Summit Therapeutics Inc. 8K

Summit Therapeutics is initiating HARMONi-GU1, a global Phase II/III registrational trial of ivonescimab plus enfortumab vedotin versus pembrolizumab plus enfortumab vedotin as first-line therapy for advanced urothelial (bladder) cancer, with global site activations planned by Q4 2026.

On August 5, 2026, Summit Therapeutics Inc. announced that it is further expanding the global, registration-enabling clinical development program for its investigational bispecific antibody ivonescimab by initiating HARMONi-GU1, a global, multi-regional Phase II/III trial in first-line treatment of locally advanced or metastatic urothelial carcinoma (bladder cancer), in which ivonescimab plus the antibody-drug conjugate enfortumab vedotin will be compared against the current standard regimen of pembrolizumab plus enfortumab vedotin. The HARMONi-GU1 trial, planned to begin global site activations by the fourth quarter of 2026, is expected to enroll approximately 800 patients through Phase III, with Phase II determining the recommended Phase III dose and Phase III focusing on progression-free and overall survival as primary endpoints. This study represents the first global registrational ivonescimab trial in a genitourinary cancer and adds to Summit’s broader ivonescimab Phase III program across multiple tumor types including non-small cell lung cancer and colorectal cancer, which already includes several positive Phase III readouts and an accepted BLA for NSCLC under FDA review.

Filing Facts

CIK

1599298

Ticker

SMMT

Form

8K

Source Type

fda

Accession

0001599298-26-000071

Alert Tier

6