Bristol Myers Squibb Launches First-in-Class CTLA-4 Inhibitor Yervoy® in China with Concurrent Patient Assistance Program

SHANGHAI, Oct. 12, 2021 /PRNewswire/ -- Bristol-Myers Squibb today announced that Yervoy, the world's first CTLA-4 inhibitor,^®(Ipilimumab Injection) has officially been launched in China. As the first and currently only CTLA-4 inhibitor approved in China, Yervoy will be used in combination with the PD-1 inhibitor Opdivo^®(Nivolumab Injection) in combination with, for the treatment ofAdult patients with unresectable, treatment-naïve, non-epithelioid malignant pleural mesothelioma.This is the first and currently only approved dual immunotherapy in China, marking the official opening of the dual immunotherapy era in China. To improve patient access to medications, the China Cancer Foundation has simultaneously launched a patient assistance program to provide medication assistance to eligible patients, thereby alleviating the financial burden of treatment.

Professor Lu Shun, Director of the Department of Medical Oncology at Shanghai Chest Hospital, Shanghai Jiao Tong University, stated:“Malignant pleural mesothelioma is a rare and highly aggressive cancer with very limited treatment options and a 5-year survival rate of less than 10%.”^[1]。Opdivo in combination with Yervoy is the first systemic therapy approved in this field in over a decade. The approval of dual immunotherapy has transformed the treatment paradigm for malignant pleural mesothelioma, is expected to deliver durable survival benefits for patients, and will become the new standard of care.”

Break15-Year Stalemate Without New Drugs: Dual Immunotherapy Delivers Durable Survival Benefits to Patients

Malignant pleural mesothelioma is a rare, highly aggressive, and lethal malignancy originating from the pleural mesothelium. Approximately 3,000 cases are diagnosed annually in China, accounting for one-third of new cases in Asia. Its incidence is strongly associated with asbestos exposure; as a major producer and user of asbestos, China is experiencing an upward trend in the incidence of malignant pleural mesothelioma.

Due to diagnostic difficulties, most patients are already at an advanced stage at the time of diagnosis. The prognosis for malignant pleural mesothelioma is generally poor; the median survival for previously untreated patients with advanced or metastatic malignant pleural mesothelioma is between 12 and 14 months, with a five-year survival rate of approximately 10%.

The lack of effective treatment options is the primary reason for the low survival rate among patients with malignant pleural mesothelioma. Over the past 15 years, no new systemic therapy capable of effectively prolonging patient survival has been approved globally. In June 2021, OPDIVO in combination with YERVOY was approved by China’s National Medical Products Administration (NMPA) for the first-line treatment of malignant pleural mesothelioma, providing a new treatment option for patients with this disease.

As the only Phase III clinical trial to date demonstrating that first-line immunotherapy improves survival outcomes in patients with unresectable malignant pleural mesothelioma, CheckMate-743 provides robust evidence-based medical evidence supporting its approval. The three-year follow-up results indicate that, compared with standard platinum-based chemotherapy, regardless of histological subtype, first-line treatment with Opdivo in combination with Yervoy for unresectable malignant pleural mesothelioma (MPM) can provide patients withDurable survival benefit。

“Compared with chemotherapy, dual immunotherapy combination therapy further the patient'sReduced risk of death27%，NearOne-quarter of patients survived beyond 3 years following dual immunotherapy.。This means that once patients benefit from dual immunotherapy, the duration of clinical response will be prolonged, which has been confirmed across multiple tumor types, including non-small cell lung cancer, demonstrating the durable efficacy of dual immunotherapy combination therapy for patients.”Professor Shun Lu, Principal Investigator for China in the CheckMate-743 trial, stated.

Unlike chemotherapy, cancer immunotherapy combats tumors by activating the body's own immune system. The combination of Opdivo and Yervoy is a unique pairing of two immune checkpoint inhibitors that respectively target two distinct checkpoints (PD-1 and CTLA-4) to help eliminate tumor cells. The two agents feature a potential synergistic mechanism of action: Yervoy promotes the activation and proliferation of T cells, while Opdivo assists existing T cells in recognizing tumor cells. A portion of the T cells activated by Yervoy can also differentiate into memory T cells, thereby retaining immunological memory and sustaining long-term antitumor efficacy. The foundational research underlying the development of both Opdivo and Yervoy has been awarded the Nobel Prize. Opdivo and Yervoy are also the only immune checkpoint inhibitors globally whose development directly involved Nobel Laureates in Physiology or Medicine.

Unlike conventional therapies, immunotherapy may induce inflammatory symptoms in corresponding organs, known as immune-related adverse events (irAEs), with cutaneous and gastrointestinal manifestations being the most common. Through years of clinical practice across multiple tumor types, the safety profile of Opdivo in combination with Yervoy has been well-characterized and effectively managed, with established and proven strategies for adverse event management.

Lifetime Director, Guangdong Provincial People's Hospital, Guangdong Lung Cancer Institute (GLCI）Honorary Director Professor Wu Yilong stated:“With established adverse event management protocols, first-line treatment of malignant pleural mesothelioma with Opdivo in combination with Yervoy is safe and manageable, and its safety profile is consistent with that previously observed for this combination in other oncology studies. Compared with chemotherapy, patients have the opportunity to achieve long-term survival with improved quality of life and fewer side effects. With the advent of the dual immunotherapy era, we look forward to ultimately realizing the goal of a ‘chemotherapy-free’ approach.”

In the newly released 《Chinese Society of Clinical Oncology (CSCO) Clinical Practice Guidelines for Immune Checkpoint Inhibitors (2021 Edition)》, Opdivo in combination with Yervoy as first-line treatment for non-epithelioid and epithelioid pleural mesothelioma has become the only treatment regimen to receive a Grade I recommendation (Category 1 evidence) and a Grade II recommendation (Category 2A evidence).

To date, the Opdivo plus Yervoy-based dual immunotherapy combination has demonstrated an overall survival (OS) benefit in six Phase III clinical trials across five tumor types, including malignant pleural mesothelioma, non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, and esophageal squamous cell carcinoma.

Patient Assistance Program Launched Concurrently to Enhance Access to Innovative Medicines

To help more patients achieve high-quality long-term survival and improve the accessibility of innovative medicines, upon the market launch of Opdualag, Bristol-Myers Squibb, in partnership with the China Cancer Foundation, has expanded the original “Opdivo Patient Assistance Program” to include malignant pleural mesothelioma as a new indication. Eligible patients may voluntarily apply for assistance for combination therapy with Opdivo and Opdualag.

The application process and program materials for new indications will be published on the official website of the China Cancer Foundation (http://www.cfchina.org.cn/) and the WeChat Official Account "China Cancer Foundation Opdivo Program". Patients may also call the program hotline at 400-669-0906 for inquiries.

Ms. Siyuan Chen, President of Bristol-Myers Squibb for Mainland China and Hong Kong, said:“As a pioneer in the immuno-oncology field, Bristol-Myers Squibb introduced Opdivo, the world’s first PD-1 inhibitor, and Yervoy, the first CTLA-4 inhibitor, to China, accelerating the launch of globally innovative therapies in the country. The recent approval of this dual immunotherapy for malignant pleural mesothelioma marks a milestone as the first indication approved since the company launched its ‘China 2030 Strategy’. Looking ahead, Bristol-Myers Squibb will continue to integrate into China’s thriving innovation ecosystem, committed to becoming an innovation leader rooted in and originating from China. Together with its partners, the company will continuously improve the accessibility of innovative medicines, transforming patients’ lives through scientific innovation.”