DecisionBase

May 2013

Prostate Cancer (Second- and Subsequent-Line Metastatic Castrate-Resistant)

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 unmet need?

  *   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?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for second- and subsequent-line mCRPC:

- 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%).

- Price.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for second- and subsequent-line mCRPC:

- 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 Modeling:

Current Therapies

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

- Docetaxel (Sanofi’s Taxotere, generics)

- Mitoxantrone (EMD Serono/Pfizer/Meda’s Novantrone, generics)

- Cabazitaxel (Sanofi’s Jevtana)

- Enzalutamide (Medivation/Astellas Pharma’s Xtandi)

Emerging Therapies

- Orteronel (Takeda/Millennium)

- Cabozantinib (Exelixis’s Cometriq)

- Radium-223 (Algeta/Bayer HealthCare’s Xofigo)

- Ipilimumab (Bristol-Myers Squibb’s Yervoy)

- Custirsen (OncoGenex/Teva)


Search Reports

Mentioned in this report:

  • - Algeta
  • - Astellas Pharma
  • - Bayer HealthCare
  • - Bristol-Myers Squibb
  • - Dendreon
  • - EMD Serono
  • - Exelixis
  • - Janssen Biotech
  • - Janssen-Cilag
  • - Johnson & Johnson
  • - Meda
  • - Medivation
  • - Millennium
  • - OncoGenex
  • - Pfizer
  • - Sanofi
  • - Takeda
  • - Teva
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