Release Date: 22-Apr-2023
Since they were introduced in the market for the treatment of different diseases, bispecific antibodies have changed the treatment landscape for cancer and some other diseases. However, they have had the most profound effects in cancer treatment, especially hematological cancers. Many companies are now undertaking the developing bispecific antibodies. While some have been approved, others are awaiting approval from the drug regulatory bodies. One of these is Glofitamab, a bispecific antibody developed for the management of B-cell malignancies, and if it approved, it would become the first fixed-duration bispecific antibody approved to treat the most aggressive type of non-Hodgkin’s lymphoma. Experts are convinced of glofitamab’s approval based on data from different clinical trials.
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Glofitamab is an experimental bispecific antibody made to bind to CD3, a protein on T cells, as well as CD20, a protein found on the surface of B cells. Thereby, glofitamab is also known as CD20/CD3 T-cell engaging bispecific antibody. Due to the T cells' recruitment to the cancer site as a result of this dual binding process, the T cells become activated and attack the cancer cells. This innovative dual-target antibody has been developed by Genentech, a subsidiary of one of the global pharmaceutical market leaders Roche, and is being investigated for the management of B-cell malignancies such as non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Several clinical trials across the world are evaluating glofitamab to demonstrate its efficacy in treating patients of various ethnic backgrounds. The results of these trials will assist the drug receive regulatory approval from different drug regulatory bodies. Early clinical trials using glofitamab, especially those involving patients with relapsed or refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia, have yielded encouraging outcomes. The drug showed a good general response rate for people with relapsed or resistant non-Hodgkin's lymphoma in a phase 1 study, along with a tolerable safety profile.
The US FDA granted the breakthrough therapy designation to Glofitamab in August 2021 for the treatment of diffuse large B-cell lymphoma (DLBCL), a sub-type of NHL, which has relapsed or is resistant to treatment. Moreover, Glofitamab was also given the priority review in January 2023 after the Roche’s Biologics License Application (BLA) was approved. The FDA is anticipated to decide whether to approve this innovative cancer immunotherapy by July 2023 and a positive response is anticipated. If approved, Glofitamab would become the first CD20andchi;CD3 T-cell engaging fixed-duration, over-the-counter antibody for the treatment of B cell malignancies.
The BLA is supported by encouraging findings from the pivotal phase I/II NP30179 investigation, which involved patients who had previously undergone numerous cycles of therapy. According to the findings, 40% of patients experienced a complete response and 51.6% of patients experienced an objective response. There was a 13.4 month median follow-up period. Although the median duration of full response was not met, 73.1% of individuals who achieved complete response were still responding after 12 months. 18.4 months on average passed before a response was made. The drug has the plus point of having a shorter half-life than other bispecific antibodies, allowing for faster removal from the body. This could lower the possibility of negative effects linked to chronic antibody contact.
As of April 2023, Glofitamab has market authorization in Canada and more approvals are anticipated in the coming months as more clinical data supporting its potential are revealed. The development of Glofitamab represents a major step forward in the area of cancer immunotherapy as a whole, and it expands the treatment options available for non-Hodgkin's lymphoma patients, who were primarily treated with chemotherapy. Glofitamab has the possibility to offer a novel therapeutic option for certain cancer patients if it is approved, especially for those who have tried and failed existing medications or have few other options.