Immunotherapy drug trial for cancer treatment in Vietnam

Two other hospitals will also conduct the trial later, under the project named VISTA-1, which was announced on the morning of December 12 in the presence of representatives from the Ministry of Health, the Ministry of Foreign Affairs and the Stanford Institute (USA). Vietnam is the first country outside the US to test the drug RBS2418.

RBS2418 is the first oral immunotherapy cancer drug approved by the US Food and Drug Administration (FDA) in September this year; the Vietnamese Ministry of Health approved the trial in early December. The drug works by activating the body's immune system to recognize and destroy cancer cells through a mechanism that converts the tumor's immune status from "cold" to "hot".

Dr. Phuong Le Tri, CEO of Tam Anh Research Institute, said that RBS2418 has been tested in phase 1 at 10 research sites in the US, and the results showed that the drug is safe and does not cause side effects. The drug's potential effectiveness is against tumor progression, both when used alone and in combination with immune checkpoint inhibitors (anti PD-1).

In the phase 2A trial, the project will recruit 150 patients in the US and Vietnam with late-stage colorectal cancer who no longer respond or are intolerant to existing treatments. They will be given the experimental drug RBS2418 to treat the disease.

"VISTA-1 is the first phase 2A clinical trial in cancer in Vietnam to date," said Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training, Ministry of Health, adding that this is also the first time a new biomarker test has been technically transferred from the beginning to be performed at the central laboratory for all research sites in Vietnam without having to transfer samples to laboratories abroad. Mr. Quang also said that participating in international clinical trials such as VISTA-1 helps Vietnam establish a domestic treatment database, contributing to the completion of drug records and promoting the process of licensing new drugs in our country.

The VISTA-1 project of the American biotechnology company Riboscience was developed by a team of experts, including experts and doctors from Stanford University. The clinical trial is divided into 4 phases. Phase 1 evaluates the safety of the drug RBS2418 on a small group of patients with different solid cancers. Phase 2 2A and 2B are clinical trials. Phase 3 compares the effectiveness of the new drug with standard treatment on a large group of patients. Phase 4 monitors the long-term effectiveness and side effects of the drug after it is licensed for circulation and applied in practice.

Speaking at the announcement ceremony, Prof. Dr. Jeffrey S. Glenn said that normally the remaining stages of drug research of this type would be carried out in the US. However, Riboscience decided to bring research "that has the potential to shape cancer in the future" to Vietnam. Prof. Dr. Jeffrey S. Glenn 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 go 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.

Experts chose to test the drug on colon cancer patients because this disease has a high incidence and mortality rate. The International Agency for Research on Cancer (IARC) predicts that by 2045, the death rate from colorectal cancer in Asia alone could increase by 80% compared to today.

Colorectal cancer has a high rate of metastasis. Patients at this stage have many difficulties in treatment, and the 5-year survival rate is low. Currently, new drugs such as targeted drugs or immunotherapy can improve treatment effectiveness and prolong the life of patients.

Dr. Tri evaluates the cancer immunotherapy drug RBS241 as an advanced and potential solution. The drug is in oral form, so it is easy to use, reduces costs, and increases access for patients, especially for cancer, which has very high treatment costs.

"The VISTA-1 project brings new treatment opportunities for rectal cancer patients and affirms Vietnam's medical research capacity in the world," said Dr. Tri.