Focusing on Exploration, Exploration and Innovation China's Innovation, New Options for Anti-HER2 Treatment - The 2022 CSCO Annual Meeting Septin ® Satellite Meeting was successfully held

On November 5, 2022, the academic event of the 25th CSCO Annual Conference kicked off as
scheduled.
3SBio actively participated in this academic annual meeting, and held the "Concentrate on Exploration, Exploration and Innovation" Cyputin ^® (Enitumab for Injection) Satellite Meeting online!

Professor Jiang Zefei of the PLA General Hospital, Professor Wang Shusen of the Affiliated Cancer Hospital of Sun Yat-sen University, and Professor Liu Jian of Fujian Cancer Hospital served as the chairmen and delivered speeches
.

First of all, Professor Jiang Zefei opened his speech to thank the participating experts and congratulate the 2022 CSCO Annual Conference Academic Week! Thanks to the invitation of YOFOTO, this conference will share the clinical research results related to the domestic self-developed drug initumab for injection and the experience of real-world medication, so that more experts can understand the contribution of domestic drugs in the field of anti-HER2 treatment!

Professor Wang Shusen said that with the development of science and technology, Chinese biopharmaceutical companies have made great progress! The continuous listing of domestically produced drugs has broken the long-term monopoly history of foreign companies and is quietly changing the pattern of tumor treatment! This conference will focus on the diagnosis and treatment pattern of advanced HER2-positive breast cancer and the research progress of inertumab for injection, hoping that everyone can get a better academic experience in mutual exchanges and have a deeper understanding of enitumab for injection! Finally, I wish this meeting a complete success!

Professor Liu Jian said that HER2-positive breast cancer was once a subtype with a poor prognosis in breast cancer, and the marketing of trastuzumab significantly prolonged the survival of
patients.
In recent years, the prognosis of patients with HER2-positive breast cancer has been improving
with the continuous introduction of anti-HER2 drugs.
Enitumab for injection is one of the excellent products
.
This conference will share the clinical practice of the product and the medication experience of experts, I hope you can gain something!

Chapter 1 Concentrate on Exploration, Exploration and Innovation

Moderator: Professor Wang Shusen

Professor Chen Wenyan of Nanchang Third Hospital shared the "New Pattern of HER2-Positive Advanced Breast Cancer Treatment"
.
Professor Chen said that 25% of breast cancers have HER2 overexpression, and HER2+ breast cancer is highly aggressive and has a poor
prognosis.
Anti-HER2 therapy significantly reduced the risk of recurrence and significantly prolonged the survival of
HER2+ breast cancer.
From the recommendation of authoritative guidelines at home and abroad, macromolecular monoclonal antibody H drugs are the cornerstone of anti-HER2 therapy, and THP regimen is the standard treatment for
advanced HER2-positive breast cancer.
CLEOPATRA RESEARCH HAS ESTABLISHED TROPATA AS THE FIRST CHOICE FOR ADVANCED FIRST-LINE
TREATMENT OF HER2+MBC.
China's independent research and development of macromolecular monoclonal antibody for injection initumab has the same mechanism
of action as trastuzumab.
The results of the HOPES study showed that enitumab is as effective as trastuzumab in the treatment of advanced HER2+ breast cancer, and can be used as a new option
for anti-HER2 therapy.
The first-line subgroup data of the HOPES study for postoperative recurrent metastasis were comparable
to the efficacy and safety data of the trastuzumab first-line study in the treatment of HER2-positive metastatic breast cancer.
Pyrotinib in combination with capecitabine is the preferred second-line regimen after failure of trastuzum and purple shirt
.
With the deepening of exploration, HER2-ADC drugs have become one of the mainstream of
international research.
The EMILIA study established T-DM1 as
a second-line treatment for HER2-positive advanced breast cancer.
DESTINY-Breast03 rewrites the pattern
of second-line treatment for HER2-positive advanced breast cancer.
From the perspective of clinical practice and guideline recommendations, after the failure of H and purple shirt treatment, continuing to use H to replace other chemotherapy drugs is also an option
for the second and later lines.
Late-line treatment is difficult, and it is necessary to consider the previous treatment situation, drug availability and patient wishes; Participation in clinical studies is also a consideration
for late-line options.

Professor Ouyang Zhichang of Hunan Cancer Hospital shared the "Interpretation and Future Development Exploration of Cyputin ^®HOPES
".
Targeting HER2 trastuzumab pioneered HER2+ MBC treatment and changed the disease development process
of HER2-positive MBC patients.
Anti-HER2 drugs continue to come out, changing the treatment pattern of HER2-positive breast cancer, including many excellent drugs
such as China's independent innovation of macromolecular monoclonal antibody enitumab.
Enitumab and trastuzumab are both macromolecular monoclonal antibodies in the HER2 extracellular IV.
domain, the Fab segment has the same structure as trastuzumab, and the Fc segment has two amino acid sites modified, which is consistent with trastuzumab in key quality attributes, coupled with the optimization of the process, so that the risk of immunogenicity is reduced
。 The results of the first-line subgroup analysis of the advanced stage of the HOPES study showed that the median PFS of the primary endpoint was significantly extended in the primary endpoint of 11.
1 months in the experimental group and 3.
3 months in the control group (P<0.
0001) in the first-line subgroup after postoperative relapse and metastasis (ORR was 61.
5% versus 29.
7%, an increase of 31.
8%; The DCR was 93.
8% compared to 59.
4%, an increase of 34.
4%, and the P value was <0.
05).
<b24> Enitumab has become recommended by many authoritative guidelines in China, and the 2022 CSCO guidelines recommend that it can be used as a first-line choice for H treatment of sensitive advanced HER2-positive breast cancer patients
.

Professor Ouyang also shared the results of a real-world study of patients with HER2-positive metastatic breast cancer treated in Hunan Cancer Hospital from June 2020 to November 2021: 75 patients were enrolled, 65 were included in the analysis, and the median number of treatment lines was four lines, and patients received enitumab treatment regimens including: enitumab + endocrine therapy, enitumab + pertuzumab + chemotherapy, initumab + TKI+ chemotherapy, enitumab + chemotherapy, etc
。 The overall results showed that the median PFS of the combination regimen with initol was 6.
1 months, with an objective response rate of 21.
7% and a clinical benefit rate of 81.
2%.

All combination regimens have achieved good efficacy, and adverse reactions are controllable and have good
safety.

Professor Wang Shusen briefly summarized the first chapter: Professor Chen Wenyan started from the treatment strategy of advanced HER2-positive breast cancer, from the arrangement of first-line, second-line and posterior drugs and the latest research trends of clinical drugs, macromolecular monoclonal antibody H drugs are the cornerstone of anti-HER2 treatment, while small molecule TKI and the latest ADC drugs are also leading the way, which is worth looking forward to! Professor Ouyang Zhichang focused on the relevant research of China's innovative initumab, and preliminarily explored the efficacy and safety of its combination of different drugs in the treatment of advanced HER2-positive breast cancer from real-world research, further verifying the excellent clinical treatment value of enitumab! The pattern of anti-HER2 treatment in China is changing, and we expect that China's intelligent drugs will continue to benefit Chinese patients with better efficacy, better drug accessibility and economy in the future!

Chapter 2: A Gathering of Heroes Each expresses his own opinion

Moderator: Professor Liu Jian

Professor Jiang Hanfang from Peking University Cancer Hospital, Professor Ma Li from the Fourth Hospital of Hebei Medical University, and Professor Nong Qiaohong, Peking University Shenzhen Hospital were invited as panelists
.
The three experts exchanged and shared
their experiences on the emergence of anti-HER2 drugs, how to manage the whole process of HER2-positive MBC patients, and the treatment experience of enitumab in the first, second and later lines of advanced HER2-positive breast cancer.

Professor Jiang Hanfang said that HER2-positive breast cancer is currently the most active field in breast cancer treatment, and the whole course of anti-HER2 therapy is the consensus
of experts.
In recent years, anti-HER2 drugs have emerged in an endless stream, and there are many choices for clinical treatment, so it is particularly important to do a good job in the arrangement of anti-HER2 treatment, which needs to be considered
from the aspects of drug efficacy, safety and economy.
THP regimen is the first-line standard treatment recommended by domestic and foreign guidelines, and class H drugs include trastuzumab, trastuzumab analogues, and Fc segment modified enitumab, which has a stronger
ADCC effect.
Since the drug was clinically studied relatively early, there was no head-to-head study with trastuzumab at that time, so it is necessary to continue to accumulate data
in clinical practice.
At present, the second-line treatment is mainly pirotinib as the representative of TKI drugs, and more will be selected
.
The listing of ADC drugs has added second-line treatment options, especially the results of the DS-8201 clinical study in China, which has not yet been marketed in China, but there may be drug accessibility issues
because it may not be included in medical insurance immediately after marketing.
DS-8201 At present, from the evidence-based evidence, it can only be selected for second-line treatment, and there is no relevant evidence-based evidence for
first-line treatment.

Professor Ma Li said that continuous anti-HER2 therapy is needed for HER2-positive breast cancer patients, and the standard first-line regimen is still THP regimen
.
Data sharing at the latest ESMO conference on pyrotinib may add an additional regimen option
to first-line therapy.
International guidelines recommend ADC as a second-line preferred, with DS-8201 and TDM-1 as recommendations
.
In domestic guidelines, TKI drugs such as pyrotinib are the second-line anti-HER2 treatment of choice
.
After the second line, there is no evidence of superiority of one regimen over which regimen is initiated after the third line of therapy, and the basic principle is to give the patient a different combination regimen of other anti-HER2 therapy
.
For hormone receptor-positive/HER2-positive patients, the basic idea is to choose a standard first-line regimen THP regimen, and if the patient is endocrine sensitive and does not tolerate chemotherapy, it can also be considered with or without anti-HER2 therapy
in addition to endocrine therapy.
With the current marketing and accumulation of clinical practice of enitumab, relevant real-world studies are also being carried out and some phased results
have been achieved.
It is also clearly mentioned in the guidelines that H includes enitumab, and H-sensitive patients can be considered in actual clinical practice, providing a new option
for clinical use.
Because of the amino acid modification of enitumab, enitumab may also be considered for patients who have progressed in trastuzumab therapy
.

Professor Nong Qiaohong also said that HER2-positive anti-HER2 treatment for advanced breast cancer is throughout
.
Current drugs include large monoclonal antibodies, small molecule TKIs, and ADCs
.
At present, the evidence-based evidence for macromolecular monoclonal antibodies is the fullest, and it is also the current first-line standard treatment regimen
.
The second line is dominated
by small molecule TKI and ADC drugs.
There is no standard treatment regimen in the third and subsequent lines, and different combination regimens of anti-HER2 therapy are generally considered depending on the mechanism of action of the drug
.
Generally, if it is a drug used before, it will be considered to replace it with another drug
in the later line treatment.
In the current stage of clinical practice, the clinical application of enitumab will also choose the combination treatment regimen according to the patient's previous anti-HER2 treatment drug selection, and will be selected and used according to the actual situation in the first-line treatment, the second-line treatment after trastuzumab resistance, or the third-line and posterior treatment after the second-line treatment failure of TKI, and good treatment results
have also been achieved.
Therefore, enitumab may be an option for patients not treated with anti-HER2, and enitumab remains an appropriate option
for trastuzumab-resistant patients.

Professor Liu Jian expressed his gratitude to the three experts for their sharing, and the experts' views and clinical drug use feelings will have a valuable impact on real clinical practice, and also give more experts a new understanding
of the clinical efficacy of enitumab.

Finally, Professor Wang Shusen, Professor Liu Jian and Professor Jiang Zefei summarized the conference
.
The conference was rich in content, focusing on the treatment strategy of HER2-positive advanced breast cancer and the research progress of domestic drug enitumab.
Experts expressed their views and views on the arrangement of drugs for advanced HER2-positive breast cancer, and also provided good guidance and suggestions for the clinical application of enitumab, looking forward to more research data to guide clinical practice in the future!