DecisionBase

March 2013

Renal Cell Carcinoma (Pretreated Advanced)

Introduction:

A Promising Immunotherapy Is on the Horizon. What Attributes Does It Need to Trump the Angiogenesis and mTOR Inhibitors?

Across the major pharmaceutical markets, the pretreated advanced renal cell carcinoma population exceeds 30,000 patients. Axitinib (Pfizer’s Inlyta) was the most recent targeted therapy to receive FDA approval, in January 2012. Before axitinib, six other targeted agents had been approved to treat advanced renal cell carcinoma. Going forward, we anticipate the approval of three more targeted agents, generating a highly competitive market in each of the pretreated settings. Despite these approvals, significant opportunity remains for additional therapies that can prolong survival, prolong progression-free survival, or reduce the toxicity burden that is associated with many approved therapies.

Questions Answered in This Report:

  *   Improved overall survival and improved progression-free survival are key goals in the treatment of pretreated advanced renal cell carcinoma. 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 pretreated advanced renal cell carcinoma?

  *   Everolimus (Novartis’s Afinitor) was the 2011 major-market sales leader for pretreated advanced renal cell carcinoma. What weaknesses exist in its profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated strengths 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 managed care organization pharmacy directors (MCO PDs) seek from new therapies?

  *   Based on its clinical profile, axitinib 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 axitinib as the future gold standard in 2016 or 2021?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for pretreated advanced renal cell carcinoma:

- Median overall survival

- Median progression-free survival

- Overall response rate

- Rate of hematological toxicity

- Rate of gastrointestinal toxicity

- Rate of dermatological toxicity

- Price/cycle

Attributes included in assessment of U.S. payers’ receptivity to new therapies for pretreated advanced renal cell carcinoma:

- Effect on overall survival

- Effect on disease progression

- Effect on hematological toxicity

- Effect on gastrointestinal toxicity

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:

Current Therapies

- Everolimus (Novartis’s Afinitor)

- Sorafenib (Bayer HealthCare/Onyx Pharmaceuticals’ Nexavar)

- Sunitinib (Pfizer’s Sutent)

- Pazopanib (GlaxoSmithKline’s Votrient)

- Temsirolimus (Pfizer’s Torisel)

- Axitinib (Pfizer’s Inlyta)

Emerging Therapies

- Nivolumab (Bristol-Myers Squibb/Ono Pharmaceuticals’ BMS-936558)

- Tivozanib (Aveo Oncology/Astellas Pharma/Kyowa Hakko Kirin’s Tivopath)

- Dovitinib (Novartis)


Search Reports

Mentioned in this report:

  • - Astellas Pharma
  • - Aveo Oncology
  • - Bayer HealthCare
  • - Bristol-Myers Squibb
  • - Chugai
  • - Genentech
  • - GlaxoSmithKline
  • - Kyowa Hakko Kirin
  • - Merck & Co.
  • - Novartis
  • - Ono Pharmaceuticals
  • - Onyx Pharmaceuticals
  • - Pfizer
  • - Roche
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