*PLEASE NOTE: ALL TIMINGS LISTED AS FOLLOWS: EST*
9:20 am Chair’s Opening Remarks
Directing Patients to the Right Treatment at the Right Time
9:30 am The Patient Perspective: The Ultimate Stakeholder on the Need for Wider Liquid Biopsy Testing
Synopsis
• Why every person with advanced/metastatic cancer should have liquid biopsy – and who I think should pay for it
• Why we need a central repository for NGS/liquid biopsy results in order to inform the direction of new research
• How industry can bring advocates to the table
10:00 am Paving the Way for Localized CGP and CDx Testing
Synopsis
• Accelerating patient access through broad testing infrastructure
• Building a single CDx solution for all markets
• Developing a leading, comprehensive CGP portfolio
10:30 am Early Reduction in Circulating Tumor DNA, Regardless of RECIST Response, is Associated with Survival on Tebentafusp
Synopsis
• Circulating tumor DNA is emerging as an important marker of response to immunotherapies
• Tebentafusp, a gp100-directed TCR-CD3 bispecific re-directs any T cell to kill gp100-expressing melanoma cells and has demonstrated survival benefit in metastatic uveal melanoma
• Early reduction in circulating tumor, regardless of RECIST response, is associated with survival on tebentafusp
11:00 am Successful Partnering to Address the Toughest Challenges in Oncology with Liquid Biopsy
Synopsis
- As an innovative R&D organization and clinical testing laboratory, we are perfectly positioned to take on one of the hardest challenges in oncology diagnostics – molecular residual disease (MRD) and cancer recurrence detection
- Detection of MRD and recurrence is a new frontier in cancer diagnostics and has the potential to significantly impact cancer drug development, study and patient outcomes
11:30 am Roles of ctDNA Molecular Response in Drug Development
Synopsis
• ctDNA molecular response (MR) is a well validated approach correlated with long
term clinical benefit
• Multiple factors associated with performance of MR
• Scenarios that MR could help clinical trials and drug development
12:00 pm Structured Networking Break
Synopsis
Take part in this ice-breaking session to spark conversation. Reunite with your old friends, and connect with global precision oncology leaders through our virtual speed networking session!
Liquid Biopsy Applications
Chair:
Improving Patient Outcomes with Repeated Biomarker Testing Programs
12:30 pm Longitudinal Studies to Reach Earlier Clinical Endpoints
Synopsis
• Repeat biomarker testing as a tool to detect disease progression or response earlier
• Building evidence to reach early and less subjective clinical endpoints to inform and speed up drug development
• How modelling of data analysis impacts ctDNA monitoring response conclusions
1:00 pm Clinical Evidence for ctDNA MRD – Where Are We Today and Where Are We Headed?
Synopsis
• Overview of key clinical evidence supporting the use of ctDNA MRD in identifying patients at high risk of relapse, detecting molecular relapse or progression, and monitoring response to treatment
• Top areas of research interest and future opportunities for ctDNA MRD studies, including innovative biomarker analyses
1:30 pm Phase 1/2 Data from GRANITE (Individualized Neoantigen Immunotherapy Program) Demonstrating Objective Evidence of Efficacy in End-Stage CRC Patients who have “Cold” Tumors at Baseline
Synopsis
• Updated results from Phase 1/2 study evaluating the safety, immunogenicity, and clinical activity of GRANITE individualized neoantigen immunotherapy
• In 26 patients with end-stage solid tumors, efficacy was assessed by radiology, molecular response (ctDNA) and overall survival
• GRANITE is now advancing into a potentially pivotal, randomized, controlled, phase 2/3 clinical trial (single protocol) for the maintenance treatment of newly diagnosed metastatic MSS-CRC patients – ctDNA response is the primary efficacy endpoint of the phase 2 trial component
2:00 pm From Research to the Clinic: Successful Development of Novel Blood-Based Proteomic Tests for Lung Nodule Management
Synopsis
• Understand the requirements for bringing diagnostic tests from development into the clinic, including initial validation, assay refinement for integrationn into standard of care, and clinical studies to establish reimbursement
• How we developed a cohesive testing strategy to leverage the strengths of the rule-in type Nodify CDT and rule-out type Nodify XL2 tests to aid physicians with lung nodule management
• Review case studies demonstrating the real-world impact of blood-based lung
2:30 pm Minimal Residual Disease (MRD)-Based Clinical Trials that are Actively Enrolling in Clinic and Opening in the Near Future: Focus on GI Malignancies with Implications for Other Tumor Types
Synopsis
• Learn about some of the key minimal residual disease (MRD)-based clinical trials that are actively enrolling in clinic
• Understand how MRD is changing clinical trial designs and some trials opening in the near future
• Understand challenges of incorporating MRD into clinical trial designs and the road ahead
Developmental & Commercialization Pathways
Moving Testing into Routine Practice
12:30 pm Pricing & Reimbursement Strategies for Novel Therapies and Diagnostics
Synopsis
• What do promoters of liquid biopsy technology have to learn from how manufacturers of novel cell and gene therapies are distributing their products
• How is volume of testing & value provided to the employer baked into commercialization plans including reimbursement assessment
• How liquid biopsies fit into the secular shift to value-based care
1:00 pm Barriers to Adoption of Liquid Biopsy Use in Today’s Healthcare System
Synopsis
• Although precision medicine therapies have demonstrated benefit to cancer patients the failure to adopt a biomarker testing routine can result in suboptimal patient care
• Identification of key barriers to adoption of diagnostics tests and examples of strategies to overcome these barriers will be discussed with respect to liquid biopsy tests
• Intrinsic characteristics of liquid biopsy tests make them well suited to overcome some barriers to adoption in today’s healthcare system but also at a disadvantage to other barriers
1:30 pm Moving to Answers from Data with Next Generation Multiplex Genomic Testing
2:00 pm Panel Discussion: Adoption of Liquid Biopsies & Comprehensive Genomic Profiling
Synopsis
• What are the largest concerns impacting reimbursement of assays?
• How is industry interpreting liquid biopsy utility compared to tissue?
• What can industry take away from the past year of Covid-19 to improve access to testing?
• Considerations between panel size and reimbursement application – What does the future hold for screening?
• A discussion to unite stakeholders on the collaboration needed to identify, record, and show improved outcomes and healthcare savings
3:00 pm Networking Break
Synopsis
• Remain connected with your precision oncology community with the opportunity for 1:1 networking to stay ahead of the curve on the technological advances that could take your drugs to market
• If you are new to the liquid biopsy or precision oncology space and need advice, get in touch and we can facilitate the most meaningful conversations for your work.
Leveraging Liquid Biopsies for Optimized Trial Design
3:30 pm ctDNA Enabled Clinical Trials
Synopsis
• At AZ our vision is to deliver on the promise of ctDNA by changing the ways in which cancer is detected, treated, and monitored by leading drug approvals for new opportunities made possible only with ctDNA analyses
• New data will highlight the value of ctDNA testing as a valuable drug development tool
• Examples will be presented on novel, ctDNA enabled, clinical trial designs both for selecting patients and measuring outcomes in early and advanced cancers
4:00 pm Validating Liquid Biopsy Tests for CDx Use
Synopsis
• Patient selection strategies using liquid biopsy
• Integrating liquid biopsy into clinical development plans
• Utility of liquid biopsy as a CDx for rare tumors
Foreseeing a Future with Non-Invasive Testing a Standard of Care
Chair:
3:30 pm Evolution ctDNA as a Biomarker in GI Cancers: Hurdles and Opportunities
Synopsis
• Underutilization of ctDNA as a biomarker in clinical care: Missed opportunities
• Establishing ctDNA as a biomarker: From analytic validity to clinical utility
• Ongoing clinical trials in North America
4:00 pm Current Utility of Testing in the Clinic
Synopsis
• How is testing used in clinical practice today
• Clinician’s perspective of the value of testing and when these would be ordered
• From discovery to clinical application – the road that needs to be paved
4:30 pm Afternoon Networking Break
Synopsis
Use this final networking break to exchange virtual business cards with innovative liquid biopsy leaders and take back valuable insights to your team
Future Directions for Liquid Biopsy Testing
Chaired by:
5:00 pm The Next Steps for Liquid Biopsy: Moving into the Community Oncologist Setting
Synopsis
• Liquid biopsies allow us to meet some of the future challenges on the healthcare horizon
• How can industry plan ahead for the decentralization of patient care through leveraging liquid biopsy based biomarker testing
• Moving towards a more equitable provision of care where biomarker testing is made more accessible
5:30 pm Personalized Assays to Investigate Unique Tumor-Specific DNA Junctions
Synopsis
• Large genomic rearrangements commonly occur in solid tumors, resulting in highly unique somatic DNA junctions from chromosomal shufflings. These DNA junctions present as alternatives to point mutations as unique tumor-specific DNA markers for ctDNA monitoring
• Genome wide DNA junctions can be accurately identified at the precise breakpoint level by mapping fragments discordant to the reference human genome as obtained from Mate-Pair sequencing of tumor derived DNA
• Using this interesting approach, taking a look across new data from this initiative using unique tumor-specific DNA junctions to measure recurrence, MRD, relapse detection, monitoring, ctDNA detection in CSF, recurrence and response to therapy