The world's first CTLA-4 inhibitor Yiwo was launched in China, and the patient assistance project was launched simultaneously

On October 12, Bristol-Myers Squibb announced that the world's first CTLA-4 inhibitor Yiwo® (ipilimumab injection) has been officially launched in China
.

As the first and currently the only CTLA-4 inhibitor approved in China, Yiwo will be combined with the PD-1 inhibitor Odivo® (nivolumab injection) for non-resectable, initial Treated adult patients with non-epithelial malignant pleural mesothelioma
.

This is the first and currently only approved dual immunotherapy in China, marking the official opening of the era of dual immunotherapy in China
.

In order to improve the availability of medicines for patients, the China Cancer Foundation simultaneously launched a patient assistance project to provide medical assistance to eligible patients and reduce the economic burden of patients' treatment
.

Professor Lu Shun, Director of the Oncology Department of the Thoracic Hospital Affiliated to Shanghai Jiaotong University, said: “Malignant pleural mesothelioma is a highly aggressive and rare cancer with limited treatment options and a 5-year survival rate of less than 10%1
.

Odivo United Yiwo is the first systemic therapy approved in this field in more than ten years.
The approval of dual immunotherapy has changed the treatment model of malignant pleural mesothelioma, which is expected to bring long-lasting survival benefits to patients and become the new standard treatment
.

"to break the deadlock 15 years without new drugs, double immunotherapy for patients to bring lasting survival benefit malignant pleural mesothelioma is a rare and highly aggressive and lethal cancer originating in the pleural mesothelial's
.

There are approximately 3,000 confirmed cases in China each year, accounting for one third of the new cases in Asia
.

Its incidence is highly correlated with asbestos exposure.
As a large country in the production and use of asbestos, the incidence of malignant pleural mesothelioma in China is increasing
.

Due to the difficulty of diagnosis, most patients are already at an advanced stage at the time of diagnosis
.

The prognosis of malignant pleural mesothelioma is generally poor.
The median survival of patients with untreated advanced or metastatic malignant pleural mesothelioma is between 12 and 14 months, and the five-year survival rate is about 10%
.

The lack of effective treatment is the main reason for the low survival rate of patients with malignant pleural mesothelioma
.

In the past 15 years, no new systemic treatment plan that can effectively prolong the survival of patients has been approved globally
.

In June 2021, Odiwo and Yiwo were approved by the National Medical Products Administration of China for the first-line treatment of malignant pleural mesothelioma, providing new treatment options for patients with this type of disease
.

As the only phase III clinical study that proves that first-line immunotherapy can improve the survival benefit of patients with unresectable malignant pleural mesothelioma, CheckMate-743 provides reliable evidence-based medical evidence for the approval of malignant pleural mesothelioma
.

The three-year follow-up results showed that compared with platinum-containing standard chemotherapy, Odivo combined with Yiwo for the first-line treatment of unresectable malignant pleural mesothelioma (MPM) can bring long-lasting survival for patients regardless of histological type.
Benefit
.

"Compared with chemotherapy, dual immunotherapy further reduces the patient's risk of death by 27%.
Nearly a quarter of patients survive for more than 3 years after receiving dual immunotherapy
.

This means that once patients benefit from dual immunotherapy , The duration will be very long, which has been confirmed in multiple tumor types including non-small cell lung cancer, demonstrating the long-lasting effect of dual-immune therapy for patients
.

"CheckMate-743 China Lead Researcher Professor Lu Shun said
.

Unlike chemotherapy, tumor immunotherapy fights tumors by activating the body's own immune system
.

Odivo combined with Yiwo is a unique combination of two immune checkpoint inhibitors, which target two different checkpoints (PD-1 and CTLA-4) to help kill tumor cells.
The two have a potential synergistic mechanism.
: Yiwo can promote the activation and proliferation of T cells, while Odivo helps existing T cells recognize tumor cells
.

Some T cells activated by Yiwo can also differentiate into memory T cells, so as to keep fighting in mind and maintain long-term combat strength
.

The early research based on the development of Odiwo and Yiwo has been awarded the Nobel Prize
.

Odiwo and Yiwo are also the only immune checkpoint inhibitors directly involved in the development of Nobel Prize winners in Physiology or Medicine in the world
.

Different from traditional treatment, immunotherapy may cause inflammatory symptoms in corresponding organs, called immune-related adverse reactions (irAE), with skin and gastrointestinal symptoms being the most common
.

In many years of cross-tumor clinical practice, the safety of Odivo and Yiwo has been fully understood and managed, and an effective treatment method for adverse reactions has been established
.

Professor Wu Yilong, Life Director of Guangdong Provincial People’s Hospital and Honorary Director of Guangdong Lung Cancer Institute (GLCI), said: “Through established adverse event management plans, Odivo and Yiwo first-line treatment of malignant pleural mesothelioma are safe and controllable.
The sexual characteristics are consistent with the safety of the combination therapy in other tumor studies before
.

Compared with chemotherapy, patients have the opportunity to achieve long-term survival with a higher quality of life and fewer side effects
.

With the advent of the era of dual immunotherapy, We are expected to finally achieve the goal of'de- chemotherapy'
.

"In the latest "Chinese Society of Clinical Oncology (CSCO) Immune Checkpoint Inhibitors Clinical Application Guidelines (2021 Edition)", Odivo combined with Yiwo first-line treatment of non-epithelial Type and epithelioid pleural mesothelioma become the only treatment that has received grade I (type 1 evidence) and grade II recommendations (type 2A evidence)
.

Up to now, the dual immune combination therapy based on Odivo and Yiwo has shown overall survival (OS) benefits in 6 phase III clinical studies of five tumor types, including malignant pleural mesothelioma, non-small Cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, and esophageal squamous cell carcinoma
.

 The patient assistance project was launched simultaneously to improve the accessibility of innovative drugs.
In order to help more patients achieve high-quality long-term survival and improve the accessibility of innovative drugs, Bristol-Myers Squibb joined hands with the China Cancer Foundation in the original " New indications for malignant pleural mesothelioma were added on the basis of the Odivo Patient Assistance Project
.

Patients who meet the project criteria can voluntarily submit an application for assistance from Odiwo combined with Yiwo treatment
.

According to the approved indications for malignant pleural mesothelioma, the Odivo Drug Assistance Program will provide differentiated assistance programs based on the dosage and medication cycle of Odivo
.

For patients receiving the 3mg/kg, once every 2 weeks program, the “3+3, 3+X” program will be used when applying for Odivo’s drug assistance, that is, patients who meet the project standards will be reviewed and approved by the project office.
You can pay for up to 6 times in an application year, and you can get the remaining medicine assistance in that year (the assistance is up to 18 times)
.

For patients who receive 360mg, once every 3 weeks, the "2+2, 2+X" plan will be adopted, that is, patients who meet the project criteria will pay at most 4 times in an application year after being approved by the project office.
You can get the remaining medicine assistance in the year (up to 12 times of assistance)
.

Patients can apply according to the annual application cycle until 24 months or the disease progresses
.

The Yiwo drug assistance program will adopt the "1+3" program, that is, patients who meet the project standards will be approved by the project office and paid once by themselves, and they can get up to 3 free drug assistance
.

Patients can apply in cycles until 24 months or the disease progresses
.

The application process and project materials for the new indications of the project will be announced on the official website of the China Cancer Foundation (http:// and the WeChat public account "China Cancer Foundation Odivo Project"
.

Patients can also call the project hotline 400-669-0906 for consultation
.

Ms.
Chen Siyuan, President of Bristol-Myers Squibb China and Hong Kong, said: “As a pioneer in the field of immuno-oncology treatment, Bristol-Myers Squibb will separate the world’s first PD-1 inhibitor Odivo and the first CTLA-4 inhibitor Yiwo.
Bringing into China has accelerated the implementation of global innovative therapeutic drugs in China
.

The approval of dual immunotherapy for malignant pleural mesothelioma is the first indication approved by the company after launching the "China 2030 Strategy", which is a milestone.

In the
future, Bristol-Myers Squibb will continue to integrate into China’s booming innovation ecosystem, and is committed to becoming an innovation leader rooted in China and originating from China.
It will work with partners to continuously improve the availability of innovative drugs and change through scientific innovation.
Patient’s life
.

" About CheckMate-743 CheckMate-743 is an open-label, multicenter, randomized phase III clinical study designed to evaluate nivolumab combined with ipilimumab versus standard chemotherapy (pemetrexed combined with cisplatin).
Or carboplatin) for the treatment effect of malignant pleural mesothelioma (MPM) patients (n=605) who have not been treated before
.

The study excluded patients with interstitial lung disease, active autoimmune disease, clinical need for systemic immunosuppression, and active brain metastases
.

In this study, 303 patients were randomized to receive Odivo (3mg/kg, once every 2 weeks) combined with Yiwo (1mg/kg, once every 6 weeks) treatment, and continued treatment until disease progression or intolerable toxicity , The longest treatment time is 24 months
.

302 patients were randomized to receive cisplatin (75mg/m2) or carboplatin (AUC 5) combined with pemetrexed (500 mg/m2) every 3 weeks for 6 cycles, or disease progression or intolerability The toxicity
.

The primary endpoint of the trial is the overall survival (OS) of all randomized patients.
Other efficacy outcome indicators include progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), which are reviewed by a blinded independent center review committee (BICR) Evaluation is based on the modified RECIST standard
.

Exploratory endpoints include safety, pharmacokinetics, immunogenicity, and patient-reported treatment outcomes
.

 About Malignant Pleural Mesothelioma Mesothelioma is a rare and highly aggressive malignant tumor that originates in mesothelial cells.
About 3,000 cases are diagnosed in China every year2, with pleural mesothelioma being the main ones3
.

Its incidence is highly correlated with asbestos exposure4
.

Due to delays in diagnosis, most patients have progressed or metastasized at the time of diagnosis5
.

The prognosis of malignant pleural mesothelioma is generally poor.
The median survival of patients with untreated advanced or metastatic malignant pleural mesothelioma is between 12 and 14 months, and the five-year survival rate is about 10% 6
.

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