Dermatological Conditions, Cancer Immunotherapy CME ACCREDITED Watch Time: 37 mins

touchEXPERT OPINIONS A patient’s journey through the immuno-oncology treatment landscape in melanoma

Watch leading experts explore the impact of immunotherapy incorporating PD-1 blockade on the treatment landscape and patient experience in melanoma.

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Prof. James Larkin
The Royal Marsden NHS Foundation Trust, London, UK
Optimizing PD-1 blockade in melanoma: Factors associated with patient selection

Prof. James Larkin summarizes key factors guiding patient selection for treatment with PD-1 inhibitors and evaluates the current clinical value of prognostic and predictive biomarkers, including PD-L1 and emerging biomarkers, in melanoma.

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Interview Questions

In this interview, Prof. James Larkin answers the following questions:

  • Which patients with melanoma are eligible for treatment with PD-1 inhibitors?
  • What is the utility of PD-L1 expression as a predictive biomarker in selecting patients most likely to benefit from PD-1 blockade?
  • What other patient- and/or disease-related factors are important for anti-PD-1 treatment selection?
  • How does the safety profile affect making decisions between single-agent and combination anti-PD-1 therapy?
  • Which novel prognostic and predictive biomarkers might help to optimize therapeutic application of PD-1 inhibitors in melanoma?
About Prof. James Larkin

James Larkin, MD, PhD, is a Consultant Medical Oncologist specializing in the treatment of melanoma and cancers of the kidney. read more

His research interests involve trying to understand cancer and its consequences better, as well as developing improved treatments, particularly with targeted therapies and immunotherapies.

In 2018 he was elected as a Fellow of the Academy of Medical Sciences. Since 2019 he has been Vice Chair of the Medical Oncology Specialist Advisory Committee for the Joint Royal Colleges of Physicians Training Board and in 2020 he was appointed as an National Institute of Health Research senior investigator.

He serves as a senior clinical adviser to Cancer Research UK, as a medical advisor to the patient advocacy group Melanoma UK, as a trustee of the Kidney Cancer Support Network and serves on the Medical Advisory Board of the International Kidney Cancer Coalition.

Prof. James Larkin discloses: Consultancy fees from Achilles, AstraZeneca, Boston Biomedical, Bristol-Myers Squibb, Eisai, EUSA Pharma, GlaxoSmithKline, Ipsen UltraGenyx, Imugene, Incyte, iOnctura, Kymab, Merck Serono, Merck Sharp & Dohme, Nektar, Novartis, Pierre Fabre, Pfizer, Roche/Genentech, Secarna, Vitaccess.

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Prof. Reinhard Dummer
University Hospital of Zürich, Switzerland
Maximizing therapeutic potential of PD-1 blockade in combination treatment regimens

Prof. Reinhard Dummer reviews the mechanistic rationale underpinning anti-PD-1-based treatment regimens in melanoma before appraising the latest clinical data surrounding emerging novel treatment strategies incorporating PD-1 inhibitors with new and existing agents, alongside their potential impact on treatment sequencing options in future.

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Interview Questions

In this interview, Prof. Reinhard Dummer answers the following questions:

  • What is the rationale for immune checkpoint blockade in treatment regimens for melanoma?
  • What impact is PD-1 blockade having on outcomes in melanoma?
  • How is PD-1 blockade being deployed in combination with other agents approved in melanoma?
  • What other novel therapeutic approaches incorporating PD-1 blockade are on the horizon in melanoma?
  • How might PD-1 blockade influence treatment sequencing options in future?
About Prof. Reinhard Dummer

Reinhard Dummer, MD, is Professor and Vice-Chairman of the Department of Dermatology at the University of Zurich and University Hospital of Zürich, Switzerland, where he currently leads the Skin Cancer Unit and the Clinical Trial Unit. read more

Prof. Dummer’s principal research interests are molecular biology, immunology and immunotherapy of cutaneous malignancies, including cutaneous lymphomas and melanomas.

He is a founding and board member of the European Association of Dermato-Oncology, European Society of Medical Oncology, Undergraduate Research Participation Pool and Past President of the European Society for Dermatological Research. He is Past-President of the Melanoma Project Group of the Swiss Institute for Applied Cancer Research from 1999 to 2016, is a member of German National Academy of Sciences (Leopoldina) and is past board member of the Society for Melanoma Research and Past President of the International Society for Cutaneous Lymphomas.

Prof. Reinhard Dummer discloses: Consultancy and/or advisory board fees from Alligator, AmGen, Bristol-Myers Squibb, Catalym, Merck Sharp & Dohme, Novartis, Pierre Fabre, Regeneron, Roche, Sanofi, Second Genome, Sun Pharma, Takeda.

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Prof. Caroline Robert
Goustave Roussy, Paris, France
Impact of PD-1 inhibitors on patient journey and treatment experience: Learnings from long-term and real-world data

Prof. Caroline Robert explores the long-term impact of PD-1 blockade in melanoma and contextualizes factors informing treatment discontinuation decisions to highlight the critical importance of the patient–physician dynamic in optimizing the patient journey through the immuno-oncology treatment landscape in melanoma.

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Interview Questions

In this interview, Prof. Caroline Robert answers the following questions:

  • How are long-term efficacy and safety data for PD-1 blockade impacting patient outcomes in melanoma?
  • What impact does earlier intervention with immune checkpoint blockade in the adjuvant setting have on long-term outcomes?
  • How do recent 5-year follow-up data with dabrafenib plus trametinib in the adjuvant setting contribute to our understanding of long-term survival?
  • When is it appropriate to discontinue PD-1 blockade in patients with melanoma?
  • How important are patient–physician conversations in managing the expectations of patients with melanoma during their treatment journey?
About Prof. Caroline Robert

Caroline Robert, MD, PhD, is the Head of the Dermatology Service at Gustave Roussy Cancer Campus and Co-director of the Melanoma Research Unit at INSERM 981, Paris-Sud University. read more

Her main interests are clinical and translational research on melanoma involving immunotherapy and targeted therapy.

She is national and international coordinator of many clinical trials investigating targeted therapy and immunotherapy for melanoma patients. She has authored more than 350 peer-reviewed articles, including a number of publications on new treatments for metastatic melanoma. She is Past-President of the melanoma group of the European Organization for the Research and Treatment of Cancer, and is a board member for the European Association of Onco-Dermatology, the European Society of Medical Oncology, the European Association of Dermato-Venereology, the French Society of Dermatology and Venereology, the American Society of Oncology, and the American Association of Clinical Research.

Prof. Caroline Robert discloses: Consultancy fees from Biothera, Bristol-Meyers Squibb, CureVac, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi.

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Overview & Learning Objectives
Overview

In this activity, leading dermato-oncology experts explore the impact of immune checkpoint inhibition with PD-1 blockade on the treatment landscape and patient experience in melanoma.

This activity has been jointly provided by Oakstone and touchIME IMMUNOLOGY.  Oakstone Publishing is accredited by the ACCME to provide continuing medical education to physicians. read more

Target audience

This activity is designed to meet the educational needs of oncologists, and in particular, dermato-oncologists specializing in skin cancer, dermatologists, primary care physicians, nurses, pharmacists and other HCPs worldwide involved in the treatment and care of patients with melanoma.

Disclosures

Prof. James Larkin discloses: Consultancy fees from Achilles, AstraZeneca, Boston Biomedical, Bristol-Myers Squibb, Eisai, EUSA Pharma, GlaxoSmithKline, Ipsen UltraGenyx, Imugene, Incyte, iOnctura, Kymab, Merck Serono, Merck Sharp & Dohme, Nektar, Novartis, Pierre Fabre, Pfizer, Roche/Genentech, Secarna, Vitaccess.

Prof. Reinhard Dummer discloses: Consultancy and/or advisory board fees from Alligator, AmGen, Bristol-Myers Squibb, Catalym, Merck Sharp & Dohme, Novartis, Pierre Fabre, Regeneron, Roche, Sanofi, Second Genome, Sun Pharma, Takeda.

Prof. Caroline Robert discloses: Consultancy fees from Biothera, Bristol-Meyers Squibb, CureVac, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi.

Oakstone Publishing has assessed conflict of interest with its faculty, authors, editors, and any individuals who were in a position to control the content of this CME activity. Any identified relevant conflicts of interest were resolved for fair balance and scientific objectivity of studies utilized in this activity.

Content Reviewer

Walter Murray Yarbrough, MD has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Kathy Day has no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

Oakstone Publishing designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™️. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

In order to receive credit for this activity, participants must review and complete the post-test and evaluation form. A score of 70% or higher is needed to obtain CME credit. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AME).  European physicians interested in converting 0.5 AMA PRA Category 1 Credit™ into European CME credit (ECMEC) should contact the UEMS (www.uems.eu)

Date of original release: 6 January 2021.  Date credits expire: 6 January 2022.

Learning Objectives

After watching this touchEXPERT OPINIONS, you should better be able to:

  • Discuss factors to consider when selecting PD-1 inhibitors to treat melanoma
  • Understand the rationale for combination regimens incorporating PD-1 blockade
  • Analyse the role of long-term clinical and real-world data in informing treatment decisions

This content is intended for healthcare professionals only. Please confirm that you are a healthcare professional.

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Question 1/4
Which of the following statements best reflects the role of PD-L1 expression as a biomarker for the selection of anti-PD-1 therapy in patients with melanoma?
Correct

With the exception of BRAF mutational status as a validated biomarker for BRAF therapy, there are currently no established predictive biomarkers.1 PD-L1 is an imperfect biomarker with limited clinical utility as a predictive biomarker in melanoma.2

Abbreviations
BRAF, B-Raf proto-oncogene; PD-1, programmed cell death protein-1; PD-L1, programmed death ligand-1; WT, wild-type.

References

  1. Keilholz U, et al. Ann Oncol. 2020;S0923-7534(20)39939-7.
  2. Michelin O, et al. Ann Oncol. 2019;30:1884–1901.
Question 2/4
In the CheckMate-067 trial comparing combination anti-PD-1/anti-CTLA-4 immunotherapy with single-agent PD-1 or CTLA-4 blockade in treatment-naive advanced melanoma, which immunotherapy regimen achieved the highest OS rate at 5 years?
Correct

In the CheckMate-067 trial, OS was 52% in patients treated with combination anti-CTLA-4/anti-PD-1 (ipilimumab/nivolumab) and 44% in patients receiving single-agent PD-1 (nivolumab), compared with 26% in the single-agent anti-CTLA-4 (ipilimumab) cohort.

Abbreviations
CTLA-4, cytotoxic T-lymphocyte associated antigen-4; OS, overall survival; PD-1, programmed cell death protein-1.

Reference
Larkin J, et al. New Engl J Med. 2019;381:1535–46.

Question 3/4
A patient is diagnosed with stage IV BRAF-mutated melanoma. The patient has elevated LDH >2x ULN and ECOG PS 0, and has no history of autoimmune disease. What first-line therapy would you consider for this patient based on available evidence-based recommendations?
Correct

For patients with BRAF-mutated metastatic melanoma and elevated LDH, first-line combination therapy with anti-CTLA-4 (ipilimumab) and anti-PD-1 (nivolumab) is broadly preferred over TT with BRAFi/MEKi, depending on presence of other adverse prognostic factors. For patients with LDH >1x and ≤2x ULN, anti-PD-1 monotherapy is an option.1,2

Abbreviations
BRAF, B-Raf proto-oncogene; BRAFi, BRAF inhibitor; CTLA-4, cytotoxic T-lymphocyte associated antigen-4; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; MEKi, mitogen-activated protein kinase kinase inhibitor; PD-1, programmed cell death protein-1; TT, targeted therapy; ULN, upper limit of normal.

References

  1. Keilholz U, et al. Ann Oncol. 2020;S0923-7534(20)39939-7.
  2. Michelin O, et al. Ann Oncol. 2019;30:1884–1901.
Question 4/4
What were the key survival data reported in the KEYNOTE-022 trial evaluating triplet therapy incorporating PD-1 blockade with TT in advanced BRAF-mutant melanoma?
Correct

In the recent Phase II KEYNOTE-022 trial, triplet therapy with anti-PD-1 (pembrolizumab) in combination with TT (dabrafenib plus trametinib) achieved numerically prolonged PFS (16.0 months) compared with doublet TT alone (10.3 months; HR 0.66; p=0.043). Median OS was not reached in the triplet arm.

Abbreviations
HR, hazard ratio; PD-1, programmed cell death protein-1; OS, overall survival; PFS, progression-free survival; TT, targeted therapy.

Reference
Ascierto PA, et al. Nat Med. 2019;25:941–6.

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