Health Canada authorizes POLIVY® (polatuzumab vedotin for injection) for the first-line treatment of adults with large B-cell lymphoma

  • Inside Canadait is estimated that by 2022, 11,400 Canadians will be diagnosed with non-Hodgkin’s lymphoma1of which 30-40% of cases are a subtype of diffuse large B-cell lymphomatwo

  • POLIVY® offers a new option, after more than 20 years with very limited advances in treatment options for first-line DLBCL patients, providing a 27% reduction in risk of disease progression, relapse or death compared to the current standard of care. treatment3

  • Authorization is based on essential data from the phase III POLARIX trial, which achieved its primary endpoint with a statistically significant improvement in progression-free survival in previously untreated patients with DLBCL

MISSISSAUGA, IN🇧🇷 November 24, 2022 /CNW/ – Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that in November 14, 2022Health Canada has authorized POLIVY® (polatuzumab vedotin for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including large cell lymphoma B (DLBCL) not otherwise specified (NOS), high-grade B-cell lymphoma, Epstein-Barr virus positive (EBV+) DLBCL NOS, and T-cell/histiocyte-rich LBCL.3

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Lymphoma is the name for a group of blood cancers that develop in the lymphatic system, which is the system that works with other parts of the immune system to help the body fight infection and disease.4.5 In particular, large B-cell lymphomas comprise a broad spectrum of tumors that affect the B cells of the lymphatic system.5.6 B cells are responsible for producing antibodies to fight bacteria, viruses and other foreign material such as fungi within the body.5

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL).7 It is estimated that by 2022, 11,400 Canadians will be diagnosed with non-Hodgkin’s lymphoma.1 The DLBCL is an aggressive and fast-growing form of the NHL.7 While it generally responds to frontline treatment, up to 40% of people will have relapsed or refractory disease, where options may not offer optimal outcomes for patients and disease management can become complex.8 This situation is further complicated by the fact that currently most disease relapses in DLBCL 1L occur within the first 24 months after starting treatment. Overall, by introducing an additional treatment option for patients in this setting, there is the potential to reduce the need for subsequent treatments and the associated burden of additional treatment for the patient.

“Lymphoma Canada is excited that there is a new, first-line therapy available for patients diagnosed with diffuse large B-cell lymphoma,” said Antonella Rizza, Chief Executive Officer (CEO) of Lymphoma Canada. “As the most common form of non-Hodgkin’s lymphoma, DLBCL affects thousands of Canadians each year. With Health Canada’s approval of polatuzumab vedotin in combination with R-CHP, Canadian lymphoma patients have an alternative option available regarding to your treatment.”

POLIVY contains the active substance, polatuzumab vedotin, an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. The monoclonal antibody part allows the substance to find and kill cancer cells in the body.3

“The initial management of LBCL remains a challenge,” said Dr. Laurie Sehnchairman of the Lymphoma Tumor Group at the BC Cancer Center for Lymphoid Cancer and clinical professor of medicine in the Division of Medical Oncology at university of british columbia🇧🇷 “The POLARIX trial demonstrates a significant improvement in progression-free survival with the addition of polatuzumab vedotin and represents an important advance in first-line therapy.”

The Health Canada authorization is based on data from POLARIX, an international, multicenter, randomized, double-blind, placebo-controlled Phase III study evaluating efficacy, safety, and pharmacokinetics in 879 previously untreated patients with LBCL.3 The results of this study support the potential of POLIVY as an effective treatment option for people living with LBCL to improve progression-free survival with safety outcomes comparable to standard of care.3

POLIVY currently has two approved indications in Canada🇧🇷 It was previously authorized by Health Canada, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are ineligible for autologous stem cell transplantation and have received at least one prior therapy.3

Roche is committed to working to ensure patient access to POLIVY, where this treatment may have the potential to benefit patients in Canada🇧🇷

About Health Canada approval3

Results from the Phase III POLARIX study compare patients receiving 6 cycles of POLIVY in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, or R-CHP, (n=440) with standard care, rituximab, cyclophosphamide, doxorubicin hydrochloride, sulfate of vincristine and prednisone or R-CHOP (n=439). The primary endpoint of the study was investigator-assessed progression-free survival (PFS) (INV). The risk of disease progression, relapse, or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57-0.95; p<0.018). These are promising results after more than 20 years with very limited advances in treatment options for this patient population. The safety profile of POLIVY plus R-CHP was comparable to R-CHOP.About Polivy® (polatuzumab vedotin for injection)3

Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers an antimitotic agent (monomethyl auristatin E or MMAE) to B cells, resulting in the death of malignant B cells. The monoclonal antibody binds to CD79b, a cell surface component of the B cell receptor. Expression of CD79b is restricted to normal cells within the B cell lineage (with the exception of plasma cells) and malignant B cells; is expressed in >95% DLBCL. By binding CD79b, polatuzumab vedotin is rapidly internalized, aiding in the delivery of MMAE intracellularly. MMAE then works to kill dividing cells by inhibiting cell division and inducing apoptosis.

About diffuse large B-cell lymphoma (DLBCL)

Lymphoma is the name for a group of blood cancers that develop in the lymphatic system.4 Lymphomas come in two main types: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), where out of all lymphoma cases diagnosed, 85% of them are NHL.9 While it usually responds to frontline treatment, up to 40% of people will have relapsed or refractory disease, where options may be limited.8.10 It is estimated that approximately 150,000 people worldwide are diagnosed with DLBCL each year, with approximately 11,400 Canadians diagnosed with NHL overall in 2022.1, 11

About Roche Canada

Patients and science are at the heart of everything we do. At Roche, our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world’s leading pharmaceutical, in vitro diagnostics and healthcare technology companies. And we’re adding our expertise in new areas such as artificial intelligence, real-world data collection and analysis, and collaborating with diverse sectors and industries.

We are innovators in key disease areas including oncology, infectious diseases, diabetes, ophthalmology and central nervous system diseases.

rock Canada was founded in 1931 and employs more than 1,800 people nationwide through its Pharmaceuticals division in mississauga, ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Québec🇧🇷

For more information, visit www.RocheCanada.com or follow Roche Canada on LinkedIn or Twitter @RocheCanada.

References

[1] Canadian Cancer Society. Non-Hodgkin lymphoma statistics. Available in https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics🇧🇷 Accessed in November 11, 2022🇧🇷

[2]Lymphoma Canada. Diffuse Large B-Cell Lymphoma (DLBCL). Available in https://www.lymphoma.ca/diffuse-large-b-cell-lymphoma/#:~:text=Understanding%20Diffuse%20Large%20B%20cell,to%2040%25%20of%20all%20cases🇧🇷 Accessed in November 11, 2022🇧🇷

[3] Polivy Product Monograph, November 14, 2022🇧🇷

[4] Leukemia and Lymphoma Society of Canada🇧🇷 Diffuse Large B-Cell Lymphoma (DLBCL). Available in https://www.bloodcancers.ca/diffuse-large-b-cell-lymphoma-dlbcl🇧🇷 Accessed in November 11, 2022🇧🇷

[5] Canadian Cancer Society. What is non-Hodgkin’s lymphoma? Available in https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/what-is-non-hodgkin-lymphoma🇧🇷 Accessed in November 11, 2022🇧🇷

[6] Alaggio, R., Amador, C., Anagnostopoulos, I. et al. The 5th edition of the World Health Organization Classification of Hematolymphoid Tumors: Lymphoid Neoplasms. Leukemia 36, ​​1720-1748 (2022). https://doi.org/10.1038/s41375-022-01620-2

[7] Canadian Cancer Society. Diffuse large B-cell lymphoma. Available in https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/what-is-non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma🇧🇷 Accessed in November 11, 2022🇧🇷

[8] Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biological heterogeneity. Blood. 2015;125(1):22-32.

[9] Lymphoma Canada. Types of Lymphoma. Available in https://www.lymphoma.ca/lymphoma/overview/types-of-lymphoma/🇧🇷 Accessed in November 11, 2022🇧🇷

[10] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust endpoint for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073.

[11] Globocan 2020. World Fact Sheet. [Internet; cited 2022 July]🇧🇷 Available at: http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.

SOURCE Roche Canada

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Health Canada authorizes POLIVY® (polatuzumab vedotin for injection) for the first-line treatment of adults with large B-cell lymphoma

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