Roche’s Avastin and Xeloda show benefit for women with HER2-negative metastatic breast cancer in two new Phase III studies

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the phase III IMELDA study which showed that the combination of Avastin (bevacizumab) plus Xeloda (capecitabine) chemotherapy as a maintenance treatment following initial induction treatment with Avastin-based therapy resulted in clinically meaningful gains in overall survival (OS) and progression-free survival (PFS) in women with HER2-negative metastatic breast cancer. The study met its primary endpoint, with a near threefold improvement in the time that patients lived without their disease getting worse (PFS) when treated with Avastin plus Xeloda maintenance treatment compared to Avastin alone (median PFS after induction treatment: 11.9 months vs. 4.3 months; HR=0.38, p<0.001). It also demonstrated that women lived for an average of 15.3 months longer (OS) when treated with combination maintenance (median OS: 39.0 months vs. 23.7 months, HR=0.43, p<0.001), which was a secondary endpoint of the study. The safety findings of the study were consistent with the known safety profiles of Avastin or Xeloda.

A second positive phase III study (TANIA) showed that women who received Avastin plus standard chemotherapy as initial treatment for their HER2-negative metastatic breast cancer and then continued with Avastin plus chemotherapy after their disease had progressed (in the second-line setting), lived significantly longer without their disease getting worse, compared with people who received chemotherapy alone second-line. The TANIA study met its primary endpoint of improving PFS, with a statistically significant 25 percent reduction in the risk of tumour progression for women who received Avastin plus chemotherapy in the second-line compared to chemotherapy alone (median PFS: 6.3 months vs 4.2 months; HR=0.75, p=0.0068). Safety findings were consistent with the known profiles of Avastin and Xeloda (the most frequently chosen chemotherapy in the second-line setting). 

Full results of the IMELDA study will be presented on Sunday 28 September, 2:10 to 3:45 pm CEST, in the Madrid room at the European Society of Medical Oncology (ESMO) 2014 Congress by Joseph Gligorov, M.D; PhD, Principal Investigator of the IMELDA study, Head of the Cancer Coordination Center HUEP and Breast Cancer Expert Center at the APHP Tenon-University Cancer Institute – Pierre & Marie Curie, Sorbonne University, Paris, France.

Full results of the TANIA study will be presented on Sunday 28 September, 2:10 to 3.45 pm CEST, in the Madrid room at the ESMO 2014 congress by Gunter von Minckwitz, M.D, PhD, Principal Investigator of the TANIA study, Chairman of the German Breast Group, Neu-Isenburg, and Professor of Gyneacology at the University Women’s Hospital, Frankfurt, Germany.

Both the IMELDA and TANIA studies have been accepted for publication with The Lancet Oncology, with an anticipated publication date of 28th September 2014.

Avastin is currently approved in the European Union (EU) for use in combination with paclitaxel for the first-line (initial) treatment of adult patients with metastatic breast cancer. Avastin is also approved in the EU in combination with Xeloda for the first-line treatment of adult patients with metastatic breast cancer, in whom treatment with other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate. It is recommended that Avastin treatment is continued until progression of the underlying disease or until unacceptable toxicity.