DecisionBase

June 2013

Malignant Melanoma (Unresectable)

Introduction:

As Vemurafenib and Ipilimumab Gain Traction in the Market, What Key Attributes Will Differentiate Emerging Therapies According to Oncologists and Payers?

High-profile drug approvals revolutionized the treatment paradigm for unresectable malignant melanoma. Bristol-Myers Squibb’s ipilimumab (Yervoy) and Roche/Genentech/Daiichi Sankyo/Chugai’s vemurafenib (Zelboraf) have demonstrated significant overall survival improvements over dacarbazine (Bedford Laboratories’ DTIC-Dome, generics), the traditional standard of care in the treatment of unresectable malignant melanoma. The approval of vemurafenib stratified the unresectable malignant melanoma population according to their BRAF mutational status—50% harbor the activating mutation. Exciting new agents for the treatment of both BRAF mutation-positive and -negative disease are on the horizon, and we anticipate these new entrants will deliver both efficacy and safety and tolerability benefits for patients, potentially revolutionizing treatment once more.

Questions Answered in This Report:

  *   Increased overall survival and increased time to disease progression are key goals in the treatment of unresectable malignant melanoma. 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 unresectable malignant melanoma?

  *   Increased overall survival and increased time to disease progression are key areas of unmet need for unresectable malignant melanoma, according to the insights of surveyed U.S. and European oncologists. Which therapies in development for unresectable malignant melanoma 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?

  *   Based on its clinical profile, and the presence of a predictive biomarker, vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf) 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 vemurafenib as the future gold standard in 2016 or 2021??

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for unresectable malignant melanoma:

- Median overall survival

- Median progression-free survival

- Objective response rate

- Rate of cutaneous squamous-cell carcinoma (all grades)

- Rate of neutropenia (all grades)

- Rate of diarrhea (all grades)

- Price per course

Attributes included in assessment of U.S. payers’ receptivity to new therapies for unresectable malignant melanoma:

- Effect on median overall survival

- Effect on progression-free survival

- Effect on BRAF-inhibitor-associated incidence of cutaneous squamous-cell carcinoma/keratoacanthoma

- Delivery burden

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

- Ipilimumab (Bristol-Myers Squibb’s Yervoy)

- Vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf)

- Dacarbazine (Bedford Laboratories’ DTIC-Dome, generics)

- Temozolomide (Merck & Co.’s Temodar/Temodal, generics)

- Interleukin-2 (Novartis/Prometheus’s Proleukin/Macrolin)

Emerging Therapies

- Dabrafenib (GlaxoSmithKline’s Tafinlar)

- Dabrafenib + trametinib (GlaxoSmithKline’s Mekinist)

- Nivolumab (Bristol-Myers Squibb/Ono Pharmaceuticals’ BMS-936558)

- Vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf) + cobimetinib (Roche/Genentech/Exelixis’s GDC-0973)

- Nanoparticle paclitaxel (Celgene’s Abraxane)


Search Reports

Mentioned in this report:

  • - Amgen
  • - Bayer Healthcare
  • - Bedford Laboratories
  • - Bristol-Myers Squibb
  • - Celgene
  • - Chugai
  • - Daiichi Sankyo
  • - Exelixis
  • - Genentech
  • - GlaxoSmithKline
  • - Merck & Co.
  • - Novartis
  • - Ono Pharmaceuticals
  • - Prometheus
  • - Roche
  • - Servier
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