DecisionBase

April 2013

Extensive-Disease Small-Cell Lung Cancer (Newly Diagnosed)

Introduction:

How Receptive Would Oncologists and Payers Be to Therapies That Partially Address the Unmet Needs of Patients with Advanced Disease?

In 2012, there were an estimated 59,000 patients with newly diagnosed, extensive-disease small-cell lung cancer (ED-SCLC) in the major markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan), most of whom would be offered the same standard of care that has been used for past decades. With median overall survival at just under one year, there is dire need for new therapies that can dramatically improve survival. In the absence of validated biomarkers, clinical development of new therapies has been challenging; however, several new therapies, all in different drug classes, are currently making their way through clinical development and have generated interest in leading SCLC experts.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including overall survival (OS), is important for drug approval and physician use. What are the key primary and secondary clinical trial end points on which new therapies are evaluated? How do U.S. and European oncologists weight efficacy measures and other drug attributes in their prescribing decisions for newly diagnosed ED-SCLC?

  *   Increased overall survival rate, reduced disease progression rate, and increased tumor response are key areas of unmet need for newly diagnosed ED-SCLC, according to the insights of surveyed U.S. and European oncologists. Which therapies in development for newly diagnosed ED-SCLC are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   Effect on overall survival, rate of hematological toxicity, and frequency of administration are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new ED-SCLC therapies. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging therapies for the treatment of ED-SCLC? Based on the trade-offs in price and performance across key drug attributes that U.S. oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for ED-SCLC?

  *   Based on its clinical profile, a regimen of etoposide (Bristol-Myers Squibb’s Etopophos/VePesid, generics) and carboplatin (generics) 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 etoposide/carboplatin as the future gold standard in 2016 or 2021?

Scope:

Attributes included in conjoint-analysis-based assessment of target product profiles for newly diagnosed ED-SCLC:

- Effect on overall survival

- Effect on disease progression

- Improvements in tumor response

- Hematological toxicity

- Route of administration

- Frequency of administration

- Price

Attributes included in assessment of U.S. payers’ receptivity to new therapies for newly diagnosed ED-SCLC:

- Improvement in overall survival 

- Effect on disease progression

- Effect on tumor response

- Effect on hematological toxicities

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

Payers surveyed: 20 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Etoposide (Bristol-Myers Squibb’s Etopophos/VePesid, generics) + carboplatin (generics)

- Etoposide (Bristol-Myers Squibb’s Etopophos/VePesid, generics) + cisplatin (generics)

Emerging Therapies

- Palifosfamide (Ziopharm Oncology’s Zymafos)

- Ipilimumab (Bristol-Myers Squibb’s Yervoy)

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

- Lorvutuzumab mertansine (Immunogen’s IMGN-901)

- Obatoclax (Teva)


Search Reports

Mentioned in this report:

  • - Baxter
  • - Bristol-Myers Squibb
  • - Celgene
  • - Chugai
  • - Daiichi
  • - Eli Lilly
  • - Genentech
  • - GlaxoSmithKline
  • - Kyowa Hakko Kirin
  • - MolMed
  • - Nippon Kayaku
  • - Pfizer
  • - Polaris Group
  • - Roche
  • - Sanofi
  • - Synta
  • - Teva
  • - Yakult
  • - Ziopharm Oncology
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