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Malignant Melanoma: KOL Insight

  • November 2015
  • -
  • Firstword Pharma

Malignant Melanoma: KOL Insight reveals the impact of immunotherapy on first-line treatment combination choices

The arrival of cancer immunotherapy in 2011 significantly changed the landscape for drugs used by oncologists for treating malignant melanoma. The availability of mutation testing is also impacting the choice of treatments, particularly for targeted therapies. With new approvals for Bristol-Myers Squibb’s Opdivo and Amgen’s T-VEC, the options available continue to grow
As the treatment landscape for malignant melanoma becomes more crowded, you need to understand how and why physicians are making complex decisions about their first-line drug choices. Find out what KOLs are saying about your brands, and the brands of your closest competitors

Answering Key Questions

Recently marketed drugs and vaccines
Yervoy (ipilimumab): Will the drug's adoption, gained from early approval, be threatened by new arrivals with better response rates and reduced toxicity?
Keytruda (pembrolizumab): What role does dosing schedule play in driving preference for this drug?
Opdivo (nivolumab): What concerns still underlie the positive reception of this recently approved therapy?
Cotellic (cobimetinib): Does combination therapy offer a way forward, and will its use depend on side-effects or pricing?
Mekinist (trametinib): For patients with BRAF mutations, what will be the driving factor for selection of combination therapy, and will safety concerns outweigh this in treatment decisions?
Zelboraf (vemurafenib): What is the impact of not having an approved combination on its label in relation to its use as a first-line therapy?
Tafinlar (dabrafenib): Does its side-effect profile give it an edge, or will it lose out if a cobimetinib and vemurafenib combination becomes available?
M-Vax: Has immunotherapy side-lined the role of vaccines in melanoma treatments because of the limited efficacy of vaccines? Or is it useful for a niche subset of patients?
Talimogene laherparepvec (T-VEC): While some activity has been shown, and there is potential benefit for a niche patient group, is this enough to overcome the restrictions and challenges presented by this recently-approved vaccination?

Pipeline drugs and vaccines

Masitinib: Should trials concentrate on the Far East where there is a higher-rate of c-KIT mutated melanoma in order to speed up possible access to an on-label option?
Encorafenib: Is the safety profile going to be enough to get physicians to switch treatments in an already crowded field?
Binimetinib: Is this just another 'me-too' third-line drug or do KOLs, waiting on Phase III trial results, think it has potential for NRAS-mutated patients?
Zastumotide: The results of NSCLC data from an adjuvant setting is already colouring the view of this vaccine. Does it have any future as a malignant melanoma treatment?
Seviprotimut-L (POL 103A): KOLs are still asking big questions about this vaccine – especially about potential results. Will it find a place in the treatment paradigm?
Eltrapuldencel-T: Will the complications of it as a treatment be a barrier to take-up if efficacy is proved?



Key issues explored

Which combinations are KOLs preferring to use as first-line treatments based on efficacy, toxicity and patient profiles?
How new drug combination approvals are likely to effect the first-line choice of treatments in future, and which KOLs are keen to be able to prescribe.
Whether the practical difficulties with resources for testing patients with c-KIT mutations will outweigh the benefits of using a different treatment pathway for relevant patients? Or does this targeting offer a real niche market?
What concerns exist about the sequencing of treatments?
Where KOLs think the alternatives to immunotherapy will find their niche with particular populations.
Some of the surprising factors that can influence choices – from availability of fridges and experience with injections, to paperwork and dosing schedules.
A round-up of the latest clinical trials for each drug included.


Contributors

KOLs from North America
Dr Richard W. Joseph, MD. Assistant Professor of Oncology, Mayo Clinic Health System, Florida, USA.
Dr Igor Puzanov, MD, MSCI, FACP. Associate Professor of Medicine, Vanderbilt University, Nashville, TN, USA.
Dr Rene Gonzalez, MD. Professor of Medicine, Division of Medical Oncology, University of Colorado Denver, USA.
Prof. Bartosz Chmielowski, MD, Ph.D. Assistant Professor, Department of Medicine, UCLA, CA, USA.
Dr Anthony Olszanski, MD, RPh. Medical Oncologist, Fox Chase Cancer Center, Philadelphia, PA, USA.
Dr Stergios Moschos MD. University of North Carolina at Chapel Hill, School of Medicine, UNC Lineberger, Carolina, USA.

KOLs from Europe

Dr Nicolas Blin, MD. Consultant Physician at Nantes University Hospital, France.
Dr J Mayordomo, Ph.D. Medical Director, Translational Research Unit, Albacete University Hospital, Spain.
Dr Maria Elisabetta Fratto, MD. Oncologist, University Campus Bio Medico, Rome, Italy.
German KOL, Prof. Dr. A chief consultant, head of the Clinical Cooperation Unit Dermato-oncology in the Department of Dermatology, Venereology and Allergology at the University Hospital.
Prof. Ruth Plummer, MA, DPhil, BMBCh, MD, FRCP. Consultant Medical Oncologist, Newcastle Upon Tyne Hospitals, UK.
Dr Marianne Nicolson, MD, FRCP. Consultant, Aberdeen Royal Infirmary, Scotland, UK.

Ongoing Benefits

The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.
Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update
Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date, Nov 2015
You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.

Table Of Contents

Malignant Melanoma: KOL Insight
1Executive summary
2Research Objectives
3Research Focus
31Malignant malanoma treatment
4Marketed therapies
41Overview
5Immunotherapies
51Recently marketed drugs?52Yervoy (ipilimumab; Bristol-Myers Squibb)?53Keytruda (pembrolizumab; Merck and Co)?54Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical)
6MEK inhibitors
61Overview?62Recently marketed drugs
63Cotellic (cobimetinib; Exelixis/Roche)
64Mekinist (trametinib; GlaxoSmithKline)
5BRAF inhibitors
51Overview?52Recently marketed drugs
53Zelboraf (vemurafenib; Roche/Genentech/Chugai)
54Tafinlar (dabrafenib; GlaxoSmithKline)

6Melanoma vaccines/immunostimulants
61Overview Marketed drugs
62M-Vax (melanoma vaccine; AVAX Technologies)
7Pipeline therapies
71Overview
8c-Kit inhibitors
81Overview?82Masitinib (AB Science)
9BRAF/MEK inhibitors
91Overview?92Encorafenib (Array Biopharma/Novartis) Binimetinib (Array Biopharma/ Novartis)
10Immunostimulants/vaccines
101Overview?102T-VEC (Talimogene laherparepvec; Amgen) Zastumotide (GlaxoSmithKline) Seviprotimut-L (POL 103A; Polynoma) Eltrapuldencel-T (Caladrius Biosciences)
11Conclusion
111Current and future treatment algorithm
12Appendix
121KOL biographies?122KOLs from North America KOLs from Europe

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