Dermatological Cancer, Immunotherapy CME ACCREDITED Watch Time: 37 mins

touchEXPERT OPINIONS Navigating the emerging complexities of melanoma treatment: New insights for clinical practice

Watch leading experts discuss evolving neoadjuvant, adjuvant and metastatic treatment options for patients with melanoma, taking in the latest data presented at the ESMO Congress 2021.

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Dr Ana Arance
Hospital Clinic, Barcelona, Spain
Translating the long-term survival results in melanoma to the clinic

Dr Arance discusses the long-term survival rates for patients receiving current standard of care therapies, and the potential for some patients to achieve long-term control of their melanoma

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Interview Questions

In this interview Dr Arance answers the following questions:

  • What are the 5-year survival rates for agents targeting the MAPK pathway in patients with metastatic melanoma?
  • What are the long-term survival rates for immunotherapy in the treatment of metastatic melanoma?
  • What is the role of adjuvant targeted therapies and immune checkpoint inhibitors in high-risk melanoma?
  • What is the potential role of neoadjuvant targeted therapies and immune checkpoint inhibitors in high-risk melanoma?
  • Can long-term control be defined in advanced melanoma?
About Dr Ana Arance

Ana Arance, MD, PhD, is a consultant at the Melanoma Unit in the Department of Medical Oncology at the Hospital Clinic in Barcelona, Spain. read more

Dr Arance obtained her medical degree from the University of Barcelona, Faculty of Medicine, and completed her specialist training in medical oncology at the Catalan Institute of Oncology in Barcelona. She continued her oncology training as a research fellow at Christie Hospital, Paterson Institute for Cancer Research in Manchester, UK, studying gene therapy. Thereafter, she obtained a fellowship from the UK Medical Research Council to complete her translational training by joining the PhD programme at Hammersmith Hospital, Imperial College London, UK, to study the mechanisms of resistance to chemotherapy.

Dr Arance is actively involved in the design of and recruitment for numerous clinical trials in melanoma, and in the study of biomarkers in melanoma. She has authored articles, books and monographs related to melanoma diagnosis and treatment. She is an active member of the Spanish Melanoma Group (GEM) and several professional organizations, including the Spanish Society of Medical Oncology (SEOM), the European Society of Medical Oncology (ESMO), and the American Society of Clinical Oncology (ASCO).

Dr Arance discloses: Advisory board/panel discussion fees from Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme; consultancy fees from Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme; grants and research support fees from Amgen, Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme; speaker’s bureau fees from Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme.

 
Prof. Paolo A Ascierto
National Tumour Institute, “Fondazione G. Pascale” Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy, Naples, Italy
Maximizing survival outcomes in melanoma and poor prognosis

Prof. Ascieto highlights the factors that influence response to treatment and provides insights on the strategies that may optimize survival in patients who have a poor prognosis, including the use of treatment sequencing

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Interview Questions

In this interview Prof. Ascierto answers the following questions:

  • Which patients with metastatic melanoma have the best survival outcomes?
  • How important are first-line treatment choices in optimizing survival in patients with melanoma?
  • How do data from clinical trials impact treatment sequencing options for patients with advanced melanoma?
  • Can the use of biomarkers help to predict which patients may benefit from first-line targeted therapy or immunotherapy?
  • What is the future of new and emerging combination therapies for improving outcomes in more patients with melanoma?
About Prof. Paolo. A Ascierto

Paolo A Ascierto, MD, is Director of the Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy at the National Tumour Institute “Fondazione G. Pascale” in Naples, Italy. read more

He is an active scientific reviewer for several international journals, including Journal of Clinical Oncology, Lancet Oncology and Clinical Cancer Research; the Editor-in-Chief of the Combination Strategies section of the Journal of Translational Medicine; and Chief Section Editor of Expert Reviews of Immunology Vaccines and Informatics.

As a result of Prof. Ascierto’s experience and expertise, he has been a valued invited speaker at more than 350 national and international meetings. Furthermore, he is an active member of the Italian Society of Medical Oncology (AIOM), American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), European Organization for Research and Treatment of Cancer (EORTC) and the Society of Immuno Therapy of Cancer (SITC).

Prof. Ascierto has presided as principal investigator on over 50 clinical trials and is the author of numerous publications in peer-reviewed journals. Such journals include The New England Journal of Medicine, Lancet Oncology, Journal of Clinical Oncology and Clinical Cancer Research, among others.

His major research interests are the genetics and proteomics of melanoma, the assessment of molecular markers for tumour progression in melanoma, management of targeted therapies for melanoma, vaccination treatments and immunotherapy of cancer, biochemical and immunological monitoring, and combination approaches for cancer treatment.

Prof. Ascieto discloses: Advisory board/panel discussion fees from 4SC, Alkermes, Array BioPharma, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai Co. Ltd., Genentech; Idera Pharmaceuticals, Immunocore, Incyte Corp., Italfarmaco SpA., iTeos Therapeutics, MedImmune, Merck Serono, Merck Sharp & Dohme, Nektar Therapeutics, Novartis, Oncosec Medical, Pfizer, Pierre Fabre, Regeneron, Sandoz, Sanofi Genzyme, Seagen, Sun Pharmaceutical Industries Ltd., Syndax Pharmaceuticals Inc. and Ultimovacs; consultancy fees from 4SC, Bristol Myers Squibb, Genentech, Italfarmaco SpA., Lunaphore Technologies SA, Merck Sharp & Dohme, Nouscom, Novartis, Pfizer, Sandoz, Sanofi Genzyme and Takis Biotech; grants and research support from Array BioPharma, Bristol Myers Squibb, Genentech and Sanofi Genzyme; travel support from Merck Sharp & Dohme.

 
Dr Allison Betof Warner
Melanoma and Immunotherapeutics Service, Memorial Sloan Kettering Cancer Center, New York, USA
Evolving treatment options and future directions in melanoma

Dr Betof Warner reviews the evolving treatment landscape in melanoma to discuss the latest data on triplet combinations and novel therapies, and provides insights on how these may impact future directions in melanoma.

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Interview Questions

In this interview Dr Betof Warner answers the following questions:

  • How is the treatment landscape evolving in melanoma?
  • What other triplet combination therapies are being evaluated in unresectable or metastatic melanoma?
  • What is the most promising immune checkpoint inhibitor other than CTLA-4 and PD-1 in metastatic melanoma?
  • What is the rationale and evidence for TIL therapy in metastatic melanoma?
  • What data from ESMO 2021 on predictive/prognostic biomarkers is of interest for melanoma?
About Dr Allison Betof Warner

Allison Betof Warner, MD, PhD, is Assistant Attending Physician on the Melanoma Service at Memorial Sloan Kettering Cancer Center, New York, USA. read more

Dr Betof Warner graduated magna cum laude from Cornell University, and went on to graduate with her MD/PhD from the Medical Scientist Training Program at Duke University. She completed her PhD under the supervision of Drs Mark Dewhirst and Lee Jones, studying the effects of exercise on tumour angiogenesis and chemotherapeutic efficacy. Dr Betof Warner went on to internal medicine residency at Massachusetts General Hospital then medical oncology fellowship at Memorial Sloan Kettering Cancer Center in New York.

Her research explores how modulations in the tumour microenvironment affect tumour immunobiology and immunotherapy. Clinically, she is the principal investigator of several trials focusing on immunotherapy-refractory melanoma and novel immunotherapy agents. She leads the Memorial Sloan Kettering melanoma group’s trials in cellular therapy and brain/central nervous system metastases. A main focus of her research investigates mechanisms and treatment strategies to overcome immune-related adverse events.

Dr Allison Betof Warner discloses: Advisory board/panel discussion fees from Iovance Biotherapeutics; consultancy fees from Iovance Biotherapeutics, Novartis, Pfizer, and Novartis and Shanghai Jo’Ann Medical Technology (relationships terminated).

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Overview & Learning Objectives
Overview

Watch leading experts discuss evolving neoadjuvant, adjuvant and metastatic treatment options for patients with melanoma, taking in the latest data presented at the ESMO Congress 2021.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of Oncologists, including dermato-oncologists and other HCPs involved in the management of patients with melanoma.

Disclosures

All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty

Dr Arance discloses: Advisory board/panel discussion fees from Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme; consultancy fees from Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme; grants and research support fees from Amgen, Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme; speaker’s bureau fees from Bristol Myers Squibb, Merck/Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi Genzyme.

Prof. Ascieto discloses: Advisory board/panel discussion fees from 4SC, Alkermes, Array BioPharma, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai Co. Ltd., Genentech; Idera Pharmaceuticals, Immunocore, Incyte Corp., Italfarmaco SpA., iTeos Therapeutics, MedImmune, Merck Serono, Merck Sharp & Dohme, Nektar Therapeutics, Novartis, Oncosec Medical, Pfizer, Pierre Fabre, Regeneron, Sandoz, Sanofi Genzyme, Seagen, Sun Pharmaceutical Industries Ltd., Syndax Pharmaceuticals Inc. and Ultimovacs; consultancy fees from 4SC, Bristol Myers Squibb, Genentech, Italfarmaco SpA., Lunaphore Technologies SA, Merck Sharp & Dohme, Nouscom, Novartis, Pfizer, Sandoz, Sanofi Genzyme and Takis Biotech; grants and research support from Array BioPharma, Bristol Myers Squibb, Genentech and Sanofi Genzyme; travel support from Merck Sharp & Dohme.

Dr Allison Betof Warner discloses: Advisory board/panel discussion fees from Iovance Biotherapeutics; consultancy fees from Iovance Biotherapeutics, Novartis, Pfizer, and Novartis and Shanghai Jo’Ann Medical Technology (relationships terminated).

Content Reviewer

Angela Massey Hill, Pharm.D., CPh, RPh 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.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu 

Accreditations
Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 1 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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 (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu)

Advanced Practice Providers

Physician Assistants may claim a maximum of 1 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 12 October 2021. Date credit expire: 12 October 2022.

If you have any questions regarding credit please contact cpdsupport@usf.edu 

Learning Objectives

After watching this activity, participants should be better able to:

  • Describe the long-term survival results in patients with melanoma and their relevance to treatment decisions
  • Evaluate current strategies to improve outcomes for patients with melanoma who do not experience a durable response
  • Recall the latest data for emerging treatment options, including the use of triple combination approaches, and how these therapies fit into the melanoma treatment paradigm
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Question 1/5
For your patient presenting with metastatic melanoma, what baseline characteristics would you associate with rapid disease progression and poor prognosis, requiring a more aggressive approach to treatment?

LDH, lactate dehydrogenase.
Correct

The baseline characteristics of patients with metastatic melanoma may influence response to treatment.1,2

Baseline factors associated with more rapid disease progression include characteristics that result in inactive or impaired immune surveillance against cancer cells:1,2

• Multiple brain metastasis (>3)
• High tumour burden (>3 organs involved)
• High LDH

Baseline characteristics associated with longer OS include no/minimal brain metastases, low tumour burden and normal LDH, which result in active immune surveillance against cancer cells.1,2

Abbreviations

LDH, lactate dehydrogenase; OS, overall survival.

References

  1. Ascierto P and Dummer R. Oncoimmunology. 2018;7:e1468955.
  2. Michielin O, et al. J Immunother Cancer. 2020;8:e000948.
Question 2/5
In the KEYNOTE-716 trial, which of the following statements most accurately reflects the interim analysis results for patients with completely resected stage IIB and IIC melanoma following adjuvant pembrolizumab when compared with placebo?
Correct

Patients with stage IIB and IIC melanoma have the same risk of recurrence and death as those with stage IIIA and IIIB melanoma. The results of the randomized phase III KEYNOTE-716 study, in which patients with resected stage IIB or stage IIC melanoma received adjuvant pembrolizumab, demonstrated a 35% reduction in risk for disease recurrence.1,2

Overall, 976 patients were randomized to receive pembrolizumab or placebo. At median follow-up of 14.4 months, pembrolizumab significantly prolonged RFS vs placebo, HR 0.65, p=0.007. Fewer patients in the pembrolizumab group experienced recurrence (11.1% vs 16.8%). The incidence of grade 3 or 4 toxicities was 25.9% vs 17.1% in the pembrolizumab vs placebo group. This data has the potential to change practice with earlier use of immunotherapy in the disease course, with a favourable risk:benefit profile.2

Abbreviations

HR, hazard ratio; RFS, recurrence-free survival.

References

  1. ClinicalTrials.gov. Available at: www.clinicaltrials.gov/ct2/show/NCT03553836 (accessed 30 September 2021).
  2. Luke J, et al. Ann Oncol. 2021:32(Suppl. 5):S1283–346.
Question 3/5
Based on data from the SECOMBIT trial, which sequential approach showed a trend towards the lowest 2- and 3-year survival rates in patients with BRAF-mutated melanoma?

BRAF, v-raf murine sarcoma viral oncogene homolog B1.
Correct

Data from the phase II SECOMBIT study, involving 251 patients with untreated BRAF-mutated metastatic melanoma, suggests that treatment with ipilimumab + nivolumab then encorafenib + binimetinib (arm B) or a ‘sandwich’ strategy (encorafenib + binimetinib for 8 weeks, then ipilimumab + nivolumab followed by encorafenib + binimetinib at the time of disease progression [arm C]) may help to improve survival rates.

Results for 2- and 3-year survival rates showed a trend towards more favourable effects in arm B (73% and 62%, respectively) and with the sandwich strategy (arm C; 69% and 60%, respectively) compared with encorafenib + binimetinib then ipilimumab + nivolumab (arm A; 65% and 54%, respectively). Data collection is ongoing to help provide further insights.

Abbreviations

BRAF, v-raf murine sarcoma viral oncogene homolog B1.

Reference

  1. Ascierto P, et al. Ann Oncol. 2021;32(Suppl. 5):S1283–346.
Question 4/5
Based on recent data reporting durable complete responses in metastatic melanoma, for which patients would you recommend enrolment in a clinical trial with TIL therapy?
BRAF, v-raf murine sarcoma viral oncogene homolog B1; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; MEK, mitogen-activated protein kinase; PD-1, programmed cell death protein 1; TIL, tumour infiltrating lymphocyte.

Correct

TIL therapy is a personalized therapy that has been tested in patients with previously treated metastatic melanoma. TILs recognize antigens specific to the individual patient’s tumour, and have been demonstrated to produce durable responses in heavily pre-treated metastatic melanoma.1

In a 2019 systematic review and meta-analysis of 410 heavily pre-treated melanoma, the pooled overall ORR was 41% and the overall CRR was 12%.1

These data are supported by recently reported results from a phase II trial of lifileucel (LN-144),2 and a retrospective analysis of TILs for compassionate use treatment of metastatic melanoma,3 in which the ORRs were 36% and 53%, respectively. Subgroup analyses in patients refractory to anti-PD-1/PD-L1 therapy have also shown durable complete responses.2,3

Abbreviations

CRR, complete response rate; ORR, overall response rate; PD-1, programmed cell death protein 1, PD-L1, programmed death-ligand 1; TIL, tumour infiltrating lymphocyte.

References

  1. Dafni U, et al. Ann Oncol. 2019;30:1902–13.
  2. Sarnaik A,et al. J Clin Oncol. 2021;39:2656–66.
  3. Hawkins R, et al. Presented at: AACR 2021. April 10, 2021. LB150.
Question 5/5
Based on data for triplet combination therapy (immunotherapy + BRAF + MEK inhibition), what are the overall findings in terms of survival outcome and toxicity when compared with doublet combination therapy (BRAF + MEK inhibition) for the treatment of unresectable or metastatic melanoma?

BRAF, v-raf murine sarcoma viral oncogene homolog B1; MEK, mitogen-activated protein kinase.
Correct

In 2020, the combination of atezolizumab plus vemurafenib plus cobimetinib was approved by the FDA for patients with BRAFV600 mutation-positive unresectable or metastatic melanoma.1 Efficacy was evaluated in the randomized, double-blind, phase III IMspire150 trial in 514 patients. At follow-up of 18.9 months, PFS was significantly prolonged with the atezolizumab + BRAF/MEK combination vs control (15.1 months vs 10.6 months; HR 0.78; 95% CI 0.63–0.97; p=0.025).2

Survival benefit has also been reported in other investigational triplet combination therapies (e.g. pembrolizumab or nivolumab in combination with dabrafenib plus trametinib).3,4

However, in the phase III COMBI-I trial, investigating triplet combination therapy with spartalizumab plus dabrafenib plus trametinib, the primary endpoint of PFS was not met, and analysis of the OS benefit is ongoing.5

Furthermore, a higher rate of grade 3–5 toxicities has been reported with triplet combination therapy when compared with doublet therapy in these trials, leading to some patients discontinuing due to toxicities.3–5

Abbreviations

CI, confidence interval; BRAF, v-raf murine sarcoma viral oncogene homolog B; FDA, US Food and Drug Administration; HR, hazard ratio; MEK, mitogen-activated protein kinase; OS, overall survival; PFS, progression-free survival.

References

  1. FDA approvals. Available at: www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-braf-v600-unresectable-or-metastatic-melanoma (accessed 30 September 2021).
  2. Gutzmer R, et al. Lancet. 2020;395:1835–44.
  3. Ferucci P, et al. J Immunother Cancer. 2020;8:e001806.
  4. Burton E, at al. Ann Oncol. 2019;30(Suppl. 5):v533–63.
  5. Nathan P, et al. Ann Oncol. 2020;31(Suppl. 4):S1172.
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