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Focus Questions
What are the current unmet treatment needs of patients with RM-NPC in the first and later lines?
What are the key clinical data supporting the use of ICIs in the first-line setting for RM-NPC?
What are some of the key considerations for identifying patients with RM-NPC who may particularly benefit from treatment with an ICI in the first line?
What are the key clinical data supporting the use of ICIs to treat patients with RM-NPC in the second- and later-line settings?
How do you identify patients with RM-NPC who are likely to benefit from treatment with ICIs in the second- and later-line settings?
What are some of your key recommendations for monitoring for and managing the side effects associated with ICIs when used to treat patients with RM-NPC?
How would your management approach to RM-NPC differ based on the presence/absence of Epstein-Barr virus (EBV) infection?
Which investigational immunotherapy approaches are showing particular promise for the future treatment of patients with RM-NPC in the first- and later-line settings?
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Updates in recurrent/metastatic nasopharyngeal carcinoma: The evolving role of immune checkpoint inhibitors

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Prof. Barbara Burtness is an Anthony N Brady Professor of Medicine at the Yale School of Medicine, and Chief Translational Research Officer, Associate Director for Translational Science, and Chief, Division of Head and Neck/Sarcoma Oncology at the Yale Cancer Center, New Haven, CT, USA. read more

Prof. Burtness serves as co-leader of the Yale Cancer Center Developmental Therapeutics Program and director of the Yale Head and Neck Specialized Program of Research Excellence.

Prof. Burtness is internationally recognized for her research in head and neck cancer. She chairs the ECOG-ACRIN Cooperative Group Head and Neck Cancer Therapeutics Committee, and leads national and international trials of targeted therapy in head and neck cancer.

Prof. Burtness has served on the editorial board for a number of journals, including the Journal of Clinical Oncology and Clinical Cancer Research. She has contributed to a number of practice guidelines, standards and consensus statements in head and neck cancer, and has also published widely on the topic, with over 200 publications.

Prof. Barbara Burtness discloses: Employee or independent contractor relationships with ALX Oncology and Merus. Advisory board or panel fees from AstraZeneca, Coherus BioSciences, Genmab, GSK, Merck KGaA and Rakuten Medical. Consultancy fees from IO Biotech, Merus and Vaccinex, Inc (relationships terminated). Speaker Bureau fees from Coherus BioSciences.

Learning Objectives

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

  • Discuss the role of immune checkpoint inhibitors in the first-line setting for recurrent or metastatic nasopharyngeal carcinoma
  • Summarize the use of immune checkpoint inhibitors in the second- and subsequent-line treatment of recurrent or metastatic nasopharyngeal carcinoma
Overview

In this interview, Prof. Barbara Burtness answers a series of questions focused on the evolving role of immune checkpoint inhibitors (ICIs) in the first- and subsequent-line settings for recurrent/metastatic nasopharyngeal carcinoma (RM-NPC).

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 medical oncologists, including head and neck cancer specialists, and oncology nurses involved in the management of recurrent/metastatic nasopharyngeal carcinoma.

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. 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

Prof. Barbara Burtness discloses: Employee or independent contractor relationships with ALX Oncology and Merus. Advisory board or panel fees from AstraZeneca, Coherus BioSciences, Genmab, GSK, Merck KGaA and Rakuten Medical. Consultancy fees from IO Biotech, Merus and Vaccinex, Inc (relationships terminated). Speaker Bureau fees from Coherus BioSciences.

Content reviewer

Danielle Walker, DNP, APRN, AGNP-C, nurse reviewer and planner, has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Contributors

Christina Mackins-Crabtree 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 0.5 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 0.5 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.

Nurses

USF Health is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

A maximum of 0.5 contact hours may be earned by learners who successfully complete this continuing professional development activity. USF Health, the accredited provider, acknowledges touchIME as the joint provider in the planning and execution of this CNE activity.

This activity is awarded 0.5 ANCC pharmacotherapeutic contact hour.

Date of original release: 26 September 2024. Date credits expire: 26 September 2025.

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

This activity is CE/CME accredited

To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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Topics covered in this activity

Head and Neck Cancer / Immunotherapy
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Updates in recurrent/metastatic nasopharyngeal carcinoma: The evolving role of immune checkpoint inhibitors
0.5 CE/CME credit

Question 1/5
Based on the phase III JUPITER-02 clinical trial, what were the approximate 3-year overall survival rates for patients with RM-NPC treated first line with toripalimab + GC versus placebo + GC?

GC, gemcitabine-cisplatin; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

The JUPITER-02 trial assessed the efficacy and safety of first-line toripalimab + GC (n=146) versus placebo + GC (n=143) in patients with RM-NPC.1 In the final overall survival analysis, the 3-year overall survival rate for toripalimab was 65.1 % versus 49.2% for placebo.2

Abbreviations
GC, gemcitabine-cisplatin; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

References

  1. Mai HQ, et al. JAMA. 2023;330:1961–70.
  2. Mai HQ, et al. J Clin Oncol. 2023;41(Suppl. 16):6009.
Question 2/5
Which of the following RM-NPC patient profiles would you consider the most suitable candidate to receive an ICI + CT in the first-line setting?

CT, chemotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; ICI, immune checkpoint inhibitor; PD-L1, programmed death ligand 1; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

The NCCN guidelines indicate toripalimab or other PD-1 inhibitor (e.g. pembrolizumab or nivolumab) + GC-based CT as a preferred first-line therapeutic regimen for recurrent, unresectable, oligometastatic or metastatic disease (with no surgery or RT option).1

Exclusion criteria in the pivotal trials investigating ICI + CT as first-line treatment in RM-NPC included: recurrence amenable to resection, prior ICI therapy, history of autoimmune disease and ECOG PS >1.2–4

Abbreviations
CT, chemotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; GC, gemcitabine-cisplatin; ICI, immune checkpoint inhibitor; PD-1, programmed death 1; PD-L1, programmed death ligand 1; NCCN, National Comprehansive Cancer Network; PFS, progression-free survival; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma; RT, radiotherapy; TPS, tumour proportion score.

References

  1. NCCN Guidelines®. Head and Neck Cancers Version 4.2024 — May 1, 2024. Available at: www.nccn.org (accessed 11 September 2024).
  2. Mai HQ, et al. JAMA. 2023;330:1961–70.
  3. Yang Y, et al. Lancet Oncol. 2021;22:1162–74.
  4. Yang Y, et al. Cancer Cell. 2023;41:1061–72.
Question 3/5
You are discussing treatment options with a patient with RM-NPC who also has Crohn's disease. The patient would like to be treated with an ICI + GC because he has heard that outcomes tend to be better than for GC alone. How do you counsel him?

GC, gemcitabine-cisplatin; ICI, immune checkpoint inhibitor; irAE, immune-related adverse event; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

Patients with a history of autoimmune disease may be more likely to discontinue ICI treatment due to an irAE, or be at higher risk of an irAE specific to their condition (e.g., colitis in a patient with a history of inflammatory bowel disease).1 Reflecting these concerns, patients with autoimmune disease, other than stable hypothyroidism or type I diabetes, and patients who required systemic immunosuppression were ineligible for the pivotal JUPITER-02 trial of toripalimab + GC in patients with RM-NPC.2

Abbreviations
GC, gemcitabine-cisplatin; ICI, immune checkpoint inhibitor; irAE, immune-related adverse event; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

References

  1. Conroy M, Naidoo J. Nat Commun. 2022;13:392.
  2. FDA. Toripalimab PI. 2023. Available at: https://bit.ly/3Zkk7OJ (accessed 11 September 2024).
Question 4/5
When evaluating a patient with RM-NPC, which of the following specific clinical/biological characteristics would favour your incorporation of an ICI in the second-line treatment setting?

ECOG PS, Eastern Cooperative Oncology Group performance status; ICI, immune checkpoint inhibitor; PD-L1, programmed death ligand 1; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma; TMB, tumour mutational burden; TPS, tumour proportion score.

A recent meta-analysis suggested that first-line immunotherapy could significantly improve PFS in patients with RM-NPC, regardless of the PD-L1 expression levels. However, positive PD-L1 expression (≥1%) might be a potential predictive biomarker for a better overall response to immunotherapy in patients with RM-NPC in subsequent-line settings.

Abbreviations
PD-L1, programmed death ligand 1; PFS, progression-free survival; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

Reference

Liu X, et al. Front Oncol. 2024;14:1386381.

Question 5/5
What role do the clinical trials suggest ICI monotherapy plays in the treatment of patients with RM-NPC in the second- or later-line settings?

ICI, immune checkpoint inhibitor; mPFS, median progression-free survival; mOS, median overall survival; ORR, objective response rate; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma.

Clinical trials of pembrolizumab,1 nivolumab2,3 and toripalimab4 reported ORRs of approximately 20%. Based on these results, they are included in the NCCN guidelines as possible treatment options in the second or later line.5

Abbreviations
NCCN, National Comprehansive Cancer Network; ORR, objective response rate.

References

  1. Chan ATC, et al. Ann Oncol. 2023;34:251–61.
  2. DeLord JP, et al. J Clin Oncol. 2017:35(15_Suppl.):6025.
  3. Ma BBY, et al. J Clin Oncol. 2018;36:1412–18.
  4. Wang FH, et al. J Clin Oncol. 2021;39:704–12.
  5. NCCN Guidelines®. Head and Neck Cancers Version 4.2024 — May 1, 2024. Available at: www.nccn.org (accessed 11 September 2024).
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