The Ministry of Health licensed phase 2A testing of the US oral immunotherapy drug RBS2418 to treat cancer, first deployed at Tam Anh hospital system.
Three other hospitals will also carry out testing later, according to a project called VISTA-1 announced on the morning of December 12 with the witness of representatives of the Ministry of Health, the Ministry of State and the Stanford Institute (USA). Vietnam is the first country outside the US to test the drug RBS2418.
Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training, Ministry of Health, (left) handed over the “Decision to approve the implementation of VISTA-1 clinical trial” to representatives of the Tam General Hospital system. Older brother. Image: Hospital provided
RBS2418 is the first oral immuno-cancer treatment drug approved by the US Food and Drug Administration (FDA) in September this year; Vietnam’s Ministry of Health approved the trial in early December. The drug works by activating the body’s immune system to identify and destroy cancer cells through the mechanism of switching the tumor’s immune status. from “cold” to “hot”.
Doctor Phuong Le Tri, Executive Director of Tam Anh Research Institute, said that RBS2418 has been tested in phase one 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 effect 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 enroll 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 Science, Technology and Training, Ministry of Health. , adding that this is also the first time a new biomarker test has been technically transferred right from the start to be performed at a 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 completing drug records and promoting the process of licensing drugs for circulation. new in our country.
The VISTA-1 project of the American biotechnology company Riboscience was developed by a group of experts, including experts and doctors from Stanford University. The clinical trial is divided into 4 phases. Phase one evaluated the safety of RBS2418 in a small group of patients with different solid tissue cancers. Phase two 2A and 2B are clinical trials. Phase three compares the effectiveness of the new drug with standard treatments in a large group of patients. Phase 4 monitors the effectiveness and long-term side effects of the drug after it is licensed for circulation and applied in practice.
Speaking at the announcement ceremony, Prof.Dr.BS. Jeffrey S. Glenn said that normally the remaining stages of drug research of this type will be carried out in the US. However, Riboscience decided to bring research “with the potential to shape cancer in the future” to Vietnam. Professor, PhD. 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 drugs many years earlier than people in other countries. “Currently, patients must come to the US to participate in research. Vietnam is the only place outside the US where patients can access this drug,” he explained further.
Professor, PhD. Jeffrey S. Glenn represented the group of scientists participating in the research and shared at the event. Image: Tam Anh General Hospital
Experts chose to test the drug on colon cancer patients because this is a disease with high morbidity and mortality. The International Agency for Research on Cancer (IARC) predicts that by 2045, the death rate from colorectal cancer in Asia alone could increase by up to 80% compared to today.
Colorectal cancer has a high metastasis rate. Patients treated at this stage face many difficulties, with a low 5-year survival rate. Currently, new drugs such as targeted or immune drugs can improve treatment effectiveness and prolong patient life.
Dr. Tri evaluates the cancer immunotherapy drug RBS241 as an advanced and potential solution. Medicines are in oral form so they are easy to use, reduce costs, and increase access opportunities for patients, especially for cancer, where treatment costs are very high.
“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.