Health Canada Approves TECENTRIQ™ (atezolizumab) for Patients with Locally Advanced and Metastatic Bladder Cancer

Early data suggests TECENTRIQ shows strong efficacy for metastatic bladder cancer patients, offering the first new treatment option in more than 30 years¹

MISSISSAUGA, ON, April 18, 2017 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved with conditions TECENTRIQ™ (atezolizumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who:

• Have disease progression during or following platinum-containing chemotherapy
• Have disease progression within 12 months of neoadjuvant (before surgery) or adjuvant (after surgery) treatment with platinum-containing chemotherapy²

Health Canada has approved TECENTRIQ under provisions made in its Notice of Compliance with Conditions (NOC/c) policy. This policy facilitates earlier access to promising new medicines that treat, prevent or diagnose serious, life-threatening and/or severely debilitating diseases for which there is no alternative medicine available in Canada, or where the new medicine offers a significant improvement through its risk/benefit profile over existing medicines.

Each year, an estimated 8,700 Canadians are diagnosed with bladder cancer,³ making it the fifth most common cancer in Canada.⁴ More than 90 per cent of urothelial cancers originate in the bladder, and urothelial carcinoma (UC) is the most common subtype of bladder cancer.⁵ While advanced UC is less common, it is associated with a poor prognosis and has limited treatment options.

"Metastatic urothelial cancer progressing on cisplatin-based chemotherapy is a disease that carries a poor prognosis and has limited treatment options," says Dr. Srikala Sridhar, MD FRCPC, Associate Professor of Medicine, University of Toronto, and Head of the Genitourinary Medical Oncology Group at the Princess Margaret Cancer Center. "Health Canada's approval of TECENTRIQ, a PD-L1 targeted immunotherapy, is good news for our patients as it provides a new treatment option in a disease that has seen no new drugs approved in over three decades."

TECENTRIQ is the first anti-PD-L1 cancer immunotherapy approved in Canada that works by reactivating a patient's immune system to fight the tumour. The immune system is a collection of specialized organs and cells that help protect the body against infection and disease, including cancer. However, a protein called PD-L1 can allow cancer cells to hide from the immune system and prevent it from being able to recognize and kill the cancer.^6,7

TECENTRIQ is designed to block PD-L1 and is thought to boost the body's own immune system to target and kill cancer cells.^8,9

"While bladder cancer is one of the most common cancers, research funding lags behind that of most other cancers, so it's exciting to see advancements being made in the treatment of this disease," says Tammy Northam, Executive Director at Bladder Cancer Canada. "This new treatment provides a much needed option for Canadians living with the disease – and one that could mean more time with friends and loved ones."

"Living with advanced bladder cancer was a downhill struggle," says Ed London, bladder cancer patient. "Finding out there was a new treatment option available to me through a clinical trial allowed me to focus on other things that are important to me."

Health Canada's approval of TECENTRIQ is based on the Phase II IMvigor 210 study, sponsored by Roche.

About the Phase II IMvigor 210 Study

IMvigor 210 is an open-label, multi-center, two-cohort Phase II study that evaluated the safety and efficacy of TECENTRIQ in patients with locally advanced or metastatic urothelial carcinoma (also known as urothelial bladder cancer), regardless of their primary tumour location (i.e., bladder, renal pelvis, ureter, urethra). Patients in a cohort of the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen (n=310) received a 1200-mg intravenous dose of TECENTRIQ on day one of a 21-day cycle, until loss of clinical benefit as assessed by the investigator.¹⁰

TECENTRIQ shrank tumours in 14.8 per cent of patients in this cohort of the IMvigor 210 study. In a subset of patients (n=57) with disease progression within 12 months of neoadjuvant or adjuvant platinum-containing therapy, TECENTRIQ shrank tumours in 22.8 per cent of patients.¹¹

The most common adverse events (reported by ≥10% patients) were fatigue (51.0%), decreased appetite (27.1%), nausea (26.5%), constipation (26.1%), urinary tract infection (23.2%), pyrexia (22.3%), edema, peripheral (14.2%), diarrhea (21.6%), vomiting (19.4%), back pain (18.1%), dyspnea (17.4%), chills (10.6%), arthralgia (17.7%), anemia (17.1%), cough (16.5%), hematuria (16.1%), pruritus (14.8%), abdominal pain (13.9%), rash (11.6%), pain in extremities (10.3%), headache (10.0%), and pain (10.0%). The majority of adverse reactions were mild to moderate (Grade 1 or 2) in severity.¹²

Roche is also evaluating TECENTRIQ in a confirmatory phase III study (IMvigor 211), which compares TECENTRIQ to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

About TECENTRIQ

TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T-cells. TECENTRIQ may also affect normal cells.¹³

About Bladder Cancer

The most common symptom for bladder cancer is hematuria, or visible blood in the urine, which occurs in more than 80 per cent of bladder cancer cases. Other symptoms could include increased frequency and urgency of urination, trouble urinating, or a burning sensation or pain during urination.^14,15 Men are three times more likely to suffer from bladder cancer, compared with women,¹⁶ and the disease is three times more common in developed countries than in less developed countries.¹⁷

Bladder cancer has a high recurrence rate of 60 - 70 per cent and requires multiple treatment options.¹⁸ For patients whose tumours have grown into the muscle of the bladder or spread into other tissues, organs, or lymph nodes, treatment may include chemotherapy, surgery, radiation, or a combination of these.¹⁹ If warranted, surgery usually involves removal of the entire bladder, also known as radical cystectomy, and may result in the patient requiring a urostomy bag - a small pouch attached to the abdomen to help collect waste.^20,21

About Roche

Headquartered in Basel, Switzerland, 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 have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

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 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

In 2016, the Roche Group employed more than 94,000 people worldwide, invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

Roche Canada was founded in 1931. The company employs almost 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com. 

All trade-marks mentioned are the property of their respective owners.
© Copyright 2017; Hoffmann-La Roche Limited

REFERENCES

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¹ Hahn, N.M. New treatments for bladder cancer. Clinical Advances in Hematology and Oncology, 14(11): 884-887.
² TECENTRIQ (atezolizumab) Product Monograph; April 12, 2017.
³ Canadian Cancer Society. Bladder cancer statistics. http://www.cancer.ca/en/cancer-information/cancer-type/bladder/statistics/?region=on. Last accessed March 24, 2017.
⁴ Bladder Cancer Canada. Facing bladder cancer: Bladder cancer facts. https://bladdercancercanada.org/en/facing-bladder-cancer/bladder-cancer-facts/. Last accessed March 24, 2017.
⁵ Canadian Cancer Society. Urothelial carcinoma. http://www.cancer.ca/en/cancer-information/cancer-type/bladder/bladder-cancer/urothelial-carcinoma/?region=bc. Last accessed March 24, 2017.
⁶ Kim, J.W. and J.P. Eder. Prospects for Targeting PD-1 and PD-L1 in Various Tumor Types. Oncology Journal, Supplements. November 10, 2014. http://www.cancernetwork.com/oncology-journal/prospects-targeting-pd-1-and-pd-l1-various-tumor-types. Last accessed March 24, 2017.
⁷ Kim, J.W. and J.P. Eder. Prospects for Targeting PD-1 and PD-L1 in Various Tumor Types. Oncology Journal, Supplements. November 10, 2014. http://www.cancernetwork.com/oncology-journal/prospects-targeting-pd-1-and-pd-l1-various-tumor-types. Last accessed March 24, 2017.
⁸ Kim, J.W. and J.P. Eder. Prospects for Targeting PD-1 and PD-L1 in Various Tumor Types. Oncology Journal, Supplements. November 10, 2014. http://www.cancernetwork.com/oncology-journal/prospects-targeting-pd-1-and-pd-l1-various-tumor-types. Last accessed March 24, 2017.
⁹ TECENTRIQ (atezolizumab) Product Monograph; April 12, 2017.
¹⁰ TECENTRIQ (atezolizumab) Product Monograph; April 12, 2017.
¹¹ TECENTRIQ (atezolizumab) Product Monograph; April 12, 2017.
¹² TECENTRIQ (atezolizumab) Product Monograph; April 12, 2017.
¹³ TECENTRIQ (atezolizumab) Product Monograph; April 12, 2017.
¹⁴ Bladder Cancer Canada. Facing bladder cancer: Bladder cancer facts. https://bladdercancercanada.org/en/facing-bladder-cancer/bladder-cancer-facts/. Last accessed March 24, 2017.
¹⁵ Canadian Cancer Society. Symptoms of bladder cancer. http://www.cancer.ca/en/cancer-information/cancer-type/bladder/signs-and-symptoms/?region=bc. Last accessed March 24, 2017.
¹⁶ Canadian Cancer Society. Bladder cancer statistics. http://www.cancer.ca/en/cancer-information/cancer-type/bladder/statistics/?region=on. Last accessed March 24, 2017.
¹⁷ World Cancer Research Fund International. Comparing more & less developed countries. http://www.wcrf.org/int/cancer-facts-figures/comparing-more-less-developed-countries. Last accessed March 13, 2017.
¹⁸ Bladder Cancer Canada. Facing bladder cancer: Bladder cancer facts. https://bladdercancercanada.org/en/facing-bladder-cancer/bladder-cancer-facts/. Last accessed March 24, 2017.
¹⁹ American Society of Clinical Oncology. Bladder Cancer – Treatment options. http://www.cancer.net/cancer-types/bladder-cancer/treatment-options. Last accessed March 13, 2017.
²⁰ Bladder Cancer Canada. Facing bladder cancer: Bladder cancer facts. https://bladdercancercanada.org/en/facing-bladder-cancer/bladder-cancer-facts/. Last accessed March 24, 2017.
²¹ Canadian Cancer Society. Living with an ostomy. http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/rehabilitation/living-with-an-ostomy/?region=on. Last accessed March 13, 2017.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Claire Cockburn, Roche Canada, T: 905-542-4648, E: [email protected]; Abigail Bueno, Agnostic, T: 416-969-2724, E: [email protected]

Related Links

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