Colorectal Cancer (Stage IV): Therapies Must Increase Overall Survival over IFL plus Bevacizumab to Reach Blockbuster Status

DecisionBase PDFs -- 2008

  Overview:

The pipeline for stage IV colorectal cancer (CRC) comprises a wide range of therapies from drugs designed to enhance the efficacy of existing regimens to immunostimulant vaccines. However, few agents are in Phase III trials for this indication. Significant unmet need and drug development opportunity remain for therapies that can provide convincing survival and quality-of-life benefits.

  Questions Answered in This Report:

A drug’s performance on at least three efficacy end points, including overall survival and progression-free 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 oncologists weight efficacy measures and other drug attributes in their prescribing decisions for stage IV CRC?

FOLFOX4 plus bevacizumab (5-fluorouracil, generics; leucovorin, generics; oxaliplatin [Sanofi-Aventis’s Eloxatin/Eloxatine, Yakult-Honsha’s Elplat] plus Roche/Genentech/Chugai’s Avastin) is the 2006 major-market sales leader for stage IV CRC. Do thought leaders expect emerging therapies to offer significant improvements in efficacy,  safety and tolerability, or delivery over FOLFOX4 plus bevacizumab? Which emerging therapies pose the greatest threat to FOLFOX4 plus bevacizumab?

Based on its clinical profile, CAPOX (capecitabine [Roche’s Xeloda], oxaliplatin [Sanofi-Aventis’s Eloxatin/Eloxatine, Yakult-Honsha’s Elplat]) plus bevacizumab (Roche/Genentech/Chugai’s Avastin) is the 2006 clinical gold standard in our drug comparator model because it achieves the most favorable overall product score. What attributes do thought leaders believe differentiate this drug from competing current and emerging therapies? Will any drugs in development challenge CAPOX plus bevacizumab as the future gold standard in 2011 or 2016?

  Scope:

Key drug development opportunity tested in our target product profiles for stage IV colorectal cancer: A therapy that improves median overall survival better than the IFL plus bevacizumab regimen for the first-line treatment of stage IV colorectal.

Physicians surveyed for this study: 60 U.S. oncologists.

Comprehensive List of Therapies Included in Our Research and Modeling

Current therapies:

- Oxaliplatin (Sanofi-Aventis’s Eloxatin/ Eloxatin, Yakult-Honsha’s Elplat)

- 5-fluorouracil, generics

- Leucovorin, generics

- Irinotecan (Pfizer’s Camptosar, Sanofi-Aventis’s Campto, Yakult-Honsha’s Topotecin)

- Capecitabine (Roche’s Xeloda)

- Bevacizumab (Roche/Genentech/Chugai’s Avastin)

Emerging therapies:

- Cetuximab (Bristol-Myers Squibb/ImClone Systems/Merck KGaA)

- Cediranib (AstraZeneca)

- Sunitinib (Pfizer)

About DecisionBase

Colorectal Cancer (Stage IV): Therapies Must Increase Overall Survival over IFL plus Bevacizumab to Reach Blockbuster Status is a DecisionBase 2008 study from Decision Resources. DecisionBase 2008 combines market forecasts with clinical and commercial end points to assess market share projections in 35 indications. These outputs are driven by quantitative and qualitative primary research. DecisionBase 2008 provides detailed market share, patient share, and price-per-day projections for emerging drugs in development. The market share projections are based on prescriber surveys that compare physicians’ expectations of a potential target product profile with an emerging product profile of the leading drugs in development.