cgp identi˜es actionable biomarkers that help ... - oncology … · enable simultaneous detection...

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Comprehensive genomic profiling (CGP) is driving a new standard of care Enable simultaneous detection of multiple oncology biomarkers in a single next-generation sequencing test CGP identifies actionable biomarkers that help optimize treatment CGP-based tumor profiling assays cover multiple relevant biomarkers Consolidating biomarker detection into a single assay limits the input of precious biopsy sample, provides faster results, and reduces the need for rebiopsy 10-12 CGP consolidates testing for faster results using fewer samples TODAY'S CHALLENGE: Increasing number of biomarkers plus limited biopsy sample IN A SERIES OF STUDIES, UP TO 90 % OF PATIENTS had actionable alterations identified by CGP 1-6 References: 1. Stransky N, et al. The landscape of kinase fusions in cancer. Nat Commun. 2014;5:4846. 2. Boland GM, Piha-Paul SA, Subbiah V, et al. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget. 2015;6(24):20099-20110. 3. Massard C, Michiels S, Ferte C, et al. High-throughput genomics and clinical outcome in hard-to-treat advanced cancers: results of the MOSCATO 01 trial. Cancer Discov . 2017;7(6):586-595. 4. Harris MH, et al. Multicenter feasibility study of tumor molecular profiling to inform therapeutic decisions in advanced pediatric solid tumors: the individualized cancer therapy (iCat) study. JAMA Oncol . 2016;2(5):608-615. 5. Parsons DW, Roy A, Yang Y, et al. Diagnostic yield of clinical tumor and germline whole-exome sequencing for children with solid tumors. JAMA Oncol . 2016;2(5):616-624. 6. Reitsma et al., 2019. Effect of a Collaboration Between a Health Plan, Oncology Practice, and Comprehensive Genomic Profiling Company from the Payer Perspective. Journal of Managed Care & Specialty Pharmacy . 2019;25(5):601-611. 7. Sabatini LM, Mathews C, Ptak, S, et al. Genomic sequencing procedure microcosting analysis and health economic cost-impact analysis: a report of the association for molecular pathology. J Mol Diag. 2016;18(3):319-328. 8. Clinical Trials. https://clinicaltrials.gov. Accessed May 22, 2019. 9. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf. Accessed May 22, 2019. 10. Pennel AP, Mutebi A, Zheng-Yi Z, et al. Economic Impact of Next-Generation Sequencing Versus Single-Gene Testing to Detect Genomic Alterations in Metastatic Non–Small-Cell Lung Cancer Using a Decision Analytic Model. JCO Precis Oncol . 2019. doi.org/10.1200/PO.18.00356. 11. National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed March 25, 2019. 12. Lindeman NI, et al. Guideline from the college of American pathologists, the international association for the study of lung cancer, and the association of molecular pathology: updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors. J Thor Onc. 2017;13(3):323-358. © 2019 Illumina, Inc. All rights reserved. QB 7595 Increased clinical trial enrollment Patient eligibility from 4% to 54% 7 CGP offers substantial savings to the health care system $ 2.1 in potential savings as compared to exclusionary, sequential testing, and hotspot panels 10 MILLION UP TO potential savings to the insurer per patient enrolled in a clinical trial 2 THOUSAND $ 24 All known DNA and RNA variants Biomarkers associated with approved and developing therapies across multiple tumor types Genetic signatures such as tumor mutational burden (TMB) and microsatellite instability (MSI) CONSOLIDATED TESTING VS. ITERATIVE TESTING 1200 + ongoing clinical trials 8 approved cancer therapies 9 50 Increased targeted therapy use Patient assignment from 6% to 13% 7

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Page 1: CGP identi˜es actionable biomarkers that help ... - Oncology … · Enable simultaneous detection of multiple oncology biomarkers in a single next-generation sequencing test CGP

Comprehensive genomic pro�ling (CGP) is driving a new standard of careEnable simultaneous detection of multiple oncology biomarkersin a single next-generation sequencing test

CGP identi�es actionable biomarkers that help optimize treatment

CGP-based tumor pro�ling assays cover multiple relevant biomarkers

Consolidating biomarker detection into a single assay limits the input of precious biopsy sample, provides faster results, and reduces the need for rebiopsy10-12

CGP consolidates testing for faster results using fewer samplesTODAY'S CHALLENGE: Increasing number of biomarkers plus limited biopsy sample

IN A SERIES OF STUDIES, UP TO 90%

OF PATIENTShad actionable alterations identi�ed by CGP1-6

References:1. Stransky N, et al. The landscape of kinase fusions in cancer. Nat Commun. 2014;5:4846. 2. Boland GM, Piha-Paul SA, Subbiah V, et al. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget. 2015;6(24):20099-20110. 3. Massard C, Michiels S, Ferte C, et al. High-throughput genomics and clinical outcome in hard-to-treat advanced cancers: results of the MOSCATO 01 trial. Cancer Discov. 2017;7(6):586-595. 4. Harris MH, et al. Multicenter feasibility study of tumor molecular pro�ling to inform therapeutic decisions in advanced pediatric solid tumors: the individualized cancer therapy (iCat) study. JAMA Oncol. 2016;2(5):608-615. 5. Parsons DW, Roy A, Yang Y, et al. Diagnostic yield of clinical tumor and germline whole-exome sequencing for children with solid tumors. JAMA Oncol. 2016;2(5):616-624.6. Reitsma et al., 2019. Effect of a Collaboration Between a Health Plan, Oncology Practice, and Comprehensive Genomic Pro�ling Company from the Payer Perspective. Journal of Managed Care & Specialty Pharmacy. 2019;25(5):601-611.7. Sabatini LM, Mathews C, Ptak, S, et al. Genomic sequencing procedure microcosting analysis and health economic cost-impact analysis: a report of the association for molecular pathology. J Mol Diag. 2016;18(3):319-328.8. Clinical Trials. https://clinicaltrials.gov. Accessed May 22, 2019.9. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf. Accessed May 22, 2019.10. Pennel AP, Mutebi A, Zheng-Yi Z, et al. Economic Impact of Next-Generation Sequencing Versus Single-Gene Testing to Detect Genomic Alterations in Metastatic Non–Small-Cell Lung Cancer Using a Decision Analytic Model. JCO Precis Oncol. 2019. doi.org/10.1200/PO.18.00356.11. National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed March 25, 2019. 12. Lindeman NI, et al. Guideline from the college of American pathologists, the international association for the study of lung cancer, and the association of molecular pathology: updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors. J Thor Onc. 2017;13(3):323-358.

© 2019 Illumina, Inc. All rights reserved. QB 7595

Increased clinical trial enrollment

Patienteligibility

from 4% to 54%7

CGP offers substantial savings to the health care system

$2.1 in potential savings as compared to exclusionary, sequential testing, and hotspot panels10MILLION

UP TO

potential savings to the insurer per patient enrolled in a clinical trial2THOUSAND

$24

All known DNA and RNA variants

Biomarkers associated with approved and developing therapies across multiple

tumor types

Genetic signatures such as tumor mutational burden (TMB)

and microsatellite instability (MSI)

CONSOLIDATED TESTINGVS.ITERATIVE TESTING

1200+ ongoingclinicaltrials8

approved cancer therapies950

Increased targeted therapy use

Patientassignmentfrom 6% to 13%

7