What Advantages Do Surveyed Oncologists and Payers Believe Emerging Therapies Must Offer to Gain Traction in This Increasingly Competitive Market?
In recent years, several new, high-priced therapies have been approved for the first-line (chemotherapy-naive) treatment of metastatic castrate-resistant prostate cancer (mCRPC), making this lucrative market more dynamic and competitive. 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 (OS). Several therapies are in late-stage development for first-line (chemotherapy-naive) mCRPC, although we do not anticipate that all of them will be approved for this indication.
Questions Answered in This Report:
- A drug’s performance on at least seven efficacy end points, including median overall survival (MOS), 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 first-line (chemotherapy-naive) mCRPC?
- Increased OS, delayed disease progression, and improved symptom control and quality of life are key areas of unmet need for first-line (chemotherapy-naive) mCRPC, according to the insights of surveyed U.S. and European oncologists. Which therapies in development 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?
- MOS and radiographic progression-free survival (rPFS) are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new first-line (chemotherapy-naive) mCRPC therapies. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging therapies for first-line (chemotherapy-naive) mCRPC? Based on the trade-offs in price and performance across key drug attributes that U.S. oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for first-line (chemotherapy-naive) mCRPC?
- 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 2018 or 2023?
Attributes included in conjoint analysis based assessment of target product profiles for first-line (chemotherapy-naive) mCRPC:
- Median overall survival (months)
- Median radiographic progression-free survival (months)
- Objective response rate (%)
- PSA response rate (% of patients) defined as a ? 50 % decline in serum PSA
- Incidence of diarrhea (all grades) (% of patients)
- Incidence of fatigue (all grades) (% patients)
- Price per course of treatment
Attributes included in assessment of U.S. payers’ receptivity to new therapies for first-line (chemotherapy-naive) mCRPC:
- Effect on median overall survival
- Effect on radiographic progression-free survival
- Effect on PsA response
- Effect on incidence of fatigue (all grades)
Physicians surveyed: 63 U.S. and 32 European oncologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Abiraterone (Johnson & Johnson/Janssen Biotech/Janssen-Cilag’s Zytiga)
- Enzalutamide (Medivation/Astellas Pharma’s Xtandi)
- Sipuleucel-T (Dendreon’s Provenge)
- Radium-223 (Bayer HealthCare’s Xofigo)
- Docetaxel (Sanofi’s Taxotere, generics)
- Rilimogene galvacirepvec (Prostvac-VF-Tricom) (Bavarian Nordic)
- DCVAC/PCa (Sotio)
- Galeterone (Tokai Pharmaceuticals)
- Ipilimumab (Bristol-Myers Squibb’s Yervoy)
- Tasquinimod (Active Biotech/Ipsen)