Iteos Therapeutics (ITOS) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Clinical development overview

• Three clinical assets: TIGIT antibody partnered with GSK, and two adenosine pathway inhibitors in early-stage development.

• Phase 3 trial for TIGIT antibody in non-small cell lung cancer (NSCLC) started in June, with a $35M milestone from GSK.

• Dose selection for phase 3 set at 400 mg, balancing risk and benefit, with ongoing FDA discussions.

• Data-driven approach guides all development and investment decisions.

• Strong collaboration with GSK, with shared focus on data-driven milestones.

Key clinical data and trial design

• Early ESMO data in first-line NSCLC (high PD-L1) showed ~60% response rate for all TIGIT doses, with a 30% improvement over dostarlimab alone.

• Safety profile considered manageable and consistent across doses; discontinuation rates similar to competitors.

• Largest published TIGIT dataset in this indication, with nearly 100 patients.

• Phase 3 trial design incorporates learnings from competitor failures, with robust statistical planning and a 1,000-patient enrollment.

• Enrollment in ongoing studies is on track, with strong clinician engagement.

Competitive positioning and strategy

• Recent data positions the program as a potential leader in NSCLC, moving from fifth to first based on quality of results.

• Differentiation based on asset quality, indication selection, and optimized phase 3 design.

• Phase 3 compares directly to pembrolizumab, unlike SKYSCRAPER-01, which uses atezolizumab as control.

• Strategy includes exploring chemo combinations and biomarker-driven approaches for PD-L1 low populations.