Summit Therapeutics Inc. 8K

Summit Therapeutics announced updated Phase III HARMONi trial data showing improved overall survival trends and consistent safety for ivonescimab plus chemotherapy, supporting its pending BLA with a November 14, 2026 FDA PDUFA date.

On July 22, 2026, Summit Therapeutics Inc. reported updated overall survival data from its global Phase III HARMONi trial of ivonescimab plus platinum-doublet chemotherapy in EGFR‑mutated, locally advanced or metastatic non-squamous NSCLC patients previously treated with a third‑generation EGFR TKI, showing a progressively improving overall survival hazard ratio—from 0.79 at the April 2025 primary analysis to 0.78 in September 2025 and 0.76 at a June 2026 data cut—in both the full intention-to-treat population and the western patient subgroup, with a safety profile consistent with prior results; these updated data have been provided to the FDA in support of Summit’s pending Biologics License Application, which has a PDUFA goal action date of November 14, 2026.

Filing Facts

CIK

1599298

Ticker

SMMT

Form

8K

Source Type

fda

Accession

0001599298-26-000058

Alert Tier

6