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Research & Reports

Searching in Biopharma (1575)

Breast Cancer (Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic)

Representing more than 50% of diagnosed incident cases of
breast cancer (CaB), the hormone-receptor (HR)-positive, human epidermal growth
factor receptor-2 (HER2)-negative population represents a large and potentially
lucrative market segment for drug developers. Nevertheless, developments in the
treatment of this population had stagnated until recently, with almost all
frequently prescribed hormonal therapies suffering from patent expiry. Mid 2012
saw the approval of the mTOR inhibitor everolimus (Novartis’s Afinitor) for use
in this population in the United States and Europe, invigorating this market
segment and paving the way for targeted therapy prescribing in these patients.
Opportunities are open in HR-positive, HER2-negative CaB for agents that extend
response to hormonal therapy, or for those that prevent or reverse resistance
to these treatments.

Questions Answered in This Report:

  • Increased overall survival, increased time to disease progression, and increased overall response rate are key goals in the treatment of advanced/metastatic HR-positive, HER2-negative CaB. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European oncologists weight specific efficacy end points and other drug attributes in their prescribing decisions for HR-positive, HER2-negative CaB?

  • Increased overall survival and increased time to disease progression are key areas of unmet need for HR-positive, HER2-negative CaB, according to the insights of surveyed U.S. and European oncologists. Which therapies in development for HR-positive, HER2-negative CaB are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • Based on its clinical profile, everolimus/exemestane (Novartis’s Afinitor/Pfizer’s Aromasin, generics) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge everolimus/exemestane as the future gold standard for 2016 or 2021?


Attributes included in conjoint analysis-based assessment of target product profiles for recurrent (second- and subsequent-line) HR-positive, HER2-negative CaB:

- Median overall survival

- Progression-free survival

- Overall response rate

- Incidence of grade 3/4 anemia

- Incidence of grade 3/4 hyperglycemia

- Incidence of gastrointestinal disturbance (all grades [anorexia, vomiting, diarrhea, and nausea])

- Price per 28-day cycle

Attributes included in assessment of U.S. payers’ receptivity to new therapies for advanced/metastatic HR-positive, HER2-negative CaB:

- Effect on progression-free survival

- Effect on overall response rate

- Effect on incidence of gastrointestinal toxicities

- Effect on incidence of hematological toxicities

Physicians surveyed: 61 U.S. and 30 European oncologists

Payers surveyed: 20 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Anastrozole (AstraZeneca’s Arimidex, generics)

- Everolimus (Novartis’s Afinitor, generics)

- Exemestane (Pfizer’s Aromasin, generics)

- Fulvestrant (AstraZeneca’s Faslodex)

- Letrozole (Novartis’s Femara, generics)

Emerging Therapies

- Buparlisib (Novartis’s BKM-120)

- Palbociclib (Pfizer’s PD-0332991)

- Entinostat (Syndax Pharmaceuticals)

- Abiraterone (Johnson & Johnson/Janssen Biotech/Janssen-Cilag’s Zytiga)

- Cabozantinib (Exelixis’s Cometriq)