Subject : Clinical trials / Medical discoveries
- COLUMVI(glofitamab for injection) is the first bispecific anti-CD20-CD3 activating fixed-dose T-cell antibody to achieve regulatory approval in Canada and around the world to treat diffuse large B-cell lymphoma1, 2, 3.
- Approval based on results of Phase I/II study NP30179, which demonstrated that COLUMVI induces durable response rates in people with multiple prior therapies with large B-cell lymphoma4.
- It is estimated that in 2022, 11,400 Canadians will be diagnosed with non-Hodgkin’s lymphoma5and that 30 to 40% of them had diffuse large B-cell lymphoma subtype6.
MISSISSAUGA, ON, March 25, 2023 /CNW/ – Hoffmann-La Roche Limited/Limit (Roche Canada) today announces that effective March 24, 2023, Sant Canada authorized the use of COLUMVI (glofitamab for injection) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, DLBCL secondary to follicular lymphoma (transformed FL) or primary mediastinal B-cell lymphoma (LPCBL), in adults who have received at least two cycles of systemic treatment and who are not eligible for CAR-T cell therapy or who have already received this therapy4. COLUMVI has received marketing authorization with conditions, pending trial results to confirm its clinical benefit.
Large B-cell lymphomas include a broad spectrum of tumors affecting B lymphocytes of the lymphatic system7.8. COLUMVI is the first DLBCL treatment approved in the Canada which works by targeting both T-lymphocytes and B-lymphocytes. By binding to these two types of cells, it activates the proliferation of T-lymphocytes and causes the rapid breakdown of cancerous B-lymphocytes4.
DLBCL is an aggressive (rapidly growing) form of non-Hodgkin’s lymphoma (NHL) and the most common NHL subtype, accounting for 30% to 40% of all cases6. COLUMVI offers another treatment option for this patient population at Canadaespecially those who cannot receive CAR-T therapy, and it is readily available as a concentrated solution for infusion4.
“It is encouraging to see the results of the international study NP30179, which show the potential of the bispecific antibody glofitamab as an effective targeted therapy for people with relapsed or refractory DLBCL,” says Dr.rJohn Kuruvilla, hematologist in the medical hemato-oncology department of the Princess Margaret. The drug appears to be very active in patients who have already received multiple treatments, including CAR-T therapy directed against the CD19 antigen.
Based on positive results from the multi-center, multi-cohort, Phase I/II open-label clinical trial (NP30179), COLUMVI may offer an effective new treatment option for people with relapsed or refractory DLBCL, because it produces lasting responses even in patients who have already received several treatments, including CAR-T therapy4.
DLBCL is an aggressive lymphoma, and it’s the most commonly diagnosed subtype of non-Hodgkin’s lymphoma, adds Antonella Rizza, President and CEO of LymphomaCanada. Today’s announcement marks the arrival of an important new treatment option for patients with relapsed or refractory DLBCL who have already received multiple treatments and are not eligible for CAR-T cell therapy. or who have already received this therapy.
About permission from Sant Canada
Sant’s authorization Canada is based on data from the phase I/II open-label clinical trial, carried out in several centers and on several cohorts (NP30179) with the aim of evaluating COLUMVI as monotherapy in patients with relapsed or refractory B-cell lymphoma. In the DLBCL single-arm cohort (n=108), 84.3% of patients were refractory to their most recent treatment and approximately one-third (34.3%) had previously received CAR-T cell therapy. The primary criterion for evaluating effectiveness was the complete response rate (CR) as assessed by the independent review committee using the response criteria of Lugano from 2014. The results reported a complete response rate (i.e. the disappearance of all signs of cancer) of 35.2% (38 patients out of 108) and an objective response rate (i.e. obtaining a complete response or a partial response associated with a decrease in the number of cancer cells in the body) of 50.0% (54 out of 108 patients ).
About COLUMVI (glofitamab for injection)4
COLUMVI (glofitamab for injection) is a bispecific monoclonal antibody that binds bivalently (with high affinity) the CD20 protein expressed on the surface of B lymphocytes and monovalently the CD3 protein of the antigen receptor complex expressed on the surface of B cells. T lymphocytes. By simultaneously binding CD20 on B lymphocytes and CD3 on T lymphocytes, COLUMVI allows the formation of an immunological synapse which leads to a powerful activation of T lymphocytes and their proliferation, the secretion of cytokines and the release of cytolytic proteins thus causing the lysis of B lymphocytes expressing CD20. COLUMVI is a concentrate solution for infusion, supplied in a vial containing 2.5 mg (in 2.5 mL) or 10 mg (in 10 mL) of glofitamab. Each mL contains 1 mg of glofitamab.
About Diffuse Large B Cell Lymphoma (DLBCL)
The term lymphoma refers to a group of blood cancers that develop in the lymphatic system9. The two main types of lymphoma are: Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL). Diffuse large B-cell lymphoma (DLBCL) is an aggressive (rapidly growing) form of blood cancer and also the most common subtype of NHL, accounting for 30% to 40% of all cases6. Although DLBCL generally responds well to first-line treatment, up to 40% of people with DLBCL will have the disease recur or be refractory to treatment. Treatment options may then not produce optimal results, and disease management may become complex.10.
About Roche Canada
Patients and science are at the heart of everything we do. At Rocheour passion for science and our relentless pursuit of the impossible for patients has made us one of the world leaders in the pharmaceutical, diagnostics in vitro and health technologies. We are also cultivating our expertise in new areas, such as artificial intelligence and the collection and analysis of data in real context, while collaborating with different sectors and industries.
Roche is an innovator in leading therapeutic areas including oncology, infectious diseases, diabetes, ophthalmology and central nervous system disorders.
rock Canada was founded in 1931 and now has more than 1,800 employees across the country in its pharmaceutical division Mississaugain Ontarioand its Diagnoses and Diabetes Care divisions Lavalin Quebec.
For more information, visit our website www.RocheCanada.comor follow rock Canada on LinkedIn or Twitter @RocheCanada.
All trademarks used or mentioned are the property of their respective owners.
References
1. BREYANZI Monograph, May 6, 2022.
2. POLIVY Product Monograph, January 20, 2023.
3. MINJUVI Monograph, August 19, 2021.
4. COLUMVI Monograph, March 24, 2023.
5. Canadian Cancer Society. Non-Hodgkin’s lymphoma statistics. Available online: https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed January 18, 2023.
6. Lymphoma Canada. Diffuse large B-cell lymphoma (DLBCL). Available online: https://www.lymphoma.ca/diffuse-large-b-cell-lymphoma/#:~:text=Understanding%20Diffuse%20Large%20B%20cell,to%2040%25%20of%20all% 20 cases. Accessed January 18, 2023.
7. Canadian Cancer Society. What is non-Hodgkin’s lymphoma? Available online: https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/what-is-non-hodgkin-lymphoma. Accessed January 20, 2023.
8. Alaggio R, Amador C, Anagnostopoulos I, et al. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Lymphoid Neoplasms. Leukemia 2022;36:1720-48. https://doi.org/10.1038/s41375-022-01620-2
9. Leukemia and Lymphoma Society of the Canada. Diffuse large B-cell lymphoma (DLBCL). Available online: https://www.cancersdusang.ca/lymphoma-diffus-grandes-cellules-b. Accessed January 24, 2023.
10. Sehn LH, Gascoyne RD. Diffuse wide B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood 2015;125(1):22-32.
SOURCE Roche Canada
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