The CD38 monoclonal antibody daratumumab helps patients with multiple myeloma rejuvenate during medical insurance

2021 is the first year of the "14th Five-Year Plan" and coincides with the 100th anniversary of the founding of the party
.

The adjustment of the National Medical Insurance Drug List in 2021 will conscientiously implement the decisions and deployments of the Party Central Committee and the State Council, adhere to the people's health as the center, and strive to safeguard the vital interests of the majority of insured persons
.

Multiple myeloma (MM), as a malignant hematological tumor, has a 5-year survival rate of only 24.
8%1, which is a serious threat to the lives and health of our people
.

Daratumumab is the world's first and currently the only approved CD38 monoclonal antibody in China.
Its appearance has opened a new era of targeted immunotherapy for the treatment of MM, redefining the treatment of myeloma, and taking it deeper The clinical effects of relief and longer survival have brought the dawn of life to patients
.

Daratumumab single-drug or combination regimen for the treatment of patients with relapsed or refractory MM has been unanimously recommended by many authoritative guidelines such as NCCN3 in the United States, ESMO4 in Europe, MAYO5 in the United States, and guidelines for the diagnosis and treatment of multiple myeloma in China6
.

It coincides with its emergence to bring new hope to patients with multiple myeloma.
MM is a malignant disease with abnormal proliferation of clonal plasma cells.
It is the second most common malignant tumor in the blood system in many countries, 7-8, and it occurs mostly in the elderly.
According to the latest epidemiological survey, the incidence of MM in China is about 1.
03 per 100,000 2
.

Although the treatment of MM has made significant progress, it will eventually relapse and cannot be completely cured
.

With continuous relapses, repeated symptoms, and deterioration of quality of life, the probability and duration of remission usually decrease.
Before daratumumab is marketed, patients with multiple relapses or refractory MM often face the dilemma of no cure , And the autoimmune function is low, and the function of tissues and organs is seriously damaged
.

In 2015, Daratumumab was born as the world's first fully human CD38 monoclonal antibody approved10
.

The emergence of daratumomab fills the gap in the clinical treatment of adult patients with relapsed and refractory MM.
It is suitable for single-drug treatment of adult patients with relapsed and refractory multiple myeloma.
The patients have received proteasome inhibitors and immunization in the past.
Treatment of modulators and disease progression during the last treatment, as well as the combination of lenalidomide and dexamethasone or the combination of bortezomib and dexamethasone in the treatment of adult patients with multiple myeloma who have received at least first-line treatment in the past 11
.

A brand-new mechanism for precise attack and rapid elimination of myeloma cells.
Daratumumab has a dual mechanism of action 12,14: direct anti-tumor activity and regulation of the immune microenvironment
.

Direct anti-tumor activity is reflected in complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), Fcγ receptor-mediated cross-linking induced apoptosis The immunomodulatory effect is reflected in the regulation of the tumor microenvironment (reducing the activity of the immunosuppressive CD38 enzyme), the consumption of CD38+ immunosuppressive cells, and the activation of CD8+ killer T cells and CD4+ helper T cells
.

Compared with other targeted drugs approved in the past, daratumomab has a more direct and comprehensive mechanism of action
.

Deeper remission and longer survival benefit more patients with refractory or relapsed multiple myeloma.
In the combined analysis of two large clinical trials of GEN501 and SIRIUS, daratumomab was effective as a single agent for MM patients with multiple relapses Fast, the median time to remission for patients with ≥PR (partial remission) is 0.
95 months13
.

At the same time, daratumomab significantly prolongs the survival of patients.
In the overall patients (patients with 2-14 relapses and 5 relapses), the median overall survival (OS) can reach 20.
5 months13, compared with The traditional treatment plan (median OS is only 5-7 months14) has a significant improvement
.

The single-agent daratumomab treatment regimen has good safety and tolerability, and there are few incidents of discontinuation of treatment due to adverse reactions, which significantly improves the quality of life of patients
.

In addition, achieving deep and long-term remission in the treatment of first relapsed MM is still a huge clinical unmet need
.

The combined regimen of daratumomab in the treatment of patients with relapsed MM has a median progression-free survival (PFS) of 45 months16, which is significantly better than the 17.
5 months of lenalidomide combined with dexamethasone; for patients with first relapse, The median PFS is as high as 53.
3 months16.
At the same time, for patients with relapsed or refractory MM, a meta-analysis of a number of large phase 3 clinical studies has shown that the regimen containing daratumumab is the most effective treatment regimen17
.

Starlight lives up to the benefit of more patients and strongly urges daratumumab to enter the National Medical Insurance List.
MM is a systemic and currently incurable tumor disease, which brings serious physical, psychological and economic burdens to patients, especially For patients with multiple relapses, the quality of life generally decreases in all dimensions after the disease progresses.
Therefore, it is of great significance for patients with relapse and refractory to control the disease progression
.

The previously approved drugs have a relatively simple mechanism of action, and have limited efficacy in the treatment of relapsed and refractory myeloma, and patient benefits are very limited
.

Daratumumab is the world's first fully human CD38 monoclonal antibody, with good clinical efficacy and safety evidence.
Since its launch in 2019, it has been recognized by clinicians
.

At present, daratumumab has been included in the scope of medical insurance reimbursement by 53 countries and regions including the United States, Germany, the United Kingdom, South Korea, Taiwan, etc.
, benefiting many patients
.

For this type of clinical medication that is safe, effective and significantly prolongs the survival of patients, if it can be included in my country's medical insurance, it will inevitably benefit more myeloma patients.
Therefore, we strongly appeal to the first CD38 monoclonal antibody in the field of myeloma-daratumoma.
Anti-inclusion in national health insurance! References: 1.
2018 Lancet CONCORD-32.
J Hematol Oncol.
2019;12(1):136.
3.
NCCN Myeloma 2021 V74.
Esmo myeloma 20215.
MAYO clinical guideline 6.
China Multiple Myeloma Diagnosis and Treatment Guide (revised in 2020) 7 .
Wang S,et al.
Front Oncol,2019,9:1513.
8.
Liu W,et al.
J Hematology Oncol,2019,12(22).
9.
Liu J, et al.
J Hematol Oncol.
2019;12(1 ): 136.
10.
http:// 11.
Instructions for Daratumumab injection 12.
de Weers M, et al.
J Immunol .
2011.
13.
Usmani SZ,et al.
Blood.
2016;128(1):37-4414.
Krejcik J,et al.
Blood.
2016;128(3):384-94.
15.
Briefing Book:p54 section 7.
3.
16.
Kaufman.
POLLUX 4-year update Final.
ASH 2019.
Poster 1866.
17.
Chrissy HY et al.
J Clin Oncol.
2017 stamp "Read the original", we make progress together