The results of the ORIENT-15 study were released, and the immunotherapy of esophageal cancer reached a new high!

*For medical professionals only, the ORIENT-15 study is a randomized, double-blind, international, multicenter, large-scale phase III trial comparing sintilimab combined with chemotherapy versus chemotherapy alone in first-line treatment of locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
The clinical study (hereinafter referred to as ORIENT-15), led by Professor Shen Lin from Peking University Cancer Hospital, involved 79 centers around the world
.

In this trial, researchers can choose different chemotherapy regimens (TP/CF) as the basic chemotherapy regimen according to the clinical practice in different regions
.

Compared with chemotherapy alone, sintilimab combined with chemotherapy for first-line treatment of patients with locally advanced, recurrent or metastatic esophageal squamous cell carcinoma significantly prolongs overall survival, improves progression-free survival, improves overall response rate, and has controllable safety
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Sintilimab combined with chemotherapy can become a new first-line standard treatment for advanced esophageal squamous cell carcinoma
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In September 2021, ORIENT-15, as the only representative in the field of esophageal cancer, was selected into 11 breakthrough clinical studies of ESMO changing practice in 2021
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In April this year, the full text of the ORIENT-15 research was published by the world-renowned medical journal "British Medical Journal", which means that the global research initiated by Chinese experts has reached the international first-class level! Screenshot of the article published On April 29, the "Press Conference on Major Scientific Research Achievements in Esophageal Cancer Immunotherapy" was held online
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A major victory in the field of medical research, Professor Shen Lin, as the chairman of the conference and the ORIENT-15 Research Leading PI, said in his speech: "China is a big country in digestive tract tumors, and it is also facing a series of high incidence and refractory digestive tract tumors.
The advent of the era
of
immunotherapy has brought revolutionary progress to gastrointestinal tumors
.

ORIENT-15 is an international multi-center clinical study of first-line immunotherapy for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma led by Chinese experts.
With its scientific and rigorous design, with the joint efforts of everyone, it has achieved the preset end point.
It has become one of the 11 breakthrough clinical studies of ESMO in 2021, and it is also the only research in the field of esophageal cancer that has been selected as a breakthrough clinical research result.
More importantly, it is also an international study on esophageal cancer clinical research by our Chinese researchers.
manifestation of recognition
.

Thank you to all the patients and their families who participated in the study, to all the Chinese and foreign researchers, to all colleagues in the Department of Gastrointestinal Oncology including Professor Zhihao Lu, to the research nurses and the CRC
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As a researcher and as a clinician, we have a mission and responsibility to forge ahead for the goals of the Healthy China 2030 Plan
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"Professor Shen Lin, Vice President of Peking University Cancer Hospital, in addition to Professor Shen Lin, also invited Professor Liang Jun, Vice President of Peking University International Hospital, Sun Yat-sen University Cancer Center, and the current director of Guangdong Esophageal Cancer Research Institute.
Prof.
Fu Jianhua and Prof.
Wang Luhua, Dean of Cancer Hospital Shenzhen Hospital, Chinese Academy of Medical Sciences delivered speeches at the press conference.
All the experts congratulated the ORIENT-15 Institute for its achievements.
Esophageal cancer immunotherapy expressed his views and expectations
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Professor Liang Jun said in his speech: "The arrival of the era of big data has given a new connotation to the transformation of clinical scientific research.
In the next three to five years, the precision treatment of digestive tract tumors will surely blossom and achieve continuous results.
'spring'
.

"Professor Fu Jianhua also said: "The exploration of immunotherapy in the field of esophageal cancer has completely changed the pattern of esophageal cancer treatment, from the second line to the first line, and is now moving towards the exploration of postoperative adjuvant therapy and preoperative neoadjuvant therapy, allowing We usher in a new spring
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"After 20 years of arduous and unremitting efforts, Chinese medical science has achieved its own outstanding research results in clinical research.
In the future, with the joint efforts of everyone, we will continue to achieve new victories.
Let the results of Chinese clinical research guide Chinese clinical practice.
Also guides global clinical practice
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"Professor Wang Luhua said in his speech
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Professor Liang Jun, Vice President of Peking University International Hospital, Professor Fu Jianhua, Director of Sun Yat-sen University Cancer Center and Director of Guangdong Esophageal Cancer Research Institute, Professor Wang Luhua, Director of Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences Provide patients with more possibilities.
Then, Professor Shen Lin reported the results of the ORIENT-15 study, in which she said: "The ORIENT-15 study is a comparison of sintilimab combined with chemotherapy and chemotherapy alone in the first-line treatment of locally advanced disease.
, a randomized, double-blind, international, multi-center, large-scale phase III clinical study of recurrent or metastatic esophageal squamous cell carcinoma, involving a total of 79 centers around the world
.

In this trial, researchers can choose different chemotherapy regimens (TP/CF) as the basic chemotherapy regimen according to the clinical practice in different regions
.

OS is the gold standard reflecting the survival benefit of advanced esophageal squamous cell carcinoma
.

ORIENT-15 fully met the pre-designed dual endpoints of the study, and the overall survival time of the whole population and patients with PD-L1 CPS ≥ 10 was significantly prolonged
.

Among all patients, the median OS of the sintilimab plus chemotherapy group was 16.
7 months, which was much better than the 12.
5 months of the double-drug chemotherapy group (HR=0.
63), and the risk of death was reduced by 37%
.

Among patients with PD-L1 CPS ≥10, the median OS was 17.
2 months vs 13.
6 months, respectively, and the risk of death was reduced by about 36%
.

Prespecified subgroup analysis showed that almost all patient subgroups benefited significantly regardless of PD-L1 expression level, and sintilimab combined with chemotherapy significantly prolonged patient survival regardless of PD-L1 expression level
.

Sintilimab in combination with chemotherapy also significantly prolonged PFS and reduced the risk of disease progression
.

The combination therapy of sintilimab and chemotherapy significantly improved PFS in the whole population (7.
2 vs.
5.
7 months, HR=0.
56) and reduced the risk of disease progression by 44%.
The objective response rate (ORR) was 66.
1%, an increase of 20.
6% compared with the ORR of the chemotherapy group of 45.
5%; the median duration of response (DoR) was 9.
7 months, which was 2.
8 months longer than the chemotherapy group
.

In the ORIENT-15 study, the overall safety of sintilimab combined with chemotherapy was manageable, and the incidence of treatment-related adverse events was comparable between the two groups
.

Health-related quality of life analysis showed that the sintilimab combined with chemotherapy group had better quality of life
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The study was presented in the form of an oral presentation at the ESMO Congress in September 2021, and was named the 2021 ESMO 11 breakthrough studies with the potential to change clinical practice
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The full text of the half-year study was accepted by the British Medical Journal (BMJ), and the research that fully reflected ORIENT-15 was recognized by global experts
.

In recent years, the gap between China's innovative research and international research has become smaller and smaller.
The research design level in esophageal squamous cell carcinoma has reached the international advanced level and is clearly at the forefront of the world
.

As a typical representative, the ORIENT-15 study is a study that we all work together and are proud of
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Experts Talking Together: Promoting Esophageal Cancer Research in China During the subsequent conference, Professor Lu Zhihao, Department of Gastrointestinal Oncology, Peking University Cancer Hospital, as the host of this session, communicated with many experts and professors
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Professor Lu Zhihao, Department of Digestive Oncology, Peking University Cancer Hospital, first asked Professor Shen Lin: "From the release of the oral report at the 2021 ESMO Conference, to being selected as the only study in China to be selected as the "2021 ESMO 11 Breakthrough Research that Changes Clinical Practice", Now it is published in the world's top medical journal BMJ, what kind of enlightenment and change do you think the ORIENT-15 research will bring to the clinical practice of esophageal cancer immunotherapy?" Professor Shen Lin replied: 1.
ORIENT-15 Research Journal Globally, it has a very significant impact on global clinical practice
.

I believe that after the national CDE approves the indication of sintilimab for first-line treatment of esophageal cancer, the ORIENT-15 regimen will surely become the standard of first-line treatment
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2.
It is expected that a drug such as sintilimab, which is effective, safe and controllable, can enter the medical insurance and benefit more patients
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3.
It took less than 2 years for PD-1 inhibitors represented by sintilimab to go from second-line treatment to first-line treatment of esophageal cancer
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I believe that in the near future, immunotherapy will definitely enter the perioperative period to further improve the survival of patients
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Later, when communicating with Professor Zhang Yanqiao, Vice President of the Cancer Hospital Affiliated to Harbin Medical University, he asked: "As an important PI, you have also participated in the ORIENT-15 study.
What do you think are the worthy highlights of the ORIENT-15 study in terms of research design? "Professor Zhang Yanqiao replied: 1.
The dual chemotherapy options are particularly good.
The researchers choose the TP/CF regimen independently, which is close to the real world and has a higher value in guiding clinical practice
.

2.
The dual endpoints of OS have significant benefits, and at the same time answer the question of whether PD-L1 expression levels should be detected before the use of PD-1 inhibitors
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3.
Paclitaxel is administered on days 1 and 8 of the first cycle to reduce the risk of esophageal fistula and reduce the risk of patients leaving the group
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Prof.
Zhang Yanqiao, Deputy Dean of the Cancer Hospital Affiliated to Harbin Medical University, Prof.
Lu continued to ask Prof.
Wang Feng, Director of the Oncology Department of the First Affiliated Hospital of Zhengzhou University, "You are from Henan, where the incidence of esophageal cancer is high, and you must have extensive experience in the treatment of esophageal cancer.
Clinical experience, as a researcher, what advantages do you think the ORIENT-15 study has over other PD-1 studies in the field of esophageal cancer?” Professor Wang Feng replied: “In these 5 large-scale phase III clinical studies, Sintilide single Anti-combination chemotherapy significantly prolongs OS, PFS, DOR, improves ORR, and has outstanding performance in first-line immune combination regimens
.

1.
Good OS results: ORIENT-15 showed that OS was prolonged by 4.
2 months (16.
7 vs 12.
5), and the data was very bright
.

Phase III studies with insufficient data maturity may require longer-term follow-up to determine the final survival benefit
.

2.
The OS benefit appeared early and the trend was obvious: the ORIENT-15 OS curve was separated early and maintained in the long-term follow-up.

3.
The benefit is not affected by the expression of PD-L1: The ORIENT-15 study found that the overall survival benefit brought by sintilimab
combined with chemotherapy was not affected by the expression level of PD-L1.
In the whole population, CPS≥10 And patients with CPS < 10 all benefited significantly
.

4.
Another excellent data in the ORIENT-15 study is its ORR.
In the whole population, the overall objective response rate (ORR) of sintilimab combined with chemotherapy group was compared.
The chemotherapy group improved by 21%, which is the largest ORR improvement in the first-line clinical study of immunocombination chemotherapy
.

The DoR of the combination therapy group was as long as 9.
7 months and the longest in previous studies
.

Professor Wang Feng, Director of the Oncology Department of the First Affiliated Hospital of Zhengzhou University Finally, Professor Lu asked Professor Wang Junye, Director of the Oncology Department of the Affiliated Hospital of Jining Medical College: "A lot of subjects have been enrolled in your clinical research center for the ORIENT-15 study.
The enrollment speed is fast and the enrollment rate is high.
During the whole research process, are there any impressive subjects?" Professor Wang Junye shared several typical patient cases, the first postoperative recurrence patient, TPS test <10% , the metastases gradually shrunk after the medication, and now he can watch opera and dance square dance normally; the second patient with lymph node metastasis after operation, TPS is also <10%, the patient achieved complete remission; the third subject is esophageal squamous cell carcinoma With lung metastasis, TPS examination is also less than 10%, the current state of using sintilimab is very good, and there is only a little residual metastasis
.

All experts jointly focused on a series of issues such as the enlightenment and change brought by the clinical practice of esophageal cancer immunotherapy, the highlights of ORIENT-15 study design, and the advantages of ORIENT-15 study compared with other PD-1 studies in the field of esophageal cancer.
In-depth discussion and sharing, so that all colleagues who participated in the meeting gained a lot
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Professor Wang Junye, director of the Oncology Department of the Affiliated Hospital of Jining Medical College, entered the media questioning session.
Many social media and medical media asked the participating experts to discuss in detail the progress of esophageal cancer diagnosis and treatment and the advantages of immunotherapy
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It is believed that with the convening of this conference, ORIENT-15, an excellent first-line treatment plan, will be brought to patients with advanced esophageal cancer more quickly, contributing to improving the quality of life of patients and bringing more hope for survival
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At the same time, it will also provide stronger support to achieve the goal of increasing the overall cancer 5-year survival rate by 15% in 2030 and help accelerate the implementation of the "Healthy China 2030" initiative
.