Malignant Melanoma: KOL Insight

Malignant Melanoma: KOL Insight

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Published on Oct 17, 2014

Malignant Melanoma: PD-1 inhibitors revolutionise treatment is a comprehensive report with insights from 12 leading US and European KOLs offering their latest views on current and late-stage pipeline products, why and when they would prescribe them, and the factors likely to affect their future positioning and competitiveness.

The recent US approval of Merck's PD-1 inhibitor Keytruda (pembrolizumab) and the expected approval of BMS' Opdivo (nivolumab) are ushering in a major advance in the treatment of malignant melanoma. Early data indicate the PD-1 inhibitors provide high response rates, are effective across multiple patients groups and are better tolerated than existing therapies.

Despite limited data and clinical experience, KOLs are excited about the benefits, and the extension of these products into first line and adjuvant settings is anticipated. What impact will this class have on the role of current products, many of which have only been on the market for a few years?

Get Answers to Critical Questions
  • The PD-1 revolution: why do KOLs view Merck's Keytruda more favourably than BMS' Opdivo at this early stage?
  • Is a reliable biomarker for predicting response to PD-1 inhibitors on the horizon and will it affect prescribing?
  • What are the potential opportunities and risks for Yervoy/Opdivo combination therapy?
  • What "real world" experiences are influencing KOLs in their choice of Roche's Zelboraf or GSK's Tafinlar for BRAF inhibition and will either survive as monotherapies?
  • Combination therapy is being widely investigated - which drug combinations do KOLs view positively, and why?
  • How do KOLs view BMS' Yervoy (ipilimumab) as an adjuvant therapy and could new clinical trial results change attitudes about efficacy, tolerability and cost-benefit?
  • With little research to indicate best practice, drug sequencing is a critical issue for KOLs - what could the industry do to help?
  • Vaccines, T-VEC, c-KIT inhibitors: what next generation development approaches are in the pipeline and do KOLs think they will represent a further breakthrough?
Key Benefits
  • Know the detailed views and opinions of leading front line clinicians on current and future malignant melanoma treatments and what they see as critical advantages/disadvantages affecting their decision to prescribe.
  • Appreciate the important factors affecting the fast changing malignant melanoma sector to identify the key battlegrounds for market share.
  • Evaluate the potential impact of PD-1 and PD-L1 inhibitors on established treatments and determine what role they might play as first, second or third line options. Know the product combinations which are viewed as the most promising to remove uncertainty about the future treatment landscape.
  • Understand the critical need of drug sequencing data to establish best practice for good clinical outcomes.
  • Evaluate the role that biomarkers could play in the malignant melanoma market to assess future patient opportunities.
Key Takeaways
  • Know the concerns of KOLs and formulate effective strategies for clinician communication
  • Map current treatment options to metastatic melanoma patient groups
  • Identify critical areas of clinical research aimed at clarifying important unanswered questions
  • Evaluate the changing competitive landscape
  • Review next generation development approaches and identify opportunity areas
KOL Panel

North America
  • Dr. Philip Friedlander, Director of the Melanoma Medical Oncology Program, Mount Sinai Hospital, New York
  • Dr. Roger Lo, Assistant Professor of Medicine/Dermatology and Molecular and Medical Pharmacology, UCLA School of Medicine and the Jonsson Comprehensive Cancer Center, California
  • Dr. Kim Margolin, Clinical and Research Director of Melanoma and Renal Cancer Clinical Trials Group, University of Washington Fred Hutchinson Cancer Research Center, Seattle
  • Dr. Janice Mehnert, Translational Medical Oncologist, Professor and Director, Rutgers Cancer Institute of New Jersey
  • Dr. Igor Puzanov, Associate Director of Phase I Drug Development Program, Clinical Director of Renal Cancer and Associate Professor of Medicine in the Division of Hematology-Oncology, Vanderbilt University Medical Center, Tennessee
Europe
  • Prof Salvador Algarra, Associate Professor, Faculty of Medicine, University of Navarra, Pamplona, Spain
  • Prof Reinhard Dummer, Professor and Vice Chairman, Department of Dermatology, University Hospital of Zurich, Switzerland
  • Prof Jean-Jacques Grob, Head of Dermatology and Skin Cancer Department, Aix-Marseille University Hospital Timone, Marseille, France
  • Anonymous European KOL
  • & 3 Anonymous German Key Opinion Leaders
KOL Quotes

"Both pembrolizumab and nivolumab are well tolerated, and probably much better tolerated than ipilimumab, although there is also the potential for autoimmunity [with the PD-1 inhibitors], which is quite impressive. Unlike ipilimumab, the PD-1 inhibitors exert a direct effect on the tumour, so we are seeing clinical responses quite quickly in a substantial portion of patients. The response rates are very low with ipilimumab. With the PD-1 inhibitors, we have higher clinical response rates and we have a longer duration of the response." EU Key Opinion Leader

"Even though they [ipilimumab and the targeted agents] represent enormous progress, they are still largely ineffective. So, I always put my patients on a clinical trial. For most solid tumour malignancies, there is a myth in this country [US] that clinical trials are just an act of philanthropy, but I think the melanoma community has really proven that wrong. The SOC [standard of care] in this disease still remains a clinical trial." US Key Opinion Leader

"It seems that the MEK inhibitors, after failure of BRAF inhibitor monotherapy, do not have additional efficacy, so if you start with a monotherapy of dabrafenib for example, and you then use Mekinist, it is not of any benefit. So, you have to either start off with the combination right away, or use some other therapy." EU Key Opinion Leader

"Running trials for melanoma is going to become very difficult, because there will be fewer patients and the trials will take forever. If the benchmark is median survival of 40 [months], in order to beat it your benchmark becomes median survival of 50 or 60 [months] and who is going to run these trials? This is why I think the companies who have PD-1 or PD-L1 will completely dominate the field, and the others will just die away." US Key Opinion Leader

Ongoing Benefits