dependent phagocytosis (ADCP) are enhanced by more than 35 times, and can effectively enhance the direct cell killing effect, and overall reduce the risk of disease deterioration and recurrence
.

The statistical results of the "White Paper" also show that the vast majority of interviewed patients indicated that they have a very urgent need for new drugs for the treatment of follicular lymphoma, and otuzumab is one of the drugs most expected to be marketed by patients
.

Right now, the approval of otuzumab has ushered the treatment of follicular lymphoma in China into a new era
.

In the future, as a new generation of humanized anti-CD20 monoclonal antibody, the application of otuzumab in the entire field of lymphoma treatment is also expected to continue to expand, bringing new treatment options to more patients, whether it is otuzumab The development of the "de-chemotherapy" regimen combined with lenalidomide in the first-line treatment of patients with high tumor burden follicular lymphoma is a further exploration of the indications for chronic lymphocytic leukemia and small lymphocytic lymphoma that have been approved by the global drug regulatory authority , Are constantly achieving new results
.

We have reason to believe that in the future, patients with more lymphoma will surely get more life bargaining chips, and get a longer and higher-quality survival time
.

1: Marcus R, et al.
N Engl J Med 2017;377:1331–442: Launonen A et al.
ASH 2017.
Poster 14903: Chinese Follicular Lymphoma Diagnosis and Treatment Guidelines (2013 Edition) Retrospective Slide View More previous issues