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Today, the 24th National Clinical Oncology Conference and the 2021 CSCO Academic Annual Conference jointly sponsored by the Chinese Society of Clinical Oncology (CSCO) and Beijing Xisk Clinical Oncology Research Foundation came to a successful conclusion.
This conference attracted dozens of With the attention of medical practitioners in the field of clinical oncology across the country, the content of the conference was wonderful.
Today at 12:20, Selinexor (ATG-010) combined with low-dose dexamethasone in the treatment of relapsed and refractory multiple myeloma (R /R MM) The results of the MARCH study of patients were announced by Professor Fu Weijun to medical professionals nationwide in ORAL format
.
In addition, this research was announced in the form of a poster at the 18th International Myeloma Symposium (IMW) this month.
The IMW was successfully held in Vienna, Austria and online recently to promote multiple myeloma and related plasma cell diseases.
The latest breakthrough scientific research and clinical communication
.
On this occasion, Yimaitong invited Professor Qiu Lugui from the Hematology Hospital of the Chinese Academy of Medical Sciences and Professor Fu Weijun from the Shanghai Changzheng Hospital to give a wonderful interpretation and comment on the application of Celiniso in MM based on the MARCH research results! Professor Fu Weijun from Changzheng Hospital of the Second Military Medical University announced the results of MARCH research in the form of oral at the 2021 CSCO annual meeting.
Research background MM is a malignant tumor with abnormal proliferation of clonal plasma cells.
In recent years, with the improvement of medical standards and the emergence of new therapeutic drugs The multidisciplinary diagnosis and treatment model continues to advance, and the level of treatment of MM in China continues to develop.
However, primary drug resistance and disease recurrence make MM still incurable.
After relapse, MM patients lack effective treatment methods and treatment options are limited
.
Celiniso is a new oral selective nuclear export inhibitor (SINE) against nuclear export protein 1 (XPO1)
.
In preclinical and clinical studies, Celiniso has shown good anti-MM activity
.
Based on the results of the STORM study, Celiniso (80 mg, twice a week) combined with dexamethasone (20 mg twice a week) (ie Xd regimen) was approved by the U.
S.
Food and Drug Administration (FDA) for treatment in 2019.
MM patients who are refractory to drugs
.
Study Design MARCH is a single-arm, phase 2 clinical study aimed at evaluating the effectiveness and safety of the Xd regimen in the treatment of R/R MM patients in China
.
The study population was MM patients who had previously received proteasome inhibitor (PI) and immunomodulator (IMiD) treatment and were refractory to both drugs and refractory to the end-line regimen
.
The Xd program takes every four weeks as a course of treatment
.
The primary study endpoint is the overall response rate (ORR) assessed by the independent review committee
.
This article will introduce the data analysis results of the first 60 subjects
.
The results of the study as of October 13, 2020, 18 of the 60 subjects (30%) are still receiving treatment
.
The median follow-up time was 9.
5 months (range: 1.
9-12.
8)
.
The median age of the subjects was 61 years old (range: 43-82, 42%>65 years old), and the median number of MM treatment regimens received in the past was 5 (range: 1-16)
.
The ORR of 60 subjects was 26.
7% (95% CI: 16.
1, 39.
7), the median duration of response (DOR) was 4.
6 months (95% CI: 1.
42, NE), and the median progression-free survival (PFS) ) Was 3.
7 months (95% CI: 1.
92, 4.
66), and the median overall survival (OS) was not reached
.
The 9-month OS rate was 68.
5%
.
The ORR of patients who have previously received daratumumab treatment was 33.
3%
.
The ORR of 9 subjects who had previously received CAR-T treatment reached 44.
4%, and the median DOR was 3.
0 months (95% CI: 0.
96, 4.
63)
.
ORR has the same benefit among the other subgroups
.
Experts commented that Professor Qiu Lugui’s MM is the second most common hematological malignant tumor after lymphoma.
It has an extremely high recurrence rate and a poor prognosis.
For patients with relapsed and refractory MM after multi-line treatment, the treatment effect and survival prognosis are facing challenges , A new treatment plan and drugs are needed
.
The latest results of the Celiniso study reported at the IMW meeting further proved the effectiveness and safety of the Xd regimen after the STORM study, enabling multi-line treatment of MM patients to benefit from it
.
Based on the excellent results in clinical trials, several treatment options of Celiniso have been unanimously recommended by the latest authoritative clinical guidelines
.
The NCCN MM Diagnosis and Treatment Guidelines (Version 2021 V4) recommends Celinisol combined with bortezomib and dexamethasone treatment plan (XVd) for the treatment of R/R MM patients (Class I recommendation)
.
In addition to the NCCN guidelines, the EHA-ESMO MM clinical practice guidelines (2021 version) also recommend the combination of Celinisole, bortezomib, and dexamethasone (XVd) for the first-line use of bortezomib and lenalidomide combined with dexamethasone.
Methosone (VRd) regimen treats patients who relapse (I, A); for patients who relapse using daretuzumab combined with lenalidomide and dexamethasone (Dara-Rd) regimen in the first-line treatment, the guidelines also recommend the XVd regimen ( I, A)
.
As more and more new drugs are applied to the clinic, it brings more treatment options to patients with R/R MM after multi-line treatment.
I believe that through the continuous in-depth research of Celiniso, there will be more and better clinical trials.
Evidence supports its entry into the global market
.
As the most authoritative academic event on cancer in China, Professor Fu Weijun CSCO Conference has strongly promoted the development of cancer treatment.
The CSCO guidelines have become one of the most important guidelines for clinical oncologists in China
.
The MARCH study was selected for this CSCO conference ORAL, and its research results show that the Xd regimen as a new oral treatment regimen has good effectiveness and controllable safety, which can help prolong the long-term survival of MM patients
.
For patients with relapsed MM, the 2021 CSCO guideline level I expert recommendation (class 1 evidence) celinisol + dexamethasone treatment plan
.
MM is still an incurable disease and the recurrence rate is extremely high.
The lack of standard treatment options after recurrence limits the treatment options for Chinese MM patients
.
In the era of new drugs, the emergence of PI, IMiD, and various monoclonal antibodies has brought more treatment options for Chinese MM patients, but MM has obvious clonal heterogeneity, and drugs with different mechanisms of action may be needed to induce deep remission in patients
.
Celiniso is the world's first and only oral SINE compound approved by the FDA.
It can cause nuclear storage and activation of tumor suppressor proteins and other growth regulator proteins, and down-regulate a variety of oncogenic proteins, and is tested in vitro and in vivo Proved to induce apoptosis of a large number of solid and blood tumor cells
.
Celiniso's new mechanism of action fills the gap in the treatment of R/R MM in China and brings new hope for the treatment of MM patients in China
.
Professor Qiu Lugui, Chief Physician, and Doctoral Supervisor Director of Lymphoma Diagnosis and Treatment Center, Hospital of Hematology, Chinese Academy of Medical Sciences Director of Tianjin Cord Blood Hematopoietic Stem Cell Bank, Member of International Myeloma Society Membership Committee Member of International Myeloma Working Group Expert Committee Member of "Blood Advances" magazine editor Committee Chairman of the Hematology and Oncology Committee of the Chinese Anti-Cancer Association Vice Chairman of the Lymphoma Research Alliance of the Chinese Society of Clinical Oncology Vice Chairman of the Hematology Professional Committee of the Integrated Physician Association Vice Chairman of the Hematology Professional Committee of the Chinese Medical Education Association Tianjin Anticancer Association Hematology Oncology Committee chairman, "Chinese Journal of Hematology" and other 6 core journals.
Completion of more than 20 key projects of the National Science and Technology Support Program, National Key Projects of Nature and other fund projects.
Published nearly 500 papers, including more than 120 SCI papers, Professor Fu Weijun, Shanghai Long March Department of Hematology of the Hospital, Member and Secretary of the Shanghai Hematology Committee of the PLA Lymphoma Myeloma Disease Center, Deputy Chairman of the Shanghai Medical Industry Association Hematology Transformation Committee, Member of the Standing Committee of the Shanghai Society of Traditional Chinese and Western Medicine and Hematology, Vice Chairman of the Myeloma Committee of the Chinese Medical Education Association Chairman, Member of the Diagnostics Group of the Hematology Committee of the Chinese Medical Association, Member of the Asian Myeloma Working Group, Associate Editor of the "Chinese Internal Medicine Yearbook", and the Chief Editor of Hematology stamp "Read the original text", and we will make progress together
This conference attracted dozens of With the attention of medical practitioners in the field of clinical oncology across the country, the content of the conference was wonderful.
Today at 12:20, Selinexor (ATG-010) combined with low-dose dexamethasone in the treatment of relapsed and refractory multiple myeloma (R /R MM) The results of the MARCH study of patients were announced by Professor Fu Weijun to medical professionals nationwide in ORAL format
.
In addition, this research was announced in the form of a poster at the 18th International Myeloma Symposium (IMW) this month.
The IMW was successfully held in Vienna, Austria and online recently to promote multiple myeloma and related plasma cell diseases.
The latest breakthrough scientific research and clinical communication
.
On this occasion, Yimaitong invited Professor Qiu Lugui from the Hematology Hospital of the Chinese Academy of Medical Sciences and Professor Fu Weijun from the Shanghai Changzheng Hospital to give a wonderful interpretation and comment on the application of Celiniso in MM based on the MARCH research results! Professor Fu Weijun from Changzheng Hospital of the Second Military Medical University announced the results of MARCH research in the form of oral at the 2021 CSCO annual meeting.
Research background MM is a malignant tumor with abnormal proliferation of clonal plasma cells.
In recent years, with the improvement of medical standards and the emergence of new therapeutic drugs The multidisciplinary diagnosis and treatment model continues to advance, and the level of treatment of MM in China continues to develop.
However, primary drug resistance and disease recurrence make MM still incurable.
After relapse, MM patients lack effective treatment methods and treatment options are limited
.
Celiniso is a new oral selective nuclear export inhibitor (SINE) against nuclear export protein 1 (XPO1)
.
In preclinical and clinical studies, Celiniso has shown good anti-MM activity
.
Based on the results of the STORM study, Celiniso (80 mg, twice a week) combined with dexamethasone (20 mg twice a week) (ie Xd regimen) was approved by the U.
S.
Food and Drug Administration (FDA) for treatment in 2019.
MM patients who are refractory to drugs
.
Study Design MARCH is a single-arm, phase 2 clinical study aimed at evaluating the effectiveness and safety of the Xd regimen in the treatment of R/R MM patients in China
.
The study population was MM patients who had previously received proteasome inhibitor (PI) and immunomodulator (IMiD) treatment and were refractory to both drugs and refractory to the end-line regimen
.
The Xd program takes every four weeks as a course of treatment
.
The primary study endpoint is the overall response rate (ORR) assessed by the independent review committee
.
This article will introduce the data analysis results of the first 60 subjects
.
The results of the study as of October 13, 2020, 18 of the 60 subjects (30%) are still receiving treatment
.
The median follow-up time was 9.
5 months (range: 1.
9-12.
8)
.
The median age of the subjects was 61 years old (range: 43-82, 42%>65 years old), and the median number of MM treatment regimens received in the past was 5 (range: 1-16)
.
The ORR of 60 subjects was 26.
7% (95% CI: 16.
1, 39.
7), the median duration of response (DOR) was 4.
6 months (95% CI: 1.
42, NE), and the median progression-free survival (PFS) ) Was 3.
7 months (95% CI: 1.
92, 4.
66), and the median overall survival (OS) was not reached
.
The 9-month OS rate was 68.
5%
.
The ORR of patients who have previously received daratumumab treatment was 33.
3%
.
The ORR of 9 subjects who had previously received CAR-T treatment reached 44.
4%, and the median DOR was 3.
0 months (95% CI: 0.
96, 4.
63)
.
ORR has the same benefit among the other subgroups
.
Experts commented that Professor Qiu Lugui’s MM is the second most common hematological malignant tumor after lymphoma.
It has an extremely high recurrence rate and a poor prognosis.
For patients with relapsed and refractory MM after multi-line treatment, the treatment effect and survival prognosis are facing challenges , A new treatment plan and drugs are needed
.
The latest results of the Celiniso study reported at the IMW meeting further proved the effectiveness and safety of the Xd regimen after the STORM study, enabling multi-line treatment of MM patients to benefit from it
.
Based on the excellent results in clinical trials, several treatment options of Celiniso have been unanimously recommended by the latest authoritative clinical guidelines
.
The NCCN MM Diagnosis and Treatment Guidelines (Version 2021 V4) recommends Celinisol combined with bortezomib and dexamethasone treatment plan (XVd) for the treatment of R/R MM patients (Class I recommendation)
.
In addition to the NCCN guidelines, the EHA-ESMO MM clinical practice guidelines (2021 version) also recommend the combination of Celinisole, bortezomib, and dexamethasone (XVd) for the first-line use of bortezomib and lenalidomide combined with dexamethasone.
Methosone (VRd) regimen treats patients who relapse (I, A); for patients who relapse using daretuzumab combined with lenalidomide and dexamethasone (Dara-Rd) regimen in the first-line treatment, the guidelines also recommend the XVd regimen ( I, A)
.
As more and more new drugs are applied to the clinic, it brings more treatment options to patients with R/R MM after multi-line treatment.
I believe that through the continuous in-depth research of Celiniso, there will be more and better clinical trials.
Evidence supports its entry into the global market
.
As the most authoritative academic event on cancer in China, Professor Fu Weijun CSCO Conference has strongly promoted the development of cancer treatment.
The CSCO guidelines have become one of the most important guidelines for clinical oncologists in China
.
The MARCH study was selected for this CSCO conference ORAL, and its research results show that the Xd regimen as a new oral treatment regimen has good effectiveness and controllable safety, which can help prolong the long-term survival of MM patients
.
For patients with relapsed MM, the 2021 CSCO guideline level I expert recommendation (class 1 evidence) celinisol + dexamethasone treatment plan
.
MM is still an incurable disease and the recurrence rate is extremely high.
The lack of standard treatment options after recurrence limits the treatment options for Chinese MM patients
.
In the era of new drugs, the emergence of PI, IMiD, and various monoclonal antibodies has brought more treatment options for Chinese MM patients, but MM has obvious clonal heterogeneity, and drugs with different mechanisms of action may be needed to induce deep remission in patients
.
Celiniso is the world's first and only oral SINE compound approved by the FDA.
It can cause nuclear storage and activation of tumor suppressor proteins and other growth regulator proteins, and down-regulate a variety of oncogenic proteins, and is tested in vitro and in vivo Proved to induce apoptosis of a large number of solid and blood tumor cells
.
Celiniso's new mechanism of action fills the gap in the treatment of R/R MM in China and brings new hope for the treatment of MM patients in China
.
Professor Qiu Lugui, Chief Physician, and Doctoral Supervisor Director of Lymphoma Diagnosis and Treatment Center, Hospital of Hematology, Chinese Academy of Medical Sciences Director of Tianjin Cord Blood Hematopoietic Stem Cell Bank, Member of International Myeloma Society Membership Committee Member of International Myeloma Working Group Expert Committee Member of "Blood Advances" magazine editor Committee Chairman of the Hematology and Oncology Committee of the Chinese Anti-Cancer Association Vice Chairman of the Lymphoma Research Alliance of the Chinese Society of Clinical Oncology Vice Chairman of the Hematology Professional Committee of the Integrated Physician Association Vice Chairman of the Hematology Professional Committee of the Chinese Medical Education Association Tianjin Anticancer Association Hematology Oncology Committee chairman, "Chinese Journal of Hematology" and other 6 core journals.
Completion of more than 20 key projects of the National Science and Technology Support Program, National Key Projects of Nature and other fund projects.
Published nearly 500 papers, including more than 120 SCI papers, Professor Fu Weijun, Shanghai Long March Department of Hematology of the Hospital, Member and Secretary of the Shanghai Hematology Committee of the PLA Lymphoma Myeloma Disease Center, Deputy Chairman of the Shanghai Medical Industry Association Hematology Transformation Committee, Member of the Standing Committee of the Shanghai Society of Traditional Chinese and Western Medicine and Hematology, Vice Chairman of the Myeloma Committee of the Chinese Medical Education Association Chairman, Member of the Diagnostics Group of the Hematology Committee of the Chinese Medical Association, Member of the Asian Myeloma Working Group, Associate Editor of the "Chinese Internal Medicine Yearbook", and the Chief Editor of Hematology stamp "Read the original text", and we will make progress together
