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The golden qi is at the autumn equinox, and the rain in the gorge falls
.
CStone Pharmaceuticals' world's first IDH1 inhibitor, Tosuvo ® (ivoranib tablets), has entered clinical application in China, from domestic approval to the first single issuance, and then to the grand launch, opening a new treatment
door for AML patients in China.
Precise guidance, caring for patients, the journey of ivonib tablets in AML continues
.
September 25, 2022, Topsuvo ® (ivonib tablets) China listing meeting · East China & Central China Station was held in Hangzhou and Fuzhou in the form of offline and online, and the conference invited Professor Hu Yu of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Professor Jin Jie of the First Affiliated Hospital of Zhejiang University School of Medicine, Professor Sun Zimin of the First Affiliated Hospital of University of Science and Technology of China and Professor Wang Shaoyuan of Union Hospital Affiliated to Fujian Medical University as the chairman of the conference, and invited well-known domestic experts to conduct in-depth discussions
on AML diagnosis and treatment trends and future development.
Yimaitong specially compiled the essence of the conference to feed readers
.
Message from the conference
Professor Hu Yu said that in recent years, thanks to the strong support of national policies, China's pharmaceutical innovation and development have made rapid progress, and it is gratifying that ivoranib tablets, as the world's first IDH1 inhibitor, can be quickly approved for marketing in China, and this "acceleration" of running for life enables Chinese AML patients to have the opportunity to benefit
from precision targeted drugs earlier.
It is expected that colleagues in the field of blood will join hands with CStone Pharmaceuticals to jointly promote the construction of AML precision diagnosis and treatment disciplines and bring more hope
to patients.
Professor Jin Jie said that ivoranib tablets have shown excellent efficacy and safety in IDH1 mutant AML patients, and have been recommended by a number of authoritative guidelines at home and abroad, and are the preferred treatment drugs
for IDH1 mutant AML patients.
The launch of ivoranib will fill the gap in the field of precision targeted therapy for leukemia and provide new options
for AML patients.
Professor Sun Zimin believes that with the continuous development of molecular detection technology, people's awareness of tumors has been continuously improved, and many precise targeted drugs have emerged in the field of hematological tumors, creating many therapeutic "miracles"
.
It is expected that CStone Pharmaceuticals will continue to create more good drugs
for hematological cancer patients with related fields.
Professor Wang Shaoyuan said that in the past, AML only relied on 3+7 or transplantation for treatment, and the application of targeted drugs in recent years has provided a new treatment option
for AML patients.
With the launch of ivoranib tablets, clinicians should also consider how to standardize the management of patients so that the drug achieves the desired effect
.
Dr.
You Zhou, General Manager and Head of Commercial Department of CStone Greater China, said that ivoranib tablets were finally approved for marketing
in China after multiple stages such as R&D, registration and approval.
Looking back on the process, the listing of ivoranib tablets is inseparable from the support of many experts and scholars and the trust and cooperation
of doctors and patients.
The launch of ivosannib tablets will bring a new weapon for the treatment of hematological tumors in China, and CStone will continue to explore breakthrough therapies in the future to bring more valuable innovative therapeutic drugs
to the clinic by adhering to the principle of innovation.
Opening remarks
After the wonderful speech, the conference held a grand listing launch ceremony, and many experts joined hands to light up the light
of hope in life.
Launch ceremony
Precision in leadership
The present and future of AML precision care
Professor Tong Hongyan gave a wonderful report
Professor Tong Hongyan from the First Affiliated Hospital of Zhejiang University School of Medicine shared the present and future of AML precision diagnosis and treatment, with the following key points:
➤ After years of development, leukemia treatment has made significant progress, but AML remains one of
the most challenging hematological tumors.
Especially in elderly patients, there is a large gap
in survival compared with younger patients.
➤In recent years, the development of molecular detection technology and the emergence of targeted therapy drugs have greatly promoted the development of the field of AML, and innovative therapeutic drugs represented by ivoranib have gradually moved AML from pan-targeted therapy to the era of
precision targeted therapy.
➤ Evonebub provides AML patients with a "double-excellent" treatment option that takes into account both efficacy and safety, which brings infinite possibilities for improving the survival rate of AML and lights up the dawn of life for AML patients
.
➤AML precision diagnosis and treatment not only includes precision targeted drug treatment, but also builds a multi-dimensional and accurate framework
such as accurate detection, accurate diagnosis, precision treatment, and accurate monitoring.
Master Dialogue
Professor Huang Jian of the First Affiliated Hospital of Zhejiang University School of Medicine, Professor Lin Ying of the Second Affiliated Hospital of Wenzhou Medical University, Professor Xu Bing of the First Affiliated Hospital of Xiamen University and Professor Yang Yanli of the First Affiliated Hospital of Bengbu Medical College had a heated discussion on the above sharing, believing that AML patients usually have multiple types of gene mutations, and in the treatment process, a combination drug regimen should be tried in a standardized and ethical situation, and domestic clinical trials need to actively explore the clinical use experience of ivonib , accumulate evidence-based medical evidence, and find treatment options
that are truly suitable for AML patients.
Pioneering New Bureau
The path of exploration of IDH1 mutation AML
Professor Li Fei gave a wonderful speech
Under the chairmanship of Professor Jin Jie, Professor Li Fei of the First Affiliated Hospital of Nanchang University shared the exploration of IDH1 mutation AML, the main points are as follows:
➤The emergence of ivosnib tablets is a double breakthrough
in the field of targeted tumor metabolism and cell differentiation.
In terms of targeted tumor metabolism, IDH1 mutation is one of the most representative mutated metabolic genes, and the emergence of ivonib tablets has promoted the development of the field; In terms of inducing cell differentiation, ivonib tablets can rapidly inhibit the production of 2-HG and reduce it to normal physiological level, induce normal differentiation of tumor cells, and thus play a role
in the treatment of IDH1 mutation AML.
➤ Evovinib tablets have achieved good efficacy and safety in both single and combination therapy, and its unique mechanism of action is expected to bring broad prospects
for exploring more combination treatment regimens based on ivovinnib tablets.
➤Authoritative guidelines at home and abroad have recommended ivocyb for the treatment of patients with IDH1 mutation-naïve or relapsed refractory AML, and more treatment models should be explored in the future to further promote the development of
precision treatment of AML.
Master Dialogue
Professor Fu Danhui, Professor Lin Yanjuan of Fujian Medical University Union Hospital and Professor Zeng Qingshu of the First Affiliated Hospital of Anhui Medical University shared their thoughts on the above report, saying that AML is a highly heterogeneous hematological tumor, and it is very critical to select the corresponding treatment according to the prognosis stratification, and the efficacy of ivonebub in patients with IDH1 mutation AML has been confirmed by a large amount of evidence-based medical evidence, but China's clinical experience is still relatively lacking.
More clinical application issues need to be further explored
by domestic clinicians.
The light of the new world
From the update of the guidelines, we can see the new ideas of AML diagnosis and treatment
Professor Li Qiumai gave a wonderful speech
Under the chairmanship of Professor Sun Zimin, Professor Li Qiumai of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology elaborated on the new ideas of AML diagnosis and treatment according to the update of the guidelines, the main contents are as follows:
➤ After more than 50 years, the 3+7 chemotherapy regimen is still the standard induction treatment for
AML recommended by the guidelines.
However, in this process, the prognosis stratification of AML has been gradually refined, and the current comprehensive stratification system based on molecular genetics, molecular biology, MRD monitoring, etc.
has laid the foundation
for the precise treatment of AML.
➤In the process of molecular biology technology development, a large number of AML targets with therapeutic potential, such as IDH and BCL-2, have received clinical attention, and a variety of targeted drugs have entered clinical applications, enriching the treatment options
of AML.
➤ Starting in 2019, NCCN guidelines recommend precision treatment options for AML based on whether there are mutant targets
.
Evoridanib tablets are recommended as the first
choice for the treatment of patients with IDH1 mutant AML because of their excellent efficacy and safety profile with single and combined drugs.
➤The latest guidelines of NCCN further confirm the recommended status of targeted drugs, and precision diagnosis and treatment models will also be the development trend
in the field of AML.
Master Dialogue
Professor Lin Yun of Fujian Provincial Hospital, Professor Ye Haige of the First Affiliated Hospital of Wenzhou Medical University and Professor Zhang Min of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology shared their views on the above topics, believing that for AML patients who cannot tolerate strong chemotherapy, the status of targeted drug therapy is very important, but in the process of clinical practice, they often encounter the combination of multiple gene mutations, and how to weigh the therapeutic balance between various gene mutations requires more clinical exploration.
This will also be an urgent question
to be answered in the future of clinical practice.
Guardian Light
Interpretation and thinking of important clinical research data of Tosuvo ®
Professor Honghu gave a wonderful sharing
Professor Honghu, the head of the First Affiliated Hospital of Zhejiang University School of Medicine, interpreted the core clinical research data related to ivovinnib tablets and shared relevant thoughts, the main points are as follows:
➤ When ivosnib monotherapy was used in patients with relapsed and refractory AML, the median overall survival (OS) of CR/CRh patients was as high as 18.
8 months, and the median OS of patients with initial AML was 12.
6 months; the median OS of patients with IDH1 mutation AML was up to 24 months, which brought AML patients a treatment option
to break through the current dilemma.
➤Based on the good results of ivovinnib tablets, clinical considerations should be given to key questions
such as ivovinnib tablets combined with small molecule targeted drugs or immunotherapy drugs, whether they can be used for maintenance therapy after AML transplantation, whether they can be used for other myeloid tumors, and whether they are effective for solid tumors.
There are already a number of relevant clinical studies underway, and we look forward to future results to provide answers
.
Master Dialogue
Professor Hong Zhenya of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Professor Liang Yun of the Second Affiliated Hospital of Zhejiang University School of Medicine, Professor Xie Wanzhuo of the First Affiliated Hospital of Zhejiang University School of Medicine and Professor Zhang Jin of Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine conducted heated discussions on the above topics, believing that in clinical practice, when ivorannib tablets are used to treat AML, patient management has obvious advantages and outstanding safety compared with other targeted drugs, but domestic clinical experience is still insufficient.
Further exploration
is needed.
Toshuvo's ® R&D path and cornerstone R&D pipeline
Dr.
Liu Tieqin gave a wonderful speech
Dr.
Liu Tieqin, Business Assistant to CStone CEO and Head of Clinical Strategy and Planning
, briefly introduced CStone's ivoranib tablets and R&D pipeline.
Dr.
Liu Tieqin said CStone's product pipeline is driven by immuno-oncology therapy and targeted therapy, and there are currently as many as 15 innovative products under development, of which 4 have been successfully launched
.
In the future, CStone will take innovation as its own responsibility, take patient needs as the guide, and continue to contribute innovative drugs to the clinic to benefit more Chinese patients
.
Mechanics in practice
IDH1 mutation AML case sharing
Professor Zheng Zhengjin gave a wonderful sharing
Professor Yu Kang, the First Affiliated Hospital of Wenzhou Medical University, Professor Zheng Zhengjin of the Union Hospital of Fujian Medical University, shared the diagnosis and treatment process and thoughts
of a patient with IDH1 mutation AML.
The main points are as follows:
➤Patient diagnosis and treatment process: IDH1 and DNMT3A mutations were detected at the first visit, and IDH1 and DNMT31 mutations AML were diagnosed; CR was not reached at the initial induction of the 3+7 regimen, and CR was not achieved after reinduction therapy; Consolidation therapy phase with cytarabine based therapy; After the patient had an early relapse, it was recommended that the patient join the Chinese clinical trial of ivovinib tablets, give the patient with monotherapy oral therapy with ivovinib tablets, and complete remission after 2 courses, and the patient received 4 courses of ivoranib treatment, and underwent bone marrow transplantation in the outer hospital; So far, the patient has remained negative
for CR and MRD.
➤ IDH1 mutations may be an early event of AML occurrence that may not be completely cleared by chemotherapy, and ivoranib tablets can target leukemia stem cells, resulting in deep and lasting remission
.
Master Dialogue
Professor Huang Gofang of the First Affiliated Hospital of Gannan Medical College, Professor Jiang Jinhong of Lishui People's Hospital, Professor Wu Yong of Union Hospital Affiliated to Fujian Medical University, Professor Lu Ying of the Affiliated People's Hospital of Ningbo University and Professor Zeng Hui of Jiaxing First Hospital conducted heated discussions on the above cases, believing that the significance of ivorannib tablets to Chinese AML patients is self-evident, but in the process of medication, problems related to transplantation and maintenance treatment still need to be actively explored by clinicians
。
Summary of the conference
After wonderful sharing and heated discussion, the conference ended successfully
.
At the end of the meeting, the chairman of the conference believed that the participating experts shared and discussed in detail the development process, diagnosis and treatment mode, future trend and other topics of IDH1 mutation AML diagnosis and treatment from different angles and levels, providing an academic feast
for the field of hematological cancer.
We look forward to actively accumulating clinical experience in innovative drugs in the future, and exploring ways to improve the accessibility of innovative drugs to benefit more AML patients
.