Malignant Melanoma: KOL Insight

October 2015 | | ID: M798743756AEN
FirstWord

Abstracts

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

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Contents

1. EXECUTIVE SUMMARY

2. RESEARCH OBJECTIVES

3. RESEARCH FOCUS

3.1. Malignant malanoma treatment

4. MARKETED THERAPIES

4.1. Overview

5. IMMUNOTHERAPIES

5.1. Recently marketed drugs
5.2. Yervoy (ipilimumab; Bristol-Myers Squibb)
5.3. Keytruda (pembrolizumab; Merck & Co. )
5.4. Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical)

6. MEK INHIBITORS

6.1. Overview
6.2. Recently marketed drugs
6.3. Cotellic (cobimetinib; Exelixis/Roche)
6.4. Mekinist (trametinib; GlaxoSmithKline)

5. BRAF INHIBITORS

5.1. Overview
5.2. Recently marketed drugs
5.3. Zelboraf (vemurafenib; Roche/Genentech/Chugai)
5.4. Tafinlar (dabrafenib; GlaxoSmithKline)

6. MELANOMA VACCINES/IMMUNOSTIMULANTS

6.1. Overview Marketed drugs
6.2. M-Vax (melanoma vaccine; AVAX Technologies)

7. PIPELINE THERAPIES

7.1. Overview

8. C-KIT INHIBITORS

8.1. Overview
8.2. Masitinib (AB Science)

9. BRAF/MEK INHIBITORS

9.1. Overview
9.2. Encorafenib (Array Biopharma/Novartis) Binimetinib (Array Biopharma/ Novartis)

10. IMMUNOSTIMULANTS/VACCINES

10.1. Overview
10.2. T-VEC (Talimogene laherparepvec; Amgen) Zastumotide (GlaxoSmithKline) Seviprotimut-L (POL 103A; Polynoma) Eltrapuldencel-T (Caladrius Biosciences)

11. CONCLUSION

11.1. Current and future treatment algorithm

12. APPENDIX

12.1. KOL biographies
12.2. KOLs from North America KOLs from Europe