Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 1 of 232 PageID #: 11796
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`Exhibit A
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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 2 of 232 PageID #: 11797
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 2 of 232 PagelD #: 11797
`
`Jones, Steven (A0123456)
`Patient MRN: 1000000000 | DOB: DEC—09—1946 | Gender: Male
`Diagnosis: Prostate adenocarcinoma | Test Number 1
`
`GUARDANT 36! CD‘-
`
`Therapy Finder Page
`
`REPORTING
`
`PHYSICIAN
`
`Report Date:
`
`NOV-16-2020
`
`John Miller
`
`Receipt Date:
`collection Date:
`Specimen:
`Status:
`
`NOV—062020
`NOV-04-2020
`Blood
`FINAL
`
`Account: Pleasantville Oncology
`Address: 1234 Main Street
`Anaheim, CA 94063, United States Ph:
`(123) 456-7890 | Fax: (123) 456-7899
`
`Additional Recipient: N/A
`
`Complete Tumor Response Map on page 3
`
`This content is provided as a professional service and has not been reviewed or approved by the FDA
`
`Summary of Detected Somatic Alterations, lmmunotherapy Biomarkers & Associated Treatment Options
`
`KEY 0 Approved in indication Q Approved in other indication ® Lack of response
`
`Detected Alteration(s) /
`Biomarker(s)
`
`Associated FDA-approved
`therapies
`
`Clinical trial availability
`(see page 4)
`
`% chNA or
`Amplification
`
`AR L702”
`
`AR “[7420
`
`0 Degarelix, Flutamide, Goserelin,
`Leuprolide, Nilutamide, Triptorelin
`Abiraterone, Apalutamide,
`Enzalutamide
`
`o Degarelix, Flutamide, Goserelin,
`Leuprolide, Nilutamide, Triptorelin
`Bicalutamide
`
`None
`
`o Olaparib
`ATM RSOOBC
`a Niraparib, Rucaparib, Talazoparib
`
`TP53 G244C
`
`Variants of Uncertain Significance
`ATM K2302E (0.6%)
`The functional consequences and clinical significance of alterations are unknown. Relevance of therapies targeting these alterations is uncertain.
`
`Comments
`
`Microsatellite status: MSl-High NOT DETECTED. A “Not Detected” result in samples where the highest % chNA is < 0.2% is an inconclusive
`result because it does not preclude MSl-High status in tissue.
`
`Results reviewed by: Martina Lefterova, MD PhD
`
`This content is provided as a professional sen/ice and has not been reviewed or approved by the FDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`analguardanthealthcom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-OOOO10 R2 | Pg 1 of 20
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`

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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 3 of 232 PageID #: 11798
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 3 of 232 PagelD #: 11798
`
`Jones, Steven (A0123456)
`DOB: DEC-09-1946 | Test Number 1
`
`Additional Biomarkers
`
`GUARDANT 36! CD"'
`_
`Therapy Finder Page
`
`
`
`Biomarker Additional Details
`
`NOT DETECTED
`
`MSl-High
`
`Alterations or biomarkers that were "NOT DETECTED" have been excluded from the summary table above.
`
`Thiscontentispmvidedasapmfassrbnalsem'oeamihasnotbeenmviewedorappmvadbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`mrtalguardanthealthxom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 2 of 20
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`

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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 4 of 232 PageID #: 11799
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 4 of 232 PagelD #: 11799
`
`Jones, Steven (A0123456)
`DOB: DEC-09-1 946 | Test Number 1
`
`GUARDANT 36r CD‘-
`
`Tumor Biology Page
`
`Guardant360 Tumor Response Map
`The Guardant360 laboratory developed test (LDT) Tumor Response Map illustrates the variant allele fraction (% chNA) of observed somatic variants at each sample
`submission. Amplifications are not plotted, and only the first and last five test dates are plotted. Please see the Physician Portal (mitalguardanthoalthsom) for the
`Tumor Response Map with all test dates
`
`Hi hest Variant
`AI ele Fraction
`
`66.7%
`
` NOV—0:1-2020
`
`Detected Alteration(s) l Biomarker(s)
`
`% chNA or Amp
`
`AR L702H
`
`TP53 62440
`
`66.7%
`
`55.8%
`
`ATM K2302E
`0.6%
`Variant of Uncertain Significance ‘5
`
`
`ATM R30080
`
`AR W742C
`
`0.2%
`
`0.1 %
`
`The table above annotates the variant allele fraction (96 chNA) detected in this sample. listed in descending order.
`§Seedefinitionssectimformoredetal
`
`Thiscontentispmvidedasapmfassiondsem'oeamihasnotbeenraviewedorappmvadbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`mrtalguardanthealthxom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 3 of 20
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`

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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 5 of 232 PageID #: 11800
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 5 of 232 PagelD #: 11800
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`GUARDANT 36! CD‘-
`
`Clinical Trial Page
`
`Available Clinical Trials (within the same state as the ordering physician)
`There may be additional trials not listed here. Visit: analguardanthealthcom or email clientservices©guardanthealth.com with A0301313 in the subject line of the
`email, for additional trials.
`
`Alteration
`
`Tfial ID I Contact
`
`Title
`
`AR
`L702H
`
`NCT02566772
`Elizabeth Calleja, MD,
`clinicaltrialinfofltaihooncologycom,+1 —
`609-285-5280
`
`NCT03689699
`Lisa OImos,cancerclinicaltrials@cumc.
`c0|umbia.edu,212.342.5162
`
`Study of TA83681 in Metastatic Castration
`Resistant Prostate Cancer
`
`Phase
`
`Site(s)
`
`Phase 1
`
`New York, NY
`
`Nivolumab and BMS-986253 for Honnone-
`Sensitive Prostate Cancer (MAGIC-8)
`
`Phase 1
`/Phase 2
`
`New York, NY (2)
`
`NCT03951831
`Lisa Olmos, RN.cancerclinicaltrials@cumc.
`columbia.edu,212-342-5162
`
`REGN2810 Followed by Chemoimmunotherapy Phase 2
`for Newly Metastatic Honnone—sensitive
`Prostate Cancer
`
`New York, NY
`
`\fisit portalguardanthealthnom for trials not within the same state as the physician's office
`
`ATM
`R30080
`
`NCT03150810
`BeiGene.clinicaltrialsGbeigene.com,1
`(877) 828—5568
`
`NCT03742895
`Toll Free Number,Tria|sitesOmerck.com,
`1—888—577—8839
`
`Study to Assess Safety, Tolerability and Clinical
`Activity of 368-290 in Combination With
`Temozolomide (TM2) in Participants With
`Locally Advanced or Metastatic Solid Tumors
`
`Efficacy and Safety of Olaparib (MK—7339) in
`Participants With Previously Treated,
`Homologous Recombination Repair Mutation
`(HRRm) or Homologous Recombination
`Deficiency (H RD) Positive Advanced Cancer
`(MK—7339—002 / LYNK—002)
`
`Phase 1
`[Phase 2
`
`New York, NY (2)
`
`Phase 2
`
`Harrison. NY
`New York, NY (3)
`
`Harrison. NY
`A Study of Olaparib and Durvalumab in Prostate Phase 2
`NCT03810105
`Karen Autio, MD, MSc,autiok@mskcc.org, Cancer
`Commack, NY
`646-422-4632
`New York, NY
`
`
`Uniondale, NY
`A Study of the Drugs Talazoparib and
`NCT04019327
`Harrison. NY
`Karen Autio, MD,AutioK@mskcc.org,646- Temozolomide in Prostate Cancer
`422-4632
`Commack, NY
`New York, NY
`
`
`Phase 1
`[Phase 2
`
`Study of Olaparib (MK—7339) in Combination
`NCT04123366
`Toll Free Number,TrialsitesOmerck.com, With Pembrolizumab (MK-3475) in the
`1—888—577—8839
`Treatment of Homologous Recombination
`Repair Mutation (HRRm) and/or Homologous
`Recombination Deficiency (HRD)-Positive
`Advanced Cancer (MK-7339-007IKEYLYNK—
`007)
`
`Phase 2
`
`Port Jefferson Station, NY
`
`\fisit portal.guardanthealth.com for trials not within the same state as the physician's office
`
`AR
`W7420
`
`$334C
`
`\fisit portalguardanthoalthsom for trials not within the same state as the physician's office
`
`\fisit portal.guardanthealth.com for trials not within the same state as the physician's office
`
`More clinical trial options available at mnalguardanthealthcom
`
`Miscontentispmvidedasapmfaasrbnelsem'ceandhasnotbeenraviewedorappmvedbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`wrtalguardanthealthsom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 4 of 20
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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 6 of 232 PageID #: 11801
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 6 of 232 PagelD #: 11801
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`Definitions
`
`GUARDANT 36! CD‘-
`
`Variant of Uncertain Significance: The functional consequences and clinical significance of alterations are unknown. Relevance of therapies
`targeting these alterations is uncertain.
`
`Interpretation
`
`Somatic alterations were detected in the circulating cell-free DNA isolated from this patient's blood specimen. These genomic alterations are
`cancer-associated somatic variants, some of which have been associated with either increased or reduced clinical response to specific
`treatments. The percentage of altered cell—free DNA circulating (% chNA) in blood is related to the unique tumor biology of each patient.
`Factors that may affect the % chNA of detected somatic alterations include tumor growth, turn over, size, heterogeneity, vascularization,
`disease progression, and treatment.
`
`Miscontentispmvidedasapmfmbnelsem'oeandhasnotbeenraviewedorappmvedbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`wrtalguardanthealthsom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 5 of 20
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`

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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 7 of 232 PageID #: 11802
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 7 of 232 PagelD #: 11802
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 I Test Number 1
`
`Method and Limitations
`
`GUARDANT 36! CD‘-
`
`Guardant360 sequences 74 cancer-associated genes to identify somatic alterations. Cell-free DNA (chNA) is extracted from plasma, enriched
`for targeted regions, and sequenced using the Illumina platform and hg19 as the reference genome. All exons are sequenced in some genes;
`only clinically significant exons are sequenced in other genes. The types of genomic alterations detected by Guardant360 include single
`nucleotide variants, gene amplifications, fusions, short insertions/deletions (longest detected, 70 base pairs), and splice site disrupting events
`(see Table 1). Microsatellite Instability (MSI) is assessed for all cancer types by evaluating somatic changes in the length of repetitive
`sequences on the Guardant360 panel. A "Not Detected' result in samples where the highest % chNA is < 0.2% is an inconclusive result
`because it does not preclude MSI-High status in tissue. MSI status is currently not reported for earlier panel versions. This version of the
`Guardant360 test is not validated for the detection of other types of genomic alterations, such as complex rearrangements or gene deletions.
`Certain sample or variant characteristics, such as low chNA concentration, may result in reduced analytic sensitivity. Guardant360 cannot
`discern the source of circulating chNA, and for some variants in the range of ~40 to 60% chNA, the test cannot easily distinguish germline
`variants from somatic alterations. Guardant360 is not validated for the detection of germline or de novo variants that are associated with
`hereditary cancer risk. Tissue genotyping should be considered when plasma genotyping is negative, if clinically appropriate.
`
`Table 1: Genes on the Guardant360 Panel
`Guardant360 reports single nucleotide variants. splice site mutations, and insertion and deletion variants (indels) in all clinically relevant exons in 74 genes and reports
`other variant types in select genes as indicated below.
`
`AKT1
`BRCA2
`CTNNB1
`FGFR3 "
`JAK2
`MLH1
`NmK1 "
`RHEB
`1301
`
`ALK "
`cc~o1 T
`0032
`GATA3
`JAK3
`MPL
`NrnKa
`RHOA
`VHL
`
`APC
`ccuoz T
`EGFR T
`GNA11
`KITT
`MTOFt
`PDGFRA T
`RIT1
`
`An T
`CCNE1 T
`ERBBZ T
`GNAQ
`KRAS T
`MYC T
`PIK3CA T
`nos1 "
`
`ARAF
`com
`ESR1
`GNAS
`MAP2K1
`NF1
`PTEN
`SMAD4
`
`ARID 1A
`CDK12
`EZH2
`HNF1A
`MAP2K2
`NFE2L2
`PTPN11
`SMO
`
`ATM
`CDK4 T
`FBXW7
`HRAS
`MAPK1
`NOTCH1
`RAF1 T
`er11
`
`BRAF T
`CDK6 T
`FGFFH T
`IDH1
`MAPK3
`NPM1
`R81
`TERT T
`
`BRCA1
`CDKN2A
`chz T *
`IDH2
`METT
`NRAS
`REr “
`71353
`
`t Guardant360 reports alterations in the promoter region of this gene.
`
`# Guardant360 reports fusion events involving this gene for all known gene partners.
`
`1' Guardant360 reports amplifications of this gene.
`
`Table 2: Guardant360 Test Specifications
`
`Alterations
`
`Reportable Range
`
`SNVs
`
`20.04%
`
`Allelic Fraction] Copy Number
`0.5—100%
`
`Analytical Sensitivity
`100%
`
`0.1 -0.5%
`
`0.5-100%
`
`88.3%
`
`99.8%
`
`PPV*
`100%
`
`99.4%
`
`100%
`
`Indels
`20.04%
`0.1—0.5%
`73.9%
`100%
`
`
`Fusions“
`
`100%
`100%
`0.3-100%
`20.04% —
`ODS-0.3%
`90.8%
`100%
`
`CNAs'“
`
`22.14 copies
`
`22.3 copies
`
`MSI
`
`MSI—H DETECTED
`
`>0.1 %
`
`100%
`
`95.0%
`
`99.6%
`
`100%
`
`Based on cell—tree DNA input of 30 ng in patient or contrived samples. Analytical sensitivity cited above are for targeted, clinically important regions.
`Sensitivity outside these regions or in highly repetitive sequence contexts may vary.
`
`'Over entire genomic reportable range of Guardant360 panel.
`"Based on fusion detection in ALK, N'IRK1, REF, HOS 1.
`'“Based on ERBB2 (HER2) and MET analytical sensitivity. Copy number sensitivity may vary with other genes.
`
`Miscontentispmvidedasapmfaasrbnelsem'ceandhasnotbeenraviewedorappmvedbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`wrtalguardanthealthsom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 6 of 20
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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 8 of 232 PageID #: 11803
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 8 of 232 PagelD #: 11803
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 I Test Number 1
`
`GUARDANT 36! CD‘-
`
`Regions with insufficient coverage
`
`The following targeted regions failed to meet the minimum coverage required for reliable detection of single nucleotide, insertion—deletion, and
`fusion variants: None.
`
`About the Test
`
`The Guardant360 assay was developed and its performance characteristics were determined by Guardant Health, Inc. This test has not been
`cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not
`necessary. This test may be used for clinical purposes and should not be regarded as investigational or for research only. Guardant Health's
`clinical reference laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high
`complexity clinical laboratory testing. The laboratory report should be interpreted in the context of other clinical information and laboratory,
`pathology, and imaging studies by a qualified medical professional prior to initiating or changing a patient's treatment plan. The selection of
`any, all, or none of the drugs associated with potential clinical benefit (or potential lack of clinical benefit) is entirely at the discretion of the
`treating medical professional. Drug and trial information are based on the diagnosis written on the submitted test request form; this
`information is not based on any supplemental information provided by the requesting medical professional, including pathology reports or
`other molecular studies. Some drugs listed in this report may not be approved or cleared by the FDA for the indicated use. Guardant Health
`makes no endorsement, express or implied, of any product, physician, or procedure contained in this report. This report makes no promises or
`guarantees that a particular medication will affect (or not affect) the clinical outcome of any patient.
`
`Testing performed at: Guardant Health
`
`Laboratory Director: Arthur Baca, MD PhD | CLIA ID: 05D2070300 | CAP #: 8765297 | 505 Penobscot Drive, Redwood City, CA, 94063, United States
`
`Additional information is available
`
`Any therapeutic annotations are based on publicly available information. This information is described in the "Detailed Therapy Results' and
`"Relevance of Detected Alterations" sections.
`
`Visit portal.guardanthealth.com or email clientservices@guardanthealfl1.com with A0123456 in the subject line of the email for:
`— Additional clinical trials
`— Relevance of Detected Alterations
`
`— Detailed Therapy Results
`
`— References
`
`If you would like to receive this additional information with every Guardant360 report, please call client services at 855.698.8887 to opt-in.
`
`Thiscontentispmvidedasapmfaasrbnelsem'oeandhasnotbeenraviewedorappmvedbyfheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`wrtalguardanthealthsom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 7 of 20
`
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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 9 of 232 PageID #: 11804
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 9 of 232 PagelD #: 11804
`
`Jones, Steven (A0123456)
`DOB: DEC-09-1946 | Test Number 1
`
`GUARDANT 36! CD“-
`
`Additional Information
`
`Additional information begins on the next page.
`
`Thiscontentispmvidedasapmfasskmelsem'oeamihasnotbeenreviewedorappmvadbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`mrtalguardanthealthxom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-000010 R2 | Pg 8 of 20
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`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 10 of 232 PageID #: 11805
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 10 of 232 PagelD #: 11805
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`GUARDANT 36r CD“-
`
`Additional lnforrnation
`
`List of Available Clinical Trials
`
`Alteration
`
`Trial ID I Contact
`
`Title
`
`AR
`L702H
`
`NCT02566772
`Elizabeth Calleja, MD,
`clinicaltrialinfofltaihooncologysom ,+1 -
`609-285-5280
`
`NCT03069937
`Mike Wheeler,hoc—clinical—trialsGmusc.
`edu,843-792-9321
`
`NCT03361 735
`Savita Dandapani. MD,sdandapani@coh.
`org,626 256-4673
`
`NCT03689699
`Lisa OImos,cancerclinicaltrials@cumc.
`columbia.edu,212.342.5162
`
`Study of TAS3681 in Metastatic Castration
`Resistant Prostate Cancer
`
`Phase
`
`Phase 1
`
`Site (number in parenthesis is
`count of trial sites)
`
`Seattle, WA; New York, NY;
`Sacramento, CA; Sarasota, FL;
`United Kingdom (2)
`
`Phase II Study of Docetaxel Before Degarelix in
`Patients With Newly Diagnosed Metastatic
`Prostate Cancer.
`
`Radium Ra 223 Dichloride, Hormone Therapy
`and Sterectactic Body Radiation Therapy in
`Treating Patients With Metastatic Prostate
`Cancer
`
`Phase 2
`
`Charleston, SC
`
`Phase 2
`
`Duane, CA
`
`Nivolumab and EMS—986253 for Hormone
`Sensitive Prostate Cancer (MAGIC-8)
`
`Phase 1
`/Phase 2
`
`Philadelphia, PA; New York, NY (2)
`
`NCT03951 831
`Lisa Olmos, RN.cancerclinicaltrials0cumc.
`columbia.edu,212-342-5162
`
`REGN2810 Followed by Chemoimmunotherapy Phase 2
`for Newly Metastatic Honnone—sensitive
`Prostate Cancer
`
`New York, NY
`
`ATM
`R3OOBC
`
`NCT03150810
`BeiGene.cIinicattrialsObeigene.com,1
`(877) 828-5568
`
`Study to Assess Safety, Tolerability and
`Clinical Activity of BGB-290 in Combination
`With Temozolomide (TM2) in Participants With
`Locally Advanced or Metastatic Solid Tumors
`
`Phase 1
`[Phase 2
`
`Houston, TX; Saint Louis, MO; Grand
`Rapids, MI; Dallas, TX; Nashville, TN;
`New York, NY (2): United Kingdom
`(4); Australia (3); Spain (5)
`
`NCT03432897
`kayla rosati, EdM,kayla_rosati@brown.
`edu,4018633000
`
`BrUOG 337: Olaparib Prior to Radical
`Prostatectomy For Patients With Locally
`Advanced Prostate Cancer and Defects in DNA
`Repair Genes
`
`Phase 2
`
`Providence, RI
`
`NCT03533946
`Jill Broghammer,jill.broghammerahci.
`utah.edu,801-213-6232
`
`Rucaparib in Nonmetastatic prOstAte With
`BRCAness
`
`Phase 2
`
`Salt Lake City, UT
`
`NCT03742895
`Toll Free Number,TrialsitesOmerck.com,
`1—888—577—8839
`
`Efficacy and Safety of Olaparib (M K-7339) in
`Participants With Previously Treated,
`Homologous Recombination Repair Mutation
`(HRRm) or Homologous Recombination
`Deficiency (HRD) Positive Advanced Cancer
`(MK-7339-002 / LYNK-002)
`
`Phase 2
`
`Harrison, NY; Philadelphia, PA; Sioux
`Falls, SD; Saint George, UT; Lincoln,
`NE; Worcester, MA; Fullerton, CA;
`San Francisco, CA; Tulsa, OK;
`Middletown, NJ; Los Angeles, CA;
`Tucson, AZ; Detroit, MI; Augusta, GA;
`Atlanta, GA; Aurora, CO; Lexington,
`KY; New York. NY (3); Baltimore, MD
`(2); Seattle, WA (2); Colombia (9);
`Russian Federation (10); Argentina
`(4): Romania (7); Japan (6); United
`Kingdom (4); Switzerland (3); Spain
`(2); Canada (4); Turkey (8); Ireland (4);
`Korea, Republic of (3); Guatemala (4);
`Denmark (3); Mexico (8); Italy (3);
`Israel (5); France (6); Australia (3);
`
`Peru (8)
`
`Basking Ridge, NJ; Harrison, NY;
`A Study of Olaparib and Durvalumab in
`NCT03810105
`Duarte, CA; Detroit. MI; Montvale, NJ;
`Karen Autio, MD, MSc,aufiokOmskcc.org, Prostate Cancer
`646—422-4632
`Commack, NY; New York, NY;
`
`Chicago, IL
`
`Phase 2
`
`A Study of the Drugs Talazoparib and
`NCT04019327
`Karen Autio, MD,AutioKOmskcc.org,646- Temozolomide in Prostate Cancer
`422—4632
`
`Phase 1
`/Phase 2
`
`Basking Ridge, NJ; Uniondale, NY;
`Harrison, NY; Montvale, NJ;
`Commack, NY; New York, NY
`
`NCT04030559
`See httpszllclinicaltrials.gov/show
`
`Niraparib Before Surgery in Treating Patients
`With High Risk Localized Prostate Cancer and
`
`Phase 2
`
`Sacramento, CA
`
`Miscontentispmvidedasapmfaasrbnalsem'oeandhasnotbeenraviewedorappmvadbytheFDA
`
`Q) GUARDANT'
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`wrtalguardanthealthcom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT-00001O R2 | Pg 9 of 20
`
`

`

`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 11 of 232 PageID #: 11806
`Case 1:20-cv-01580-LPS
`Document 55-1 Filed 04/21/21 Page 11 of 232 PageID #: 11806
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`GUARDANT 36r CD“-
`
`Additional lnforrnation
`
`List of Available Clinical Trials
`
`Alteration
`
`Trial ID I Contact
`
`Title
`
`Phase
`
`Site (number in parenthesis is
`count of trial sites)
`
`INCT04030559
`
`DNA Damage Response Defects
`
`Study of Olaparib (MK—7339) in Combination
`NCT04123366
`Toll Free Number,TriaIsitesOmerck.com, With Pembrolizumab (MK-3475) in the
`1-888-577-8839
`Treatment of Homologous Recombination
`Repair Mutation (HRRm) and/or Homologous
`Recombination Deficiency (HRD)-Positive
`Advanced Cancer (MK—7339—007/KEYLYNK—
`007)
`
`Phase 2
`
`Oklahoma City, OK; Louisville, KY;
`Greeley, CO; Sacramento, CA;
`Gilbert, AZ; Tacoma, WA; Houston,
`TX; Cleveland, OH; Atlanta, GA;
`Marietta, GA; Gainesville, GA;
`Birmingham, AL; Gainesville, FL; Port
`Jefferson Station, NY; Salt Lake City,
`UT; Summit, NJ; Fairfax, VA; San
`Francisco, CA (2); Dallas, TX (2);
`Colombia (5); Puerto Rico (4):
`Argentina (4); Romania (4); Ukraine
`(10); Spain (3): Canada (2); Sweden
`(3); Latvia (4); Turkey (11); Poland (2);
`Korea, Republic of (4); Guatemala (4);
`South Africa (6); Mexico (7); Italy (4);
`Israel (6); France (5); Australia (4);
`Peru (6); Germany (3)
`
`NCT04336943
`Michael Schweizer,schweize@uw.edu,
`203606—6252
`
`Durvalumab and Olaparib for the Treatment of
`Prostate Cancer in Men Predicted to Have a
`High Neoantigen Load
`
`Phase 2
`
`Seattle, WA
`
`W742C
`
`NCT00303784
`See httpszllclinicaltrials.gov/show
`INCT00303784
`
`Prostate Adenocarcinoma TransCutaneous
`Hormones
`
`Phase 3
`
`United Kingdom (32)
`
`NCT02799706
`EORTC HQ,1414@eortc.org,
`003227741611
`
`Trial Comparing Irradiation Plus Long Term
`Adjuvant Androgen Deprivation With GnRH
`Antagonist Versus GnRH Agonist Plus Flare
`Protection in Patients With Very High Risk
`Localized or Locally Advanced Prostate Cancer
`
`Phase 3
`
`Denmark; United Kingdom; Belgium
`(8); Italy (2); France (10); Switzerland
`(3); Germany (3); Spain (11)
`
`ODM-201 Maintenance Therapy in Patients
`NCT02933801
`Gilles Godar, PhD,trialsOsakk.ch,+41 31 With mCRPC Previously Treated With Novel
`389 91 91
`Hormonal Agents.
`
`Phase 2
`
`Italy (8): France (4); Switzerland (1 O);
`Spain (10)
`
`Prostate Cancer Biomarker Enrichment and
`NCT03385655
`Lesley Seymour,lseymour@ctg.queensu.
`Treatment Selection
`ca,61 3—533-6430
`
`
`Canada (11)
`
`Phase 2
`
`TP53
`6244C
`
`Assessing Induction of Double Strand Breaks
`NCT03507608
`Daniel Song, M.D.,dson92@jhmi.edu,410- With Androgen Receptor Partial Agonist in
`502-5875
`Patients on Androgen Suppression
`
`Early
`Phase 1
`
`Baltimore, MD
`
`NCT03654547
`Peng Peng, Ph.D.,
`peng_peng@transtherabio.com,86 25
`86901 1 07
`
`NCT03968653
`Debiophann International SA,
`clinicaltrialsOdebiopharm.com,+41 21
`321 01 11
`
`NCT04197713
`See httpszllclinicaltrials.govlshow
`INCT041 9771 3
`
`Safety of TT—00420 Monotherapy in Patients
`With Advanced Solid Tumors and Triple
`Negative Breast Cancer
`
`Phase 1
`
`Houston, TX
`
`Study of Oral Debio 0123 in Combination With
`Carboplatin in Participants With Advanced Solid
`Tumors
`
`Phase 1
`
`Spain; Netherlands (3)
`
`Testing the Sequential Combination of the Anti-
`cancer Drugs Olaparib Followed by Adavosertib
`(AZD1775) in Patients With Advanced Solid
`Tumors With Selected Mutations and PARP
`Resistance, STAR Study
`
`Phase 1
`
`Houston, TX
`
`NCT04383938
`Eyal Attar, MD,info@aprea.com,+1 617
`804 6947
`
`NCT04555837
`Faye M. Johnson,fmjohns0mdanderson.
`
`Phase 1/2 Study of APR—246 in Combination
`With Pembrolizumab in Subjects With Solid
`Tumor Malignancies
`Alisertib and Pembrolizumab for the Treatment
`of Patients With Rb—deficient Head and Neck
`
`Phase 1
`/Phase 2
`
`Phase 1
`[Phase 2
`
`Houston, TX; Saint Louis, MO
`
`Houston, TX
`
`Miscontentispmvidedasaprofaasrbnalsem'oeandhasnotbeenraviewedorappmvedbytheFDA
`
`Q) GUARDANT'
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`wrtalguardanthealthcom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT—000010 R2 | Pg 10 of 20
`
`

`

`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 12 of 232 PageID #: 11807
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 12 of 232 PagelD #: 11807
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`GUARDANT 36! CD‘-
`
`Additional Information
`
`List of Available Clinical Trials
`
`Alteration
`
`Trial ID I Contact
`
`Title
`
`org.713—792-6363
`
`Squamous Cell Cancer
`
`Phase
`
`Site (number in parenthesis is
`count of trial sites)
`
`Thiscontentispmvidedasapmfassrbnelsem'oeamihasnotbeenmviewedorappmvadbytheFDA
`
`GUARDANT
`
`.
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`mrtalguardanthealthcom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT—000010 R2 | Pg 11 of 20
`
`

`

`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 13 of 232 PageID #: 11808
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 13 of 232 PagelD #: 11808
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`Detailed Therapy Results
`Alteration
`
`Drug
`
`TP53
`6244C
`
`Adavosertib
`
`GUARDANT 36( CD“-
`
`Additional lnforrnation
`
`Trade Name
`
`Target
`
`Current Status
`
`Wee1 tyrosine kinase inhibitor.
`
`Phase 2 (Prostate carcinoma) Phase 2 (Embryonal
`tumor with multi-layered rosettes (ETMR),
`Medulloblastoma, Small cell lung carcinoma
`(SCLC), Solid Tumor, Primary myelofibrosis (PMF),
`Ovarian carcinosarcoma, Acute myeloid leukemia
`(AML), MDS/MPN, unclassifiable, Chronic
`myelomonocytic leukemia (CMML), Peritoneal
`papillary serous carcinoma, Myelodysplastic
`Syndrome (MDS))
`
`Aurora A small molecule kinase
`Alisertib
`Phase 2 (Prostate carcinoma) Phase 3 (Peripheral
`
`inhibitor.
`T—cell lymphoma (PTCL))
`
`ALT—801
`
`AMG 900
`
`AT9283
`
`AZD281 1
`
`p53—targeted T—cell receptor—IL2
`fusion.
`
`Phase 1 (Solid Tumor) Phase 2 (Melanoma,
`Urothelial carcinoma, Bladder carcinoma, Urethral
`melanoma, Urethral carcinoma, Multiple myeloma
`(MM))
`
`Aurora A, B, C small molecule
`kinase inhibitor.
`
`Phase 1 (Solid Tumor) Phase 1 (Acute myeloid
`leukemia (AML))
`
`Aurora A, B, Jak2, Jak3, Bcr-Abl
`kinase inhibitor.
`
`Phase 1 (Solid Tumor) Phase 2 (Acute myeloid
`leukemia (AML), Multiple myeloma (MM), Acute
`lymphoblastic leukemia (ALL))
`
`Nanoparticle formulation of Aurora
`kinase B inhibitor barasertib
`(A201 152).
`
`Phase 1 (Solid Tumor) Phase 2 (Acute myeloid
`leukemia (AML), Myelodysplastic Syndrome
`(MDS))
`
`COTl—2
`
`Phase 1 (Endometrial carcinoma, Head and neck
`Reactivates mutant p53.
`squamous cell carcinoma (HNSCC), Ovarian
`
`carcinoma, Cervical carcinoma)
`
`Debio 0123
`
`ENMD-2076
`
`Wee1 tyrosine kinase inhibitor.
`Aurora A kinase inhibitor.
`
`Eprenetapopt
`
`Reactivates mutant p53.
`
`Blocks Mdm2-p53 interaction,
`restoring transcriptional activity of
`p53.
`
`Aurora kinase A—specific inhibitor.
`
`Kevetrin
`
`LY3295668
`
`SGT—53
`
`Phase 1 (Solid Tumor)
`
`Phase 1 (Solid Tumor) Phase 2 (Fibrolamellar
`hepatocellular carcinoma, Ovarian carcinoma,
`Breast carcinoma, Fallopian tube
`adenocarcinoma, Sarcoma)
`
`Phase 1 (Prostate carcinoma) Phase 3
`(Myelodysplastic Syndrome (MDS))
`
`Phase 1 (Solid Tumor) Phase 2 (Ovarian
`carcinoma)
`
`Phase 1 (Solid Tumor) Phase 2 (Head and neck
`squamous cell carcinoma (HNSCC), Small cell
`lung carcinoma (SCLC), Breast carcinoma (triple
`negative), Breast carcinoma (hormone receptor +,
`HER2-))
`
`TP53 gene therapy delivered via
`transferrin-targeted nanoparticles.
`
`Phase 1 (Solid Tumor) Phase 2 (Glioblastoma,
`Glioma, Pancreatic carcinoma)
`
`SNS-314
`
`Phase 1 (Solid Tumor)
`
`TAS—1 19
`Selective Aurora A kinase inhibitor.
`Phase 1 (Solid Tumor)
`
`Aurora kinase A/B inhibitor.
`
`1T—00420
`
`AZDS312
`
`AR
`L702H
`W742C
`
`Aurora kinase A/B inhibitor.
`
`AR antisense oligonucleotide.
`
`Phase 1 (Solid Tumor) Phase 1 (Breast carcinoma
`(triple negative»
`Phase 2
`Tumor)
`
`(Prostate carcinoma) Phase 1 (Solid
`
`Miscontentispmvidedasapmfmbnelsem'ceamihasnotbeenmviewedorappmvedbytheFDA
`
`Q) GUARDANT'
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`mrtalguardanthealthsom. To set up an account, contact Client Services: 855.698.8887
`
`BEC-PRT—000010 R2 | Pg 12 of 20
`
`

`

`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 14 of 232 PageID #: 11809
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 14 of 232 PagelD #: 11809
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`GUARDANT 36( CD“-
`
`Additional Information
`
`Detailed Therapy Results
`
`Alteration
`
`Drug
`
`Trade Name
`
`Target
`
`Current Status
`
`Cyproterone
`
`Androcur
`
`Androgen receptor inhibitor; binds
`to the androgen receptor and
`inhibits activation.
`
`Phase 3 (Prostate carcinoma)
`
`Darolutamide
`
`Androgen receptor inhibitor.
`
`Phase 3 (Prostate carcinoma)
`
`Degarelix
`
`Firmagon
`
`GnRH antagonist, LHRH inhibitor.
`
`FDA Approved in this indication (Prostate
`carcinoma) Phase 2 (Breast carcinoma)
`
`Flutamide
`
`Eulexin
`
`Anti—androgen; prevents androgen
`uptake by androgen—sensitive
`tumor tissue.
`
`FDA Approved in this indication (Prostate
`carcinoma)
`
`Goserelin
`
`Zoladex
`
`LHRH agonist, inhibits
`gonadotropin secretion.
`
`FDA Approved in this indication (Prostate
`carcinoma) FDA Approved in other indications
`(Breast carcinoma)
`
`Leuprolide
`Eligard
`LHRH agonist, inhibits
`FDA Approved in this indication (Prostate
`gonadotropin secretion, used in
`carcinoma) Phase 3 (Breast carcinoma)
`
`combination with anti—androgen.
`
`LY01 005
`
`goserelin acetate extended—release
`microspheres.
`
`Phase 3 (Prostate carcinoma)
`
`Nilutamide
`
`Nilandron
`
`Anti-androgen; blocks the
`androgen receptor, preventing
`interaction with testosterone.
`
`FDA Approved in this indication (Prostate
`carcinoma)
`
`Seviteronel
`
`SHR3680
`
`TAS3681
`
`TRC253
`
`Blocks androgen synthesis through Phase 2 (Prostate carcinoma) Phase 2 (Breast
`Cyp17a1 lyase inhibition.
`carcinoma)
`
`Androgen receptor antagonist.
`
`Phase 3 (Prostate carcinoma) Phase 2 (Breast
`carcinoma (triple negative»
`
`Androgen receptor antagonist.
`
`Phase 1 (Prostate carcinoma)
`
`Inhibitor/antagonist of wild—type
`and certain mutant androgen
`receptors, including AR F877L.
`
`Phase 2 (Prostate carcinoma)
`
`Triptorelin
`
`Decapeptyl
`
`ATM
`R3008C
`
`LHRH agonist, inhibits
`gonadotropin secretion, used in
`combination with anti-androgen.
`
`BAY—1895344
`Atr inhibitor.
`Phase 1 (Solid Tumor)
`_
`_
`_
`_
`Berzosertlb
`Atr lnhlbltor.
`
`FDA Approved in this indication (Prostate
`carcinoma) Phase 3 (Breast carcinoma)
`
`_
`_
`Phase 2 (Prostate carcmoma) Phase 2 (Gastrlc
`carcinoma, Small cell carcinoma, Osteosarcoma,
`Non—small cell lung carcinoma (NSCLC), Ovarian
`carcinoma, Small cell lung carcinoma (SCLC),
`Gastroesophageal junction carcinoma, Urothelial
`carcinoma, Bladder carcinoma, Leiomyosarcoma)
`
`Ceralasertib
`
`Atr inhibitor.
`
`IDX—1197
`
`PARP inhibitor.
`
`Phase 2 (Prostate carcinoma) Phase 2 (Pancreatic
`carcinoma, Melanoma, Non-small cell lung
`carcinoma (NSCLC), Endometrial carcinoma,
`Renal cell carcinoma, Ovarian carcinoma, Small
`cell lung carcinoma (SCLC), Gastroesophageal
`junction carcinoma, Urothelial carcinoma, Bladder
`carcinoma, Breast carcinoma, Cervical carcinoma,
`Chronic lymphocytic leukemia (CLL),
`Cholangiocarcinoma, Lung cancer)
`
`Phase 2 (Solid Tumor) Phase 2 (Brain and Central
`Nervous System Tumors)
`
`Niraparib
`
`Zejula
`
`PARP inhibitor.
`
`Phase 3 (Prostate carcinoma) FDA Approved in
`
`Miscontentispmvidedasapmfmbnelsem'oeamihasnotbeenmviewedorappmvedbytheFDA
`
`Q) GUARDANT'
`
`A more detailed Guardant360 Patient Report is available through our online portal:
`mrtalguardanthealthsom. To set up an account, contact Client Services: 855.698.8887
`
`REC-PRT—000010 R2 | Pg 13 of 20
`
`

`

`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 15 of 232 PageID #: 11810
`Case 1:20-cv-01580-LPS Document 55-1 Filed 04/21/21 Page 15 of 232 PageID #: 11810
`
`Jones, Steven (A0123456)
`DOB: DEC—09-1946 | Test Number 1
`
`GUARDANT 36r CD“-
`
`Additional Information
`
`Detailed Th