Helman #worldcdx Follow-up at Dana Farber via ddPCR, correlation chart shown. Shows results of NILE study G360 vs tissue SoC in 1L NSCLC
9:38am September 11th 2019 via Twitter Web App
Helman #worldcdx Odegaard CCR '18 chart: SNVs 0.2% drivers, fusions 0.2%, CNAs 2.24 copies, MSI 0.1%
9:36am September 11th 2019 via Twitter Web App
Helman #worldcdx Shows chart of ctDNA levels - VAF median at 0.5%. Signal gets lost in noise. Bioinf., machine learning so impt
Helman #worldcdx Key analytical validation, and full validation of CDx with narrow indication
9:35am September 11th 2019 via Twitter Web App
Helman #worldcdx FDA has an evolved oncopanel review paradigm: analytical validation by a representative approach
9:34am September 11th 2019 via Twitter Web App
Helman #worldcdx Shows testing rates from Gutieerrez '17 Clin Lung Ca across genes. G360 is 74-gene assay for mutations, 18 ampl, 6 fusion
9:33am September 11th 2019 via Twitter Web App
Helman #worldcdx 20-30% of mBC have only bone mets: 50% of bone biopsy have insuff DNA.
9:31am September 11th 2019 via Twitter Web App
Helman #worldcdx NCCN recommends genotyping across lung, breast, CRC, GIST, Prostate, Ovarian. Tissue availability: 60% lung insuff
Helman #worldcdx Medicare, strong private payer coverage. Footprint expanding; lab in CA, TX, Singapore, Japan. Working on EU, China
9:30am September 11th 2019 via Twitter Web App
Helman #worldcdx 50+ clin studies, partnership with AZ for Tagrisso and Guardant360; Imfinzi w/GuardantOmni
9:29am September 11th 2019 via Twitter Web App
Helman #worldcdx Their digital sequency: 'high-eff chemistry'. 75+ patents issued, 150+ patents pending, machine learning
9:28am September 11th 2019 via Twitter Web App
Helman #worldcdx For MRD: 56% of CRC pts referred for recurrence have not had recurrence.
9:27am September 11th 2019 via Twitter Web App
Helman #worldcdx Have 100K+ tests to-date. Late-stage Rx selection: tissue avail, exhaustion, TAT time. Only 8% of… https://t.co/yllV7oFUgc
9:26am September 11th 2019 via Twitter Web App
Helman #worldcdx Targeting the cancer care continuum: Rx selection, recurr monitoring (LUNAR-1), early det (LUNAR-2)
9:25am September 11th 2019 via Twitter Web App
Elena Helman (Guardant Health) #worldcdx Comprehensive Liquid Biopsy: Clinical & Commercial Use Cases
Q: How are CRO's adapting? Anderson #worldcdx Broad-service providers are better-equipped. Cell-based and gene-based assay dev
9:24am September 11th 2019 via Twitter Web App
Anderson #worldcdx Factors impacting delivery of Precision Med: Policy, payers, providers, prescribers, specificty, Dx/Rx industry
9:20am September 11th 2019 via Twitter Web App
Anderson #worldcdx For gene therapy: CDx oppy to look for neutralizing Abs via Elisa, or cell-based assays.
9:17am September 11th 2019 via Twitter Web App
Anderson #worldcdx With rare disease: natural history critical; KOL and pt-centric approach vital (advocacy groups).
9:15am September 11th 2019 via Twitter Web App
Anderson #worldcdx Even in CAR-T, resistance develops. Can get tumor Ag loss, or T-cell dysfunction and exhaustion.
9:12am September 11th 2019 via Twitter Web App
Anderson #worldcdx CAR-T cells eval w/cell-based assays (via flow), the molecules via qPCR, persistence, deep seq of T cell populations
9:08am September 11th 2019 via Twitter Web App
Anderson #worldcdx 1 pt, 1 product lot. A very different mfg paradigm: a real challenge. Shows cartoon of constructs
9:07am September 11th 2019 via Twitter Web App
Anderson #worldcdx Overview of CAR-T: CD19+ tumor, engineered B-cells w/scFv, how pts own T-cells are expanded ex-vivo and re-infused.
9:05am September 11th 2019 via Twitter Web App
Anderson #worldcdx Recently: Yescarta has ORR of 83%, CRR 53% for N-Cell NHL; Kymriah ORR 81%, CRR 60% for B-cell ALL
9:03am September 11th 2019 via Twitter Web App
Anderson #worldcdx expect 200 INDs each year by 2020. FDA adding 50 new clinical reviewers to enable approval of 10-20 Rx/year by 2025.
9:01am September 11th 2019 via Twitter Web App
Anderson #worldcdx For cell and gene Rx, 58% in oncology. FDA: 800 active INDs for CGT (cell and gene therapy) candidates.
9:00am September 11th 2019 via Twitter Web App
Anderson #worldcdx Cell and Gene-modified cell Rx: over 1K in development (globally), in various phases.
Anderson #worldcdx Trends: impr disease models, new Rx modalities, expanding CDx applications, lab technology, regulatory guidance
8:57am September 11th 2019 via Twitter Web App
Anderson #worldcdx in Drug Dev - probability of success: earlier implementation = better; trend: 2018 now 42% of PM… https://t.co/fOn3ZuQZyE
8:55am September 11th 2019 via Twitter Web App
Anderson #worldcdx Over 300 biomarkers in current drug labels (efficacy, dosage, AEs) PM at intersection of biomarkers, CDx, Cell/Gene Rx
8:53am September 11th 2019 via Twitter Web App
Anderson #worldcdx Drivers for implementation of Precision Medicine: ~40 CDx on market today. All but one for oncology. 4 approved for CAR-T
8:52am September 11th 2019 via Twitter Web App
Steve Anderson (Covance) #worldcdx The Evolving Precision Medicine Landscape: The role of biomarkers, CDx and advanced therapies
8:51am September 11th 2019 via Twitter Web App
Q: What about different populations? Haviland #worldcdx Very similar criteria; quality, TAT, feasibility of implementation.
8:49am September 11th 2019 via Twitter Web App
Haviland #worldcdx (Observes a moment of silence in honor of 9/11.)
8:47am September 11th 2019 via Twitter Web App
Q: Why only 50% for GIST? Haviland #worldcdx A way to act on testing is impt. Access and other issues (awareness in comm. oncol settings)
8:45am September 11th 2019 via Twitter Web App
Q: How have you chosen CDx tech? Haviland #worldcdx Quality, TAT, Global footprint.
Haviland #worldcdx Only ~50% of GIST patients get molecular testing; they want to change the paradigm. In <10y: 2 approved Rx, many in de
8:43am September 11th 2019 via Twitter Web App
Haviland #worldcdx Tumor-agnostic approach: As varied as RET fusions in papillary thyroid, panc ca, bile duct carcinoma.
8:40am September 11th 2019 via Twitter Web App
Haviland #worldcdx Clin example: real-time monitoring in EGFR-mutant NSCCL and acquired RET fusion, treated w/Tagrisso and pralsetinib.
8:39am September 11th 2019 via Twitter Web App
Haviland #worldcdx Thus KIT-driven Ph III precision medicine trial for their compound in 2L GIST with liquid biopsy excl criteria
8:37am September 11th 2019 via Twitter Web App
Haviland #worldcdx For KIT-driven GIST, used liquid biposy to understand emerging clin data. KIT V654A/T670I (non-responders for GIST)
Haviland #worldcdx Showed expanding results in adv systemic mastocytosis to the smoldering form w/Avapritinib (still in dev)
8:35am September 11th 2019 via Twitter Web App
Haviland #worldcdx Adv systemic mastocytosis, and adv GIST: KIT D816V and PDGFRA D842V - two homol mutant kinases, w/same inhibitor
8:33am September 11th 2019 via Twitter Web App
Haviland #worldcdx And then to use their platform to adapt to tumor evolution. Then expanding the pt popul'n.
8:31am September 11th 2019 via Twitter Web App
Haviland #worldcdx A cycle: detect, interpret, act. Lays out Blueprint's approach: durable selective inhibitors, bi… https://t.co/3ZMKitY3qa
8:30am September 11th 2019 via Twitter Web App
Haviland #worldcdx Recognizes that progress with cancer optimism is fleeting, due to the dynamic nature of cancer.
8:27am September 11th 2019 via Twitter Web App
Haviland #worldcdx Starts with a note: will remember 9/11 in a moment of silence. And remember how long we've come… https://t.co/CoZHdHzXIP
8:26am September 11th 2019 via Twitter Web App
Kate Haviland (Blueprint Medicines) A Virtuous Cycle of Medical Innovation Fueling Advances in Precision Oncology #worldcdx
8:25am September 11th 2019 via Twitter Web App
Salzman #worldcdx Pursuit for precision medicine - 'biomarkers the currency for drug development'.
8:22am September 11th 2019 via Twitter Web App
Chair's opening remarks - Rachel Salzman (SwanBio Therapeutics) The goal: the right drug at the right time to the right patient. #worldcdx
8:20am September 11th 2019 via Twitter Web App
