COLUMVI® (Glofitamab for Injection) Receives Health Canada Authorization with Conditions for Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

• COLUMVI^® (glofitamab for injection) is the first fixed treatment duration CD20xCD3 T-cell engaging bispecific antibody approved in Canada, and globally, to treat diffuse large B-cell lymphoma^{1, 2, 3}
• Authorization is based on results from the phase I/II NP30179 study, which demonstrated COLUMVI induced durable response rates in people with heavily pre-treated large B-cell lymphoma⁴
• In Canada, it is estimated that in 2022, 11,400 Canadians were diagnosed with non-Hodgkin lymphoma⁵, of which 30-40% of cases are diffuse large B-cell lymphoma subtype⁶

MISSISSAUGA, ON, March 25, 2023 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that on March 24, 2023 Health Canada authorized COLUMVI^® (glofitamab for injection) 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), 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.⁴ COLUMVI has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit.

Large B-cell lymphomas comprise a wide spectrum of tumours that affect the B-cells of the lymphatic system.^7,8 COLUMVI is the first treatment for DLBCL in Canada that acts by targeting both the T cells and B cells. By binding both targets, COLUMVI activates the T cells causing them to multiply, as well as causing the rapid breakdown of the cancerous B cells.⁴

DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL), and is the most common type of NHL, accounting for 30% to 40% of all cases.⁶ COLUMVI offers an alternative option for this patient population in Canada, including those who cannot receive CAR-T therapy, and comes as a readily available concentrate for solution for infusion.⁴

"It is encouraging to see the results of the international NP30179 trial which supports the potential of glofitamab as an effective targeted bispecific antibody treatment for people living with relapsed or refractory DLBCL," said Dr. John Kuruvilla, Hematologist in the Division of Medical Oncology and Hematology, Princess Margaret Hospital. "The drug appears very active in a heavily pre-treated population that has received multiple treatments including CD19 directed CAR-T therapy." 

Positive results from the open-label, phase I/II, multicenter, multi-cohort trial (NP30179) support the potential of COLUMVI to offer an effective new treatment option for people living with relapsed or refractory DLBCL, by demonstrating durable responses in a heavily pre-treated population, including post CAR-T therapy.⁴   

"DLBCL is an aggressive lymphoma that is the most commonly diagnosed subtype of non-Hodgkin lymphoma," says Antonella Rizza, CEO, Lymphoma Canada. "Today's announcement provides an important new treatment option for relapsed and/or refractory DLBCL patients after multiple lines of therapy and ineligible for or having previously received CAR-T therapy."

The Health Canada authorization is based on data from the open-label, phase I/II, multicenter, multi-cohort trial (NP30179) conducted to evaluate COLUMVI as monotherapy in patients with relapsed or refractory B-cell lymphoma. In the single-arm DLBCL cohort (n=108), 84.3% of patients were refractory to their most recent therapy and about one-third (34.3%) had received prior CAR T-cell therapy. The primary efficacy outcome measure was complete response (CR) rate as assessed by the IRC using 2014 Lugano response criteria. Results showed that 35.2% of patients (n=38/108) achieved a complete response (CR; a disappearance of all signs of cancer), and 50.0% (n=54/108) achieved an objective response (OR; the combination of CR or partial response, a decrease in the amount of cancer in their body).

COLUMVI (glofitamab for injection) is a bispecific monoclonal antibody that binds bivalently (with high avidity) to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells.  By simultaneous binding to CD20 on the B cell and CD3 on the T cell, COLUMVI mediates the formation of an immunological synapse with subsequent potent T-cell activation and proliferation, secretion of cytokines, and release of cytolytic proteins that results in 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 COLUMVI. Each mL contains 1 mg of COLUMVI.  

Lymphoma is the name for a group of blood cancers that develop in your lymphatic system.⁹ Lymphomas occur in two main types: Hodgkin lymphoma and non-Hodgkin lymphoma. In particular, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and the most common form of non-Hodgkin lymphoma (NHL), accounting for 30% to 40% of all cases.⁶ While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, where options may not offer optimal outcomes for patients and managing the disease can become complex.¹⁰

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1. BREYANZI Product Monograph, May 6, 2022.
2. POLIVY Product Monograph, January 20, 2023.
3. MINJUVI Product Monograph, August 19, 2021.
4. COLUMVI Product Monograph, March 24, 2023.
5. Canadian Cancer Society. Non-Hodgkin lymphoma statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed on January 18, 2023.
6. Lymphoma Canada. Diffuse Large B cell Lymphoma (DLBCL). Available at https://www.lymphoma.ca/diffuse-large-b-cell-lymphoma/#:~:text=Understanding%20Diffuse%20Large%20B%20cell,to%2040%25%20of%20all%20cases. Accessed on January 18, 2023.
7. Canadian Cancer Society. What is non-Hodgkin lymphoma? Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/what-is-non-hodgkin-lymphoma. Accessed on 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 36, 1720?1748 (2022). https://doi.org/10.1038/s41375-022-01620-2
9. Leukemia and Lymphoma Society of Canada. Diffuse large B-cell Lymphoma (DLBCL). Available at https://www.bloodcancers.ca/diffuse-large-b-cell-lymphoma-dlbcl. Accessed on January 24, 2023.
10. Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood. 2015;125(1):22-32.

SOURCE Roche Canada