8:00 am Preconference Virtual Networking
8:50 am Chair’s Opening Remarks
Harnessing Cutting Edge Blood Brain Barrier Penetrable Drugs to Tackle Cancer Metastases in the Brain From HER2 Positive Primary Tumors
9:00 am HER2+ Breast Cancer Brain Metastases: Current Treatments & New Frontiers
Synopsis
• Use of TKIs for BCBM, including data from HER2Climb
• Data on efficacy of ADCs in the management of BCBM
• New therapies including immune checkpoint inhibition in the TOPAZ study
9:20 am The Use of Highly Selective TKIs for HER2+ CNS Metastases- Tucatinib in Combination With Capecitabine & Trastuzumab
Synopsis
• Expanding clinical trials to include patients with active brain metastases
• Exploration of the use of dual HER2 inhibition
• Understanding the complexity of clinical endpoints for measuring activity of therapeutics against brain metastases
9:40 am A Novel CAR therapy for Metastatic Breast Cancer
Synopsis
• Persistence and fitness are key features of successful cell therapy
• Our HER2-targeting CAR is uniquely engineered to incorporate these features
• This solution is presented in the context of CNS metastasis, and is given alongside standard of care biologics
10:00 am Augmenting HER2 Inhibition by Targeting PI3K – Lessons From Metastatic Brain Cancer
Synopsis
• PI3K is part of the signaling cascade for HER2 and therefore drugs modulating both targets are potentially synergistic
• PI3K inhibition has been explored as a means to overcome resistance to HER2-directed therapies
• Paxalisib, a brain-penetrant PI3K inhibitor, is under investigation for HER2+ breast cancer brain metastases
10:20 am Live Presenter Q&A
10:50 am Virtual Speed Networking & Break
Exploring HER2 Heterogeneity in Diseases Beyond Breast Cancer to Identify Treatment Opportunities
11:50 am Development of the Keynote 811 Protocol, Biomarker Work & Future Combination Strategies
12:10 pm Investigating the Safety & Efficacy of Pembrolizumab Plus Trastuzumab in Patients With HER2-Positive Gastric Cancer (KEYNOTE 811)
Synopsis
• Phase 3 trial building on promising Phase 2 data in HER2 positive gastric cancer
• Challenges of Global Biomarker selected Clinical trial
• Impact/challenges of Practice Preferences/Standards on maintaining homogeneity of trial subjects
12:30 pm BDTX-189: A MasterKey Inhibitor of Allosteric EGFR & HER2 Mutations
Synopsis
- The role of Black Diamond’s proprietary MAP platform to identify and validate allosteric EGFR and HER2 oncogenic driver mutations
- Overview of the profile of BDTX-189, including a presentation of pharmacokinetic, safety, and anti-tumor activity pre-clinical data
- The ongoing MasterKey-01 trial, a Phase 1/2 clinical trial designed to evaluate BDTX-189 for the treatment of patients with solid tumors with a range of EGFR and HER2 mutations
12:50 pm Lunch Networking Break
1:50 pm Live Presenter Q&A
Investigating HER2-Targeted Therapies for HER2 Negative or HER2 Low Cancers
2:10 pm Considerations for HER2 Low Expressing Breast Cancer
Synopsis
• Linker in T-DxD uniquely cleaves drug conjugate
• Leaks into surrounding HER2 negative parts of the tumor, known as the bystander effect
• Opens up the potential to “target” tumors that previously weren’t considered targetable
2:30 pm Assessment of HER2 Expression: Beware of the Dynamic Range
Synopsis
• The current IHC companion diagnostics and why they work the way they do
• Assessing HER2 by reading pathologists and by measuring machines
• Why a new assay is needed for the new drugs
2:50 pm Live Presenter Q&A
New Frontiers for HER2-Targeted Therapies in Niche HER2 Expressing Cancers
3:05 pm HER2, Where You Do Not Think to Find It
Synopsis
• Prevalence of HER2 alterations in rare cancers and their dependence on HER2-driven signaling
• Therapeutic opportunities in previously unexplored territories
• Rational-based combinations depending of the histology
3:25 pm Targeting HER2 in Advanced Gastroesophageal Adenocarcinoma: 2nd Line & Beyond
Synopsis
• Outlining existing data on the use of anti-HER2 agents after progression on trastuzumab
• Reviewing novel agents in development and ongoing clinical trials
3:40 pm Live Presenter Q&A
3:55 pm Afternoon Networking Break
4:20 pm Panel Discussion: ‘Old Science – New Opportunities’: Profiling the Competitive Landscape & Accelerating Next Generation HER2-Targeted Therapies to Patients In Need
To conclude year’s meeting, we want YOU to get involved in this interactive online discussion.
During this discussion we will address:
Paul Rennert, President & Chief Scientific Officer Aleta Biotherapeutics
David Poon, VP Business Development Zymeworks
Strengths
• What are the strengths of existing HER2-targeted therapies that continue to drive its development in pharma and biotech pipelines?
• What is the therapeutic and commercial opportunity of expanding anti-HER2 drugs into multiple caner indications?
Opportunities
• What is the market opportunity versus unmet patient clinical need that needs to be addressed by emerging therapeutic approaches for HER2 expressing cancers?
• As we are working outside of orphan disease states, what will treatment costs look like and what will the patient share of costs be?
Weaknesses
• How have competing approaches reached late-stage clinical testing so quickly and why?
• How can we overcome the high bar set by standard of care?
Threats
• What does the landscape of emerging competing therapeutic approaches look like in this space? What are the challenges in regulation?
• What are the existing healthcare professional and industry attitudes towards different HER2-targeted therapies that must be taken into consideration?