Treatment options for triple-negative breast cancer patients are limited, as patients are ineligible for treatment with either hormonal or HER2-targeted agents. Treatment typically involves nontargeted cytotoxic chemotherapies. Therefore, great commercial opportunity exists in developing effective, targeted therapies for this patient population. Interviewed oncologists are hopeful that more-effective targeted therapies are on the horizon for this patient population. However, the most promising emerging agents in development for triple-negative breast cancer target only specific subsets of patients, such as those with BRCA1/2 -mutation positive disease. As a result, the majority of the triple-negative breast cancer population is likely to remain underserved for the foreseeable future.
Questions Answered in This Report:
- A drug’s performance on at least three efficacy end points, including overall survival (OS), is important for drug approval and physician use. 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 efficacy measures and other drug attributes in their prescribing decisions for advanced/metastatic triple-negative breast cancer?
- Nanoparticle paclitaxel is the 2012 major-market sales leader for advanced/metastatic triple-negative breast cancer. What weaknesses exist in its profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated potential on the attributes that surveyed oncologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?
- By 2017, niraparib will emerge as the gold-standard therapy for BRCA1/2-mutation positive disease in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is niraparib most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by niraparib?
Attributes included in conjoint analysis based assessment of target product profiles for advanced/metastatic triple-negative breast cancer:
- Median overall survival.
- Progression-free survival.
- Overall response rate.
- Lymphopenia (grade 3/4).
- Neuropathy (grade 3/4).
- Thrombocytopenia (grade 3/4).
- Price per 21-day cycle.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for advanced/metastatic triple-negative breast cancer:
- Effect on median overall survival.
- Effect on median progression-free survival.
- Effect on frequency of hematological toxicities.
- Effect on frequency of gastrointestinal toxicities.
Physicians surveyed: 60 U.S. and 30 European oncologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Nanoparticle paclitaxel (Celgene’s Abraxane)
- Paclitaxel (Bristol-Myers Squibb’s Taxol, generics)
- Paclitaxel + carboplatin (Bristol-Myers Squibb’s Taxol, generics plus Bristol-Myers Squibb’s Paraplatin, generics)
- Bevacizumab + paclitaxel (Roche/Genentech/Chugai’s Avastin plus Bristol-Myers Squibb’s Taxol, generics)
- Capecitabine (Roche/Chugai’s Xeloda, generics)
- Niraparib (Tesaro)
- Buparlisib (Novartis)
- Enzalutamide (Medivation’s Xtandi)
- Sorafenib + capecitabine (Bayer HealthCare/Onyx Pharmaceutical’s Nexavar plus Roche’s Xeloda, generics)
- Glembatumumab vedotin (Celldex Therapeutics)