Immuno-oncology, Dermatological Conditions CE/CME ACCREDITED Watch Time: 34 mins

touchEXPERT OPINIONS Immunotherapy and evolving approaches for basal cell carcinoma

Watch leading experts discuss evolving treatment options for patients with advanced basal cell carcinoma, and how novel immunotherapeutic approaches within the emerging clinical study landscape may improve patient care.

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Dr Emily Ruiz
Brigham and Women’s Hospital, Boston, MA, USA
Management of advanced BCC: Can we do more?

Dr Emily Ruiz highlights the unmet needs among patients with advanced BCC, using a real-world case to illustrate the importance of having alternative treatment choices when standard of care therapy has failed.

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In this interview Dr Emily Ruiz answers the following questions:

  • How significant is progressive disease in patients with basal cell carcinoma, and what is the current standard of care?
  • How has the introduction of hedgehog pathway inhibitors altered the management of basal cell carcinoma?
  • How might hedgehog inhibitors be used in the neoadjuvant setting in patients with locally advanced disease?
  • What clinical challenges remain with hedgehog inhibitor-based treatment strategies in basal cell carcinoma?
  • How might the approval of immune checkpoint inhibitor therapy as a second-line therapy address current unmet needs in basal cell carcinoma?

Emily Ruiz, MD, MPH, is Associate Physician at the Mohs and Dermatologic Surgery Center at Brigham and Women’s Faulkner Hospital, Assistant Professor in Dermatology at Harvard Medical School and Director of the High-Risk Skin Cancer Clinic at Dana Farber/Brigham and Women’s Hospital. read more

Dr Ruiz’s career is dedicated to patient care, clinical innovation, education and skin cancer research. She spends 60% of her time in outpatient clinical activities and the remainder of time is devoted to clinical research and education. The majority of her clinical time is spent performing Mohs micrographic surgery and one clinic a week at Dana-Farber Cancer Institute. This clinic is a referral site for aggressive non-melanoma skin cancers, and provides skin cancer surveillance to high-risk patients, including transplant patients and individuals with a history of a high-risk skin cancer. It is also a site for two clinical trials for a programmed cell death protein 1 (PD-1) inhibitor in patients with locally advanced and metastatic cutaneous squamous cell carcinoma and basal cell carcinoma.

Dr Ruiz’s primary research interest is cost analyses of skin cancer care. She received a Career Development Award from the Dermatology Foundation and a Cutting-Edge Research Grant from the American Society for Dermatologic Surgery for her study titled Skin Cancer Equity and Expenditure Analysis. 

In addition, she is interested in treatment and outcomes of non-melanoma skin cancer. She is the principal investigator on a clinical study at Brigham and Women’s Hospital that evaluates intraoperative immunohistochemistry staining with p40 antibody during Mohs micrographic surgery for poorly-differentiated cutaneous squamous cell carcinoma. She is also evaluating outcomes of adnexal carcinomas in a retrospective cohort.


Dr Emily Ruiz discloses: Advisory Board/panel discussion fees from Checkpoint Therapeutics and Leo Pharma; consultancy fees from Jounce Therapeutics, PellePharm and Sanofi-Genzyme; grants/research support fees from Regeneron (PI).

 
Prof. Ketty Peris
Catholic University of Rome, Rome, Italy
Immunotherapy and emerging options in BCC: Key data and insights

Prof. Ketty Peris reviews the rationale and current evidence for immunotherapy and emerging clinical study landscape for patients with advanced basal cell carcinoma.

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In this interview Prof. Ketty Peris answers the following questions:

  • What is the rationale for the use of immunotherapy in basal cell carcinoma?
  • What is the evidence base for the approval of cemiplimab for the treatment of locally advanced or metastatic basal cell carcinoma?
  • What are the key safety considerations surrounding the use of immunotherapy in patients with basal cell carcinoma?
  • What other efficacy outcomes from clinical trials using anti-PD-1 therapies have been reported in advanced basal cell carcinoma?
  • How might ongoing research result in further treatment options being available?

Ketty Peris, MD, is Professor of Dermatology and Head of the Institute of Dermatology, Catholic University of Rome, Rome in Italy. read more

Her main research interests include dermato-oncology, particularly melanoma and non-melanoma skin cancers, and immune-mediated diseases. She has been an investigator in numerous therapeutic trials in skin diseases. 

Prof. Peris is a member of the board of national and International scientific societies, such as the European Dermatology Forum and European Association of Dermato-oncology. She has authored over 350 scientific publications in international, peer-reviewed journals, and over 20 book chapters.

Prof. Peris has also participated as speaker at over 500 national and International meetings, training sessions and congresses in the area of dermatology and venereology, molecular biology, and dermato-oncology.

Prof. Ketty Peris discloses: Advisory Board/panel discussion fees from AbbVie, Almirall and Sun Pharmaceutical Industries; consultancy fees from Sanofi-Genzyme.

 
Prof. Axel Hauschild
University Hospital Schleswig-Holstein, Kiel, Germany
Transforming BCC treatment: What does the future hold?

Prof. Hauschild provides insights on the impact of novel and emerging treatment options on the modern management of patients with advanced basal cell carcinoma

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In this interview Prof. Axel Hauschild answers the following questions:

  • What is the role of the multidisciplinary tumour board in the modern management of basal cell carcinoma?
  • How might immunotherapy-based treatment strategies impact the current treatment paradigm for patients with advanced basal cell carcinoma?
  • Is there a rationale for biomarker testing to optimize use of immunotherapy in basal cell carcinoma?
  • What approaches to safety management are needed for the integration of immunotherapy-based treatment regimens in basal cell carcinoma?
  • How might ongoing trials with hedgehog inhibitors impact the future treatment paradigm?

Axel Hauschild, MD, PhD, is Head of the Skin Cancer Working Group at the University Hospital Schleswig-Holstein, Campus Kiel, Germany. read more

Prof. Hauschild’s main clinical interests are the diagnosis and treatment of melanoma and non-melanoma skin cancer. He has been the principal investigator of more than 100 phase I–III clinical trials on melanoma, cutaneous lymphomas and epithelial skin cancers. 

During his scientific career, Prof. Hauschild has been honoured with the German Skin Cancer Award and the German Cancer Award. He is the past president of the German Dermatologic Cooperative Oncology Group (DeCOG) and is a board member of the European Association of Dermato-Oncology (EADO) and the Melanoma World Society (MWS). 

Prof. Hauschild was the Congress President of the 8th World Congress on Melanoma in Hamburg in 2013, and the Designated President of the 10th World Congress on Melanoma in April 2021. He has been invited to speak at more than 700 conferences across the world. Prof. Hauschild has published over 420 articles in peer-reviewed journals, such as the New England Journal of Medicine, Lancet, Lancet Oncology and Journal of Clinical Oncology.

Prof. Axel Hauschild discloses: Advisory Board/panel discussion fees from Bristol Myers Squibb, Eisai, Immunocore, Laboratoires Pierre Fabre, Merck KGaA/Pfizer, Merck Sharp & Dohme/Merck & Co. Inc, Novartis, Pfizer, Regeneron, Replimune, Roche, Sanofi Genzyme and Seagen; consultancy fees from Bristol Myers Squibb, Eisai, Laboratoires Pierre Fabre, Merck Sharp & Dohme/Merck & Co Inc., Novartis, Philogen, Regeneron, Roche and Sanofi Genzyme; grants/research support fees from Amgen, Bristol Myers Squibb, Eisai, Laboratoires Pierre Fabre, Merck KGaA/Pfizer, Merck Sharp & Dohme/Merck & Co. Inc, Novartis, Regeneron, Roche and Sanofi Genzyme; salary/contractual services from Amgen, Bristol Myers Squibb, Eisai, Laboratoires Pierre Fabre, Merck KGaA/Pfizer, Merck Sharp & Dohme/Merck & Co. Inc, Novartis, Regeneron, Roche and Sanofi Genzyme.

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Overview & Learning Objectives
Overview

In this activity, experts in dermato-oncology discuss the potential impact of novel treatment options, including the use of anti-PD-1 therapy, on current standard of care approaches for advanced basal cell carcinoma.

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 care of patients with non-melanoma skin cancer.

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 Emily Ruiz discloses: Advisory Board/panel discussion fees from Checkpoint Therapeutics and Leo Pharma; consultancy fees from Jounce Therapeutics, PellePharm and Sanofi-Genzyme; grants/research support fees from Regeneron (PI).

Prof. Ketty Peris discloses: Advisory Board/panel discussion fees from AbbVie, Almirall and Sun Pharmaceutical Industries; consultancy fees from Sanofi-Genzyme.

Prof. Axel Hauschild discloses: Advisory Board/panel discussion fees from Bristol Myers Squibb, Eisai, Immunocore, Laboratoires Pierre Fabre, Merck KGaA/Pfizer, Merck Sharp & Dohme/Merck & Co. Inc, Novartis, Pfizer, Regeneron, Replimune, Roche, Sanofi Genzyme and Seagen; consultancy fees from Bristol Myers Squibb, Eisai, Laboratoires Pierre Fabre, Merck Sharp & Dohme/Merck & Co Inc., Novartis, Philogen, Regeneron, Roche and Sanofi Genzyme; grants/research support fees from Amgen, Bristol Myers Squibb, Eisai, Laboratoires Pierre Fabre, Merck KGaA/Pfizer, Merck Sharp & Dohme/Merck & Co. Inc, Novartis, Regeneron, Roche and Sanofi Genzyme; salary/contractual services from Amgen, Bristol Myers Squibb, Eisai, Laboratoires Pierre Fabre, Merck KGaA/Pfizer, Merck Sharp & Dohme/Merck & Co. Inc, Novartis, Regeneron, Roche and Sanofi Genzyme.

Content reviewer

Angela Massey Hill, PharmD, 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 0.75 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 0.75 Category 1 credit for completing this activity. NCCPA accepts AMA PRA Category 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: 27 September 2021. Date credits expire: 27 September 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:

  • Recognize the current unmet needs and rationale for alternative treatment options for patients with basal cell carcinoma (BCC)
  • Evaluate the latest data for using immunotherapy to treat patients with advanced BCC
  • Define how the latest advances in BCC may impact clinical practice
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This Activity Is Funded By:

An independent medical education grant from Regeneron Pharmaceuticals, Inc. and Sanofi Genzyme. This activity is jointly provided by USF Health and touchIME.

The information provided by this CE activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CE to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

This content is intended for healthcare professionals.

Date of original release: 27 September 2021. Date credits expire: 27 September 2023.

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

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Question 1/5
What makes basal cell carcinomas an attractive target for immunotherapy?

PD-L1, programmed cell death ligand 1.
 Correct

Molecular profiling of metastatic basal cell carcinoma has shown a high tumour mutational burden, consistent with a UV light pattern of damage.1 In addition, PD-L1 is expressed on the surface of immune cells, and binds to the receptor PD-1 to attenuate immune responses and promote peripheral tolerance.2 These features predict response to checkpoint blockade immunotherapy.

 

PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1; UV, ultraviolet.

 

References

  1. Jayaraman SS, et al. J Invest Dermatol. 2014;134:213–220.
  2. Lipson EJ, et al. J Immunother Cancer. 2017;5:23.
Question 2/5
Your patient with basal cell carcinoma initially treated with surgery, now has local recurrence and is about to start treatment with a hedgehog inhibitor. Which of the following should you be most concerned about regarding treatment with hedgehog inhibitors?
 Correct

Hedgehog inhibitors, sonidegib and vismodegib, are approved for the treatment of adults who have metastatic or locally advanced basal cell carcinoma that has recurred after surgery, and who are not candidates for radiation. Although the majority of adverse events associated with hedgehog inhibitors are grade 1 or 2, the long-term nature of these adverse events can lead to decreased quality of life and treatment interruption, meaning hedgehog inhibitors are associated with high rates of discontinuation.1,2 

 

References

  1. Tay EY-X, et al. Dermatol Ther (Heidelb). 2019;9:33–49.
  2. Lacouture ME, et al. Oncologist. 2016;21:1218–29.
Question 3/5
For patients with metastatic or locally advanced basal cell carcinoma starting cemiplimab after progression or intolerance to a hedgehog inhibitor, which adverse events should you counsel them as being most likely to occur during therapy?
 Correct

Fatigue (26%) and diarrhoea (24%) were the most commonly reported grade 1 and 2 adverse events with cemiplimab in a phase II study in this setting. Nausea and headache were less common (13% each). Neutropenia, thrombocytopenia and upper respiratory tract infections were not reported, and lower respiratory tract infections occurred in 1% of patients (grade 3).  

 

Reference

Stratigos AJ, et al. Lancet Oncol. 2021;22:848–57.

Question 4/5
For patients with locally advanced basal cell carcinomas in locations that are aesthetically or functionally challenging to treat, what would be the rationale for earlier treatment with hedgehog inhibitors?
 Correct

In the VISMONEO trial, neoadjuvant oral vismodegib 150 mg once daily for 4–10 months was successfully used to downstage facial tumours prior to surgery. The success group of patients had a mean 66% reduction in the size of their target lesion versus 29% for the failure group of patients. In addition, there was a significant and clinically relevant improvement in Ski-dex-16 score in the study (decrease by 49%).

 

Reference

Bertrand N, et al. EClinicalMedicine. 2021;35:100844.

Question 5/5
In a small proof-of-concept, phase II study, how did ORR at 18 weeks, and PFS at 1 year following combined immunotherapy and hedgehog inhibitor therapy compare with immunotherapy alone?

ORR, overall response rate; PFS, progression-free survival.
 Correct

In the phase II, proof-of-concept, non-randomized, open-label trial of pembrolizumab with or without vismodegib (NCT02690948), 18-week ORR was 29% for combination therapy and 44% for monotherapy, while 1-year PFS was 83% and 62%, respectively.

 

ORR, overall response rate; PFS, progression-free survival.

 

References

Chang ALS, et al. J Am Acad Dermatol. 2019;8:564–6.

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