Summit Therapeutics: HARMONi Delivers Consistent Western OS Signal Ahead of FDA Decision; No Change To Our View on Approvability or Competition

Research evidence excerpt

Summit Therapeutics: HARMONi Delivers Consistent Western OS Signal Ahead of FDA Decision; No Change To Our View on Approvability or Competition

Equity Research

U.S. Small & Mid Cap Biotechnology

22 July 2026

Summit Therapeutics

HARMONi Delivers Consistent

Western OS Signal Ahead of FDA

SMMT EQUAL WEIGHTDecision; No Change To Our View

U.S. Small & Mid Cap POSITIVE Biotechnologyon Approvability or Competition Price Target USD 18.00

Price (21-Jul-26) USD 14.63

Western outcomes appear consistent with the broader Potential Upside/Downside +23.0%

HARMONi dataset; we note the reported HR comparisons with Source: Bloomberg, Barclays Research

contemporaries amivantamab and sac-TMT in the post-TKI

EGFRm settings. Etzer Darout, PhD, MBA

+1 212 526 6940

etzer.darout@barclays.comSummit Therapeutics reported via press release an update on the global trial HARMONi

BCI, US

evaluating ivonescimab in combination with platinum-doublet chemotherapy vs chemo alone

in 2L EGFRm NSCLC. Our key takeaways below. Gustave Diep, MD

+1 212 526 0347

Overall, we view the updated overall survival analysis (HR 0.76 globally, and 0.76 in the gustave.diep@barclays.com

Western subgroup) as providing additional visibility into the Western component of the BCI, US

dataset, which has remained a focus for investors given the geographic composition of Lukas Shumway, PhD

HARMONi and the relatively limited contribution of North American patients to prior OS +1 212 526 7293

analyses. Recall, the original BLA package included data which incorporated a large lukas.shumway@barclays.com

percentage (~74%) of patients from Akeso’s HARMONi-A China-only trial. The initial BCI, US

HARMONi OS readout was not significant (p=0.057), and the longer term follow up did not Jordan Becker, PhD