Summit Therapeutics (SMMT) TD Cowen 46th Annual Health Care Conference summary

Partnership and clinical development overview

• Entered partnership with Akeso Bio for ivonescimab, a PD-1/VEGF bispecific antibody, in late 2022, expanding into global late-stage development and regulatory review.

• Multiple phase III studies initiated globally, including HARMONi, HARMONi-3 (squamous and non-squamous cohorts), HARMONi-7, and a new colorectal cancer study.

• Announced the ILLUMINE study in head and neck cancer, with plans for further expansion and additional studies in 2026.

• Ongoing close collaboration with Akeso, leveraging their data and experience to inform study design and expansion.

Molecule design and clinical implications

• Ivonescimab's unique design enables intramolecular cooperativity and daisy chaining, potentially enhancing efficacy compared to other PD-1/VEGF bispecifics.

• Differences in molecular format among competitors may lead to clinically meaningful differences in outcomes.

• Daisy chaining and binding site configuration are believed to impact receptor downregulation and therapeutic effect.

Regulatory progress and clinical data

• FDA accepted the BLA for ivonescimab in second-line EGFR mutant NSCLC, with a PDUFA date set for November 2026.

• Four phase III studies have shown positive data, with HARMONi demonstrating statistically significant PFS and a nominal OS benefit.

• Safety profile considered manageable and favorable compared to current standard of care.

• Data consistency observed between Western and Eastern populations, with pre-negotiated Western patient enrollment targets met.