DecisionBase

May 2013

Ovarian Cancer (Platinum-Resistant Advanced)

Introduction:

Are Emerging Targeted Therapies Poised to Fill the Significant Unmet Need for This Difficult-to-Treat Patient Population?

In 2011, more than 50,000 cases of epithelial ovarian cancer (CaO) were reported in the seven major pharmaceutical markets we cover; the majority (77%) were diagnosed with advanced disease. Treatment in the advanced setting is largely palliative, and following first-line treatment with platinum-based therapy, disease that recurs rapidly (within six months) is considered platinum-resistant. Treatment of platinum-resistant CaO is limited to non-platinum-based chemotherapies given as monotherapies, such as pegylated liposomal doxorubicin (PLD; Janssen Biotech’s Doxil/Caelyx) or paclitaxel (Bristol-Myers Squibb’s Taxol, generics). Unlike current treatment for platinum-sensitive patients, treatment in the platinum-resistant setting typically yields low tumor response rates, and patients experience shorter progression-free survival and overall survival. Commercial opportunity awaits therapies that can provide greater survival benefits to CaO patients than the current standards of care.

Questions Answered in This Report:

  *   Delaying disease progression and improving overall survival are key goals in the treatment of platinum-resistant advanced CaO. What are the key primary and secondary clinical trial end points on which new therapies are evaluated? How do U.S. and European medical oncologists weight specific efficacy end points and other drug attributes in their prescribing decisions for platinum-resistant advanced CaO?

  *   PLD is the 2011 major-market sales leader for platinum-resistant advanced CaO. What weaknesses in its profile would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated strengths on the attributes that surveyed medical oncologists indicate are most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  *   Overall survival and progression-free survival are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new platinum-resistant advanced CaO therapies. What trade-offs on these and other clinical attributes are U.S. medical oncologists willing to make when considering the use of emerging therapies for the treatment of platinum-resistant advanced CaO? Given the trade-offs in price and performance across key drug attributes that U.S. medical oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for platinum-resistant advanced CaO? Based on its clinical profile, PLD monotherapy is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge PLD as the future gold standard in 2016 or 2021?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for platinum-resistant advanced CaO:

- Overall survival

- Progression-free survival

- Overall response rate

- Rate of ≥ grade 2 peripheral neuropathy

- Rate of ≥ grade 2 hand-foot syndrome

- Rate ≥ grade 3 of hypertension

- Price per 28-day cycle

Attributes included in assessment of U.S. payers’ receptivity to new therapies for platinum-resistant advanced CaO:

- Effect on progression-free survival

- Effect on overall survival

- Risk of grade ≥ 2 peripheral neuropathy

- Risk of grade ≥ 2 hand-foot syndrome

Physicians surveyed: 60 U.S. and 30 European medical oncologists

Payers surveyed: 20 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Pegylated liposomal doxorubicin (PLD) (Janssen Biotech’s Doxil/Caelyx)

- Topotecan (GlaxoSmithKline’s Hycamtin, generics)

- Gemcitabine (Eli Lilly’s Gemzar, generics)

- Weekly paclitaxel (Bristol-Myers Squibb’s Taxol, generics)

Emerging Therapies

- Bevacizumab (Roche/Genentech/Chugai’s Avastin) + PLD

- Bevacizumab + weekly paclitaxel

- Trebananib (Amgen/Takeda Pharmaceutical’s AMG-386) + weekly paclitaxel

- Vintafolide (Merck’s EC-145) + PLD

- Olaparib (AstraZeneca’s AZD-2281)


Search Reports

Mentioned in this report:

  • - Amgen
  • - AstraZeneca
  • - Bristol-Myers Squibb
  • - Centocor Ortho Biotech
  • - Chugai
  • - Eisai
  • - Eli Lilly
  • - Endocyte
  • - Genentech
  • - GlaxoSmithKline
  • - Janssen Biotech
  • - Merck
  • - PharmaMar
  • - Roche
  • - Takeda Pharmaceutical
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