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Novartis: Afinitor plus exemestane extended OS, PFS in HR-positive/HER2-negative breast cancer
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Novartis International recently reported secondary endpoint results of the phase 3 BOLERO-2 trial, which found that everolimus plus exemestane extended OS by 4.4 months compared to exemestane alone.
Presented at the European Breast Cancer Conference in Glasgow, Scotland, secondary endpoint results also demonstrated median OS in everolimus (Afinitor) arm was 31 months while the primary endpoint results showed everolimus plus exemestane more than doubled PFS.
“The BOLERO-2 trial shows that treatment with Afinitor in combination with exemestane works against multiple target pathways to slow the progression of hormone receptor-positive advanced breast cancer, even among patients who have progressed while on or within 12 months of completing adjuvant non-steroidal aromatase inhibitor therapy,” Gabriel Hortobagyi, MD, professor of breast medical oncology at The University of Texas MD Anderson Cancer Center. “This dual approach both extends the benefits of endocrine therapy while delaying the time until the patient needs chemotherapy, which can have an important impact on patients living with this disease.”
A median OS duration of 31 months was observed in the combination arm vs. 26.6 months for those on exemestane monotherapy, a difference of 4.4 months (HR=0.89 [95% CI: 0.73 to 1.10]; P=0.1426). This secondary endpoint did not reach the threshold of statistical significance.
The median OS is the longest reported to date in a phase 3 hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR-positive/HER2-negative) advanced breast cancer trial following prior treatment with a non-steroidal aromatase inhibitor.
The final OS results were assessed as part of a prospectively planned secondary endpoint analysis. Previously reported PFS results found that treatment with everolimus plus exemestane more than doubled median PFS to 7.8 months, compared to 3.2 months with exemestane alone, meeting the study's primary endpoint (HR=0.45 [95% Cl: 0.38 to 0.54]; P<0.0001), confirmed by central assessment (11 months vs. 4.1 months PFS).
The most common adverse reactions (incidence ≥ 30%) were stomatitis, infections, rash, fatigue, diarrhea and decreased appetite. The most common grade 3-4 adverse reactions (incidence ≥ 2%) were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.
“These data, along with experience from more than 18 months of real-world use, add to the growing body of evidence regarding the use of Afinitor plus exemestane in patients with hormone receptor-positive, HER2 negative advanced breast cancer after they progress on a non-steroidal aromatase inhibitor,” Alessandro Riva, MD, president of Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs said. “We continue to research the role of Afinitor in advanced breast cancer and are committed to developing other novel therapies, such as those targeting the PI3K/AKT/mTOR and CDK 4/6 pathways.”