On November 18, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that results from a number of studies from across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS), from 10-14 December 2019 (Press release, Hoffmann-La Roche, NOV 18, 2019, View Source [SID1234551405]). These data include new results in HER2-positive breast cancer and studies of new molecules in hormone receptor-positive (HR-positive) breast cancer.
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"For the past three decades we have remained dedicated to improving outcomes for people with breast cancer," said Levi Garraway, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "This sustained commitment is exemplified by new data for our approved and investigational medicines across the spectrum of breast cancer being presented at SABCS this year."
Key presentations
New data will be presented from a second interim overall survival (OS) analysis of the phase III APHINITY trial evaluating Perjeta (pertuzumab) and Herceptin (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC). This latest interim OS analysis also includes updated descriptive invasive disease-free survival (iDFS) and cardiac safety data.
Roche will also present data from the primary analysis of the phase III FeDeriCa study which evaluated a new investigational fixed-dose combination (FDC) of Perjeta and Herceptin administered as a single subcutaneous (SC) formulation in combination with intravenous (IV) chemotherapy. The FDC is administered under the skin in just minutes, significantly reducing the time spent receiving treatment and providing people with HER2-positive breast cancer a potential new treatment option for faster delivery of the Perjeta-based regimen.
Data will also be presented from studies in HR-positive breast cancer, including findings from early studies investigating Roche’s pipeline molecules GDC-9545, a selective oestrogen receptor degrader, and GDC-0077, a selective PI3Kα inhibitor.
Overview of Roche studies to be presented at SABCS 2019
About the APHINITY study1,2
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, 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 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is 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, OS, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.
About the FeDeriCa study3
FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the pharmacokinetics, efficacy and safety of SC injection of the FDC of Perjeta and Herceptin in combination with chemotherapy, compared with standard IV infusions of Perjeta and Herceptin in combination with chemotherapy, in people with HER2-positive eBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pCR, meaning there is no tumour tissue detectable at the time of surgery.
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 companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer which have changed the natural history of the disease. As our understanding of breast cancer biology has rapidly evolved, we have expanded our focus to identify new biomarkers and approaches to treatment for other types of breast cancer, such as triple-negative and HR-positive disease, where there remains a significant unmet need.
Our HER2-targeted medicines Herceptin, Perjeta and Kadcyla continue to transform the treatment of early and advanced HER2-positive breast cancer and now, through our large clinical trial programmes with Tecentriq and ipatasertib and recent approvals for Tecentriq, we are bringing new treatment options to people with TNBC.