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Precision Oncology
Biomarkers: State-
of-the-Art
Technologies and
Emerging Strategies
Emerging Tech Webinar
May 2023
2
Speakers
Dr. Michael R. Rossi
Vice President, ConcertAI
Dr. Shibicharkravarthy Kannan
CEO, Oncophenomics
Nitish Kumar Singh
Principal Consultant
BIS Research Inc.
3
Agenda
▪ Multi-Modal Approaches to Improve Clinical Biomarker
Interpretation
Key Speaker 2 : Dr. Shibicharkravarthy Kannan
▪ Tumor Agnostic Biomarkers
Key Speaker 3 : Mr. Nitish Kumar Singh
▪ Clinical Biomarkers
▪ Oncology Biomarkers
Insight Monk and Previous Reports
Q&A
Introduction
Key Speaker 1 : Dr. Michael R. Rossi
Multi-Modal Approaches to
Improve Clinical Biomarker
Interpretation and Translational
Science
Dr. Michael R. Rossi, Ph.D., FACMG
VP of Translational Science and Multi-Modal RWE
ConcertAI
Disclosure Statement
• I am an employee of ConcertAI.
• I was formerly employed by Sema4 (now GeneDx).
• The information presented here is not confidential or proprietary
• I have nothing to disclose
Outline
• Historical context of multi-modal precision medicine
• Clinical breast cancer vignette of the importance of clinical
history in interpreting genomics and disease progression
Amplifications
Translocations
Gene mutations
http://www.vicc.org/research/shared/translational/services/snapshot.php
8
1 0
1 1
SABC 2021: Clinical WTS/WTS vs Oncomine®v3
SABC 2021: Clinical WTS/WTS vs Oncomine®v3
• We identified clinically significant variants in 92% (281/307) of breast
tumors sequenced of which 41% (127/307) were clinically actionable and
13% (17/127) were assigned to therapy
• These numbers are similar to NCI-MATCH: “Assignment rates for NSCLC,
colorectal, breast, and prostate cancer were 17.4%, 13.7%, 17.8%, and
23.0%, respectively.” DOI: 10.1200/JCO.19.03010 Journal of Clinical
Oncology 38, no. 33 (November 20, 2020) 3883-3894.
Patients with Longitudinal FFPE specimens
Acquired ERS1 fusion (Pair 2) and
ESR1 p.Y537C (Pair 5) Fulvestrant
resistance variants
2005: DCIS, 2016: metastatic
1st line: Letrozole + Paobociclib (2016-11 to 2018-01) POD 2nd line: Fulvestrant + Ribociclib (2018-01 to 2018-05) POD
3rd line: Capecitabine (2018-05 to 2018-12) POD 4th line: Tamoxifen (2018-12 to 2019-03) POD
5th line: Paclitaxel (2019-03 to now)
Follow-up Replicates
Days from 1st
Collection
Collection Date
ReportExportDat
e
Tumor/Blast % RSM subtype Stage Variant tag Significant_variants VUS
Yes Pair2 0 11/11/2016 2018-10-08 50 HR+/HER2- IV MDM2 AMP
Yes Pair2 746 11/27/2018 2019-01-04 80 HR+/HER2- IV ESR1 mutation
CDKN2A p.R58*, ESR1
p.Y537S, MDM2 AMP
ESR1 ESR1-
AKAP12
Pair 2
1985: early stage breast cancer, 2018: met
1st line: Fulvestrant + Palbociclib 2021-04: POD 2nd line: Exemestane + Ribociclib (2021-05-05 to 2021-06-30) 2021-06-30: POD 3rd line: Olaparib (2021-07-01 to now)
Follow-up Replicates
Days from 1st
Collection
Collection Date
ReportExportDat
e
Tumor/Blast % RSM subtype Stage Variant tag Significant_variants VUS
Yes Pair5 0 9/26/2018 2019-02-02 20 HR+/HER2- IV
BRCA1
mutation
BRCA1 p.T1122Rfs*10,
FGFR1 Gain
Yes Pair5 954 5/7/2021 2021-05-26 HR+/HER2- IV
BRCA1
mutation, ESR1
mutation
BRCA1 p.T1122Rfs*10, ESR1 p.Y537C,
FGFR1 AMP, MYC AMP
Pair 5
Acknowledgements (Too Many People)
Lab
Dan Sisco
Stephanie McDade
Crina Sanchioni
Lab Directors
Feras Hantash
Hussam Al-Kateb
Leadership
Eric Schadt
Michelle Zimmerman
Oncologists
Amy Tiersten
William Oh
Ken Onel
Tomi Jun
Bioinformatics
Andrew Uzilov
Huan Wang
Jonathan Keeling
Chris Dwan
Data and Software
Rong Chen
Scott Newman
Marc Fink
Zhiqiang (John) Li
Xiang Zhou
Pathologists
Sertac Kip
Wanying Zhang
Kim Cole
Conclusions
• Multi-modal data, combining multiple data points and data types, is
required to understand complex diseases like cancer.
• More emphasis must be placed on clinicogenomics and clinical multi-
omics data to interpret response to therapy and disease progression.
• Future biomarkers will likely be derived by complex datasets.
• Artificial Intelligence (AI) will be most effective as a physician assistant if
the data elements are clear and vetted.
Tumor
Agnostic
Biomarkers
For Tumor Agnostic Therapies
PRECISION ONCOLOGY
BIOMARKERS
S T A T E O F T H E A R T A N D E M E R G I N G T E C H N O L O G I E S
Dr. Shibichakravarthy Kannan, MBBS, PhD
Founder & CEO Oncophenomics Inc.
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
3
Precision Medicine in Oncology
Targeted
Therapies
Immuno-
therapies
• Precision medicine in oncology is a patient-centered approach that aims to customize cancer treatment based
on an individual's unique genetic makeup.
• This approach can potentially improve outcomes and reduce side effects.
• Biomarkers play a critical role in precision oncology, serving as indicators of normal biological processes,
pathogenic processes, or responses to therapeutic interventions.
• Next-generation sequencing (NGS): Enables comprehensive analysis of the cancer genome, leading to the
identification of actionable mutations.
• Liquid biopsies: Non-invasive methods for detecting circulating tumor DNA (ctDNA) and circulating tumor origin
RNA in the form of exosomes (ctRNA) and circulating tumor cells (CTCs) in blood.
Genome
Medicine
Cell-based
therapies
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
4
PRECISION ONCOLOGY NEEDS PRECISION BIOMARKERS
5
Liquid Biopsy
Emerging Strategies: Single-cell Sequencing
Single-cell sequencing offers the potential to analyze
individual cells within a tumor, providing a more
comprehensive picture of tumor heterogeneity.
Multi-omics, multi-analyte and multi-modal
integration of genomics, epigenomics,
transcriptomics, proteomics, metabolomics, etc., to
provide a more comprehensive understanding of
cancer biology from circulating biomarkers.
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
6
CIRCULATING TUMOR BIOMARKERS
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
7
NTRK Gene Fusion
A Key Driver in Multiple Tumor Types
NTRK gene fusions have been found in more than 21 adult and
pediatric solid tumor types
• Colorectal, biliary, pancreatic, and appendiceal.
• Glioma and glioblastoma.
• Mammary analogue secretory carcinoma.
• Infantile fibrosarcoma and soft tissue sarcoma.
TRK FUSION PROTEINS ARE THE KEY
ONCOGENIC DRIVER FOR MANY CANCERS
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
8
NTRK Gene Fusions Lead to the Formation of Oncogenic TRK Fusion Proteins
• In TRK fusion cancer, the NTRK gene (NTRK1, NTRK2, and NTRK3) fuses with an unrelated gene
• This fusion causes the expression of TRK fusion proteins
• Which results in cell proliferation and tumor growth
How VITRAKVI works in TRK fusion cancer1
• VITRAKVI is highly selective and potent
against the TRK family of proteins (TRKA,
TRKB, and TRKC)
• VITRAKVI was purposefully designed to avoid
activity with off-target kinases
• The only other kinase activity occurred at 100-
fold higher concentrations
• VITRAKVI blocks the downstream signaling
pathway
• This results in inhibition of the tumor growth
and survival that lead to TRK fusion cancer
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
9
VITRAKVI: THE TRK INHIBITOR EXCLUSIVELY DESIGNED TO ONLY TARGET TRK
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
10
ACROSS SOLID TUMORS
VITRAKVI®
PROVEN AND
DURABLE EFFICACY
ACROSS TUMOR TYPES
Reference
•VITRAKVI [summary of product characteristics].
Leverkusen, Germany: Bayer AG; 2022.
IRC analysis by RECIST v1.1.
Evaluated per independent review committee analysis by
RECIST v1.1 for all tumor types except patients with a primary
CNS tumor who were evaluated per investigator assessment
using either RANO or RECIST v1.1 criteria.
With 2 complete, 1 partial response.
With 1 complete, 1 partial response.
One patient who is not evaluable.
+ denotes ongoing response.
CNS, central nervous system; DOR, duration of response; IRC,
independent review committee; NA, not applicable due to
small numbers or lack of response; NR; not reached; ORR,
overall response rate; RANO, Response Assessment in Neuro-
Oncology; RECIST, Response Evaluation Criteria in Solid Tumors
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
11
COMPREHENSIVE GENOMIC PROFILING BY NGS IS PREFERRED OVER IHC
TEST ALL PATIENTS EARLY TO IDENTIFY THOSE
WITH NTRK GENE FUSIONS WHO CAN BENEFIT
FROM VITRAKVI®
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
12
TAFINLAR, IN COMBINATION WITH MEKINIST FOR BRAF MUTATIONS
INDICATIONS
TAFINLAR, in combination with MEKINIST, is indicated:
•for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test
•for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of
lymph nodes, following complete resection
•for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test
•for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory
locoregional treatment options
•for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who
have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval
based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of
clinical benefit in confirmatory trials
•for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
Limitation of Use: TAFINLAR, in combination with MEKINIST, is not indicated for treatment of patients with colorectal cancer because of known intrinsic
resistance to BRAF inhibition. TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors.
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
13
RETEVMO FOR PATIENTS WITH RET-ALTERED ADVANCED SOLID TUMORS
Selpercatinib (Retevmo) is a National Comprehensive Cancer Network® (NCCN®)-
recommended treatment option for certain patients with RET-positive metastatic non-
small cell lung cancer (NSCLC) and RET-positive advanced or metastatic thyroid carcinoma
Next-generation sequencing (NGS) can be an accurate and
tissue-efficient method to test for driver RET alterations and
other targetable biomarkers.
• Both RET point mutations and fusions can be detected by NGS
• Immunohistochemistry (IHC) is not preferred for detecting RET alterations
due to low sensitivity and variable specificity
• Test the tissue: molecular testing of FFPE tumor tissue specimens is
preferred for detecting RET fusions and point mutations
• Why NGS? - Broad molecular profiling to identify appropriate targeted
therapies can improve outcomes in NSCLC
• NCCN Guidelines for NSCLC recommend that, when feasible, molecular
testing of NSCLC specimens be performed via a broad, panel-based
approach, most typically performed by NGS
• Because of potential tissue limitations in metastatic NSCLC and the increased
number of actionable biomarkers, NGS testing is part of the most
comprehensive strategy to identify appropriate targeted therapies
• Consider NGS testing to identify the 69% of patients with lung
adenocarcinoma who have a potentially actionable oncogenic driver
alteration and may benefit from appropriate approved or investigational
targeted therapy
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
14
TESTING FOR RET IS ESSENTIAL TO IDENTIFY PATIENTS WHO MAY BE ELIGIBLE FOR RETEVMO
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend
testing for RET alterations in appropriate patients with advanced and/or metastatic
NSCLC and thyroid carcinoma* to determine if they are eligible for RET inhibitors
such as selpercatinib (Retevmo)
Emerging = biomarkers with therapies under investigation but not approved
Other = unknown oncogenic driver detected
EGFR = EGFR sensitizing mutations including exon 20 insertions
EGFR other = secondary EGFR mutations, including Thr790Met and Cys797Ser,
and other less common EGFR mutations
KRAS other = all KRAS mutations other than KRAS G12C
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
15
KEYTRUDA® (PEMBROLIZUMAB): PD-1 RECEPTOR BLOCKADE
Normal immune response
When functioning properly, T cells are activated
and can attack tumor cells.
Tumor evasion and T-cell deactivation
Some tumors can evade the immune system
through the PD-1 pathway. The PD-L1 and PD-L2
ligands on tumors can bind with PD-1 receptors
on T cells to inactivate the T cells.
T-cell reactivation with KEYTRUDA
KEYTRUDA binds to the PD-1 receptor and blocks its
interaction with PD-L1 and PD-L2, which helps restore
the immune response. While having an effect on the
tumor, this could also affect normal healthy cells.
Advanced Melanoma or Adjuvant Therapy for Melanoma
Advanced NSCLC or Adjuvant Therapy for Non–Small Cell Lung Cancer (NSCLC)
Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell
Carcinoma (HNSCC)
Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
Refractory or Relapsed Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Advanced Urothelial Carcinoma (UC)
High-Risk Non-muscle Invasive Bladder Cancer (NMIBC)
Advanced Gastric or GEJ Cancer
Advanced Esophageal or GEJ Carcinoma
Advanced MSI-H/dMMR Cancers – Tumor Agnostic Therapies
Advanced TMB-H Cancers
Advanced MSI-H/dMMR Colorectal Cancer (CRC)
Advanced Cervical Cancer
Advanced Merkel Cell Carcinoma (MCC)
Adjuvant Treatment for RCC or Advanced Renal Cell Carcinoma (RCC)
Advanced MSI-H/dMMR Endometrial Carcinoma
Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Advanced TNBC or High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
16
BIOMARKER TESTING – PD-L1 BY IHC
Understanding PD-L1 Testing:
• PD-L1 expression is evaluated differently depending on the type of cancer
• Combined positive score (CPS) and tumor proportion score (TPS) both evaluate PD-L1 expression and help identify
patients eligible for treatment with KEYTRUDA
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
17
BIOMARKER TESTING – TMB and MSI BY NGS
MSI-H/dMMR (Microsatellite Instability-
High/Mismatch Repair Deficient)
• Immunohistochemistry (IHC) detects the
presence and absence of MMR protein
expression
• dMMR is defined as at least 1 protein (MSH 2,
MSH 6, PMS 2 and MLH 1) showing loss of
expression
• Next-generation sequencing (NGS) compares the
length of nucleotide repeats in tumor cells and
normal cells
• NGS is a gene sequencing technique used to
identify genetic mutations or variants
Understanding TMB Testing
• Tumor mutational burden (TMB) is an
assessment of the number of somatic mutations
in a defined region of a tumor genome and varies
according to tumor type as well as among
patients.
• Tumors with high levels of TMB are more likely to
produce tumor cell surface epitopes that act as
neoantigens and induce an elevated antitumor
immune response.
• TMB status may be determined using next-
generation sequencing methods. TMB-H may be
a predictive biomarker for response to ICI therapy
in some patients with advanced solid tumors.
MSI-H/dMMR occurs in different solid tumor types, including:
CRC, Endometrial, Gastric or GEJ, Small intestinal, Brain, Ovarian, Biliary, Pancreatic, Sarcoma, Breast, anal, HNSCC,
nasopharyngeal, retroperitoneal, testicular, vaginal, vulvar, appendiceal adenocarcinoma, hepatocellular carcinoma,
carcinoma of unknown origin, and abdominal adenocarcinoma., Cervical, Neuroendocrine, Prostate, Adrenocortical,
Mesothelioma, Thyroid, Small cell lung, Bladder, Salivary, Renal cell etc.
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
18
SUMMARY AND KEY TAKE AWAY POINTS
• Tumor agnostic biomarkers and therapies represent a significant paradigm shift in oncology, with the
potential to greatly improve patient outcomes
• Tumor Agnostic Therapies – novel cancer treatments that target specific molecular alterations
irrespective of the type or location of cancer
• Tumor agnostic biomarkers - can identify potential targets for therapy across different types of cancer
• Understanding the function of these biomarkers is crucial to the development of new therapies.
• NGS allows for comprehensive genomic profiling, enabling the detection of these biomarkers
• Regulatory acceptance is crucial for the widespread adoption of tumor-agnostic therapies & biomarkers
• The ethical, access, and cost considerations of tumor-agnostic therapies and genetic testing must be
addressed to ensure equitable patient access
• Patients should be educated and empowered to understand their tumor agnostic treatment options,
including potential benefits and risks
Conclusion:
• Tumor-agnostic biomarkers and therapies offer an exciting direction for cancer care, promising a more
personalized and effective approach to treatment.
PRECISION ONCOLOGY BIOMARKERS - WEBINAR
19
Precision
Oncology
Needs
Precision
Biomarkers
THANK YOU
Clinical Biomarkers
in Oncology
Emerging Tech Webinar
May 2023
Key Speaker
Nitish Kumar
Singh
Principal Consultant
BIS Research Inc.
Clinical
Biomarkers:
Trends and Key
Market
Developments
22
Role of Biomarkers in Role of Biomarkers in Personalized Cancer Treatment
Biomarkers Provide Valuable Information about the Characteristics and Behavior of a Tumor
Applications of Biomarkers
in PCT
Prognosis
Diagnosis
Pharmacodynamics
/ Kinetics
Prediction
Likeliness of Recurrence
Helps in Assessing
Individual's risk for developing cancer
Aid in early detection
Determine prognosis
Guide treatment decisions
23
Overview of the Challenges in Biomarker Identification and Validation
Challenges in
Biomarker
Identification and
Validation
Inability to identify
low expression
level biomarkers in
abnormal cancer
growth and normal
cellular growth
Challenging to
distinguish
between a potential
biomarker and a
reliable biomarker
that can be
universally used.
The genetic and
regulatory networks
for individual
patients will differ
significantly, thus
creating a challenge
in identification of
robust biomarkers.
No governing body
with the authority
to revoke the use of
a biomarker in
clinical practice if it
has been shown to
be invalid
Validation of
scientific
justification behind
biomarkers.
High cost of
biomarker validation
assays
24
Regional Market Landscape: Clinical Biomarkers
Market adoption rates across regions and clinical area indicate a high-growth market
10.7 11.8
18.8
28.1
6.2
6.8
10.5
15.2
2.7
3.1
5.1
8.1
0.8
0.9
1.2
1.5
2021 2022 2027 2032
$Billion
North America Europe
Asia-Pacific Latin America and Middle East
CAGR (2022-2032): 8.73%
42.04%
28.94%
11.44%
6.30%
4.50%
3.21%
3.56%
Oncology Biomarker Cardiac Biomarker
Neurological Biomarker Infectious Disease Biomarker
Immunological Biomarker Non-Invasive Prenatal Testing
Other Clinical Areas
2021
Market Size: $21.3 Billion
40.10%
29.75%
11.68%
6.33%
4.51%
3.25%
4.38%
2032
Market Size: $54.3 Billion
Source: BIS Research Analysis Source: BIS Research Analysis
25
Technological Landscape
Market adoption rates across regions and clinical area indicate a high-growth market
Source: BIS Research Analysis
Benefits of NGS for clinical diagnostics and biomarker
testing in oncology
Technology adoption for clinical biomarkers
31.28%
26.37%
18.19%
13.90%
10.26%
2021
Next Generation Sequencing
Polymerase Chain Reaction (PCR)
Immunohistochemistry (IHC)
Enzyme-Linked Immuno Sorbent Assay (ELISA)
Other Technologies
34.34%
27.11%
16.88%
12.25%
9.42%
2032
26
Leading Players in the Market
Source: BIS Research Analysis
Service Provider
Product Manufacturers
Market Share > 7%
Market Share in the
Range of 5%-7%
Market
Share < 5%
Market Share > 7%
Market Share in the
Range of 5%-7%
Market
Share < 5%
Clinical
Biomarkers
Market
Dynamics
28
Factors Propelling the Demand for Oncology Biomarkers Facilitating the Understanding
of Progression and Early Diagnosis of a Disease
The Rising Rate of Cancer has been a Key Catalyst in the Growing Demand
Source: BIS Research Analysis
Increasing Demand of Clinical
Biomarkers
Increasing Prevalence of Cancer
and Infectious Diseases
16.5%
Nearly half of oncology studies and
16.5% of all trials incorporate
biomarkers
4.5 M
COVID-19 alone caused around
4.5 million deaths in 2020
Rising Key Player Initiatives
6.67%
Key players initiatives of clinical
biomarkers increased 6.67%
between 2020 and 2021
29
Main Applications of Clinical Biomarkers include Liquid Biopsy and Early Cancer Testing
There are currently 4,901 active oncology-based biomarker clinical
trials going on according to clinicaltrials.gov. They can be classified
according to cancer types as shown in table below.
Non-Small Cell Lung Cancer or Small Cell Lung Cancer Survival Rates
Depending on the Stage of Diagnosis
NSCLC or SCLC 2 Year Survival Rate 5 Year Survival Rate
Stage IA1 97% 90%
Stage IA2 94% 85%
Stage IA3 92% 80%
Stage IB 89% 73%
Stage IIA 82% 65%
Stage IIB 76% 56%
Stage IIIA 65% 41%
Stage IIIB 47% 24%
Stage IIIC 30% 12%
Stage IVA 23% 10%
Stage IVB 10% 0%
Note: NSCLC = Non-Small Cell Lung Cancer and SCLC = Small Cell Lung Cancer
Source: Web-MD
14.66%
10.69%
6.32%
5.13%
4.35%
3.00%
1.99%
1.95% 0.81%
51.10%
Breast
Lung
Prostate
Pancreatic
Ovarian
Stomach
Liver
Colon and Rectm
Skin
Others
Need for Early Cancer Detection
Source: Clinicaltrials.gov
30
Rising Detection and Better Management of Cancer is now Possible with Biomarkers
Cancers and Their Most Common Biomarker Tests
Prevalence vs. Age-Standardized Death Rate of Cancer Globally,
2010-2019 (%)
Increasing Cancer Prevalence
-9.89%
-10.86%
-11.85%
-12.82%
-13.63%
-13.98%
-14.52%
-15.21%
-15.28%
-15.22%
-15.18%
-15.72%
-16.23%
1.22%
1.23%
1.24%
1.26%
1.27%
1.29%
1.31%
1.31%
1.32%
1.33%
1.35%
1.36%
1.38%
-20.00% -15.00% -10.00% -5.00% 0.00% 5.00%
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Prevalence (% Share) Age-Standardised Cancer Death Rate (%)
Cancer Types Biomarker Tests
Non-Small Cell Lung
Cancer
Changes in genes such as EGFR, KRAS, ALK, RET, ROS1,
MET, and BRAF
Breast Cancer
Progesterone receptor (PR) and Estrogen receptor (ER)
proteins; changes in genes such as BRCA1, BRCA2, and
PIK3CA; HER2 gene or protein status
Colorectal Cancer Changes in genes such as NRAS, KRAS, and BRAF
Melanoma Skin Cancer Changes in the BRAF gene
Any Cancer
Changes in NTRK genes; changes in mismatch repair (MMR)
genes; tumor mutational burden (TMB); levels of microsatellite
instability (MSI)
Source: American Cancer Society
Source: Ourworldindata.org
Oncology
Biomarkers
32
8.9 9.8
12.8
21.7
2021 2022 2025 2032
Market
Size
and
Growth
Market Size ($ Bn)
Oncology Biomarkers: Size, Growth, Trends
Key Trends:
▪ Illumina, Inc. launched the TruSight genomic profiling test to assess tumor genes across approximately 30 types of solid tumors
▪ QIAGEN N.V. partnered with Denovo Biopharma to develop a companion diagnostic test for the treatment of diffuse large B-cell lymphoma
(DLBCL).
▪ NeoGenomics Laboratories partnered with the Biomarker Collaborative to ensure patients receive comprehensive biomarker testing and
support access to clinical trials.
CAGR (2022-2032): 8.27% 35.50%
27.29%
18.63%
10.78%
7.79%
Breast Cancer Biomarker Lung Cancer Biomarker
Colorectal Cancer Biomarker Prostate Cancer Biomarker
Other
2021
Market Size: $8.9 Billion
37.11%
28.10%
19.66%
9.11%
6.02%
2032
Market Size: $21.7 Billion
Source: BIS Research Analysis
33 www.bisresearch.com I All right reserved
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▪ Global expert network for consultations
To get a free trial access, please schedule a demo. Visit: https://www.insightmonk.com/
34
Related Reports, Links and Promotions
Related Reports from BIS Research
Clinical Biomarkers - A Global and Regional Analysis
Published: 2022
View Report Details
Liquid Biopsy Market
Published: 2022
View Report Details
Global Digital Biomarkers Market - A Global and Regional Analysis
Published: 2022
View Report Details
www.bisresearch.com
35
Liquid Biopsy: An Emerging Frontier in
Early Multicancer Detection
Speaker Contact Information
Dr. Michael R. Rossi
Reach out to him at
mirossi@concertai.com
Nitish Kumar Singh
Reach out to him at
nitish.kumar@bisresearch.com
www.bisresearch.com
Dr. Shibicharkravarthy Kannan
Reach out to him at
skannan@oncophenomics.com
36
+
+
Thank You
37
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Webinar by BIS Research on Precision Oncology Biomarkers

  • 1. Precision Oncology Biomarkers: State- of-the-Art Technologies and Emerging Strategies Emerging Tech Webinar May 2023
  • 2. 2 Speakers Dr. Michael R. Rossi Vice President, ConcertAI Dr. Shibicharkravarthy Kannan CEO, Oncophenomics Nitish Kumar Singh Principal Consultant BIS Research Inc.
  • 3. 3 Agenda ▪ Multi-Modal Approaches to Improve Clinical Biomarker Interpretation Key Speaker 2 : Dr. Shibicharkravarthy Kannan ▪ Tumor Agnostic Biomarkers Key Speaker 3 : Mr. Nitish Kumar Singh ▪ Clinical Biomarkers ▪ Oncology Biomarkers Insight Monk and Previous Reports Q&A Introduction Key Speaker 1 : Dr. Michael R. Rossi
  • 4. Multi-Modal Approaches to Improve Clinical Biomarker Interpretation and Translational Science Dr. Michael R. Rossi, Ph.D., FACMG VP of Translational Science and Multi-Modal RWE ConcertAI
  • 5. Disclosure Statement • I am an employee of ConcertAI. • I was formerly employed by Sema4 (now GeneDx). • The information presented here is not confidential or proprietary • I have nothing to disclose
  • 6. Outline • Historical context of multi-modal precision medicine • Clinical breast cancer vignette of the importance of clinical history in interpreting genomics and disease progression
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  • 12. SABC 2021: Clinical WTS/WTS vs Oncomine®v3
  • 13. SABC 2021: Clinical WTS/WTS vs Oncomine®v3 • We identified clinically significant variants in 92% (281/307) of breast tumors sequenced of which 41% (127/307) were clinically actionable and 13% (17/127) were assigned to therapy • These numbers are similar to NCI-MATCH: “Assignment rates for NSCLC, colorectal, breast, and prostate cancer were 17.4%, 13.7%, 17.8%, and 23.0%, respectively.” DOI: 10.1200/JCO.19.03010 Journal of Clinical Oncology 38, no. 33 (November 20, 2020) 3883-3894.
  • 14. Patients with Longitudinal FFPE specimens Acquired ERS1 fusion (Pair 2) and ESR1 p.Y537C (Pair 5) Fulvestrant resistance variants
  • 15. 2005: DCIS, 2016: metastatic 1st line: Letrozole + Paobociclib (2016-11 to 2018-01) POD 2nd line: Fulvestrant + Ribociclib (2018-01 to 2018-05) POD 3rd line: Capecitabine (2018-05 to 2018-12) POD 4th line: Tamoxifen (2018-12 to 2019-03) POD 5th line: Paclitaxel (2019-03 to now) Follow-up Replicates Days from 1st Collection Collection Date ReportExportDat e Tumor/Blast % RSM subtype Stage Variant tag Significant_variants VUS Yes Pair2 0 11/11/2016 2018-10-08 50 HR+/HER2- IV MDM2 AMP Yes Pair2 746 11/27/2018 2019-01-04 80 HR+/HER2- IV ESR1 mutation CDKN2A p.R58*, ESR1 p.Y537S, MDM2 AMP ESR1 ESR1- AKAP12 Pair 2
  • 16. 1985: early stage breast cancer, 2018: met 1st line: Fulvestrant + Palbociclib 2021-04: POD 2nd line: Exemestane + Ribociclib (2021-05-05 to 2021-06-30) 2021-06-30: POD 3rd line: Olaparib (2021-07-01 to now) Follow-up Replicates Days from 1st Collection Collection Date ReportExportDat e Tumor/Blast % RSM subtype Stage Variant tag Significant_variants VUS Yes Pair5 0 9/26/2018 2019-02-02 20 HR+/HER2- IV BRCA1 mutation BRCA1 p.T1122Rfs*10, FGFR1 Gain Yes Pair5 954 5/7/2021 2021-05-26 HR+/HER2- IV BRCA1 mutation, ESR1 mutation BRCA1 p.T1122Rfs*10, ESR1 p.Y537C, FGFR1 AMP, MYC AMP Pair 5
  • 17. Acknowledgements (Too Many People) Lab Dan Sisco Stephanie McDade Crina Sanchioni Lab Directors Feras Hantash Hussam Al-Kateb Leadership Eric Schadt Michelle Zimmerman Oncologists Amy Tiersten William Oh Ken Onel Tomi Jun Bioinformatics Andrew Uzilov Huan Wang Jonathan Keeling Chris Dwan Data and Software Rong Chen Scott Newman Marc Fink Zhiqiang (John) Li Xiang Zhou Pathologists Sertac Kip Wanying Zhang Kim Cole
  • 18. Conclusions • Multi-modal data, combining multiple data points and data types, is required to understand complex diseases like cancer. • More emphasis must be placed on clinicogenomics and clinical multi- omics data to interpret response to therapy and disease progression. • Future biomarkers will likely be derived by complex datasets. • Artificial Intelligence (AI) will be most effective as a physician assistant if the data elements are clear and vetted.
  • 20. PRECISION ONCOLOGY BIOMARKERS S T A T E O F T H E A R T A N D E M E R G I N G T E C H N O L O G I E S Dr. Shibichakravarthy Kannan, MBBS, PhD Founder & CEO Oncophenomics Inc.
  • 21. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 3 Precision Medicine in Oncology Targeted Therapies Immuno- therapies • Precision medicine in oncology is a patient-centered approach that aims to customize cancer treatment based on an individual's unique genetic makeup. • This approach can potentially improve outcomes and reduce side effects. • Biomarkers play a critical role in precision oncology, serving as indicators of normal biological processes, pathogenic processes, or responses to therapeutic interventions. • Next-generation sequencing (NGS): Enables comprehensive analysis of the cancer genome, leading to the identification of actionable mutations. • Liquid biopsies: Non-invasive methods for detecting circulating tumor DNA (ctDNA) and circulating tumor origin RNA in the form of exosomes (ctRNA) and circulating tumor cells (CTCs) in blood. Genome Medicine Cell-based therapies
  • 22. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 4 PRECISION ONCOLOGY NEEDS PRECISION BIOMARKERS
  • 23. 5 Liquid Biopsy Emerging Strategies: Single-cell Sequencing Single-cell sequencing offers the potential to analyze individual cells within a tumor, providing a more comprehensive picture of tumor heterogeneity. Multi-omics, multi-analyte and multi-modal integration of genomics, epigenomics, transcriptomics, proteomics, metabolomics, etc., to provide a more comprehensive understanding of cancer biology from circulating biomarkers.
  • 24. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 6 CIRCULATING TUMOR BIOMARKERS
  • 25. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 7 NTRK Gene Fusion A Key Driver in Multiple Tumor Types NTRK gene fusions have been found in more than 21 adult and pediatric solid tumor types • Colorectal, biliary, pancreatic, and appendiceal. • Glioma and glioblastoma. • Mammary analogue secretory carcinoma. • Infantile fibrosarcoma and soft tissue sarcoma. TRK FUSION PROTEINS ARE THE KEY ONCOGENIC DRIVER FOR MANY CANCERS
  • 26. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 8 NTRK Gene Fusions Lead to the Formation of Oncogenic TRK Fusion Proteins • In TRK fusion cancer, the NTRK gene (NTRK1, NTRK2, and NTRK3) fuses with an unrelated gene • This fusion causes the expression of TRK fusion proteins • Which results in cell proliferation and tumor growth How VITRAKVI works in TRK fusion cancer1 • VITRAKVI is highly selective and potent against the TRK family of proteins (TRKA, TRKB, and TRKC) • VITRAKVI was purposefully designed to avoid activity with off-target kinases • The only other kinase activity occurred at 100- fold higher concentrations • VITRAKVI blocks the downstream signaling pathway • This results in inhibition of the tumor growth and survival that lead to TRK fusion cancer
  • 27. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 9 VITRAKVI: THE TRK INHIBITOR EXCLUSIVELY DESIGNED TO ONLY TARGET TRK
  • 28. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 10 ACROSS SOLID TUMORS VITRAKVI® PROVEN AND DURABLE EFFICACY ACROSS TUMOR TYPES Reference •VITRAKVI [summary of product characteristics]. Leverkusen, Germany: Bayer AG; 2022. IRC analysis by RECIST v1.1. Evaluated per independent review committee analysis by RECIST v1.1 for all tumor types except patients with a primary CNS tumor who were evaluated per investigator assessment using either RANO or RECIST v1.1 criteria. With 2 complete, 1 partial response. With 1 complete, 1 partial response. One patient who is not evaluable. + denotes ongoing response. CNS, central nervous system; DOR, duration of response; IRC, independent review committee; NA, not applicable due to small numbers or lack of response; NR; not reached; ORR, overall response rate; RANO, Response Assessment in Neuro- Oncology; RECIST, Response Evaluation Criteria in Solid Tumors
  • 29. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 11 COMPREHENSIVE GENOMIC PROFILING BY NGS IS PREFERRED OVER IHC TEST ALL PATIENTS EARLY TO IDENTIFY THOSE WITH NTRK GENE FUSIONS WHO CAN BENEFIT FROM VITRAKVI®
  • 30. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 12 TAFINLAR, IN COMBINATION WITH MEKINIST FOR BRAF MUTATIONS INDICATIONS TAFINLAR, in combination with MEKINIST, is indicated: •for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test •for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph nodes, following complete resection •for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test •for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options •for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials •for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. Limitation of Use: TAFINLAR, in combination with MEKINIST, is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors.
  • 31. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 13 RETEVMO FOR PATIENTS WITH RET-ALTERED ADVANCED SOLID TUMORS Selpercatinib (Retevmo) is a National Comprehensive Cancer Network® (NCCN®)- recommended treatment option for certain patients with RET-positive metastatic non- small cell lung cancer (NSCLC) and RET-positive advanced or metastatic thyroid carcinoma Next-generation sequencing (NGS) can be an accurate and tissue-efficient method to test for driver RET alterations and other targetable biomarkers. • Both RET point mutations and fusions can be detected by NGS • Immunohistochemistry (IHC) is not preferred for detecting RET alterations due to low sensitivity and variable specificity • Test the tissue: molecular testing of FFPE tumor tissue specimens is preferred for detecting RET fusions and point mutations • Why NGS? - Broad molecular profiling to identify appropriate targeted therapies can improve outcomes in NSCLC • NCCN Guidelines for NSCLC recommend that, when feasible, molecular testing of NSCLC specimens be performed via a broad, panel-based approach, most typically performed by NGS • Because of potential tissue limitations in metastatic NSCLC and the increased number of actionable biomarkers, NGS testing is part of the most comprehensive strategy to identify appropriate targeted therapies • Consider NGS testing to identify the 69% of patients with lung adenocarcinoma who have a potentially actionable oncogenic driver alteration and may benefit from appropriate approved or investigational targeted therapy
  • 32. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 14 TESTING FOR RET IS ESSENTIAL TO IDENTIFY PATIENTS WHO MAY BE ELIGIBLE FOR RETEVMO NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing for RET alterations in appropriate patients with advanced and/or metastatic NSCLC and thyroid carcinoma* to determine if they are eligible for RET inhibitors such as selpercatinib (Retevmo) Emerging = biomarkers with therapies under investigation but not approved Other = unknown oncogenic driver detected EGFR = EGFR sensitizing mutations including exon 20 insertions EGFR other = secondary EGFR mutations, including Thr790Met and Cys797Ser, and other less common EGFR mutations KRAS other = all KRAS mutations other than KRAS G12C
  • 33. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 15 KEYTRUDA® (PEMBROLIZUMAB): PD-1 RECEPTOR BLOCKADE Normal immune response When functioning properly, T cells are activated and can attack tumor cells. Tumor evasion and T-cell deactivation Some tumors can evade the immune system through the PD-1 pathway. The PD-L1 and PD-L2 ligands on tumors can bind with PD-1 receptors on T cells to inactivate the T cells. T-cell reactivation with KEYTRUDA KEYTRUDA binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, which helps restore the immune response. While having an effect on the tumor, this could also affect normal healthy cells. Advanced Melanoma or Adjuvant Therapy for Melanoma Advanced NSCLC or Adjuvant Therapy for Non–Small Cell Lung Cancer (NSCLC) Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) Refractory or Relapsed Primary Mediastinal Large B-cell Lymphoma (PMBCL) Advanced Urothelial Carcinoma (UC) High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Advanced Gastric or GEJ Cancer Advanced Esophageal or GEJ Carcinoma Advanced MSI-H/dMMR Cancers – Tumor Agnostic Therapies Advanced TMB-H Cancers Advanced MSI-H/dMMR Colorectal Cancer (CRC) Advanced Cervical Cancer Advanced Merkel Cell Carcinoma (MCC) Adjuvant Treatment for RCC or Advanced Renal Cell Carcinoma (RCC) Advanced MSI-H/dMMR Endometrial Carcinoma Advanced Cutaneous Squamous Cell Carcinoma (cSCC) Advanced TNBC or High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)
  • 34. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 16 BIOMARKER TESTING – PD-L1 BY IHC Understanding PD-L1 Testing: • PD-L1 expression is evaluated differently depending on the type of cancer • Combined positive score (CPS) and tumor proportion score (TPS) both evaluate PD-L1 expression and help identify patients eligible for treatment with KEYTRUDA
  • 35. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 17 BIOMARKER TESTING – TMB and MSI BY NGS MSI-H/dMMR (Microsatellite Instability- High/Mismatch Repair Deficient) • Immunohistochemistry (IHC) detects the presence and absence of MMR protein expression • dMMR is defined as at least 1 protein (MSH 2, MSH 6, PMS 2 and MLH 1) showing loss of expression • Next-generation sequencing (NGS) compares the length of nucleotide repeats in tumor cells and normal cells • NGS is a gene sequencing technique used to identify genetic mutations or variants Understanding TMB Testing • Tumor mutational burden (TMB) is an assessment of the number of somatic mutations in a defined region of a tumor genome and varies according to tumor type as well as among patients. • Tumors with high levels of TMB are more likely to produce tumor cell surface epitopes that act as neoantigens and induce an elevated antitumor immune response. • TMB status may be determined using next- generation sequencing methods. TMB-H may be a predictive biomarker for response to ICI therapy in some patients with advanced solid tumors. MSI-H/dMMR occurs in different solid tumor types, including: CRC, Endometrial, Gastric or GEJ, Small intestinal, Brain, Ovarian, Biliary, Pancreatic, Sarcoma, Breast, anal, HNSCC, nasopharyngeal, retroperitoneal, testicular, vaginal, vulvar, appendiceal adenocarcinoma, hepatocellular carcinoma, carcinoma of unknown origin, and abdominal adenocarcinoma., Cervical, Neuroendocrine, Prostate, Adrenocortical, Mesothelioma, Thyroid, Small cell lung, Bladder, Salivary, Renal cell etc.
  • 36. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 18 SUMMARY AND KEY TAKE AWAY POINTS • Tumor agnostic biomarkers and therapies represent a significant paradigm shift in oncology, with the potential to greatly improve patient outcomes • Tumor Agnostic Therapies – novel cancer treatments that target specific molecular alterations irrespective of the type or location of cancer • Tumor agnostic biomarkers - can identify potential targets for therapy across different types of cancer • Understanding the function of these biomarkers is crucial to the development of new therapies. • NGS allows for comprehensive genomic profiling, enabling the detection of these biomarkers • Regulatory acceptance is crucial for the widespread adoption of tumor-agnostic therapies & biomarkers • The ethical, access, and cost considerations of tumor-agnostic therapies and genetic testing must be addressed to ensure equitable patient access • Patients should be educated and empowered to understand their tumor agnostic treatment options, including potential benefits and risks Conclusion: • Tumor-agnostic biomarkers and therapies offer an exciting direction for cancer care, promising a more personalized and effective approach to treatment.
  • 37. PRECISION ONCOLOGY BIOMARKERS - WEBINAR 19 Precision Oncology Needs Precision Biomarkers THANK YOU
  • 39. Key Speaker Nitish Kumar Singh Principal Consultant BIS Research Inc.
  • 41. 22 Role of Biomarkers in Role of Biomarkers in Personalized Cancer Treatment Biomarkers Provide Valuable Information about the Characteristics and Behavior of a Tumor Applications of Biomarkers in PCT Prognosis Diagnosis Pharmacodynamics / Kinetics Prediction Likeliness of Recurrence Helps in Assessing Individual's risk for developing cancer Aid in early detection Determine prognosis Guide treatment decisions
  • 42. 23 Overview of the Challenges in Biomarker Identification and Validation Challenges in Biomarker Identification and Validation Inability to identify low expression level biomarkers in abnormal cancer growth and normal cellular growth Challenging to distinguish between a potential biomarker and a reliable biomarker that can be universally used. The genetic and regulatory networks for individual patients will differ significantly, thus creating a challenge in identification of robust biomarkers. No governing body with the authority to revoke the use of a biomarker in clinical practice if it has been shown to be invalid Validation of scientific justification behind biomarkers. High cost of biomarker validation assays
  • 43. 24 Regional Market Landscape: Clinical Biomarkers Market adoption rates across regions and clinical area indicate a high-growth market 10.7 11.8 18.8 28.1 6.2 6.8 10.5 15.2 2.7 3.1 5.1 8.1 0.8 0.9 1.2 1.5 2021 2022 2027 2032 $Billion North America Europe Asia-Pacific Latin America and Middle East CAGR (2022-2032): 8.73% 42.04% 28.94% 11.44% 6.30% 4.50% 3.21% 3.56% Oncology Biomarker Cardiac Biomarker Neurological Biomarker Infectious Disease Biomarker Immunological Biomarker Non-Invasive Prenatal Testing Other Clinical Areas 2021 Market Size: $21.3 Billion 40.10% 29.75% 11.68% 6.33% 4.51% 3.25% 4.38% 2032 Market Size: $54.3 Billion Source: BIS Research Analysis Source: BIS Research Analysis
  • 44. 25 Technological Landscape Market adoption rates across regions and clinical area indicate a high-growth market Source: BIS Research Analysis Benefits of NGS for clinical diagnostics and biomarker testing in oncology Technology adoption for clinical biomarkers 31.28% 26.37% 18.19% 13.90% 10.26% 2021 Next Generation Sequencing Polymerase Chain Reaction (PCR) Immunohistochemistry (IHC) Enzyme-Linked Immuno Sorbent Assay (ELISA) Other Technologies 34.34% 27.11% 16.88% 12.25% 9.42% 2032
  • 45. 26 Leading Players in the Market Source: BIS Research Analysis Service Provider Product Manufacturers Market Share > 7% Market Share in the Range of 5%-7% Market Share < 5% Market Share > 7% Market Share in the Range of 5%-7% Market Share < 5%
  • 47. 28 Factors Propelling the Demand for Oncology Biomarkers Facilitating the Understanding of Progression and Early Diagnosis of a Disease The Rising Rate of Cancer has been a Key Catalyst in the Growing Demand Source: BIS Research Analysis Increasing Demand of Clinical Biomarkers Increasing Prevalence of Cancer and Infectious Diseases 16.5% Nearly half of oncology studies and 16.5% of all trials incorporate biomarkers 4.5 M COVID-19 alone caused around 4.5 million deaths in 2020 Rising Key Player Initiatives 6.67% Key players initiatives of clinical biomarkers increased 6.67% between 2020 and 2021
  • 48. 29 Main Applications of Clinical Biomarkers include Liquid Biopsy and Early Cancer Testing There are currently 4,901 active oncology-based biomarker clinical trials going on according to clinicaltrials.gov. They can be classified according to cancer types as shown in table below. Non-Small Cell Lung Cancer or Small Cell Lung Cancer Survival Rates Depending on the Stage of Diagnosis NSCLC or SCLC 2 Year Survival Rate 5 Year Survival Rate Stage IA1 97% 90% Stage IA2 94% 85% Stage IA3 92% 80% Stage IB 89% 73% Stage IIA 82% 65% Stage IIB 76% 56% Stage IIIA 65% 41% Stage IIIB 47% 24% Stage IIIC 30% 12% Stage IVA 23% 10% Stage IVB 10% 0% Note: NSCLC = Non-Small Cell Lung Cancer and SCLC = Small Cell Lung Cancer Source: Web-MD 14.66% 10.69% 6.32% 5.13% 4.35% 3.00% 1.99% 1.95% 0.81% 51.10% Breast Lung Prostate Pancreatic Ovarian Stomach Liver Colon and Rectm Skin Others Need for Early Cancer Detection Source: Clinicaltrials.gov
  • 49. 30 Rising Detection and Better Management of Cancer is now Possible with Biomarkers Cancers and Their Most Common Biomarker Tests Prevalence vs. Age-Standardized Death Rate of Cancer Globally, 2010-2019 (%) Increasing Cancer Prevalence -9.89% -10.86% -11.85% -12.82% -13.63% -13.98% -14.52% -15.21% -15.28% -15.22% -15.18% -15.72% -16.23% 1.22% 1.23% 1.24% 1.26% 1.27% 1.29% 1.31% 1.31% 1.32% 1.33% 1.35% 1.36% 1.38% -20.00% -15.00% -10.00% -5.00% 0.00% 5.00% 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Prevalence (% Share) Age-Standardised Cancer Death Rate (%) Cancer Types Biomarker Tests Non-Small Cell Lung Cancer Changes in genes such as EGFR, KRAS, ALK, RET, ROS1, MET, and BRAF Breast Cancer Progesterone receptor (PR) and Estrogen receptor (ER) proteins; changes in genes such as BRCA1, BRCA2, and PIK3CA; HER2 gene or protein status Colorectal Cancer Changes in genes such as NRAS, KRAS, and BRAF Melanoma Skin Cancer Changes in the BRAF gene Any Cancer Changes in NTRK genes; changes in mismatch repair (MMR) genes; tumor mutational burden (TMB); levels of microsatellite instability (MSI) Source: American Cancer Society Source: Ourworldindata.org
  • 51. 32 8.9 9.8 12.8 21.7 2021 2022 2025 2032 Market Size and Growth Market Size ($ Bn) Oncology Biomarkers: Size, Growth, Trends Key Trends: ▪ Illumina, Inc. launched the TruSight genomic profiling test to assess tumor genes across approximately 30 types of solid tumors ▪ QIAGEN N.V. partnered with Denovo Biopharma to develop a companion diagnostic test for the treatment of diffuse large B-cell lymphoma (DLBCL). ▪ NeoGenomics Laboratories partnered with the Biomarker Collaborative to ensure patients receive comprehensive biomarker testing and support access to clinical trials. CAGR (2022-2032): 8.27% 35.50% 27.29% 18.63% 10.78% 7.79% Breast Cancer Biomarker Lung Cancer Biomarker Colorectal Cancer Biomarker Prostate Cancer Biomarker Other 2021 Market Size: $8.9 Billion 37.11% 28.10% 19.66% 9.11% 6.02% 2032 Market Size: $21.7 Billion Source: BIS Research Analysis
  • 52. 33 www.bisresearch.com I All right reserved Insight Monk ▪ Over 1,000+ healthcare industry market intelligence reports ▪ Access to PDFs from over 100,000 reputed sources ▪ Market Statistics ▪ Company profiles for leading and emerging companies in the healthcare industry ▪ Database of key industry professionals ▪ Expert content like analyst notes, whitepapers ▪ Global expert network for consultations To get a free trial access, please schedule a demo. Visit: https://www.insightmonk.com/
  • 53. 34 Related Reports, Links and Promotions Related Reports from BIS Research Clinical Biomarkers - A Global and Regional Analysis Published: 2022 View Report Details Liquid Biopsy Market Published: 2022 View Report Details Global Digital Biomarkers Market - A Global and Regional Analysis Published: 2022 View Report Details www.bisresearch.com
  • 54. 35 Liquid Biopsy: An Emerging Frontier in Early Multicancer Detection Speaker Contact Information Dr. Michael R. Rossi Reach out to him at mirossi@concertai.com Nitish Kumar Singh Reach out to him at nitish.kumar@bisresearch.com www.bisresearch.com Dr. Shibicharkravarthy Kannan Reach out to him at skannan@oncophenomics.com
  • 56. 37 14 Green Hydrogen and Green Fuels – The Future of Energy www.bisresearch.com I All right reserved BIS RESEARCH INC. 39111 Paseo Padre Pkwy STE 313, Fremont CA 94538-1686, USA T el: +1-510-404-8135 BIS RESEARCH PRIVATE LIMITED Tapasya Corporate Heights, Greater Noida Expressway, Sector 126, Noida, U.P., 201303 India Tel: +91 120 4261540 www.bisresearch.com THANK YOU