Lymphoma patients at Monash Health now have an alternative treatment that has fewer side effects compared to standard treatments such as chemotherapy.
The drug Glofitamab, which has been given accelerated approval by the US Food and Drugs Administration, is for patients with cancer of the lymphatic system, specifically with relapsed diffuse large B-cell lymphoma. It is the most common form of Non-Hodgkin Lymphoma.
Director of Haematology Clinical Research and Clinical Lead for Aggressive Lymphoma Dr Gareth Gregory, who led the clinical trials into the drug, explains that Glofitamab is a new immunotherapy that binds to the lymphoma cell and to the patient’s immune T-cell, and brings them together.
“This builds on previous antibodies that have a single binding site for the lymphoma, then wait for the immune cells to recognise them.
“By having a second binding site for the immune cells, it actively brings the immune cells to the lymphoma, which improves the ability of the immune cells to recognise and destroy lymphoma cells,” he explained.
Monash Health Haematology Research has been an international leader in developing bispecific antibodies, including Glofitamab. It led early phase 1 and 2 clinical trials through to phase 3 randomised trials which are still underway.
Bispecific antibodies are a new type of immunotherapy that uses the patient’s own immune system to fight their lymphoma. The antibody binds to a protein on the surface of the patient’s immune cells, which brings their immune cells to the lymphoma and tells them to destroy it.
Dr Gregory who is also a Victorian Cancer Agency Senior Research Fellow at Monash University, says this is a significant milestone because there are currently very few effective treatments for patients with relapsed diffuse large B-cell lymphoma; historically, this has been considered an incurable and fatal condition.
“While the results of the early clinical trials of Glofitamab are ongoing, there appear to be durable remissions for a proportion of patients, indicating that some patients may have long-term benefit and remission following this treatment,” he said.
Dr Gregory says that although the initial phase 1 trial, which commenced in 2019, has completed recruiting patients, the trial will continue until 2025 to determine the duration of response for patients and allow time to detect side effects that may develop early or late after therapy.
The other phase 1 to 3 trials are ongoing and now include combinations of Glofitamab with other treatments, either as initial treatment for lymphoma or in the relapsed condition.
“The development of bispecific antibodies such as Glofitamab is providing a new frontier of cancer treatment that is available immediately off the shelf and does not have many of the side effects of prior standard treatments such as chemotherapy.
“Monash Health Haematology Research is proud to be able to offer these treatments to our patients,” he said.
Program Director of Cancer Services Professor Stephen Opat says the accelerated FDA approval is another step forward in improving the outcomes for patients with aggressive lymphoma who do not respond to initial treatment.
“Our patients are fortunate to have access to this and many other emerging treatments through participation in clinical trials. Sometimes they receive blockbuster life-prolonging drugs up to 10 years before they are generally available,” says Professor Opat, who is also a Clinical Professor at Monash University.