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Novartis announces results of trial evaluating the
use of Afinitor® in first-line treatment in HER2+ advanced breast cancer at
SABCS . Processed and transmitted by NASDAQ OMX Corporate Solutions. The
issuer is solely responsible for the content of this announcement.
* BOLERO-1 trial explored everolimus in women with HER2+ advanced breast
cancer and did not meet criteria for statistical significance in first
primary objective[1]
* The second primary objective in the HER2+ pre-defined HR- subgroup of the
trial showed an improvement in progression-free survival, though not
statistically significant, supporting continued research of the
PI3K/AKT/mTOR pathway[1]
* Afinitor is approved for use in more than 90 countries in combination with
exemestane for the treatment of HR+/HER2- advanced breast cancer, which
globally represents 70% of all invasive breast cancers[1],[2]
Basel, December 12, 2014 - Novartis today announced results of the BOLERO-1
(Breast cancer trials of OraLEveROlimus-1) trial of Afinitor^® (everolimus)
tablets in combination with trastuzumab (Herceptin*) and paclitaxel as a
first-line treatment in women with human epidermal growth factor receptor-2
positive (HER2+) advanced breast cancer at the 2014 San Antonio Breast Cancer
Symposium (SABCS).
The trial was conducted in HER2+ advanced breast cancer patients, a population
that represents approximately 20% of advanced breast cancers and differs from
the hormone receptor-positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) advanced breast cancer patients for whom Afinitor in
combination with exemestane following a non-steroidal aromatase inhibitor is
approved worldwide[3]. The study did not meet the threshold of statistical
significance for the primary objectives of progression-free survival (PFS)
among women with HER2+ advanced breast cancer or the pre-defined
hormone-receptor negative, human epidermal growth factor receptor-2 positive
(HR-/HER2+) subgroup[1].
"For more than two years, Afinitor has positively impacted the HR positive
treatment landscape as an important therapy for women living with advanced
breast cancer," said Alessandro Riva, Global Head, Oncology Development and
Medical Affairs, Novartis Oncology. "The results of this trial in HER2
positive support our research approach of investigating various treatment
combinations targeting the PI3K/AKT/mTOR pathway in advanced breast cancer and
we thank all of the researchers and patients who participated in the BOLERO-1
study."
The results of BOLERO-1, a Phase III, randomized, double-blind,
placebo-controlled multicenter trial of 719 patients with HER2+ locally
advanced or metastatic breast cancer, showed that the median PFS with
everolimus plus trastuzumab and paclitaxel was 15.0 months versus 14.5 months
with placebo plus trastuzumab and paclitaxel, a difference of 0.5 months
(hazard ratio=0.89 [95% CI: 0.73 to 1.08]; p=0.1166)[1].
In the HR- subgroup of women with HER2+ advanced breast cancer, a second
primary objective, everolimus plus trastuzumab and paclitaxel treatment
demonstrated benefit over the placebo arm prolonging median PFS by 7.2 months.
The median PFS was 20.3 months with everolimus plus trastuzumab and paclitaxel
and 13.1 months with placebo plus trastuzumab and paclitaxel. While this
difference was clinically relevant, the results did not demonstrate
statistical significance.
The combination of everolimus, trastuzumab and paclitaxel was generally
well-tolerated. Adverse events were consistent with the known safety profile
of everolimus with the most common all-grade adverse reactions (incidence >=
35%) being stomatitis, diarrhea, alopecia, rash, cough, pyrexia, neutropenia
and fatigue[1]. The most common Grade 3-4 adverse reactions (incidence >= 2%)
were neutropenia, stomatitis, diarrhea, anemia, hypokalaemia, leukopenia,
hyperglycemia, fatigue, pyrexia and dyspnea[1].
Afinitor is currently approved in more than 90 countries across the globe,
including the countries of the European Union and the United States, to treat
postmenopausal women with HR+/HER2- advanced breast cancer in combination with
exemestane after recurrence or progression following a non-steroidal aromatase
inhibitor. The specific indications vary by country. HR+/HER2- advanced breast
cancer is the most common form of the disease[4]. Approximately 70% of all
invasive breast cancers are positive for HR expression at the time of
diagnosis.
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