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Radimoxilumab, an innovative biologic ® drug developed by Eli Lilly and commercialized in China, was approved in China in March 2022 for the second-line treatment of advanced gastric cancer, and in September for the treatment
of patients with alpha-fetoprotein (AFP) ≥ 400 ng/mL in patients with hepatocellular carcinoma (HCC) who had previously received sorafenib treatment.
On November 13th, the national listing meeting of Hiran Choice ® (ramoximumab) gastric cancer and hepatocellular carcinoma indications was successfully held
online.
This conference specially invited well-known experts and scholars in the fields of gastric cancer and liver cancer from China and Japan to meet online to discuss the dynamics and cutting-edge progress of the field, bringing a wonderful academic feast
to the medical professionals in the field of oncology.
The presidium, composed of more than 60 experts from all over the country, wished remoximab a successful listing in China, and more than 100 experts in the field gathered
in the cloud.
Journey through the vicissitudes, sail away
A message from the big coffee, I wish the national launch of ramoximab a complete success
Co-chaired by Professor Zhou Jian of Zhongshan Hospital Affiliated to Fudan University and Professor Zhang Xiaotian of Peking University Cancer Hospital, Academician Chen Xiaoping of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Academician Fan Jia of Zhongshan Hospital Affiliated to Fudan University, Professor Qin Shukui of Nanjing Jinling Hospital, Professor Shen Lin of Peking University Cancer Hospital, and Professor Xu Ruihua of Sun Yat-sen University Cancer Hospital delivered speeches respectively, congratulating remoximumab on the approval of gastric cancer and hepatocellular carcinoma indications
.
Academician Chen Xiaoping said: "We found in the REACH-2 study that ramoximab monotherapy in the treatment of advanced hepatocellular carcinoma has achieved good results, which brings hope
for the long-term survival of such patients.
It will provide clinicians with one more option for formulating treatment plans, and it is hoped that it will play an important role
in bringing long-term survival to patients with intermediate and advanced liver cancer.
”
Academician Fan Jia said: "Targeted drugs and immunotherapy have entered the first-line and second-line treatment applications, and new targeted drugs have become a new choice, ramoximab, as one of them, provides a new choice
for patients with advanced liver cancer with excellent efficacy and good safety.
" ”
Professor Qin Shukui said, "This time, our national pharmaceutical company Innovent Biopharmaceutical Co.
, Ltd.
and Eli Lilly have successfully launched ramoximumab, which has been included in the CSCO guidelines for gastric and liver cancer in China, providing a new choice
for Chinese clinicians.
”
Professor Shen Lin said: "Ramoximab is currently the only approved second-line anti-angiogenic drug for gastric cancer in China and China, and the RAINBOW and RAINBOW-Asia studies jointly prove the efficacy and safety of ramoximab combined with paclitaxel in the treatment of gastric cancer patients in China and around the world, and have also become the standard for
the second-line treatment of advanced gastric cancer in China.
" ”
Professor Xu Ruihua said: "As one of the PIs of RAINBOW-Asia, I believe that the success of this study has achieved the first breakthrough in the second-line treatment of advanced gastric cancer, which will enable the application
of ramoximab combined with paclitaxel in China.
OS and PFS have dual benefits and good safety, which is of great significance for the survival of advanced gastric cancer patients in China! ”
Experts attending the meeting jointly launched the national launch ceremony of ramoximab to witness the highlight of
the listing of remoximab gastric cancer and hepatocellular carcinoma indications in China.
Canglan journey, sail away, stomach has come, liver sky!
▲ Group photo of the conference (some experts)
Dr.
Dechao Yu, Founder, Chairman and CEO of Innovent delivered a speech at the conference, and Dr.
Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics
, introduced Innovent Biologics' product pipeline in detail.
Choose your dream and sail, and "stomach" to accompany you
Current status and progress in the treatment of advanced gastric cancer
Professor Wang Fenghua of the Cancer Hospital of Sun Yat-sen University introduced the current status and progress
of advanced gastric cancer drug treatment.
Advances in second-line drug therapy have focused on targeted therapies, including antivascular therapy and anti-HER2 therapy
.
In antivascular therapy, based on RAINBOW and its bridging trial RAINBOW-Asia study, remoximab combined with paclitaxel significantly improved median PFS and OS, and PFS benefited more significantly in the Chinese group, which has become a new standard
for the second-line treatment of gastric cancer in China.
With the rise of targeted drugs, immunotherapies and the discovery of more targets, the combination therapy strategy of various drugs will surely bring survival benefits
to more patients in the whole process of gastric cancer management.
Professor Peng Zhi from Peking University Cancer Hospital deeply interpreted the exploration
of ramoximab in the second-line treatment of advanced gastric cancer.
The excellent efficacy of the REGARD, RAINBOW and RAINBOW-Asia studies has established the standard position
of ramoximab combined with paclitaxel in the second-line treatment of advanced gastric cancer.
Moreover, more exploration of the second-line treatment of ramoximumab has also achieved promising results
.
Professor Taroh Satoh of Osaka University Hospital shared the current status and real-world experience
of antiangiogenic drugs for advanced gastric cancer.
The success of ToGA research kicked off the prelude to targeted therapy for gastric cancer, followed by a series of exploratory studies on multiple targets, but with mixed
results.
Ramoximab acts on VEGFR-2, and its phase III studies REGARD and RAINBOW have achieved positive results, adding new treatment options
for the second-line treatment of advanced gastric cancer.
According to the 6th edition of the Japanese Guidelines for the Treatment of Gastric Cancer, MSI testing is performed before second-line therapy, and patients with MSI-H are recommended pembrolizumab or paclitaxel plus ramoximumab; Paclitaxel plus ramoximumab is recommended in patients with non-MSI-H, so the combination regimen of ramoximab is routinely used in Japan
.
A real-world study in Japan showed that ramoximab combined with paclitaxel after first-line chemotherapy failure can significantly improve survival prognosis, and proper judgment of disease progression is important for subsequent multi-line therapy, and CT influence, clinical symptoms, tumor markers and prognostic factors are also important factors
affecting decision-making.
China-Japan dialogue, collision of ideas
Under the chairmanship of Professor Wang Feng of Sun Yat-sen University Cancer Prevention and Control Center, Professor Taroh Satoh, Professor Chen Kai of the Affiliated Hospital of Soochow University, Professor Ji Youxin of Qingdao Central (Cancer) Hospital, Professor Lin Xiaoyan of Union Hospital Affiliated to Fujian Medical University, Professor Wang Feng of the First Affiliated Hospital of Zhengzhou University, Professor Wang Yusheng of Shanxi Provincial Cancer Hospital, Professor Xiong Jianping of the First Affiliated Hospital of Nanchang University, Professor Zeng Shan of Xiangya Hospital of Central South University, and Professor Zhang Jun of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine participated in the "China-Japan Dialogue" session.
The following views are formed:
Patients who are HER2-positive, HER2-negative, and have not previously used antiangiogenic drugs can benefit to some extent from ramoximumab plus paclitaxel second-line therapy
.There is great heterogeneity of gastric cancer in Eastern and Western populations, and the site of occurrence, biological behavior, etiology, and treatment choice will affect the prognosis
of patients.
In general, Japanese doctors have improved the treatment plan during the treatment process to make it more in line with the characteristics of Japanese patients, and pay more attention to the long-term survival benefits of patients, ensuring the efficacy and paying attention to the quality of life of
patients.
This also suggests that the implementation of refined management in the treatment of gastric cancer, and the efficacy evaluation focuses on the net benefit rather than tumor enlargement and decrease, which is conducive to optimizing the ultimate benefit
of patients.Antiangiogenic therapy plays an important role
in the treatment of advanced gastric cancer.
How to consider the positioning of antiangiogenic therapy, how to choose drugs, and whether there are opportunities for cross-line therapy, the most important thing is to pay attention to the weight
of the vascular microenvironment in the dynamic process of advanced gastric cancer.
Anti-angiogenic therapy lacks specific biomarker, and based on the response status (depth of response, survival benefit) of tumor manifestations in the second line of ramoximab therapy, it indirectly determines whether the tumor is angiogenesis-dependent, thereby determining the third-line treatment strategy
.
The "Hope to Build a Stomach" advanced gastric cancer case project was launched
Under the chairmanship of Professor Tang Yong of Xinjiang Cancer Hospital, all guests witnessed the launching ceremony
of the "Hope to Build a Stomach" advanced gastric cancer case project.
Choose the time to go far, and the "liver" expands new fields
Under the chairmanship of Professor Song Tianqiang of Tianjin Medical University Cancer Hospital, Professor Gong Xinlei of Qinhuai Medical District of Nanjing Jinling Hospital deeply interpreted the research data
of ramoximab in advanced HCC.
Clinical practice has found that HCC patients with AFP > 400 ng/mL survive worse, and the proportion of AFP ≥ 400 ng/mL in patients receiving second-line therapy is as high as half
.
Precise treatment of patients according to AFP level has become the exploration direction
of HCC.
Subgroup analysis of the REACH study was the first to find that for HCC patients with AFP≥400 ng/mL, the median OS of remoximab second-line therapy was 7.
8 months, which is worth further exploration
.
Subsequently, REACH-2 and REACH-2 China further confirmed this conclusion
.
Ramoximab has opened a new chapter in the second-line precision treatment of AFP ≥ 400ng/mL HCC in China, and has been unanimously recommended
by authoritative guidelines at home and abroad.
The REACH-2 extended cohort study published in 2022 showed that HCC patients with elevated AFP who had previously received fisorafenib first-line treatment could also benefit
from remoximab in the second line.
Professor Masatoshi Kudo of Kindai University School of Medicine introduced the development trend
of advanced liver cancer treatment in Japan.
Ramoximab was approved in Japan in June 2019 and has become one of the second-line conventional drugs for liver cancer, and HCC targeted therapy has entered the era of
multiple multi-target therapy.
Preclinical studies have shown that elevated AFP levels are a strong predictor and prognostic factor
for poor prognosis.
The subgroup of the REACH study, the REACH-2 study and its pooled data confirmed that the second-line treatment of ramoximab with AFP > 400 ng/mL (rapidly progressing, aggressive disease population) has a significant survival benefit and quality of life
.
It is worth mentioning that with age, the benefits of remoximab therapy are similar, therefore, the same dose intensity
is maintained when treating with remoximamab in elderly patients.
How to preserve liver function reserves is the key
to future HCC treatment.
Early introduction of targeted drug combinations before repeated TACE ineffectiveness leads to weakening of liver function can help achieve longer survival
.
Under the chairmanship of Professor Sun Huichuan of Zhongshan Hospital affiliated to Fudan University, Professor Masatoshi Kudo, Professor Liang Jing of the First Affiliated Hospital of Shandong First Medical University, Professor Meng Zhiqiang of Fudan University Cancer Hospital, Professor Peng Tao of the First Affiliated Hospital of Guangxi Medical University, Professor Wang Jufeng of Henan Cancer Hospital, Professor Xia Feng of Southwest Hospital Affiliated to Army Medical University, and Professor Zhu Kangshun of the Second Affiliated Hospital of Guangzhou Medical University participated in the "China-Japan Dialogue" session and formed the following views:
Japanese real-world studies have shown that maintaining the same dose intensity with remoximab in elderly patients has a clear survival benefit and a good
safety profile.
In terms of second-line treatment options, ramoximab may be one of
the dominant populations.
The median age of Chinese HCC patients is younger than that of Japanese patients, but the performance status of patients is worse, and there are also differences
in etiology between the two countries.
These differences also need to be fully considered when referring to the Japanese treatment experience
.In recent years, great progress has been made in the diagnosis and treatment of liver cancer, but few dominant groups can be screened, and the previous treatment has been mainly
pan-population.
As a predictor of efficacy, AFP can help further promote the diagnosis and treatment of
liver cancer.At present, the second-line treatment options are unprecedentedly rich, and it is necessary to screen the beneficiaries of small molecule TKI and large monoclonal antibody in more detail, so as to provide more accurate second-line treatment
for HCC patients.
Under the chairmanship of Professor Cao Dan of West China Hospital of Sichuan University, all guests participated in the launching ceremony
of the "Hope for Love" free clinic project for liver cancer patients.
Summary and outlook
Ramoximab combined with paclitaxel second-line treatment of advanced gastric cancer has achieved positive results, and Chinese patients are well tolerated, it can be said that the efficacy and safety of ramoximab has been in the leading position in the current second-line treatment drugs for gastric cancer, and will surely bring tangible benefits
to Chinese patients with advanced gastric cancer.
The approval of remoximab as monotherapy for the treatment of AFP≥ 400ng/ML in second-line patients with advanced liver cancer will also bring new treatment options to clinicians, and it is expected that more patients will benefit
from remoximab treatment in the future.
About ramoximab
Ramoximumab is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2, which can effectively block the binding of VEGF-A to VEGFR-2 and can also inhibit the binding
of VEGF-C and VEGF-D to VEGFR-2.
Studies have shown that the anti-vascular endothelial growth factor (VEGF) pathway is an important signaling pathway
involved in tumor angiogenesis.
In March 2022, remoximab was approved in China in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma during or after fluorouracil or platinum-based chemotherapy, becoming the first and only targeted drug
approved for the second-line treatment of advanced gastric cancer in China.
In September 2022, ramoximab was approved in China for the treatment
of patients with alpha-fetoprotein (AFP) ≥ 400 ng/mL of hepatocellular carcinoma (HCC) who had previously received sorafenib.
Reviewer: Wanderer
Typesetting: Wanderer
Execution: Traveler
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