Health Canada approves PERJETA® (pertuzumab) for the treatment of HER2-positive early breast cancer after surgery

New treatment option can significantly reduce risk of disease recurrence or death, preventing breast cancer from returning and progressing to an incurable stage^1,2 

MISSISSAUGA, ON, Sept. 4, 2018 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved PERJETA (pertuzumab) in combination with HERCEPTIN^® (trastuzumab) and chemotherapy for adjuvant (after surgery) treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) with lymph node positive and/or hormone receptor negative disease.³ This adjuvant PERJETA-based regimen should be administered for a total of one year (maximum 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first) as part of a complete regimen for eBC.⁴

Approximately 20 per cent of women diagnosed with breast cancer will have HER2-positive disease.⁵ This form of breast cancer is aggressive and more likely to spread and recur, reinforcing the importance of optimal treatments for patients to ensure the best possible outcomes.^6,7

Since the approval of HERCEPTIN in eBC the medical community has made significant advancements in how we treat this form of the disease, where there is a curative intent and the goal is to prevent recurrence.⁸ However, many women still have a recurrence and progress to an advanced stage of the disease.⁹ In fact, approximately one in four women with HER2-positive eBC treated with HERCEPTIN and chemotherapy will eventually see their cancer return.¹⁰ 

"Our treatment goal for early breast cancer is to cure the disease, and a big part of this is to prevent the disease from coming back," says Dr. Katarzyna Jerzak, Medical Oncologist, Sunnybrook Odette Cancer Centre. "The data show this new treatment option can be clinically meaningful and can significantly reduce the risk of recurrence for some women with breast cancer." 

Health Canada's approval of the PERJETA-based regimen for the adjuvant treatment of HER2-positive eBC is based on results of the Phase III APHINITY study, which demonstrated at the time of primary analysis, a significant reduction in the risk of invasive breast cancer recurrence or death compared to HERCEPTIN and chemotherapy.¹¹

The greatest benefit in the trial was observed in patients with lymph node-positive and/or hormone receptor-negative breast cancer.^12,13

• For patients with lymph node-positive disease, the PERJETA-based regimen reduced the risk of recurrence or death by 23% (HR=0.77; 95% CI 0.62-0.96, p=0.02).
• Among patients with hormone receptor-negative disease, the PERJETA-based regimen reduced the risk of recurrence or death by 24% (HR=0.76; 95% CI 0.56-1.04, p=0.08).

In the overall study population, the risk of recurrence or death was reduced by 19% (HR=0.81, 95% CI 0.66-1.00, p=0.045).¹⁴  

"Thankfully there are many treatment success stories when breast cancer is diagnosed early, however many patients do have a recurrence that can progress to an incurable stage," says MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer. "This approval is an important milestone, as it provides another treatment option that is effective at reducing the risk of disease recurrence, an important treatment goal for patients."

About the APHINITY Study
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial Therapy in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of PERJETA plus HERCEPTIN and chemotherapy compared to HERCEPTIN and chemotherapy as adjuvant therapy in 4,804 people with operable HER2-positive eBC.^15,16 The primary efficacy endpoint of the APHINITY study is invasive disease-free survival (iDFS), which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life.¹⁷ The study will continue to follow participants for ten years.

The safety profile of the PERJETA-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals. When PERJETA was administered in combination with HERCEPTIN and chemotherapy, the most common side effects (>30%) were diarrhea (71.2%), nausea (69%), alopecia (66.7%), fatigue (48.8%), and vomiting (32.5%). The most common Grade 3-4 adverse drug reactions (ADRs) (> 2%) were neutropenia (16.3%), febrile neutropenia (12.1%), diarrhea (9.8%), neutrophil count decreased (9.6%), anemia (6.9%), white blood cell count decreased (9.8%), leukopenia (4.4%), fatigue (3.9%), nausea (2.4%), and stomatitis (2.2%).¹⁸

About Breast Cancer
Breast cancer is the second leading cause of death in Canadian women.¹⁹ In 2017, an estimated 26,300 women were diagnosed and 5,000 died.²⁰ However, the majority of breast cancer in Canada is diagnosed at an early stage when treatment has a curative intent, and the goal is to prevent recurrence.^21,22,23 Breast cancer mostly occurs in women between 50 and 69 years of age, and the risk of being diagnosed with breast cancer increases with age.²⁴

About PERJETA
PERJETA is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. PERJETA is designed specifically to prevent the HER2 receptor from pairing (or 'dimerising') with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival.²⁵ The mechanisms of action of PERJETA and HERCEPTIN are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of PERJETA and HERCEPTIN is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.²⁶ 

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.

Roche Canada was founded in 1931. The company employs over 1,000 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 2018; Hoffmann-La Roche Limited

REFERENCES
^1 Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377:122-31.
^2 American Cancer Society. Treatment of Stage IV (Metastatic) Breast Cancer. https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-breast-cancer-by-stage/treatment-of-stage-iv-advanced-breast-cancer.html. Last assessed August 19, 2018.
^3 PERJETA® (pertuzumab) Product Monograph; August 30, 2018.
^4 PERJETA® (pertuzumab) Product Monograph; August 30, 2018.
^5 X. Zhu, MD and S. Verma, MD MSEd. Targeted therapy in her2-positive metastatic breast cancer: a review of the literature. Curr Oncol. 2015 Mar; 22:(Suppl 1): S19–S28.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4381788/pdf/conc-22-s19.pdf. Last accessed August 20, 2018.
^6Wolff AC, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline UpdateJ Clin Oncol. 2013;31(31):3997-4013.
^7 Scharl A, et al. The Right Treatment for the Right Patient – Personalised Treatment of Breast Cancer. Geburtshilfe Frauenheilkd. 2015;75(7):683-91.
^8 Scharl A, et al. Geburtshilfe Frauenheilkd. 2015;75(7):683-91.
^9 Cameron, David et al. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. The Lancet, Volume 389, Issue 10075 , 1195 – 1205.
^10 Cameron, David et al. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. The Lancet, Volume 389, Issue 10075 , 1195 – 1205.
^11 PERJETA® (pertuzumab) Product Monograph; August 14, 2018.
^12 Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377:122-31.
^13 PERJETA® (pertuzumab) Product Monograph; August 30, 2018.
^14 PERJETA® (pertuzumab) Product Monograph; August 30, 2018.
^15 Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377:122-31.
^16 PERJETA® (pertuzumab) Product Monograph; August 14, 2018.
^17 Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377:122-31.
^18 PERJETA® (pertuzumab) Product Monograph; August 30, 2018.
^19 Canadian Cancer Society. Breast Cancer Statistics. http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on. Last accessed June 18, 2018.
^20 Canadian Cancer Society, Statistics Canada, the Public Health Agency of Canada. Canadian Cancer Statistics. A 2018 special report on cancer incidence by stage. Available at: http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2018-EN.pdf?la=en. Last accessed June 18, 2018.
^21 Canadian Cancer Society, Statistics Canada, the Public Health Agency of Canada. Canadian Cancer Statistics. A 2018 special report on cancer incidence by stage. Available at: http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2018-EN.pdf?la=en. Last accessed June 18, 2018.
^22 Scharl A, et al. The Right Treatment for the Right Patient – Personalised Treatment of Breast Cancer. Geburtshilfe Frauenheilkd. 2015;75(7):683-91.
^23 National Cancer Institute. Cancer Stat Facts: Female Breast Cancer. [Internet; cited 2018 May 31]. Available from: https://seer.cancer.gov/statfacts/html/breast.html.
^24 Canadian Cancer Society. Risk factors for breast cancer. http://www.cancer.ca/en/cancer-information/cancer-type/breast/risks/?region=on. Accessed June 18, 2018
^25 PERJETA® (pertuzumab) Product Monograph; August 30, 2018.
^26 Franklin M, et al. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell. 2004;5(4):317-28.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Claire Cockburn, Roche Canada, T: 905-542-4648, E: [email protected]; Lisa Cancian, Proof Inc., T: 416-969-1662, E: [email protected]

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