Breakthrough in cancer treatment research in Vietnam

On December 12, 2024, witnessed by representatives of the Ministry of Health, the Ministry of Foreign Affairs and the US Centers for Disease Control and Prevention (CDC), Tam Anh General Hospital and Tam Anh Research Institute (TAMRI) announced the implementation of the VISTA-1 project on the oral immunotherapy drug RBS2418, bringing new hope to cancer patients.

This is an oral immunotherapy drug approved for clinical trials by the US Food and Drug Administration (FDA). Phase 1, at 10 research sites in the US, showed good results, confirming its safety in cancer patients. In September 2024, VISTA-1 continued to be approved by the FDA for phase 2 research on response effectiveness in cancer patients, primarily in late-stage colorectal cancer or patients who no longer respond to existing treatments.

Cancer is one of the leading causes of death in Vietnam, causing a heavy burden on society and the patient's family. According to statistics from the World Health Organization (WHO), 70% of deaths in Vietnam are due to non-communicable diseases, of which cancer accounts for 16%. In particular, colorectal cancer has a significant increase trend and is forecast to continue to increase, the mortality rate due to this disease can increase up to 90% compared to the present.

The major challenge in treating colorectal cancer is that the disease is often detected at a late stage, with a high rate of metastasis. Late detection, at an advanced stage, makes the treatment process very difficult, with the 5-year survival rate of patients with metastatic colorectal cancer only reaching about 10-20%.

Although the current guidelines and recommendations for cancer treatment in Vietnam are similar to those in the world, treatment, especially for metastatic colorectal cancer, is limited by the severity of the disease, late detection, and low response to treatment. Chemotherapy is one of the main treatments for many types of cancer, including metastatic colorectal cancer. However, over time, most cases of cancer cells still grow back after chemotherapy, with the risk of becoming more severe.

However, immunotherapy, a significant advance in cancer treatment in the past 10 years globally, is only effective in about 5% of patients with metastatic colorectal cancer. Therefore, the whole world, especially Vietnam, is in dire need of solutions for the remaining 95% of patients, especially those who do not respond to current treatment regimens.

Therefore, this clinical study of immunotherapy drugs for cancer treatment in Vietnam not only brings new opportunities for patients with late-stage cancer, but also affirms Vietnam's medical research capacity in the international arena. This is an important step forward for the medical sector and innovative and breakthrough science in Vietnam.

The VISTA-1 study was approved by the Vietnamese Ministry of Health in early December 2024. VISTA-1 is expected to enroll 150 patients in the United States and Vietnam for the study. With TAMRI's active cooperation and preparation from the beginning, Vietnam plans to deploy it at 5 research facilities, initially at Tam Anh General Hospital in Hanoi and Tam Anh General Hospital in Ho Chi Minh City.

According to Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training - Ministry of Health, this is the first and only phase 2A clinical trial of a cancer treatment drug in Vietnam to date, and is also the first time that a new biomarker test has been transferred in Vietnam, specifically starting from Tam Anh General Hospital, right from the start. The study was conducted at the central laboratory for all research sites in Vietnam without having to transfer samples to laboratories abroad.

The study focused on patients with advanced, metastatic colorectal cancer who had failed or were intolerant to existing therapies, opening up an innovative and potentially innovative solution. The drug is an oral formulation, easy to use, and reduces costs, increasing access to more patients, especially for cancers that are notoriously expensive to treat. Data from these studies suggest that RBS2418 has potential efficacy against tumor progression, both when used alone and in combination with immune checkpoint inhibitors (anti-PD-1).

Previously, Vietnam often only participated in clinical trials of new drugs in phase 3. With the VISTA-1 project, Tam Anh General Hospital and Tam Anh Research Institute proactively participated from the beginning, coordinated to develop research outlines, invested and received technology transfer to develop a modern laboratory system that meets international standards, becoming a central laboratory to perform new biomarkers in parallel with research labs abroad and combined with immune checkpoint inhibitors (anti PD-1).

Prof. Dr. Jeffrey S. Glenn, head of the research team, emphasized that with this project, Vietnam has the opportunity to participate in the drug development stage very early, allowing patients to access the drug many years earlier than people in other countries. "Currently, patients have to come to the US to participate in research, but Vietnam is the only place outside the US where patients can access this drug," he further explained.

He also said that the research team was very impressed with the clinical capacity and professionalism “on par with the world” of Tam Anh General Hospital. “I believe that together we will make history,” emphasized Prof. Dr. Jeffrey S. Glenn.

Dr. Phuong Le Tri, Executive Director of Tam Anh Research Institute, affirmed: "VISTA-1 is considered an important step forward in the fight against cancer in general, especially colorectal cancer. We will make every effort to contribute to this groundbreaking research. Hopefully, Tam Anh Research Institute will become a destination for Vietnamese and international scientists interested in new drugs, vaccines and methods of diagnosis and treatment."