There have been reports of noninfectious pneumonitis (including some with pulmonary hypertension as a secondary event), infections, and renal failure (including acute renal failure) in patients...
AFINITOR plus exemestane more than doubled median PFS over exemestane alone1
Substantial and rapid PFS benefit1-3
Results reported at 6 weeks and 18 months were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 errors
Important Safety Information
AFINITOR plus exemestane demonstrated improvements in other key measures1,2
Visits occurred every other week until week 6 and then continued every 6 weeks until disease progression. After 528 PFS events, tumor assessments were performed every 12 weeks until disease progression.3
Improved median PFS across all preplanned patient subgroups2,3
The prespecified exploratory subgroup analyses were observational in nature; as such, there were no prespecified statistical procedures controlling for type 1 errors.Important Safety Information
|Patients had an ECOG performance status of 0 or 13||96%|
|Patients had bone-only disease2||21%|
|Patients had visceral metastases (excluding central nervous system [CNS] metastases)2||59%|
Patients received a range of prior therapies
|Prior therapy in the AFINITOR plus exemestane arm (N=485)2|
|Letrozole or anastrozole||100%|
|Chemotherapy* (any setting)||69%|
Median time to chemotherapy or death
BOLERO-2: Designed to address an unmet need in advanced HR+, HER2-negative breast cancer1,3
Key eligibility criteria
Play the video below to learn more about AFINITOR plus exemestane for your patients with advanced HR+, HER2-negative breast cancer.
BOLERO-2, Breast Cancer Trials of Oral Everolimus-2; CBR, clinical benefit rate; CR, complete response; ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; HR+, hormone receptor-positive; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SD, stable disease.
References: 1. Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018. 2. Yardley DA, Noguchi S, Pritchard KI, et al. Everolimus plus exemestane in postmenopausal patients with HR+ breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013;30(10):870-884. 3. Data on file. AFINITOR CRAD001Y2301 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2012. 4. Piccart M, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane for hormone-receptor-positive human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol. 2014;25(12):2357-2362. 5. Piccart M, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane for hormone-receptor-positive human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol. 2014;25(suppl):1-7. 6. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520-529.
AFINITOR is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
Important Safety Information
AFINITOR is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives.
Severe Hypersensitivity Reactions
Angioedema With Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors
Impaired Wound Healing
Risk of Infection or Reduced Immune Response With Vaccinations
Please see full Prescribing Information.