Roche Canada is pleased to announce the approval of COLUMVI® (glofitamab for injection) by Health Canada for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL).
This highly effective therapy is approved for those who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy, or have previously received CAR-T cell therapy. This breakthrough therapy provides a new hope for those facing difficult diagnoses.
COLUMVI is a revolutionary new treatment for DLBCL in Canada – the first of its kind – that targets both T and B cells. By binding to both of them, COLUMVI activates the T cells, causing them to multiply, and simultaneously disrupts the cancerous B cells, leading to their rapid breakdown.
This groundbreaking treatment has the potential to revolutionize the way we treat large B-cell lymphomas, a wide spectrum of tumours that affect the B-cells of the lymphatic system.7,8
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing type of non-Hodgkin lymphoma (NHL), accounting for 30-40% of all NHL cases. For those in Canada who are ineligible for CAR-T therapy, COLUMVI provides an alternative option. This treatment comes as a readily available concentrate for solution for infusion, giving patients a much needed lifeline.
The results of the international NP30179 trial have been encouraging, providing further evidence of glofitamab’s potential as a powerful targeted bispecific antibody treatment for those with relapsed or refractory DLBCL.
Dr. John Kuruvilla, Hematologist in the Division of Medical Oncology and Hematology, Princess Margaret Hospital, notes that the drug has been particularly effective in a population that has already received multiple treatments, including CD19 directed CAR-T therapy. This is a significant step forward in the fight against DLBCL.
The NP30179 trial has provided encouraging results for COLUMVI, a potential new treatment for people with relapsed or refractory DLBCL. This open-label, phase I/II, multicenter, multi-cohort trial has demonstrated durable responses in a heavily pre-treated population, including those who have undergone CAR-T therapy, making it a promising option for these patients.
Today’s exciting announcement is a game-changer for relapsed and/or refractory DLBCL patients who are ineligible for or have already received CAR-T therapy. DLBCL, the most commonly diagnosed subtype of non-Hodgkin lymphoma, is an aggressive cancer, however this new treatment option provides hope and a chance for these patients to fight back and reclaim their lives.
According to Antonella Rizza, CEO of Lymphoma Canada, “This is an important breakthrough for DLBCL patients, giving them a chance to get the care and support they need to survive and thrive.”
About the Health Canada Authorization
COLUMVI, a recently approved monotherapy drug for the treatment of relapsed or refractory B-cell lymphoma, has demonstrated promising results in a phase I/II clinical trial. A cohort of 108 patients saw 84.3% of them refractory to their most recent therapy, with 34.3% having received prior CAR T-cell therapy.
The primary efficacy outcome measure, as assessed by the IRC using 2014 Lugano response criteria, showed that an impressive 35.2% of patients achieved a complete response (CR), with a further 50% achieving an objective response (OR). These results are incredibly encouraging and provide hope for those living with this condition.
About COLUMVI (glofitamab for injection)
COLUMVI is a powerful bispecific monoclonal antibody that binds with high avidity to both CD20 expressed on B cells and CD3 in the T-cell receptor complex expressed on T cells. This simultaneous binding causes an immunological synapse to form, resulting in the activation and proliferation of T cells, the secretion of cytokines, and the release of cytolytic proteins that ultimately leads to the lysis of CD20-expressing B cells.
COLUMVI comes as a concentrate for solution for infusion, with each vial containing either 2.5 mg (in 2.5 mL) or 10 mg (in 10 mL) of the antibody. Each mL contains 1 mg of COLUMVI, providing a potent and effective treatment.
About Diffuse Large B-cell Lymphoma (DLBCL)
Lymphoma is an umbrella term for a broad range of blood cancers, with two main types: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Of the NHLs, diffuse large B-cell lymphoma (DLBCL) is the most common, accounting for an estimated 30-40% of all cases.
DLBCL is an aggressive form of the disease, but fortunately there are effective treatments available in the early stages. However, for those who experience a relapse or have refractory disease, managing the condition can prove difficult, as options become limited and the outcomes less than optimal.
About Roche Canada
At Roche, we are driven by a passion for science and a deep commitment to transforming healthcare and improving the lives of patients around the globe. Our pioneering research and cutting-edge technology have made us a leader in pharmaceuticals, in vitro diagnostics, and healthcare technology, and now we are pushing the boundaries even further with our work in artificial intelligence, real world data collection and analysis, and collaborations with many different sectors and industries.
At AstraZeneca, we are revolutionizing the fight against a variety of serious and debilitating illnesses. From cancer to diabetes, from eye diseases to neurological conditions, we are utilizing cutting-edge technology and research to develop treatments that can make a real difference in people’s lives.
Our commitment to innovation and discovery drives us to push the boundaries of what’s possible in order to make the world a healthier place.
Since its founding in 1931, Roche Canada has become a leader in health care, employing over 1,800 people across the country. Its Pharmaceuticals division is based in Mississauga, Ontario, while its Diagnostics and Diabetes Care divisions are located in Laval, Quebec.
With a commitment to providing innovative products and services, Roche Canada is proud to be a trusted source of medical care for Canadians.