Health Canada Grants Market Authorization to Polivy™ (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma[i]

First-in-class antibody-drug conjugate that specifically targets CD79b and destroys B cells through the delivery of an anti-cancer agent ^ii,iii

MISSISSAUGA, ON, Sept. 24, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on July 9, 2020, Health Canada, under the Notice of Compliance with Conditions (NOC/c) policy, has granted market authorization to Polivy™(polatuzumab vedotin), in combination with bendamustine and rituximab (BR) for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy.ⁱ

DLBCL is an aggressive and fast-growing form of non-Hodgkin's lymphoma (NHL). While it is generally responsive to treatment in the frontline, as many as 40 per cent of patients do not respond to initial treatment or relapse, at which time therapy options are limited and survival is short.^iv

Health Canada's Notice of Compliance with Conditions policy provides conditional authorization for new drugs with promising evidence of clinical effectiveness, for patients suffering from serious, life- threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or for which a significant increase in efficacy or a significant decrease in risk is demonstrated in relation to an existing drug marketed in Canada.^v Prior to authorization, the sponsor must undertake to design, carry out and report on confirmatory trials to verify the clinical benefit of the drug.^v 

"Despite the significant advances made over the last few years in the treatment of lymphoma, people with relapsed or refractory diffuse large B-cell lymphoma, particularly those who are not eligible for stem cell transplantation, continue to have limited options," said Dr. Laurie Sehn, Chair, Lymphoma Tumour Group, BC Cancer Agency, and a clinical investigator on the GO29365 study. "I am pleased a much needed new and effective option is available in Canada to combat this aggressive form of lymphoid cancer."

This new authorization is based on the results from the phase I/II GO29365 study, an international, multicenter, open-label, Phase Ib/II trial.ⁱ  Results showed that 40 per cent of people treated with Polivy plus BR achieved a complete or partial response, meaning no cancer could be detected at the time of assessment (n=16/40; 95% CI: 25-57), compared to 18 per cent with BR alone (n=7/40; 95% CI: 7-33).^vi The study also showed the median duration of responsiveness to treatment was 12.6 months for patients in the Polivy plus BR arm (n=12/25) versus 7.7 months for patients in the BR arm (n=2/10).^vi

"Many DLBCL patients who have relapsed following first line or subsequent lines of therapy are ineligible for stem cell transplant, and there is a need for new treatment options for this patient group," said Kaitlyn Beyfuss-Laski, Manager of Patient Programs, Research and Advocacy at Lymphoma Canada. "The combination of polatuzumab vedotin (Polivy) with bendamustine and rituximab provides a new tool for this group of patients. We are so pleased that new treatment options are available to relapsed DLBCL patients in Canada." 

About the GO29365 study

GO29365 is an international, multicenter, open-label, Phase Ib/II trial which included a randomized cohort of 80 patients, including four Canadians with previously treated DLBCL. Eligible patients were not candidates for autologous hematopoietic stem cell transplant (HSCT) at study entry, had relapsed or refractory disease after receiving at least one prior systemic chemotherapy regimen, and had an ECOG PS ≤2. In this study, patients were randomized to receive Polivy plus BR (n=40) or BR alone (n=40) for six 21-day cycles. The median age was 69 years (range 30 to 86 years) and 71 per cent of patients were white and 66 per cent were male. The primary endpoint of the study was complete response (CR) rate at end of treatment (6 to 8 weeks after day 1 of cycle 6 or last study treatment) as assessed by independent review committee (IRC). Efficacy was based on the primary endpoint, complete response (CR) rate at the end of treatment as assessed by IRC. Key supportive efficacy endpoints were objective response rate at the end of treatment and best overall response rate. Duration of response was also assessed in the study.ⁱ

The most frequently-reported adverse drug reactions (ADRs) in patients with DLBCL treated with Polivy in combination with BR were anemia, thrombocytopenia, neutropenia, decreased appetite, neuropathy peripheral, fatigue, diarrhea, nausea, and pyrexia. Serious adverse events were reported in 64.4 per cent of Polivy plus BR treated patients which included febrile neutropenia (11.1%), pyrexia (8.9%), pneumonia (8.9%), anemia (4.4%), duodenal ulcer hemorrhage (4.4%), sepsis (4.4%), and thrombocytopenia (4.4%).ⁱ

About Polivy (polatuzumab vedotin)

Polivy is an antibody-drug conjugate (ADC) that combines the targeting ability of antibodies with chemotherapies to destroy cancer cells.^ii,iii It specifically targets CD79b, a protein expressed in the majority of B cells and destroys the B cells through the delivery of an anti-cancer agent, while minimizing the effects on normal cells.^ii,iii,vii Polivy offers a fixed-duration of treatment of six cycles through IV infusion, with each cycle lasting 21 days.ⁱ

About diffuse large B-cell lymphoma

DLBCL is the most common form of NHL that develops when the body makes abnormal B cells.^viii It accounts for up to 30 to 40 percent of cases of NHL in Canada each year, with an estimated 150,000 diagnosed worldwide each year.^ix,x It can occur at any age, however most people are diagnosed when they are in their mid-60s.^viii It is also slightly more common in men than in women.^viii Despite meaningful progress in the treatment of DLBCL, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens.^xi This makes DLBCL increasingly harder to treat after each relapse, resulting in poor prognosis with median overall survival of around six months.^xi 

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof, combined with a focus on innovation, have made Roche the leader in personalized healthcare – a strategy that aims to provide patients with timely access to their best possible healthcare solution.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.

Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.

All trade-marks mentioned are the property of their respective owners.

© Copyright 2020; Hoffmann-La Roche Limited

References:

ⁱ Polivy (polatuzumab vedotin) Canadian Product Monograph July 2020.

ⁱⁱ Dornan D, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114:2721–2729.

ⁱⁱⁱ Pfeifer M, et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29:1578-1586.

^iv Currently Oncology. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. https://www.current-oncology.com/index.php/oncology/article/view/5421/3995. Accessed May 2020.

^v Guidance Document: Notice of Compliance with Conditions (NOC/c). Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html. Accessed July 2020.

^vi Journal of Clinical Oncology: Polatuzumab vedotin in relapsed or refractory diffuse large b-cell lymphoma. Available from: https://ascopubs.org/doi/full/10.1200/JCO.19.00172. Accessed June 2020.

^vii ADC Review. What are antibody-drug conjugates? Available from: https://www.adcreview.com/the-review/what-are-antibody-drug-conjugates. Accessed May 2020.

^viii Canadian Cancer Society. Diffuse large B cell lymphoma. Available from: https://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma/?region=qc. Accessed May 2020.  

^ix Current Oncology. Real-world costing analysis for diffuse large B cell lymphoma in British Columbia. Available from: https://current-oncology.com/index.php/oncology/article/view/4565/3571. Accessed May 2020.

^x GLOBOCAN 2018. Estimated cancer incidence, mortality and prevalence worldwide in 2018. Available from: http://globocan.iarc.fr. Accessed May 2020.

^xi Gisselbrecht C, Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol. 2018;182:633–643.

SOURCE Roche Canada

Bridget Wells, Roche Canada, T: 647-284-6299, E: [email protected]; Alannah Nugent, Edelman Canada, T: 647-730-5894, E: [email protected]