Ivonescimab Beats Durvalumab in Biliary Tract Cancer: OS 14.9 vs 12.1 Months
SMMT sits 29% above its 52-week low of $12.07.
Summary
Full HARMONi-GI1 data presented at ESMO 2026 show ivonescimab plus chemo cut death risk 25% versus durvalumab plus chemo in first-line advanced biliary tract cancer (HR 0.75, p=0.0031), with median OS of 14.9 vs 12.1 months. Progression-free survival was 8.4 vs 5.8 months (HR 0.61) and response rates nearly doubled (ORR 53.8% vs 32.5%). This is the first Phase III readout for ivonescimab outside NSCLC and the first known Phase III in BTC to beat an anti-PD-(L)1 plus chemo regimen on overall survival. The trial was run entirely by Akeso in China, so U.S. registration depends on the ECOG-ACRIN EA2251 study announced October 21, with site activation expected in Q4 2026. The safety profile was consistent with prior studies and discontinuation was lower than durvalumab (3.5% vs 5.6%).
At the time of this announcement, SMMT was trading at $15.51 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $12.4B. The 52-week trading range was $12.07 to $29.23. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.