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Introduction In September 2019, Zhaoke® (daratumumab injection), as the world's first fully human monoclonal antibody targeting CD38, was approved for the first single-drug listing in China for relapsed or refractory multiple disease Adult patients with sexual myeloma
.
After Zhaoke® was approved for second-line indications in April 2021, Zhaoke® was again approved for new indications in November 2021-daratumomab combined with lenalidomide and dexamethasone (DRd) or combined The combination of bortezomib, melphalan and prednisone (DVMP) for the treatment of newly diagnosed multiple myeloma (NDMM) adult patients who are not suitable for autologous stem cell transplantation has once again revolutionized the domestic multiple myeloma treatment pattern
.
Regarding the disease and clinical unmet needs, Professor Huang Xiaojun: Multiple myeloma (MM) is a malignant plasma cell clonal proliferative disease.
It is the second most common malignant tumor in the blood system in many countries.
It occurs mostly in old age and is still incurable at this stage
.
Professor Wu Depei: MM has the characteristics of continuous progress and repeated relapses in clinical practice
.
And with the increase in the number of recurrences, tumor cell clones become more complex, the depth of remission of later-line treatment is lower, the duration of remission is shorter, and the survival prognosis is worse.
Therefore, the initial treatment of NDMM patients is particularly important
.
About MAIA and ALCYONE experiment Interpretation of MAIA study: DRd regimen, "Zhao" bright new journey for NDMM patients Professor Hu Yu: Global Phase III MAIA study 1 shows that daratumumab combined with Rd regimen treat NDMM patients who are not suitable for autologous stem cell transplantation , With a median follow-up of 56.
2 months, the strict complete remission (sCR) rate of the DRd group was twice that of the Rd group, and the negative rate of minimal residual disease (MRD) was three times that of the Rd group.
The median of the DRd group and the Rd group was no Progressive survival (PFS) was not reached (NR) and 34.
4 months (p<0.
0001; Figure 1A).
The 5-year PFS rate of the DRd group was 23.
8% higher than that of the Rd group, and the risk of disease progression or death was reduced by 47%; although in the two groups All OSs were NR, but compared with the Rd group, the 5-year overall survival (OS) rate increased by 13.
2%, lowered the risk of death by 32% (p=0.
0013; Figure 1B), and significantly improved the survival benefit of patients
.
Figure 1 DRd vs Rd: PFS, OSALCYONE study: DVMP program, bringing unlimited "ke" energy to NDMM patients Professor Wang Jianxiang: Global Phase III ALCYONE study 2 shows that the median follow-up is 40.
1 months.
Compared with the VMP program, Darley The objective response rate (ORR) of toyuzumab combined with the VMP regimen in the treatment of NDMM patients who are not suitable for transplantation was significantly improved (90.
9% vs 73.
9%), and the proportion of patients with deep remission was higher, and the sCR rate was 3 times and 4 times.
MRD negative rate
.
The median PFS was extended by 17.
1 months (36.
4 months vs 18.
3 months), and the risk of disease progression or death was reduced by 58% (p<0.
0001; Figure 2B); the median OS group was both NR, but the OS rate in the DVMP group increased by 13 %, reduce the risk of death by 40% (p=0.
0003; Figure 2A) Figure 2 DVMP vs VMP: PFS and OS regarding the treatment goals of newly treated patients with multiple myeloma Professor Qiu Lugui: The treatment goal of NDMM is to achieve the best depth of remission and Continuous remission is achieved through overall treatment to obtain the longest possible PFS, thereby prolonging the patient’s OS and improving the patient’s quality of life
.
Based on two large global phase III studies: MAIA study 1 and ALCYONE study 2, daratumomab has now entered the first-line treatment of MM, and the DVMP and DRd regimens have become the preferred treatment regimens for patients who are not suitable for transplantation of NDMM
.
What is the status of daratumumab in the international authoritative guidelines? The international authoritative guides all regard the daratumumab combination as the first choice for the treatment of NDMM patients who are not suitable for transplantation.
Professor Ma Jun: Because of its unique mechanism of action and remarkable anti-tumor effect With activity and good safety, daratumomab has become one of the most attractive drugs in the combined treatment program for NDMM patients
.
Based on the excellent results of the MAIA and ALCYONE studies, the latest NCCN, ESMO, Mayo and other international authoritative guidelines all recommend the combination regimen containing daratumumab as a category 1 recommendation for the treatment of NDMM that is not suitable for transplantation.
The approval of anti-first-line indications will bring new hope to more Chinese patients with multiple myeloma
.
About the mechanism of action of daratumumab Prof.
Juan Li: Daratumumab, as the world's first immuno-targeted CD38 monoclonal antibody, has a unique "dual mechanism of action", which can directly kill myeloma cells , And can activate immunity, allowing MM patients to obtain lasting and deep relief
.
(1) Daratumomab directly binds to CD38 on the surface of myeloma cells through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated Phagocytosis (ADCP) and the induction of apoptosis through cross-linking directly kill myeloma cells
.
(2) By regulating the immune microenvironment, Daratumumab can affect CD38 enzyme activity, eliminate CD38+ immunosuppressive cells such as regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells, and activate CD8+ cytotoxic T cells And CD4+ helper T cells, change the ratio of T cells, and continue to promote the death of myeloma cells3, allowing MM patients to obtain lasting and deep relief
.
Figure 3 The "dual mechanism" of Daratumumab Warm congratulations to Daratumumab injection [Zhaoke®] for the treatment of newly diagnosed multiple myeloma patients who are not suitable for autologous stem cell transplantation.
The indication is officially approved in China! Open a new era of treatment for patients with newly diagnosed multiple myeloma in China! References: 1.
Thierry Facon, et al.
Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial.
Lancet Oncol.
2021 Nov;22(11):1582-15962.
Mateos MV, et al.
2019 ASH Annual Meeting.
Abstract Oral 859.
3.
Lu Jin.
Progress in the treatment of multiple myeloma with daratumumab.
Chin J Hematol, 2021 Mar; 42(3) : 260-264.
Stamp "read the original text", we make progress together
.
After Zhaoke® was approved for second-line indications in April 2021, Zhaoke® was again approved for new indications in November 2021-daratumomab combined with lenalidomide and dexamethasone (DRd) or combined The combination of bortezomib, melphalan and prednisone (DVMP) for the treatment of newly diagnosed multiple myeloma (NDMM) adult patients who are not suitable for autologous stem cell transplantation has once again revolutionized the domestic multiple myeloma treatment pattern
.
Regarding the disease and clinical unmet needs, Professor Huang Xiaojun: Multiple myeloma (MM) is a malignant plasma cell clonal proliferative disease.
It is the second most common malignant tumor in the blood system in many countries.
It occurs mostly in old age and is still incurable at this stage
.
Professor Wu Depei: MM has the characteristics of continuous progress and repeated relapses in clinical practice
.
And with the increase in the number of recurrences, tumor cell clones become more complex, the depth of remission of later-line treatment is lower, the duration of remission is shorter, and the survival prognosis is worse.
Therefore, the initial treatment of NDMM patients is particularly important
.
About MAIA and ALCYONE experiment Interpretation of MAIA study: DRd regimen, "Zhao" bright new journey for NDMM patients Professor Hu Yu: Global Phase III MAIA study 1 shows that daratumumab combined with Rd regimen treat NDMM patients who are not suitable for autologous stem cell transplantation , With a median follow-up of 56.
2 months, the strict complete remission (sCR) rate of the DRd group was twice that of the Rd group, and the negative rate of minimal residual disease (MRD) was three times that of the Rd group.
The median of the DRd group and the Rd group was no Progressive survival (PFS) was not reached (NR) and 34.
4 months (p<0.
0001; Figure 1A).
The 5-year PFS rate of the DRd group was 23.
8% higher than that of the Rd group, and the risk of disease progression or death was reduced by 47%; although in the two groups All OSs were NR, but compared with the Rd group, the 5-year overall survival (OS) rate increased by 13.
2%, lowered the risk of death by 32% (p=0.
0013; Figure 1B), and significantly improved the survival benefit of patients
.
Figure 1 DRd vs Rd: PFS, OSALCYONE study: DVMP program, bringing unlimited "ke" energy to NDMM patients Professor Wang Jianxiang: Global Phase III ALCYONE study 2 shows that the median follow-up is 40.
1 months.
Compared with the VMP program, Darley The objective response rate (ORR) of toyuzumab combined with the VMP regimen in the treatment of NDMM patients who are not suitable for transplantation was significantly improved (90.
9% vs 73.
9%), and the proportion of patients with deep remission was higher, and the sCR rate was 3 times and 4 times.
MRD negative rate
.
The median PFS was extended by 17.
1 months (36.
4 months vs 18.
3 months), and the risk of disease progression or death was reduced by 58% (p<0.
0001; Figure 2B); the median OS group was both NR, but the OS rate in the DVMP group increased by 13 %, reduce the risk of death by 40% (p=0.
0003; Figure 2A) Figure 2 DVMP vs VMP: PFS and OS regarding the treatment goals of newly treated patients with multiple myeloma Professor Qiu Lugui: The treatment goal of NDMM is to achieve the best depth of remission and Continuous remission is achieved through overall treatment to obtain the longest possible PFS, thereby prolonging the patient’s OS and improving the patient’s quality of life
.
Based on two large global phase III studies: MAIA study 1 and ALCYONE study 2, daratumomab has now entered the first-line treatment of MM, and the DVMP and DRd regimens have become the preferred treatment regimens for patients who are not suitable for transplantation of NDMM
.
What is the status of daratumumab in the international authoritative guidelines? The international authoritative guides all regard the daratumumab combination as the first choice for the treatment of NDMM patients who are not suitable for transplantation.
Professor Ma Jun: Because of its unique mechanism of action and remarkable anti-tumor effect With activity and good safety, daratumomab has become one of the most attractive drugs in the combined treatment program for NDMM patients
.
Based on the excellent results of the MAIA and ALCYONE studies, the latest NCCN, ESMO, Mayo and other international authoritative guidelines all recommend the combination regimen containing daratumumab as a category 1 recommendation for the treatment of NDMM that is not suitable for transplantation.
The approval of anti-first-line indications will bring new hope to more Chinese patients with multiple myeloma
.
About the mechanism of action of daratumumab Prof.
Juan Li: Daratumumab, as the world's first immuno-targeted CD38 monoclonal antibody, has a unique "dual mechanism of action", which can directly kill myeloma cells , And can activate immunity, allowing MM patients to obtain lasting and deep relief
.
(1) Daratumomab directly binds to CD38 on the surface of myeloma cells through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated Phagocytosis (ADCP) and the induction of apoptosis through cross-linking directly kill myeloma cells
.
(2) By regulating the immune microenvironment, Daratumumab can affect CD38 enzyme activity, eliminate CD38+ immunosuppressive cells such as regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells, and activate CD8+ cytotoxic T cells And CD4+ helper T cells, change the ratio of T cells, and continue to promote the death of myeloma cells3, allowing MM patients to obtain lasting and deep relief
.
Figure 3 The "dual mechanism" of Daratumumab Warm congratulations to Daratumumab injection [Zhaoke®] for the treatment of newly diagnosed multiple myeloma patients who are not suitable for autologous stem cell transplantation.
The indication is officially approved in China! Open a new era of treatment for patients with newly diagnosed multiple myeloma in China! References: 1.
Thierry Facon, et al.
Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial.
Lancet Oncol.
2021 Nov;22(11):1582-15962.
Mateos MV, et al.
2019 ASH Annual Meeting.
Abstract Oral 859.
3.
Lu Jin.
Progress in the treatment of multiple myeloma with daratumumab.
Chin J Hematol, 2021 Mar; 42(3) : 260-264.
Stamp "read the original text", we make progress together
