8:00 am Coffee Room Opens

8:50 am Chair’s Opening Remarks

9:00 am Improving Patient Identification Through Precision Diagnostics – CDx for Mobocertinib

  • Ying Li Companion Diagnostic Lead, Takeda Pharmaceutical Company

Synopsis

  • Validated CDx test is critical for identifying all EGFR exon 20 insertion patients
    eligible for treatment with mobocertinib
  • A CDx for tissue sample testing was validated and approved by the FDA
    simultaneously with mobocertinib
  • A liquid biopsy NGS test has been validated for detection of EGFR exon 20
    insertions in NSCLC patients

Progress in Mutation-Driven NSCLC Drug Development in Earlier Lines of Therapy

9:30 am The RAF/MEK Clamp VS-6766 for Treatment of KRAS & BRAF Mutant NSCLC

Synopsis

  • Exploring anti-tumor activity across multiple MAPK pathway alterations
  • Ongoing VS-6766 combinations with FAK, KRAS G12C or mTOR inhibitors
  • Revealing new combinations with EGFR inhibitors

10:00 am Increase NSCLC Drug Commercialization Success by Incorporating Biomarker/Diagnostic Solutions into Clinical Trials

Synopsis

  • Biomarker-informed care can improve patient outcomes, but ~50% of NSCLC
    of patients currently do not have biomarker results prior to starting first-line
    treatment
  • Challenges with clinical trial enrollment can delay NSCLC drug commercialization
  • Drug developers that incorporate biomarkers into their oncology clinical trials are
    known to be 5x more successful at obtaining FDA approval.
  • How a diagnostic partner with deep expertise in both lung disease and rapid
    turnaround liquid biopsy, a broad clinical trial site network, and experience
    enrolling thousands of NSCLC patients sets drug developers up for success

10:30 am Morning Refreshments

11:30 am The Bispecific Antibody MCLA-129 Impairs EGFR Inhibitor Resistant NSCLC Tumor Growth by Targeting EGFR & c-MET

Synopsis

  • Exploring the upregulation of c-MET signaling has been associated with
    resistance to EGFR inhibition
  • Delving into MCLA-129: a bispecific antibody that blocks the signaling of EGFR as
    well as c-MET, to inhibit tumor growth and survival
  • Understand how MCLA-129 utilizes ADCC-enhancement technology, which
    increases its cell-killing potential by immune cells

12:00 pm Inhibition of the WNT/beta catenin Pathway in NSCLC

Synopsis

  • Understand the WNT/beta catenin pathway’s importance as a target in NSCLC
  • Explore the new therapeutics in development to inhibit this target
  • Combination with EGFR inhibitors has potential to impact disease progression

Immune Checkpoint Inhibitors & Rational Combinations to Improve Outcomes in Earlier Lines of Therapy

12:30 pm A Soluble LAG-3 Protein (Eftilagimod Alpha) with an Anti-PD-1 Antibody (Pembrolizumab): Results of a Phase II Study in NSCLC

Synopsis

  • An MHC class II agonist (eftilagimod) used as an antigen presenting cell (APC) activator combined with an immune checkpoint inhibitor (ICI)
  • Results in first (114 patients) and second (36 PD-X refractory patients) lines NSCLC
  • A systemic APC activator injected s.c. plus an ICI: a potent combination for PDL-1
    unselected patients

1:00 pm Lunch & Networking

Amplifying the Patient Voice to Improve Trials

2:00 pm Patient Advocacy Groups as Partners in Drug Development

Synopsis

  • PAGs like LUNGevity Foundation support patients with cancer in multiple ways, including by funding transformative research on disease biology, detection, and treatment
  • LUNGevity has a demonstrated history of engaging stakeholders in the drug development ecosystem to address pain points and working together towards implementable solutions

2:30 pm BLOODPAC: Screening, Early Detection Challenges & Opportunities Ahead

3:00 pm Chair’s Closing Remarks & End of Summit