- Source : PR Newswire
- Date : 2021-07-20
- Event type : Approved
- Companies : Roche
New Treatment Authorized and Available for Canadians With HER2+ Breast Cancer
Phesgo, a fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection combines two treatments into a single injection.
MISSISSAUGA, ON, July 20, 2021 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announce another milestone for Canadian patients with the Health Canada approval and availability of Phesgo® (pertuzumab and trastuzumab) for the treatment of early breast cancer indicated in combination with chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer with lymph node positive and/or hormone receptor negative disease. Phesgo also received approval in the metastatic setting in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC), who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.1
"The approval of Phesgo in Canada is another important step forward for patients who now have more options when it comes to safe and effective treatments that can provide flexibility and save them so much time," says Dr. Sandeep Sehdev, MD, FRCPC, a Medical Oncologist at the Ottawa Hospital Cancer Centre in Ottawa, ON. "For so many years patients were required to spend hours receiving their treatment by infusion out of their home, and with this new approval, patients can regain more time and improve their overall quality of life."
Phesgo is available as a single-dose vial for subcutaneous (SC) injection. SC administration of Phesgo takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.
"It is so important for the Canadian breast cancer community to have options when it comes to treatment, we're all unique and respond differently, so choice is always paramount," says Cathy Ammendolea, Chair of the Board of Directors of the Canadian Breast Cancer Network. "This approval and availability brings an option that can dramatically reduce the amount of time required to receive treatment in one single shot, compared to hours with an IV infusion."
"As a wife and mom living with metastatic breast cancer, I can say that the idea of less time in the cancer centre and not needing IV treatment sounds amazing," says Suzanne Horvath, a member of Rethink Breast Cancer's Metastatic Advisory Board. "Living with MBC means ongoing treatment is a reality. So doing it in a way that allows me more time for the things I want with the people I choose is really exciting news for me and others in the HER2 community."
The approval of Phesgo is based on results from the pivotal phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of pertuzumab and trastuzumab in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo with chemotherapy was comparable to IV administration of pertuzumab plus trastuzumab and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.2
Breast cancer is the second leading cause of cancer death in Canadian women with more than 27,000 women diagnosed in 2020.3 Approximately 20 per cent of women diagnosed with breast cancer in Canada will have HER2-positive disease, an aggressive form of the disease that is more likely to spread and recur.4
"This is another important step forward for Canadian patients and the approval of Phesgo represents Roche's commitment to improving the treatment experience with innovative and efficacious approaches that can reduce progression of the disease and allow for enhanced quality of life with more flexible options," says Brett Hogan Oncology Leader at Roche Canada.
The development of Phesgo highlights Roche's commitment to improving patients' experience of cancer treatment, looking beyond efficacy outcomes, and focusing on more flexible treatment solutions that provide patients with choice. Phesgo has the potential to help minimize pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation.5 The COVID-19 pandemic has further highlighted the need to utilize novel approaches that help to manage healthcare capacity to free-up time and resources and improve patient care for patients.
About the FeDeriCa study6,7
FeDeriCa is an international, multi-centre, two-arm, randomized, open-label, pivotal phase III study evaluating the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy, compared with standard intravenous (IV) infusions of pertuzumab and trastuzumab in combination with chemotherapy, in 500 people with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of pertuzumab in the blood during a given dosing interval (Ctrough), when compared to IV administration of pertuzumab. Secondary endpoints include safety; minimum levels of trastuzumab in the blood during a given dosing interval (Ctrough); and total pathological complete response, meaning there is no tumour tissue detectable in the tissue removed at the time of surgery.
The FeDeriCa study met its primary endpoint of non-inferior levels of Perjeta in the blood. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90 per cent CI: 1.14 to 1.31), with the lower limit of the 90 per cent CI of the GMR=1.14≥0.80 (the pre-specified non-inferiority margin). A secondary endpoint of non-inferior levels of trastuzumab was also met, with blood concentrations for people receiving Phesgo non-inferior to those receiving IV trastuzumab (GMR=1.33 [90 per cent CI: 1.24 to 1.43]; lower limit of 90 per cent CI of GMR=1.24≥0.80). A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with pertuzumab and trastuzumab as compared to the established IV doses at the same treatment intervals.
Phesgo combines the same monoclonal antibodies as pertuzumab and trastuzumab with Halozyme Therapeutics' Enhanze® drug delivery technology in a novel formulation for subcutaneous (SC) use.8,9 This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.
Halozyme's Enhanze drug delivery technology may enable and optimise SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – to aid in the dispersion and absorption of other injected therapeutic drugs.10
Pertuzumab in Phesgo is the same monoclonal antibody as in intravenous (IV) Perjeta, and trastuzumab in Phesgo is the same monoclonal antibody as in IV Herceptin. The mechanisms of action of pertuzumab and trastuzumab are believed to complement each other as both bind to the HER2 receptor, but in different locations. The combination of pertuzumab and trastuzumab is thought to provide a more comprehensive, dual blockade of the HER signaling pathways.11,12
The standard IV formulation of pertuzumab in combination with IV trastuzumab and chemotherapy (the Perjeta-based regimen) is approved in more than 100 countries for the treatment of both early and metastatic HER2-positive breast cancer. In the neoadjuvant (before surgery) early breast cancer (eBC) setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.13 Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) eBC setting.14 In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.15
About Breast Cancer
Breast cancer is the second leading cause of death in Canadian women, and is the second cause of cancer death in Canada. In 2020, an estimated 27,400 women were diagnosed and 5,100 died.16 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.17 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.18
About Roche in Breast Cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with biomarker tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.
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 personalized 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 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 2021 Hoffmann-La Roche Limited
SOURCE Hoffmann-La Roche Limited (Roche Canada)
For further information: Amy Haddlesey, Roche Canada, T: (647) 283-3406, E: [email protected]
1 Phesgo Canadian Product Monograph 2021.
2 Tan A. et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: https://pubmed.ncbi.nlm.nih.gov/33357420/
4 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.
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6 Tan A. et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: https://pubmed.ncbi.nlm.nih.gov/33357420/
7 Clinical trials.gov. A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer (FeDeriCa). [Internet: December 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT03493854.
8 Phesgo Canadian Product Monograph 2021.
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10 Halozyme. Enhanze® Drug Delivery Technology. [Internet; cited December 2020]. Available from: https://www.halozyme.com/enhanze/overview/default.aspx.
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