Niche Markets and Rare Diseases

September 2012

Niche Markets and Rare Diseases: Squamous Cell Carcinoma of the Head and Neck

Report Authors
Regina E. Jammen, M.S.
Donal Minihan, M.V.B., Ph.D.
  • Pages:148
  • Tables:85
  • Figures:11
  • Citations:195
  • Drugs:43
  • Interviews:11


Patients with squamous cell carcinoma of the head and neck (SCCHN)—a heterogeneous disease encompassing tumors of the oral cavity, pharynx, and larynx—suffer from high recurrence rates and few treatment choices. Progress has yet to be made with regard to finding biomarkers that can inform treatment choice. Elucidation of human papillomavirus (HPV) status for SCCHN tumors provides prognostic information, but, at this time, treatment is not differentiated between patients with HPV-positive and those with HPV-negative tumors. Thus, platinum-based therapy, induction therapy, and the EGFR inhibitor cetuximab (ImClone Systems/Merck Serono/Bristol-Myers Squibb’s Erbitux)—the only targeted therapy approved for SCCHN—are commonly used to treat both tumor types. Patients with SCCHN need new and optimized treatments to better manage disease recurrence in specific patient subsets, overcome resistance to platinum and anti-EGFR therapy, and extend overall survival.

Questions Answered in This Report:

  *   Certain subsets of SCCHN patients have a high level of unmet need. For example, patients with HPV-positive disease have a good prognosis but are likely to be overtreated with current therapies, and patients with oral cavity and soft palate tumors are typically treated with surgery but often suffer recurrence. Are there any treatments in clinical development likely to address the needs of these patients? Which patient subsets have the highest level of unmet need?

  *   EGFR is known to be overexpressed in SCCHN. Currently, cetuximab is the only EGFR inhibitor approved for SCCHN. What other EGFR inhibitors are in clinical development? What advantages do they offer over cetuximab? Will any of these emerging EGFR inhibitors launch between 2012 and 2021, and in which patients would they be used?

  *   Resistance to platinum-based therapy and cetuximab remains a problem in the recurrent/metastatic setting. What therapies are being investigated for patients with refractory SCCHN? Which of these therapies will launch between 2012 and 2021 and in which patients will they be used?

  *   Harnessing the immune system to prevent disease recurrence or combat residual disease is a strategy behind the use of vaccines and immunotherapies in other cancer indications. What vaccines or immunotherapies are in clinical development for SCCHN? Will any of them enter the SCCHN market? In which patients would they be used?


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

Primary research: 11 country-specific interviews with SCCHN experts: 1 surgeon, 1 radiation expert, and 9 medical oncologists.

Epidemiology: Diagnosed incidence segmented by stage I, II, III, IVA/IVB, and IVC SCCHN.

Population segments: Localized, locoregionally advanced, recurrent/metastatic SCCHN.

Emerging therapies: Phase I: 10; Phase II: 24 drugs; Phase III: 9 drugs.

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Mentioned in this report:

  • - Advaxis
  • - Amgen
  • - Ariad
  • - ArQule
  • - AstraZeneca
  • - Aveo
  • - Baxter
  • - Bayer
  • - Biocon Biopharmaceuticals
  • - Boehringer Ingelheim
  • - Boston Biomedical
  • - Bristol-Myers Squibb
  • - CEL-SCI
  • - Center of Molecular Immunology
  • - Curis
  • - Cyclacel
  • - Daiichi Sankyo
  • - Dainippon Sumitomo Pharma
  • - Eisai
  • - Eli Lilly
  • - EMD Serono
  • - Exelixis
  • - Genentech
  • - Genmab
  • - GlaxoSmithKline
  • - Gliknik
  • - Idera Pharmaceuticals
  • - ImClone Systems
  • - Intuitive Surgical
  • - Kyowa Hakko Kirin UK
  • - Ligand Pharmaceuticals
  • - Merck
  • - Merck KGaA
  • - Merck Serono
  • - Millennium
  • - Mylan
  • - Novartis
  • - Oncolytics Biotech
  • - OncoScience
  • - Oncosec Medical
  • - Oncothyreon
  • - Onyx
  • - OSI Pharmaceuticals
  • - PCI Biotech
  • - Pfizer
  • - Pierre Fabre
  • - Piramal Healthcare
  • - Roche
  • - Sanofi
  • - Symphogen
  • - Takeda
  • - VentiRx
  • - YM Bioscience
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