DecisionBase PDFs

April 2008

Colon Cancer (Stage III): Therapies Must Increase Survival over FOLFOX to Reach Blockbuster Status

Introduction:

The stage III colon cancer market largely consists of two therapies: FOLFOX4 and CAPOX; few therapies are in development for this indication. Entering the adjuvant stage III colon cancer market is more achievable if the therapy already has proven efficacy and tolerability in metastatic colorectal cancer (mCRC). Indeed, no therapies are in Phase III trials for stage III colon cancer that are not already indicated for mCRC. We forecast the launch of two therapies into the stage III colon cancer market during our 2006-2016 study period: bevacizumab (Roche/Genentech/Chugai’s Avastin) and cetuximab (Bristol-Myers Squibb/ImClone Systems/Merck Serono’s Erbitux), both of which are currently available in the metastatic setting.

Questions Answered in This Report:

  *   Improving therapies’ effect on overall survival and disease-free survival is a key goal in the treatment of stage III colon cancer. 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 III colon cancer?

  *   With no novel agents launched since 2004, FOLFOX4 has become the standard of care for stage III colon cancer and the highest-selling regimen. Do thought leaders expect emerging therapies to offer significant improvements in efficacy, safety and tolerability, or delivery over FOLFOX4? Which emerging therapies pose the greatest threat to FOLFOX4? How will oncologists incorporate new therapies into their treatment of patients with stage III colon cancer?

  *   Although not approved for use in either the mCRC or the adjuvant stage III colon cancer setting, CAPOX is the 2006 clinical gold standard in our drug comparator model because of its superior clinical profile over the current therapies evaluated in this study. What attributes do thought leaders believe differentiate this drug from competing current and emerging therapies? Will any drugs in development challenge CAPOX as the future gold standard in 2011 or 2016?

Scope:

Key drug development opportunity tested in our target product profiles for stage III colon cancer: A therapy that improves disease-free survival over FOLFOX4 at three years for the treatment of stage III colon cancer.

Physicians surveyed for this study: 100 U.S. oncologists.

Comprehensive List of Therapies Included in Our Research and Modeling

Current therapies:

- FOLFOX4 (5-fluorouracil [5-FU; generics], leucovorin [LV; generics], and oxaliplatin [Sanofi-Aventis’s Eloxatin/Eloxatine, Yakult’s Elplat, generics])

- CAPOX (Roche’s capecitabine [Xeloda] and oxaliplatin)

- Capecitabine (Roche’s Xeloda)

Emerging therapies:

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

- Cetuximab (Bristol-Myers Squibb/ImClone Systems/Merck Serono’s Erbitux)

About DecisionBase

Colon Cancer (Stage III): Therapies Must Increase Survival over FOLFOX to Reach Blockbuster Status is a DecisionBase 2008 report 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.

Search Reports

Mentioned in this report:

  • Companies:
  • Bristol-Myers Squibb
  • Chugai
  • Daiichi-Sankyo
  • Genentech
  • ImClone Systems
  • Merck KGaA
  • Roche
  • Pfizer
  • Sanofi-Aventis
  • Yakult Honsha