Summit Therapeutics (SMMT) The Citizens Life Sciences Conference 2026 summary

Strategic partnerships and clinical development

• Entered a strategic partnership with Akeso Inc. for ivonescimab, securing rights in major global markets outside China and Korea.

• Expanded clinical development rapidly, initiating multiple late-stage studies, including global expansion of the HARMONi study.

• Currently sponsoring four phase III studies: three in non-small cell lung cancer (NSCLC) and one in microsatellite stable (MSS) colorectal cancer.

• Over 4,000 patients dosed in clinical studies, with more than 60,000 treated commercially in China.

• More than 140 clinical trials registered globally, with significant investigator-initiated interest.

Clinical results and molecule differentiation

• Ivonescimab demonstrated statistically significant progression-free survival (PFS) in all four phase III readouts, with three showing clinically meaningful overall survival (OS) improvements.

• Unique bispecific design targets PD-1 and VEGF, enabling allosteric and associative cooperativity, leading to enhanced receptor internalization and degradation.

• Outperformed pembrolizumab in both low and high PD-L1 expressing NSCLC patients in the HARMONi-2 study, with a PFS hazard ratio of 0.51.

• In chemo combination settings, showed significant improvement over PD-1 plus chemotherapy, with a hazard ratio of 0.60 in the HARMONi-6 study.

• Demonstrated favorable tolerability profile, with positive feedback from treating physicians.

Regulatory and future milestones

• PDUFA date for the BLA submission from the HARMONi study is set for November 2026.

• HARMONi-3 squamous cohort completed enrollment; interim PFS analysis expected in Q2, final PFS and interim OS in H2 2026.

• Non-squamous cohort to complete enrollment in H2 2024, with final PFS in H1 2027.

• Interim analyses are set at higher statistical thresholds, with no impact on the ability to achieve final analysis milestones.

• Strategic approach focuses on broadening indications, with ongoing and planned studies in NSCLC and MSS colorectal cancer, and collaborations for combination therapies.