Course Library

Clinical Efficacy of Currently Available and Investigational ICIs for NSCLC

Oncology

Curriculum:
Strategies for PD-L1 Testing and Targeted Therapy With Immune Checkpoint Inhibitors for NSCLC

Credits:
.25 AMA PRA Category 1 Credit(s) ™

Launch Date:
August 17, 2021

Expiration Date:
The accreditation for this activity has expired.

Primary Audience:

Oncology physicians, nurse practitioners, physician assistants; pulmonary physicians, nurse practitioners, physician assistants; pathologists and pharmacists

Relevant Terms:

Programmed death-ligand 1, PD-L1, immune checkpoint inhibitor, chemotherapy, toxicity, immune-related adverse events, irAEs, atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, NSCLC subtype, squamous, adenocarcinoma, large cell, cytology specimen testing

COURSE FACULTY

Hossein Borghaei, DO, MS

Chief of Thoracic Medical Oncology
Professor, Department of Oncology/Hematology
Co-Director, Immune Monitoring Facility
The Gloria and Edmund M. Dunn Chair in Thoracic Malignancies
Fox Chase Cancer Center
Philadelphia, PA

Bio

Dr Hossein Borghaei earned his degree at Philadelphia College of Osteopathic Medicine and completed a residency at Graduate Hospital in Philadelphia. Since completing his fellowship training at Fox Chase, he has been involved in a number of clinical trials aimed at developing new, antibody-based therapies and immunotherapies for patients with lung cancer.

In addition to his clinical practice and participation in immunotherapy-based clinical trials, Dr Borghaei is the principal investigator (PI) of a laboratory that develops new monoclonal antibodies and novel immune-modulating drugs, with the aim of bringing these approaches to the clinic. He served as the PI of a phase III randomized study that proved the effectiveness of nivolumab in the treatment of patients with advanced non-squamous non-small cell lung cancer after progression on prior chemotherapy. This work led to the approval of nivolumab, one of the first immunotherapy-based drugs to be approved for lung cancer in this setting.

Dr Borghaei is a member of the thoracic core committee at Eastern Cooperative Oncology Group (ECOG) and, until recently, was a member of the National Comprehensive Cancer Network (NCCN) Non-Small Cell Lung Cancer panel. He is a long-standing member of the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), the International Association for the Study of Lung Cancer (IASLC), the Society for Immunotherapy of Cancer (SITC), and the ECOG thoracic committee.

Dr. Borghaei has been a recipient of the Robert Krigel Memorial Award for Teaching Excellence from Fox Chase Cancer Center, ASCO’s Young Investigator Award, and an ASCO Career Development Award. His work has been published in The New England Journal of Medicine, Journal of Clinical Oncology, Lancet Oncology, Leukemia Research, Journal of Thoracic Oncology, Clinical Cancer Research, Clinical Lung Cancer, and Journal of the National Comprehensive Cancer Network.

Kurt A. Schalper, MD, PhD

Assistant Professor of Pathology and Medicine (Medical Oncology)
Yale School of Medicine
Director, Translational Immuno-oncology Laboratory
Yale Cancer Center
New Haven, CT

Bio

Dr Kurt A. Schalper trained as a cell biologist, surgical pathologist, and served in clinical molecular diagnostics. In addition, during his postdoctoral work at Yale he focused on developing strategies to objectively and quantitatively measure key immunotherapy-related biomarkers in immune cells and cancer tissues. Most of this work has been performed in close collaboration with other Yale researchers and published in peer-reviewed journals. Recently, Dr Schalper was appointed to lead the Translational Immuno-Oncology Laboratory (T.I.L.) in the Yale Cancer Center, that aims to produce and support high quality translational research in immuno-oncology through standardized analyses of biomarkers and cross-integration with other Yale resources.

Dr Schalper’s research is focused on understanding the immunobiology of human solid tumors and developing molecular biomarkers for prediction of response or resistance to therapies. In particular, his group has been actively evaluating the role of specific tumor antigens and immune evasion pathways used by human lung malignancies including immune co-inhibitory/stimulatory ligands and receptors, tolerogenic enzymes, immune suppressive cells, antigen presenting/processing machinery, metabolic alterations in the tumor microenvironment, and oncogenic intracellular signaling. More recent and future scientific interests include the evaluation and clinical impact of tumor immune heterogeneity and editing.

LEARNING OBJECTIVES

1.	EVALUATE recent evidence for current and investigational ICIs used in monotherapy and combination regimens for NSCLC

1.	EVALUATE recent evidence for current and investigational ICIs used in monotherapy and combination regimens for NSCLC

COURSE INFORMATION

A CE-certified enduring activity jointly provided by Rutgers Biomedical and Health Sciences and Spire Learning.

This activity is supported by educational grants from Genmab US, Inc., Regeneron Pharmaceuticals, Inc. and Sanofi Genzyme.

PROGRAM OVERVIEW

Despite advances in the treatment of non-small cell lung cancer (NSCLC), overall 5-year survival has not significantly improved in recent years. Newly approved and emerging immune checkpoint inhibitor (ICI) therapies offer improvements in survival over chemotherapy alone, but toxicities and immune-related adverse events (irAEs) must be anticipated and managed for successful treatment. In this educational activity, faculty members review the role of PD-L1 testing to determine the best approach to ICI therapy, current efficacy and safety data for ICI therapies in NSCLC, and how to identify and mitigate irAEs. They evaluate clinical trial data, along with patient- and disease-related factors, that allow for the individualization of therapy selection to promote optimal patient outcomes.

TARGET AUDIENCE

Oncology physicians, nurse practitioners, physician assistants; pulmonary physicians, nurse practitioners, physician assistants; pathologists and pharmacists

LEARNING OBJECTIVES
Upon completion of this activity, learners should be better able to:

EVALUATE recent evidence for current and investigational ICIs used in monotherapy and combination regimens for NSCLC

ACCREDITATION STATEMENT

In support of improving patient care, this activity has been planned and implemented by Rutgers Biomedical and Health Sciences and Spire Learning. Rutgers Biomedical and Health Sciences is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

CREDIT DESIGNATION

Physicians: Rutgers Biomedical and Health Sciences designates this enduring material for a maximum of .25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Advanced practice nurses, nurses, and physician assistants may participate in this educational activity and earn a letter of attendance as AANP, ANCC and AAPA accept AMA PRA Category 1 Credits™ through their reciprocity agreements.

HOW TO RECEIVE CREDIT

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page. Physicians should claim only those credits that reflect the time actually spent in the activity.

To receive credit for your participation in this educational activity:

Read the learning objectives, disclosure statements and other introductory CME information
Complete the preassessment prior to the start of the activity
Participate in the online enduring activity
Complete the postassessment with a passing grade of 70% or higher and the evaluation at the conclusion of the activity

If you are seeking credit, you must complete the postassessment and evaluation at the conclusion of the activity.

For information about the accreditation of this activity, please contact Rutgers Biomedical and Health Sciences (RBHS) at ccoe@rbhs.rutgers.edu.

CONFLICT OF INTEREST STATEMENT

In accordance with the disclosure policies of Rutgers Biomedical and Health Sciences (RBHS) and to conform with Joint Accreditation requirements and FDA guidelines, all individuals in a position to control the content of this educational activity are required to disclose to the activity participants the existence of any relevant relationships with entities producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients, with the exception of non-profit or government organizations and non-health care related companies, within the past 12 months.

In order to ensure content objectivity, independence, and fair balance, and to ensure that the content is aligned with the interest of the public, RBHS has resolved all potential and real conflicts of interest through content review by a non-conflicted, qualified reviewer.

FACULTY

Hossein Borghaei, DO, MS

Chief of Thoracic Medical Oncology

Professor, Department of Oncology/Hematology

Co-Director, Immune Monitoring Facility

The Gloria and Edmund M. Dunn Chair in Thoracic Malignancies

Fox Chase Cancer Center

Philadelphia, PA

Dr Borghaei has disclosed the following relevant financial relationships.

Consultant: AbbVie; Amgen Inc; AstraZeneca; Axiom; BioNTech; Boehringer Ingelheim Pharmaceuticals, Inc; Bristol Myers Squibb; Cantargia AB; Celgene Corporation; Daiichi Sankyo, Inc; Eli Lilly and Company; EMD Serono, Inc; Genentech, Inc; Genmab US, Inc; GLG Pharma, Inc; Huya Bioscience International, LLC; Merck and Co, Inc; Novartis Pharmaceuticals Corporation; Pfizer Inc; PharmaMar; Regeneron Pharmaceuticals, Inc; Takeda Pharmaceutical Company Limited

Grant/Research Support: Bristol Myers Squibb/Eli Lilly and Company; Merck and Co, Inc/Celgene Corporation; Millennium Pharmaceuticals, Inc

Scientific Advisory Board (Stock Options): Nucleai; Rgenix, Inc; Sonnet BioTherapeutics

Data Safety and Monitoring Board: Incyte Corp; Takeda Pharmaceutical Company Limited; University of Pennsylvania CAR-T Program

Other Financial Support - Honoraria: Amgen Inc; Daiichi Sankyo, Inc; Pfizer Inc

Other Financial Support - Travel: Amgen Inc; Bristol Myers Squibb; Eli Lilly and Company; EMD Serono, Inc; Genentech, Inc; Merck and Co, Inc

Kurt A. Schalper, MD, PhD

Assistant Professor of Pathology and Medicine (Medical Oncology)

Yale School of Medicine

Director, Translational Immuno-oncology Laboratory

Yale Cancer Center

New Haven, CT

Dr Schalper has disclosed the following relevant financial relationships.

Consultant: Clínica Alemana; EMD Serono, Inc; Merck & Co, Inc; Takeda Pharmaceutical Company Limited; Torque Therapeutics, Inc

Grant/Research Support: AstraZeneca; Bristol Myers Squibb; Eli Lilly and Company; Genentech, Inc/Roche; Merck & Co, Inc; Moderna, Inc; Navigate BioPharma Services, Inc; Pierre Fabre Group; Ribon Therapeutics; Surface Oncology; Takeda Pharmaceutical Company Limited; TESARO, Inc/GlaxoSmithKline

Speakers Bureau: Bristol Myers Squibb; Genmab US, Inc; Merck & Co, Inc; PeerView, Inc; Takeda Pharmaceutical Company Limited

Scientific Advisory Board: Agenus Inc; Shattuck Labs, Inc

PLANNERS

Rutgers Biomedical and Health Sciences

Patrick Dwyer, Director, Continuing Medical Education, has no relevant financial relationships to disclose.

This activity has been peer-reviewed for relevance, accuracy of content, and balance of presentation by:

Jian Cao, PhD

Assistant Professor of Medicine

Rutgers Robert Wood Johnson Medical School
Resident Member
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

Jian Cao, PhD, has no relevant financial relationships to disclose.

This activity has been pilot-tested for time required for participation by Stephen Kranick, MD, Medicine Chief Resident, Rutgers Robert Wood Johnson Medical School; Noah Mahpour, MD, Medicine Chief Resident, Rutgers Robert Wood Johnson Medical School; and Scott Ventre, DO, Medicine Chief Resident, Rutgers Robert Wood Johnson Medical School. The testers have no relevant financial relationships to disclose.

Spire Learning

Allison Goldberg, MPA, Director, Grants and Education, Austin Ulrich, PharmD, BCACP, Medical Writer, and Mairead Early, Program Manager, have no relevant financial relationships to disclose.

Christopher Washburn, PhD, Clinical Director, has disclosed the following relevant financial relationships: Employee/Spouse: Janssen Pharmaceuticals, Inc

OFF-LABEL STATEMENT

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Rutgers Biomedical and Health Sciences and Spire Learning do not recommend the use of any agent outside of the labeled indications.

Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER

The opinions expressed in this educational activity are those of the faculty. It should not be inferred or assumed that they are expressing the views of any manufacturer of pharmaceuticals or devices, or RBHS, or Spire Learning, LLC.

It should be noted that the recommendations made herein with regard to the use of therapeutic agents, varying disease states, and assessments of risk, are based upon a combination of clinical trials, current guidelines, and the clinical practice experience of the participating presenters. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically and draw conclusions only after careful consideration of all available scientific information.

Spire Learning, LLC, and RBHS will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication or activity, including any claims related to the products, drugs, or services mentioned herein.

PRIVACY POLICY:

Rutgers Biomedical and Health Sciences

Please direct content or CE related questions or concerns to RBHS Center for Continuing and Outreach Education (CCOE) by email ccoe@rbhs.rutgers.edu.

To review RBHS’s CE privacy policy, click here. (https://ccoe.rbhs.rutgers.edu/general/privacypolicy.html)

For technical support, please email mearly@spirelearning.com

Spire Learning Privacy Policy:

Spire Learning, LLC, is committed to protecting the privacy of personal information from our participants and educational collaborators. Spire maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse, or alteration of personal information.

Collection and Use of Your Personal Information

The submission of certain personally identifiable information is necessary to award and track the credits participants may earn after completing an activity. Required items include first name, last name, degree, and email address. These items are necessary. Participants are also required to complete an evaluation of each activity. All evaluative information submitted is collected and retained, and used by Spire Learning, LLC, to continuously improve the learning experience.

Spire Learning, LLC, will not transfer, sell, or share personal information with outside parties or otherwise disclose personal information unless required to in a legal process. Spire will retain your personal data only for the period necessary to accomplish the stated purposes and to comply with applicable laws.

COPYRIGHT INFORMATION:

Copyright © 2021 by Spire Learning, LLC and Rutgers Biomedical and Health Sciences. All rights reserved including translation into other languages. No part of this publication or activity may be reproduced or transmitted in any form, by any means, without prior written permission of Spire Learning, LLC.

COURSE VIEWING REQUIREMENTS

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Additional Recommendations and Requirements
Display Resolution & Color Depth	Resolution - 960 X 768 minimum - 1024 X 768 recommended min. Color Depth - 8 bits (256 colors) minimum - 16 bits (High colors) minimum
Audio	- Microphone - Speakers or headphones - Audio recording support
Word Processing	Software that can open, modify, and save documents in Rich Text Format (RTF). Microsoft Word and PowerPoint are recommended.

Clinical Efficacy of Currently Available and Investigational ICIs for NSCLC

Primary Audience:

Relevant Terms:

COURSE FACULTY

Hossein Borghaei, DO, MS

Chief of Thoracic Medical Oncology Professor, Department of Oncology/Hematology Co-Director, Immune Monitoring Facility The Gloria and Edmund M. Dunn Chair in Thoracic Malignancies Fox Chase Cancer Center Philadelphia, PA

Kurt A. Schalper, MD, PhD

Assistant Professor of Pathology and Medicine (Medical Oncology) Yale School of Medicine Director, Translational Immuno-oncology Laboratory Yale Cancer Center New Haven, CT

LEARNING OBJECTIVES

COURSE INFORMATION

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Chief of Thoracic Medical Oncology
Professor, Department of Oncology/Hematology
Co-Director, Immune Monitoring Facility
The Gloria and Edmund M. Dunn Chair in Thoracic Malignancies
Fox Chase Cancer Center
Philadelphia, PA

Assistant Professor of Pathology and Medicine (Medical Oncology)
Yale School of Medicine
Director, Translational Immuno-oncology Laboratory
Yale Cancer Center
New Haven, CT