Considerable advances in diagnostic and surgical techniques
for high-grade glioma including glioblastoma multiforme (GBM), the focus of
this report and widely known as glioblastoma, have been made in recent decades,
and adjuvant radiotherapy and chemotherapy, namely Merck & Co.’s
temozolomide (Temodar/Temodal, generics), have shown clinical benefits. Despite
these advances in treatment, only moderate improvements in median overall
survival (MOS) have been made for GBM patients and prognosis remains poor. The
MOS for GBM is approximately 15 months, at best. Further, resistance to
chemotherapy is common, and the majority of GBM patients experience disease
recurrence. As such, considerable opportunity awaits emerging agents that can
improve outcomes over the existing standard of care (temozolomide used
concurrently with radiotherapy, then as a monotherapy adjuvant treatment).
Several promising agents from a range of drug classes are under development for
newly diagnosed GBM and are being evaluated as add-ons to chemoradiotherapy.
Questions Answered in This Report:
Extending overall survival (OS) and progression-free survival
(PFS) and improving health-related quality of life are key goals in the
treatment of newly diagnosed GBM. 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 specific
efficacy end points and other drug attributes in their prescribing decisions
for newly diagnosed GBM?
Merck’s temozolomide is the 2010 major-market sales leader for
newly diagnosed GBM. What
weaknesses exist in its profile that would allow emerging therapies to gain a
foothold in the market? Have emerging therapies demonstrated potential on the
attributes that surveyed oncologists indicate are the most important in their
prescribing decisions? Which emerging therapies boast advantages on the
attributes that surveyed managed care organization pharmacy directors (MCO PDs)
point to as the most important in their tier placement decisions?
Based on its clinical profile, temozolomide is the current
clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe
differentiate this therapy from competing current and emerging therapies? Will
any therapies in development challenge temozolomide as the future gold standard
in 2015 or 2020?
development opportunity tested in our target product profiles for newly
diagnosed GBM: A therapy that, when added to temozolomide, increases
median overall survival compared with temozolomide alone in newly diagnosed
surveyed: 61 U.S. and 32
surveyed: 21 U.S. MCO PDs.