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