Caris Molecular Intelligence ® application (breast)

Improving Outcomes
for Each Patient Depends on
The Best Possible Intelligence
4 Multiple technology approach identifies up to 57 FDA-approved therapies.
4 Extensive clinical literature assessment of 120,000+ peer-reviewed publications
guided by US Preventative Services Task Force grading methodology.
4 Over 33,000 biomarker rules established to help guide treatment decisions.
4 More than 70,000 tumors profiled.
4 Actionable biomarkers identified in ~95% of all tumors profiled.
4 Average of 25 potentially clinically relevant results reported per patient.
To order Caris Molecular Intelligence® services
or to speak with a Caris Life Sciences® representative,
please call (888) 979-8669 or visit
www.CarisMolecularIntelligence.com.
© 2015 Caris Life Sciences. All rights reserved. TN0224 v3 April 8, 2015
Other trademarks are the property of their respective owners.
The Power to Analyze
Actionable Treatment Options for
Invasive Breast Cancer
NCCN Guidelines® for Invasive Breast Cancer
No Clear Guidelines on Sequencing Additional Therapies
From NCCN v2.2015: Systemic Treatment of Recurrent or Stage IV Disease
* Indicates NCCN preferred drugs
HER2+ only
trastuzumab
Systemic
Treatment of
Recurrent
or Stage IV
disease:
Testing
performed
prior to
systemic
treatment to
determine
HER2,
ER/PR status.
T-DMI (for trastuzumab
exposed patients)
Positive
Hormone
Receptor
(ER +/PR+)
paclitaxel (TLE3, Pgp),
carboplatin (BRCA1, BRCA2, ERCC1)
lapatinib (HER2) *
+/-
aromatase inhibitor
(anastrozole; letrozole)
exemestane, everolimus
palbociclib, letrozole
fulvestrant
tamoxifen
ethinyl estradiol
LH-RH agonists
(goserlin, leuprolide)
Pertuzumab (HER2), paclitaxel
(TLE3, Pgp) *
capecitabine (TS)
clinical trials
vinorelbine
Progression
cisplatin (BRCA1, BRCA2, ERCC1)
cyclophosphamide
docetaxel (Pgp, TLE3)
doxorubicin (HER2, PGP, TOP2A) *
epirubicin (HER2, PGP, TOP2A)
Triple Negative
Breast Cancer
(ER-/PR-/HER2-)
2
gemcitabine (RRM1) *
ixabepilore
liposomal doxorubicin (HER2,
Pgp, TOP2A) *
nab-paclitaxel (TLE3, Pgp)
paclitaxel (TLE3, Pgp) *
vinorelbine *
eribulin *
No Targeted Therapy
After standard therapies
have been exhausted,
CMI may help
identify clinical trial
opportunities.
fluorourcil (TS)
carboplatin (BRCA1, BRCA2, ERCC1)
megestrol acetate
fluoxymesterone
docetaxel (TLE3, Pgp)
capecitabine (TS) *
toremifene
aromatase inactivator
(exemestane)
pertuzumab (HER2), docetaxel
(TLE3, Pgp) *
After initial therapy(ies),
CMI may help sequence
or select additional
therapies.
clinical trials
Beyond the Guidelines
Although these
guidelines focus on
recurrent or stage IV
patients, CMI may be
appropriate for patients
in earlier stages of breast
cancer such as neoadjuvant
non-responders and triple
negative breast cancer
patients.
If not performed during
early stages, HER2, ER,
and PR information can
be identified along with
therapy associations for
downstream therapy
needs or triple negative
breast cancer patients.
Information summarized from NCCN Guidelines® version 2.2015 (pages BINV18-22, BINV M-N, MS 48) Breast Cancer, for complete and current guidelines visit nccn.org.
(XXX) indicates biomarker associations made by Caris Molecular Intelligence® (CMI)
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Navigating Standard Therapies to Personalize Treatment Plans
And Identifying Non-Standard Therapies to Consider
Through the use of multiple technologies (i.e. NGS, IHC, CISH, FISH, etc.), Caris Life Sciences® is able to analyze biomarkers
to identify standard therapies to help oncologists personalize therapies for each patient. Below is a list of standard breast
cancer therapies and the associated biomarker expression frequency.
For those patients in certain clinical situations where standard therapies are not or are no longer an option, tumor profiling
may identify Off-NCCN Compendium® therapies not previously considered. Each drug association is backed by strong and
relevant biomarker literature, which is provided in each MI Profile™ report.
Drug
Brand Name(s)
trastuzumab
Herceptin®
T-DM1
Kadcyla®
pertuzumab
Perjeta™
lapatinib
Tykerb®
everolimus
Afinitor®
temsirolimus
Torisel®
palbociclib
Ibrance
capecitabine
Xeloda®
fluorouracil
Adrucil®
carboplatin
Paraplatin®
cisplatin
Platinol®
docetaxel
Taxotere®
nab-paclitaxel
Abraxane®
paclitaxel
Taxol®, Onxal®
doxorubicin
Adriamycin®, Rubex®
epirubicin
Ellence™
liposomal doxorubicin
DeprCyt™
gemcitabine
Gemzar®
anastrozole
Arimidex®
exemestane
Aromasin®
fulvestrant
Faslodex®
goserelin
Zoladex®
letrozole
Femara®
leuprolide
Eligard® Lupron® Viadur®
megestrol
Megace®
tamoxifen
Novladex®
toremifene
Fareston®
Therapy
Biologic
Targeted
Targeted
Targeted
Cytotoxic
Cytotoxic
Cytotoxic
Cytotoxic
Cytotoxic
Hormone
Biomarker
Frequency
Platform
Predicted benefit or lack of benefit
HER2
11%
IHC
High expression may predict benefit
HER2
15%
CISH
Amplification may predict benefit
ER
56%
IHC
High expression may predict benefit
PIK3CA
27%
NGS
ER
56%
IHC
HER2
89%
IHC
HER2
85%
CISH
TS
86%
IHC
Low expression may predict benefit
BRCA1
8%
NGS
Mutation may predict benefit
BRCA2
13%
NGS
Mutation may predict benefit
ERCC1
52%
IHC
Low expression may predict benefit
PGP
89%
IHC
Low expression may predict benefit
TLE3
46%
IHC
High expression may predict benefit
HER2
15%
CISH
Amplification may predict benefit
Drug
Brand Name(s)
ceritinib
Zykadia®
Therapy
Biomarker
Frequency
Platform
Predicted benefit or lack of benefit
ALK
1.4%
FISH
Translocation may predict benefit
ALK
TBD
IHC
High expression may predict benefit
Cytotoxic
MGMT
36%
IHC
Low expression may predict benefit
Targeted
crizotinib
Xalkori®
Mutation may predict benefit
dacarbazine
DTIC-Dome®
ER+/HER2- may predict benefit
temozolomide
Temodar®
irinotecan
Camptosar®
Cytotoxic
TOPO1
72%
IHC
High expression may predict benefit
pemetrexed
Alimta®
Cytotoxic
TS
86%
IHC
Low expression may predict benefit
EGFR
.4%
NGS
Mutation may predict benefit
EGFR inhibitors
–
Trial
EGFR
11%
IHC
High expression may predict benefit
cMET
16%
IHC
High expression may predict benefit
cMET
2%
CISH
Amplification may predict benefit
PTEN
59%
IHC
Low expression may predict benefit
PTEN
3%
NGS
Mutation may predict benefit
PIK3CA
27%
NGS
Mutation may predict benefit
TP53
43%
NGS
Mutation may predict benefit
PGP
89%
IHC
Low expression may predict benefit
TOP2A
8%
FISH
Amplification may predict benefit
RRM1
70%
IHC
Low expression may predict benefit
AR
50%
IHC
High expression may predict benefit
ER
56%
IHC
High expression may predict benefit
PR
40%
IHC
High expression may predict benefit
cMET inhibitors
PIK3CA/AKT/mTOR
pathway inhibitors
cell cycle checkpoint
inhibitors (WEE1,
Chk1 inhibitors)
–
–
–
Trial
Trial
Trial
IHC: Immunohistochemistry CISH: Chromogenic in situ Hybridization FISH: Fluorescence in situ Hybridization NGS: Next-Generation Sequencing
IHC: Immunohistochemistry CISH: Chromogenic in situ Hybridization FISH: Fluorescence in situ Hybridization NGS: Next-Generation Sequencing
Data from the Caris Life Sciences database of approximately 8,200 Breast Cancer tumors.
4
Data from the Caris Life Sciences database of approximately 8,200 Breast Cancer tumors.
5
Caris Can Help You Navigate
Caris Cares™ Team Provides Unprecedented Support
Managing Complexity – Caris Bioinformatics
The Caris Cares team is organized to support you and your
patients with the many complex aspects of treatment
decisions.
It is the interpretation and annotation of complex data and
results that distinguishes Caris from all others.
•Evaluation of strong medical and scientific literature –
1.
Consulting
Medical
Oncologists
more than 120,000 citations
•Distilled into more than 33,000 “rules,” which are 7.
Billing
Experts
continually updated with latest clinical data
•Rules engine combines literature data and tumor biology literature, which may allow you to treat more confidently
Image included for illustrative purposes only. Molecular Pathways: Dysregulated Glutamatergic Signaling Pathways in Cancer. Todd D. Prickett and Yardena Samuels. Clin Cancer
Res 2012;18:4240-4246. Published OnlineFirst May 30, 2012.
Connecting Patients to Relevant Clinical Trials
Currently, only 2-3%* of cancer patients enroll in clinical trials.
Our Clinical Trials Connector™ simplifies the process of
finding potential opportunities for your patient.
6.
Patient
Navigators
Physician
Patient
2. Molecular Pathologists and Geneticists
2.
Molecular
Pathologists
and Geneticists
3.
Molecular Science
Liaisons (MSLs)
* American Cancer Society; National Cancer Institute
6
•You determine the best trial for your patient by searching • Answer biomarker, assay or reporting related questions
• Internal Caris team of experts (MDs and PhDs)
3. Molecular Science Liaisons (MSLs)
• Routinely visit customer practices to discuss tumor profiling and the
latest molecular science
• Includes MDs and PhDs with expertise in biomarkers, drug
associations and related medical literature
4. Customer Support
• Ensure fast turn-around times
• Facilitate orders, monitor testing and track cases to completion
5.
Profiling
Liaisons
4.
Caris Logistics
Specialists
5. Field Representatives
• Field-based representatives providing tumor profiling information
• Includes Sales Directors (SDs) and Accounts Services Managers (ASMs)
6. Patient Navigators
•We narrow down the list to the appropriate trials based on the unique tumor profile.
• Gender
• Age
• Tumor type
• Tumor profile (biomarker results)
• Available to discuss Caris Molecular Intelligence tumor profiling and
results
• Includes medical oncologists with specialized tumor type experience
to identify drugs with and without potential benefit
•Reports biomarker/drug associations with relevant clinical 1. Consulting Medical Oncologists
• Exclusively focused on supporting patients
• Trained to assist patients with tumor profiling questions, biomarker/
therapy questions and financial options
Please call us at (888) 979-8669 or email us at
[email protected] with any questions
or to speak with any of the above listed
members of the Caris team.
7. Billing Experts
• Manage complexity of healthcare billing
• Assist with medical necessity support and address questions
regarding billing
our online portal results for a variety of study criteria.
7