Accreditation/Credit Designation

Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians’ Education Resource®, LLC, designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669, for 1.0 Contact Hours.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Bristol-Myers Squibb.

Oncology Briefings™: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology


Release Date: July 31, 2018
Expiration Date: July 31, 2019
Media: Internet - based
 

Activity Overview

This activity, Oncology Briefings™: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology, developed in Physicians’ Education Resource, LLC, (PER®) established Oncology Briefings™ legacy format, is an online interactive monograph that provides an overview of the current and future role of biomarkers in predicting pan-tumor response to immunotherapy in cancer. This presentation features a national thought leader, Hossein Borghaei, DO, MS, who provides key insights.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Bristol-Myers Squibb.

Instructions for This Activity and Receiving Credit

  • You will need to login to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video files” will be available for your reference.
  • In order to receive a CME/CE certificate, participants must complete the activity.
  • Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a CME/CE certificate upon completion of these steps.


Target Audience

This educational initiative is directed toward medical oncologists, oncology pathologists, clinical/biomedical researchers, hematologists, pathologists, and other healthcare professionals interested in personalized medicine and biomarker research. Nurse practitioners, nurses, physician assistants, pharmacists, fellows, and other healthcare professionals are also invited to participate.

Educational Objectives

Upon completion of this activity, participants should be better prepared to:

  • Define next-generation sequencing (NGS) and comprehensive gene panels, and its utility in identifying potential biomarkers and response to cancer immunotherapeutics
  • Explain the potential utility of NGS in characterizing the tumor microenvironment
  • Synthesize and integrate clinical study data illustrating the appropriate use of NGS in immuno-oncology across multiple tumor types
  • Identify current NGS technology platforms and comprehensive gene panels and their advantages and disadvantages

Faculty, Staff, and Planners' Disclosure
Hossein Borghaei
Hossein Borghaei, DO, MS
Chief, Division of Thoracic Medical Oncology
Associate Professor, Department of Hematology/Oncology
Co-Director, Immune Monitoring Facility
Lung Cancer and Mesothelioma TRDG Member
Fox Chase Cancer Center
Temple Health
Philadelphia, PA

Disclosure: Grant/Research Support: Millennium, Merck, Celgene, Lilly, BMS; Consultant: BMS, Lilly, Genentech, Pfizer, Merck, AstraZeneca, Genmab, Celgene, EMD Serono, Boehringer Ingelheim, Regeneron, BioNTech, Cantargia AB

The staff of Physicians' Education Resource®, LLC have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.
 
Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing medical and nursing education only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty member, and do not reflect those of PER® or the company that provided commercial support for this activity.

PER Pulse™ Recaps

1 of 3
Insight from Hossein Borghaei, DO, MS—PER Pulse Recap:
Oncology Briefings: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology

The online continuing medical education activity Oncology Briefings: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology examines the current and future roles of biomarkers as a predictive tool for pan-tumor response to immunotherapy. In this interactive monograph, you will investigate the role of next-generation sequencing (NGS) and comprehensive gene panels and determine clinical trial findings relevant to the delivery of personalized medicine to the care of your patients. The data will be contextualized through key insights from national thought leader Hossein Borghaei, DO, MS.

This first of 3 PER Pulse Recaps for the activity will focus on the benefits of NGS over traditional tumor-testing methodologies. Below are some highlights from the activity featuring Dr Borghaei:

From a clinical decision-making perspective, NGS offers distinct advantages for both physicians and patients.

“I want something that requires minimal tissue, has a rapid turnaround time, and gives me maximum information in a very short time. There are next-generation sequencing platforms and technologies that have most of these components. Almost all of them report back all the actionable mutations and alterations that I am interested in to help me make the clinical decision I need to make.”
—Hossein Borghaei, DO, MS

Recent and rapid technological advances in NGS have enabled oncology practitioners to have tumor exomes sequenced in a clinically meaningful time frame. NGS reveals more actionable genomic alterations than do standard diagnostic methods.1 The process of genomic profiling can be used to inform the diagnosis, prognosis, and treatment of many types of cancer. This is significant because results from studies have shown that patients with solid and hematologic malignancies treated with genetically matched therapy have improved outcomes versus patients with unmatched therapies.2,3

NGS accurately identifies substitutions, indels, copy number alterations, and gene fusions in cancer.3 It is also able to determine the necessary information on several genes at once, with potential advantages in turnaround time. Costs associated with NGS-based analysis are also lower than those of conventional molecular approaches.4

NGS is particularly useful because in many clinical situations, the only available specimen is a fine-needle core or aspiration biopsy or formalin-fixed, paraffin-embedded tissue slides, which do not provide ample DNA for classical Sanger sequencing.5

References

  1. Rozenblum AB, Ilouze M, Dudnik E, et al. Clinical impact of hybrid capture-based next-generation sequencing on changes in treatment decisions in lung cancer. J Thorac Oncol. 2017;12(2):258-268. doi: 10.1016/j.jtho.2016.10.021.
  2. Schwaederle M, Parker BA, Schwab RB, et al. Precision oncology: the UC San Diego Moores Cancer Center PREDICT experience. Mol Cancer Ther. 2016;15(4):743-752. doi: 10.1158/1535-7163.MCT-15-0795.
  3. He J, Abdel-Wahab O, Nahas MK, et al. Integrated genomic DNA/RNA profiling of hematologic malignancies in the clinical setting. Blood. 2016;127(24):3004-3014. doi: 10.1182/blood-2015-08-664649.
  4. de Unamuno Bustos B, Murria Estal R, Pérez Simó G, et al. Towards personalized medicine in melanoma: implementation of a clinical next-generation sequencing panel. Sci Rep. 2017;7(1):495. doi: 10.1038/s41598-017-00606-w.
  5. Dong L, Wang W, Li A, et al. Clinical next generation sequencing for precision medicine in cancer. Curr Genomics. 2015;16(4):253-263. doi: 10.2174/1389202915666150511205313.

2 of 3
Insight from Hossein Borghaei, DO, MS—PER Pulse Recap:
Oncology Briefings: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology

As a follow-up to the online continuing medical education activity Oncology Briefings: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology, this second of 3 PER Pulse Recaps for the activity will focus on the advantages of comprehensive and actionable gene panels for the delivery of personalized medicine. Below are some highlights from the meeting featuring Dr Borghaei:

Because all patients do not always have the same mutated genes responsible for tumorigenesis, a personalized medicine approach is warranted.

“Getting the comprehensive panel provides you with a very good snapshot of what is going on within the tumor at that time. What we’ve learned over the years is that these comprehensive panels pick up rare mutations that although we might not have a specific targeted therapy right now, 6 months down the road, we potentially could have.”
—Hossein Borghaei, DO, MS

Comprehensive Panels

These include all genes associated with all diseases. An example is TruSight One, a panel that includes more than 60 subpanels and covers 4813 genes associated with clinical phenotypes. It is designed to encompass the most commonly requested targeted gene panel assays so they can all be evaluated at the same time.1

Actionable Gene Panels

An evolution of hot spot panels includes all exons of targeted genes (or all clinically relevant regions) so that other pathogenic mutations outside frequently mutated sites can be interrogated. They focus on actionable genes, such as EGFR, BRAF, KRAS, PIK3CA, NRAS, KIT, and ALK, and testing results are used to match each patient with the appropriate (targeted) therapy. An example of this type of panel is the TruSight Tumor panel, which enables the identification of low-frequency mutations across 26 genes involved in targeted therapy for lung cancer, colon cancer, gastric cancer, ovarian cancer, and melanoma.1

The 25-gene myRisk panel is designed for the identification of clinically significant mutations affecting inherited risks for lung cancer, colon cancer, gastric cancer, ovarian cancer, and melanoma. Test results yield actionable risk assessment and specific medical management recommendations.1 TargetGxOne custom gene panels provide targeted resequencing of any gene of interest by next-generation sequencing (NGS) from the assay design through advanced bioinformatics analysis with 2 different options.2

Oncomine Focus Assay is an integrated NGS assay of 52 cancer genes with therapeutic relevance. One international practice reported a turnaround time of 3.5 days, and the assay was convenient, reliable, broadly applicable, and cost-effective in the NGS of tumor samples.3

References

  1. Dong L, Wang W, Li A, et al. Clinical next generation sequencing for precision medicine in cancer. Curr Genomics. 2015;16(4):253-263. doi: 10.2174/1389202915666150511205313.
  2. TargetGxOne custom gene panels. Genewiz website. genewiz.com/Public/Services/Next-Generation-Sequencing/Targeted-Resequencing-Panels/Custom-Targeted-Sequencing. Accessed September 4, 2018.
  3. Paasinen-Sohns A, Koelzer VH, Frank A, et al. Single-center experience with a targeted next generation sequencing assay for assessment of relevant somatic alterations in solid tumors. Neoplasia. 2017;19(3):196-206. doi: 10.1016/j.neo.2017.01.003.

3 of 3
Insight from Hossein Borghaei, DO, MS—PER Pulse Recap:
Oncology Briefings: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology

As a follow-up to the online continuing medical education activity Oncology Briefings: Harnessing the Predictive Powers of Biomarkers in Immuno-Oncology, this third of 3 PER Pulse Recaps for the activity will focus on the clinical trial findings supporting the use of next-generation sequencing (NGS) in immuno-oncology to potentially improve patient outcomes. Below are some highlights from the meeting featuring Dr Borghaei:

Incorporating NGS data can inform diagnostic, prognostic, and therapeutic decision making.

“As a result of NGS, we are able to get the data on tumor mutational burden [TMB]. The majority of the data right now suggest that high TMB is associated with clinical efficacy in terms of response rate and progression-free survival for patients.”
—Hossein Borghaei, DO, MS

A large study of 100,000 cancer genomes has revealed that many patients with cancer who have high TMB are likely to benefit from immunotherapy.1 This study identified a novel mutation hot spot in the PMS2 gene, which may have clinical implications because the PMS2 gene is mutated in ~10% of skin cancers.

Correlation between mutational landscape and PD-1 blockade has been observed in non–small cell lung cancer (NSCLC). Analysis of 2 independent cohorts of patients with NSCLC showed that higher TMB was associated with improved objective response rate and progression-free survival.2 A separate study evaluated the feasibility of a gene panel developed based on NGS to identify mutations in cell-free DNA in NSCLC, gastrointestinal stromal tumor, colorectal carcinoma (CRC), and melanoma.3 The panel had 100% specificity and 79% sensitivity relative to tumor tissue.

An ongoing phase III trial (CheckMate 227, NCT02477826) is investigating the correlation between TMB and nivolumab/ipilimumab combination or nivolumab monotherapy versus chemotherapy in patients whose tumors express PD-L1. Preliminary results indicating better response with PD-1 inhibitors in patients with high TMB have been announced. Feasibility of quantifying TMB as a potential predictive biomarker of PD-1/PD-L1 therapy in CRC is currently being explored.4

Genetic alterations with potential clinical implications in nonmuscle-invasive bladder cancer were evaluated by NGS, which revealed frequent DNA damage response and repair gene alterations in high-grade tumors associated with increased tumor mutational burden.5

The role for genomic profiling of tumors will continue to evolve as the evidence base of actionable drivers expands.

References

  1. Chalmers ZR, Connelly CF, Fabrizio, D, et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med. 2017;9(1):34. doi: 10.1186/s13073-017-0424-2.
  2. Rizvi NA, Hellmann MD, Snyder A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015;348(6230):124-128. doi: 10.1126/science.aaa1348.
  3. Malapelle U, Mayo de-Las-Casas C, Rocco D, et al. Development of a gene panel for next-generation sequencing of clinically relevant mutations in cell-free DNA from cancer patients. Br J Cancer. 2017;116(6):802-810. doi: 10.1038/bjc.2017.8.
  4. George TJ, Frampton GM, Sun J, et al. Tumor mutational burden as a potential biomarker for PD1/PD-L1 therapy in colorectal cancer. J Clin Oncol. 2016;34(suppl; abstr 3587). doi: 10.1200/JCO.2016.34.15_suppl.3587.
  5. Pietzak EJ, Bagrodia A, Cha EK, et al. Next-generation sequencing of nonmuscle invasive bladder cancer reveals potential biomarkers and rational therapeutic targets. Eur Urol. 2017;72(6):952-959. doi: 10.1016/j.eururo.2017.05.032.

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