Introduction:What Advantages Do Surveyed Oncologists and Payers
Believe Emerging Therapies Have to Offer in Order to Gain Traction in This
Crowded and Competitive Market?
The second- and
subsequent-line metastatic castrate-resistant prostate cancer (mCRPC) market is
becoming increasingly crowded. Since 2010, four new therapies have been
approved in the United States for this patient population based on Phase III
clinical data showing that these agents do offer a survival benefit. The launch
of these agents has significantly altered the treatment algorithm and improved
the outlook for patients; nevertheless, our research indicates that significant
clinical and commercial opportunity remains for therapies that can further
prolong overall survival. Several therapies are in late-stage development for
second- and subsequent-line mCRPC, and we anticipate that some of these agents
will be approved for this indication, and this lucrative market will become
even more dynamic and competitive.
Questions Answered in This Report:
A drug’s performance on at least six efficacy end points,
including median overall survival, 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
second- and subsequent-line mCRPC?
Increased overall survival and
improved symptom control and quality of life are key areas of unmet need for
second- and subsequent-line mCRPC, according to the insights of surveyed U.S.
and European oncologists. Which therapies in development for second- and
subsequent-line mCRPC are poised to partially 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
Based on its clinical profile, enzalutamide
(Medivation/Astellas Pharma’s Xtandi) 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 enzalutamide as the
future gold standard in 2016 or 2021?
Attributes included in conjoint analysis
based assessment of target product profiles for second- and subsequent-line
- Median overall survival (months).
- Median radiographic progression-free survival (months).
- PSA response rate (% of patients) defined as a ≥ 50%
decline in PSA levels (enzalutamide: 54%).
- Pain palliation rate (% of patients) (enzalutamide: 45%).
- Incidence of grade 3/4 hematological toxicity
(neutropenia/anemia, % of patients) (cabazitaxel: 82%/11%).
- Incidence of grade 1-4 gastrointestinal toxicities
(nausea/vomiting, % of patients) (cabazitaxel: 34%/23%).
Attributes included in assessment of
U.S. payers’ receptivity to new therapies for second- and subsequent-line
- Effect on median overall survival.
- Effect on radiographic progression-free survival.
- Effect on pain palliation rate.
- Effect on grade 3/4 hematological toxicity.
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
- Abiraterone (Johnson & Johnson/Janssen
- Docetaxel (Sanofi’s Taxotere, generics)
- Mitoxantrone (EMD Serono/Pfizer/Meda’s Novantrone, generics)
- Cabazitaxel (Sanofi’s Jevtana)
- Enzalutamide (Medivation/Astellas Pharma’s Xtandi)
- Orteronel (Takeda/Millennium)
- Cabozantinib (Exelixis’s Cometriq)
- Radium-223 (Algeta/Bayer HealthCare’s Xofigo)
- Ipilimumab (Bristol-Myers Squibb’s Yervoy)
- Custirsen (OncoGenex/Teva)