Decipher Prostate, Decipher Bladder and Decipher GRID

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Presentation transcript:

Decipher Prostate, Decipher Bladder and Decipher GRID Information for life Decipher Prostate, Decipher Bladder and Decipher GRID

Genomic information company founded in 2007 to transform the practice of urologic oncology Fastest growing genomics company in the space #1 Post-RP test on the market Launched Decipher Biopsy test in 2016, 4,000+ study patients in pipeline Launched Bladder Cancer test in 2017 Licensing agreement with Color Genetics to market Hereditary Testing Average 3-4 publications/month between all products Most accurate and actionable genomic information “Pure” genomic test that does not rely on clinical inputs Most accurate test (to our knowledge) based on published studies First company with Predictive data that provides meaningful information to Patients, Practitioners and value to the health care system Only company that’s focusing studies on hormone, radiation and chemo- sensitivity Open Research platform (GRID) that allows for the advancement of Biomarker discovery Platform allows for capture of 1.4 million data points per patient Whole genome data sharing and collaborative research program . Commercial Facility San Diego, CA HQ + R&D Vancouver, BC

Top 10 urology programs collaborated to develop and validate Decipher® MEDICAL CENTER MOFFITT Cancer Center & Research Institute H. LEE

Decipher: Most widely published genomic test and test platform 220 published abstracts 174 Presented posters 94 Podium Presentations 84 Peer-reviewed Publications

Role of decipher Biopsy Surgery PSA Rise Confidential

TECHNOLOGY Genomic Testing

Decipher technology + + DECIPHER CLINICAL REPORTS ANY FFPE TUMOR TISSUE Long term follow-up available GENECHIP TECHNOLOGY Genome-wide expression analysis MACHINE LEARNING Cancer disease signatures DECIPHER CLINICAL REPORTS GRID RESEARCH USE ONLY (RUO) REPORTS GRID RESEARCH DATA Guides treatment decisions Provides additional tumor insights Fuels new discoveries Bladder Prostate Bladder Other Bladder Prostate Prostate

Decipher and Clinical Risk Information Independent Genomic Risk on both biopsy and prostatectomy Does not require clinical information to be accurate Karnes et al., Journal of Urology 2013 Den et al, Journal of Clinical Oncology, 2015 Ross et al, European Urology, 2016 Glass et al., Journal of Urology, 2016 Freedland et al., European Urology, 2016 Klein et al., Urology, 2016 CD: Format font

The Decipher metastasis signature represents multiple biological pathways involved in aggressive prostate cancer Cell Proliferation, Differentiation Cell Structure, Adhesion, Motility Immune System Modulation Cell Cycle Progression Androgen-Signaling CAMK2N1 MYBPC1 PBX1 THBS2 UBE2C ANO7 EPPK1 IQGAP3 LASP1 MYBPC1 PCDH7 RABGAP1 GLYATL1P4 S1PR4 TNFRSF19 TSBP NFIB NUSAP1 ZWILCH ANO7 PCAT-32 UBE2C

Decipher PROSTATE Biopsy

Local + Systemic Therapy Role of decipher Classifies men by Decipher genomic risk for: % likelihood of Metastasis 5 years post prostatectomy % likelihood High grade disease (Primary Gleason 4 or 5) % likelihood Prostate Cancer Specific Mortality (PCSM) 10 years post prostatectomy Active Surveillance Local Therapy RP + PLND EBRT + ADT BRACHY Biopsy 1st Line Treatment Local + Systemic Therapy RP + EPLND +/- early RT EBRT + ADT (> 6mth) EBRT+BRACHY EBRT+BRACHY+ADT Confidential

Comparison of Accuracy for Predicting Metastasis after Radical Proctectomy 1 AUC > 0.7 is clinically actionable AUC=0.5 accuracy is comparable to a coin toss CD: References 1. Klein et al., Urology, 2016

Comparison of accuracy for predicting 5 year metastasis after first line radiation

PROSPECTIVE STUDY OF BIOPSY DECIPHER SCORES IN POTENTIAL CANDIDATES FOR ACTIVE SURVEILLANCE July 28, 2018 Examined Decipher score distribution in a prospective biopsy population (n=1,694) Loeb, Klein et al., AUA 2017, Podium Presentation GenomeDX Confidential

Decipher Prostate rp

What is ? July 28, 2018 Genomic signature selected for the ability to predict rapid metastasis after RP Outputs a Genomic Classifier (GC) score that ranges from 0 to 1 Actionable genomic test results Be safely observed after RP? Need adjuvant or early salvage radiation? Be better managed with salvage radiation at BCR? Possibly avoid concurrent hormone therapy with radiation at BCR? Medicare Indications** • Positive Surgical Margin (SM+) • Extraprostatic Extension (pT3a disease) • Seminal Vesicle Invasion (pT3b disease) • Bladder Neck Invasion (pT4 disease) • Rising PSA or Biochemical Recurrence GenomeDX Confidential

Decipher outperforms clinical risk factors and nomograms 0.45 0.80 0.65 Extra prostatic Extension 0.64 Gleason Score 0.59 Seminal Vesicle Invasion 0.56 Lymph Node Invasion Pre-Op PSA 0.49 Surgical Margins 0.79 Predictive power measured by Area Under the Curve (AUC) AUC > 0.7 is clinically actionable AUC=0.5 accuracy is comparable to a coin toss Decipher accuracy is primarily measured by AUC which is better than any existing path or clinical information. Also better than any combination of features (nomograms). This accuracy data is repeated in multiple validation studies. Karnes et al., Journal of Urology 2013

Decipher High Risk Patients Who Received Adjuvant Therapy Had Improved Metastasis Free Survival Adjuvant RT Salvage RT Decipher high-risk (GC ≥ 0.4) P-value = 0.008 Decipher high risk patients may experience lower incidence rates of metastasis when treated with adjuvant radiation post-RP Decipher low-risk patients may be managed safely with observation until PSA rise. Decipher low-risk (GC < 0.4) Adjuvant RT Salvage RT P-value = 0.788 This study (Den et al JCO, 2015) shown here provides further validation for the use of Decipher® as a tool to guide radiotherapy and represents a collaboration between the Mayo Clinic and TJU. It demonstrates that Decipher can predict metastasis in men following postoperative radiotherapy. You can see incidence of metastasis of post-surgery treated with adjuvant or salvage radiation for each Decipher risk category (i.e. Decipher low-risk (A), Decipher high-risk (B), N=188). For Decipher low-risk men, the results demonstrate that these patients do not benefit from adjuvant therapy and suggest these men may be safely managed with observation with PSA monitoring, while for Decipher high-risk men, there is a clear benefit in receiving adjuvant radiation. Hazard ratio (HR) for adjuvant radiotherapy relative to salvage radiotherapy is 0.2 indicating that Decipher high-risk men who received adjuvant radiotherapy had 80% reduction in metastasis risk compared to those Decipher high-risk men who received salvage radiotherapy. Den et al. Journal of Clinical Oncology 2015

Decipher low risk patients may avoid concurrent hormones after BCR Patient treated with salvage radiotherapy* Decipher high-risk patients may require intensification of therapy beyond radiation as incidence of metastasis remains high. Decipher low-risk patients have excellent prognosis with salvage radiation and may avoid concurrent hormonal therapy, as incidence of metastasis remains low. Freedland Salvage RT study results. All cases had RP followed by SRT (>0.2ng/mL) Decipher was able to predict which patients would respond well to SRT (blue), which would not (red). ~30% of Decipher high-risk men failed SRT by 5 years and probably need more systemic, intensified therapy. Freedland et al. European Urology 2016