June 2013

Colorectal Cancer (Second-Line Metastatic)


As the Second-Line Treatment Setting for Colorectal Cancer Becomes More Crowded, How Will Oncologists and Payers Differentiate Among New Therapies?

Across the major pharmaceutical markets, the second-line metastatic colorectal cancer (mCRC) incident population exceeded 150,500 patients in 2012, according to Decision Resources estimates. With median overall survival at less than 16 months, there is need for new therapies that can improve survival and/or delay tumor progression. Several new therapies belonging to different drug classes are currently being developed for the treatment of mCRC in the second-line setting; from these drugs, Decision Resources anticipates the launch of yet another antiangiogenic agent with potentially appealing characteristics that differentiate it from other therapies in this class.

Questions Answered in This Report:

  *   A drug’s performance on at least four 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-line mCRC?

  *   Increased overall survival, delayed disease progression, increased tumor response, and lower rates of neurotoxicities and gastrointestinal toxicities are key areas of unmet need for second-line mCRC, according to the insights of surveyed U.S. and European oncologists.  Which therapies in development for second-line mCRC 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?

  *   Overall survival and progression-free survival are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new second-line mCRC 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 the treatment of second-line mCRC? 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 second-line mCRC?

  *   Based on its clinical profile, bevacizumab (Genentech/Roche/Chugai’s Avastin) in combination with FOLFIRI (5-fluorouracil [generics], leucovorin [generics], irinotecan [Pfizer’s Camptosar/Campto, Daiichi Sankyo’s Topotecin, Yakult Honsha’s Campto, generics]) 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 bevacizumab/FOLFIRI as the future gold standard for 2016 or 2021?


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

- Median overall survival

- Median progression-free survival

- Overall response rate

- Rate of grade 3/4 hypertension

- Rate of grade 3/4 diarrhea

- Rate of all grades acne-like rash

- Price per 28-day cycle

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

- Median overall survival

- Median progression-free survival

- Rate of gastrointestinal toxicities

- Rate of cardiovascular toxicities

Physicians surveyed: 60 U.S. and 30 European oncologists

Payers surveyed: 20 U.S. managed care organization pharmacy directors (MCO PDs)

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Bevacizumab/FOLFIRI

- Aflibercept (Regeneron/Sanofi’s Zaltrap)/FOLFIRI

- Cetuximab (BMS/Merck Serono/ImClone Systems’ Erbitux)/irinotecan

- Panitumumab (Amgen/Takeda’s Vectibix)/FOLFIRI


Emerging Therapies

- Ramucirumab (ImClone Systems)/FOLFIRI

- Regorafenib (Bayer’s Stivarga)/FOLFIRI

- Buparlisib (Novartis’s BKM-120)/panitumumab (Amgen/Takeda’s Vectibix)

- Imgatuzumab (Roche’s GA201/RO5083945/RG7160/R7160)/FOLFIRI

- Reolysin (Oncolytics Biotech)/FOLFIRI

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Mentioned in this report:

  • - Amgen
  • - Bayer HealthCare
  • - Bristol-Myers Squibb
  • - Chugai
  • - Daiichi Sankyo
  • - Genentech
  • - ImClone Systems
  • - Keryx Biopharmaceuticals
  • - Merck Serono
  • - Novartis
  • - Oncolytics Biotech
  • - Pfizer
  • - Regeneron
  • - Roche
  • - Sanofi
  • - Takeda
  • - Yakult Honsha
Decision Resources Group brands include: