Treatment of colorectal cancer (CRC) represents a multibillion-dollar market. CRC is one of the most common forms of cancer in both men and women. Over the next ten years, the number of incident cases of CRC in the major pharmaceutical markets under study will increase as the aging population continues to expand and patients continue to be identified through screening efforts. Despite the establishment of an effective standard of care in the early-line setting, unmet need, and thus opportunity, remains for more-effective therapies in later-line treatment.

Questions Answered in This Report:

  • Although it has been well established that patients with KRAS mutations in exon 2 do not benefit from EGFR inhibitors, it has now been shown that patients with KRAS mutations in exon 3 and 4, as well as mutations in NRAS, also do not benefit from EGFR inhibitors. How will this shrinkage of the eligible population of EGFR inhibitors affect medical practice in the major markets, and what will be the impact on drug sales?

  • The CALGB 80405, FIRE-3, and PEAK studies have investigated the role of angiogenesis inhibitors and EGFR inhibitors in the first-line treatment of KRAS/RAS wild-type patients. What are oncologists’ perceptions of the efficacy of EGFR and angiogenesis inhibitors? Which of these agents do physicians prefer to prescribe in the first line? Has prescribing patterns changed as a result of these studies?

  • The launches of (ziv)-aflibercept (Regeneron/Sanofi’s Zaltrap) and regorafenib (Bayer HealthCare’s Stivarga) have given CRC patients more therapeutic options. What has been the uptake of these new therapies? What are oncologists’ perceptions of them? Have (ziv)-aflibercept and regorafenib managed to differentiate themselves from more-established drugs?

  • The emerging therapies ramucirumab (Eli Lilly), TAS-102 (Taiho Pharmaceutical), HA-irinotecan (Alchemia Oncology), and nintedanib (Boehringer Ingelheim) will compete against similar therapies in the CRC market. What advantages do oncologists believe these therapies have over current therapies? In what settings are physicians likely to prescribe these agents?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 23 country-specific interviews with thought leaders.

Epidemiology: Numbers of newly diagnosed cases of colon and rectal cancer per year, segmented according to the AJCC/UICC stages I-IV at time of diagnosis.

Population segments in market forecast: Stage II colon cancer; stage II rectal cancer; stage III colon cancer; stage III rectal cancer; stage IV CRC: first-line treatment populations include wild-type and mutated RAS; stage IV CRC: second-line treatment populations include wild-type and mutated RAS; stage IV CRC: third-line treatment populations include wild-type and mutated RAS; fourth-line treatment populations include wild-type and mutated RAS.

Emerging therapies: Phase II: 17 drugs; Phase III: 8 drugs; registered: 1 drug. Coverage of 5 Phase I products.

Market forecast features: Using a proprietary patient-flow model that incorporates mortality, we forecast population sizes and drug sales for first-, second-, third-, and fourth-line segments through 2023. The market forecast for metastatic patient populations are split according to RAS status (wild-type or mutated).

Author(s): Daniel Roberts, Ph.D.
Anouchka Seesaghur, M.B.B.S., M.P.H.

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