DecisionBase

June 2012

Glioblastoma (Newly Diagnosed): Avastin’s Future Hangs in the Balance as Oncologists Await Phase III Data—Which Other Emerging Drugs Excite Them?

Introduction:

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?

Scope:

Key drug 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 glioblastoma.

Physicians surveyed: 61 U.S. and 32 European oncologists.

Payers surveyed: 21 U.S. MCO PDs.


Search Reports

Mentioned in this report:

  • Current Therapies:
  • - Temozolomide (Merck & Co.’s Temodar/Temodal, generics)
  • - Carmustine implant (Eisai/Nobelpharma’s Gliadel Wafer)
  • - Bevacizumab (Roche/Genentech/Chugai’s Avastin)
  • Emerging Therapies:
  • - Bevacizumab + temozolomide (Roche/Genentech/Chugai’s Avastin + Merck & Co.’s Temodar/Temodal, generics)
  • - Cilengitide + temozolomide (Merck KGaA’s EMD-121974 + Merck & Co.’s Temodar/Temodal, generics)
  • - Nimotuzumab + temozolomide (YM BioSciences/Oncoscience/Daiichi Sankyo’s TheraCIM/Theraloc + Merck & Co.’s Temodar/Temodal, generics)
  • - Rindopepimut + temozolomide (Celldex Therapeutics’ CDX-110 + Merck & Co.’s Temodar/Temodal, generics)
  • - ICT-107 + temozolomide (ImmunoCellular Therapeutics)
  • Companies:
  • - Baxter
  • - Bristol-Myers Squibb
  • - Celldex Therapeutics
  • - Chugai
  • - Daiichi Sankyo
  • - Eisai
  • - Genentech
  • - ImmunoCellular Therapeutics
  • - Merck & Co.
  • - Merck KGaA
  • - Nobelpharma
  • - Oncoscience
  • - Pfizer
  • - Roche
  • - Servier
  • - YM BioSciences
  • - Yakult Honsha
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