Ivonescimab plus platinum-doublet chemotherapy - (HARMONi)

March 31, 2026 (reported in an update covering Q1 2026): Summit Therapeutics Inc. (NASDAQ: SMMT) highlighted upcoming clinical and regulatory catalysts for ivonescimab (SMT112/AK112), a PD-1/VEGF bispecific antibody licensed from Akeso (HKEX: 9926.HK).

HARMONi-6 (China; Akeso-sponsored, Phase III; 1L locally advanced/metastatic squamous NSCLC): Overall survival data will be presented as a late-breaking abstract in the ASCO 2026 Plenary Session, scheduled for Sunday, May 31, 2026 (abstract release 8:00am ET day-of). Trial compares ivonescimab + platinum chemotherapy vs tislelizumab + platinum chemotherapy, irrespective of PD-L1. Summit plans an update conference call June 1, 2026 (7:00am ET) after the plenary.

HARMONi-3 (global Phase III; 1L metastatic NSCLC):

• Squamous cohort: iDMC reviewed an interim PFS analysis (2Q 2026) and recommended continuing as planned; no safety concerns; study remains double-blinded. Final PFS data expected 2H 2026; interim OS analyses planned.
• Non-squamous cohort: enrollment expected to complete by end of 2Q 2026; PFS data expected 1H 2027.

HARMONi (global Phase III; EGFR-mutated, previously treated non-squamous NSCLC): FDA accepted Summit’s BLA (Jan 2026) for ivonescimab + chemotherapy; PDUFA goal action date is November 14, 2026.

Other catalysts/collaborations: RevMed combo study began enrolling 1Q 2026; GSK combo study expected to start dosing mid-2026; GORTEC Phase III ILLUMINE in PD-L1+ R/M HNSCC expected to begin enrollment 2Q 2026.