*All times are shown in EDT

8:00 am Coffee Room Opens

8:50 am Chair’s Opening Remarks

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

9:00 am Breakfast Panel: Bridging the TKI vs. Immunotherapy Conversations in NSCLC

  • Giovanni Selvaggi Chief Executive Officer & Chief Medical Officer, Xcovery
  • Emmett Schmidt Vice President, Lead External Collaborations Project Team Global Clinical Development, Merck & Co
  • Rob Kania Senior Vice President of Drug Discovery, Kinnate

Synopsis

  • Discussing stage of cancer, combinations, and order of treatment rationale for the well-validated
    immunotherapies and TKIs in early lines
  • Exploring shifts of focus between the immune system of the patient (immunotherapies) and the
    biology of the tumor (tyrosine kinase inhibitors)
  • How can we combine insights from both immune system markers and tumor markers, to be used as markers that
    are predictive of patient response?
  • What are the rational targeted combinations for current TKIs?

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 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

10:30 am Morning Refreshments

11:00 am 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

12:00 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

12:30 pm Exploring the Adjuvant vs. Neoadjuvant Debate

  • Anthony Jarkowski Executive Director, Early Development & Program Lead, Bristol Myers Squibb

Synopsis

  • Understanding Nivolumab with chemotherapy as neoadjuvant treatment
  • Discussing the data for adjuvant vs. neoadjuvant based on disease stage, actionable mutation status and PD-L1 status
  • Delving into the thoughts and future directions of this dynamic conversation

1:00 pm Lunch & Networking

Optimizing Trial Design, Patient Recruitment & Patient Voice to Improve Trials

2:00 pm Utility of Blood-Based Molecular Diagnostic Testing Across the Lung Cancer Continuum of Care

2:30 pm Overcoming Barriers to Clinical Trial Enrollment in NSCLC

  • Stephen Liu Associate Professor & Director, Head of Thoracic Oncology & Developmental Therapeutics, Georgetown University

Synopsis

  • Discussing thoughts on improving trial design, tailored towards clinical investigation during the pandemic
  • Exploring telemedicine
  • Overcoming barriers to trial enrollment
  • Delving into smart trial design, optimizing study design in the midst of pandemic

3:00 pm Physician Panel Discussion: Challenges & Practical Insights Into Optimizing Drug Sequencing & Patient Enrolment

  • Stephen Liu Associate Professor & Director, Head of Thoracic Oncology & Developmental Therapeutics, Georgetown University
  • Giovanni Selvaggi Chief Executive Officer & Chief Medical Officer, Xcovery

Synopsis

  • Discussing clinical trial design and patient inclusion/exclusion criteria when investigating drug sequencing
  • Challenges in running the trials from a patient selection and management perspective (especially with all the different lines of therapy as inclusion/exclusion/ selection criteria, meaning that many are not enrolled as they have been on a PD1 drug for a short time – how can pharma modify its inclusion criteria?)
  • Exploring pain points and tips on patient enrolment for NSCLC clinical trials
  • Analyzing sequencing: do you test the targeted therapy in a small biomarker select population or do you give that patient their first shot and the PD1, or do you put them together?
  • What should come first: Immunotherapy when the patient has the strongest immune system or the small target agent?
  • What is the role of chemotherapy in the above? And combining PD-1 with the TKI?
  • After Pembro-chemo and/or Pembro-monotherapy in the PDL1 population, what do you do next?
  • What is the progress in understanding the meaningful early biomarkers before you get to the 2-year endpoint?

3:30 pm Afternoon Refreshments

4:00 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

4:15 pm Centering the Patient in Our NSCLC Drug Development Journey

  • Jill Feldman Lung Cancer Patient and Advocate, Co-Founder, EGFR Resisters

Synopsis

  • Discussing working with and informing patients, working with advocacy groups and more

4:30 pm Chair’s Closing Remarks & End of Summit