Health Canada Authorizes POLIVY® (polatuzumab vedotin for injection) for the First-Line Treatment of Adults With Large B-Cell Lymphoma

• In Canada, it is estimated that in 2022, 11,400 Canadians will be diagnosed with non-Hodgkin lymphoma¹, of which 30-40% of cases are diffuse large B-cell lymphoma subtype²
• POLIVY® offers a new option, following 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 care³
• Authorization is based on pivotal data from the phase III POLARIX study, which met its primary endpoint with a statistically significant improvement in progression-free survival in patients with previously untreated DLBCL

MISSISSAUGA, ON, Nov. 24, 2022 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on November 14, 2022, Health 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 diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.³

Lymphoma is the name for a group of blood cancers that develop in your lymphatic system, which is the system that works with other parts of your immune system to help your body fight infection and disease.^4,5 In particular, large B-cell lymphomas comprise a wide spectrum of tumours that affect the B-cells of the lymphatic system.^5,6 B-cells are responsible for making 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 in 2022, 11,400 Canadians will be diagnosed with non-Hodgkin lymphoma.¹ DLBCL is a fast-growing, aggressive form of NHL.⁷ 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.⁸ This situation is complicated further by the fact that currently the majority of disease relapse in 1L DLBCL occurs 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 patient burden of additional treatment.

"Lymphoma Canada is thrilled that there is a new frontline therapy available to 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 lymphoma, DLBCL impacts thousands of Canadians each year. With Health Canada approval of polatuzumab vedotin in combination with R-CHP, Canadian lymphoma patients have an alternative option available regarding their 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 Sehn, Chair of the Lymphoma Tumour Group at the BC Cancer Centre for Lymphoid Cancer, and Clinical Professor of Medicine in the Division of Medical Oncology at the University of British Columbia. "The POLARIX trial demonstrates a meaningful improvement in progression-free survival with the addition of polatuzumab vedotin and represents important progress in frontline therapy."

The Health Canada authorization is based on data from POLARIX, a Phase III, international, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics in 879 patients with previously untreated 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 with the standard of care.³

POLIVY currently has two approved indications in Canada. It has been previously authorized with conditions 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 not eligible for autologous stem cell transplant and have received at least one prior therapy.³

Roche is committed to working towards ensuring patient access to POLIVY, where this treatment may have the potential to benefit patients in Canada.

About the Health Canada Approval³

The Phase III results of the POLARIX study compare patients receiving 6 cycles of POLIVY in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-CHP, (n=440) against the standard of care, rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, or R-CHOP (n=439). The primary endpoint of the study was investigator (INV)-assessed progression-free survival (PFS). 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 following over 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 anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells. The monoclonal antibody binds to CD79b, a cell surface component of the B-cell receptor. CD79b expression is restricted to normal cells within the B cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in >95% of DLBCL. Upon 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 your lymphatic system.⁴ Lymphomas occur in two main types: Hodgkin lymphoma and non-Hodgkin lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), where of all diagnosed lymphoma cases, 85% of them are NHL.⁹ 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 be limited.^8,10 Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year, with an estimated 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 has 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 many different sectors and industries.

We're an innovator across major disease areas, including oncology, infectious diseases, diabetes, ophthalmology, and diseases of the central nervous system.

Roche Canada was founded in 1931 and employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.

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

References

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

[2]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 November 11, 2022.

[3] Polivy Product Monograph, November 14, 2022.

[4] 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 November 11, 2022.

[5] 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 November 11, 2022.

[6] 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

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

[8] 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.

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

[10] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point 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 from: http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.

SOURCE Roche Canada