Summit Therapeutics shares advanced 8.5% in pre-market trading on Monday after partner Akeso announced positive interim results from a Phase III trial of its lead drug ivonescimab in advanced biliary tract cancer.
The HARMONi-GI1 study met its primary endpoint of overall survival at a pre-specified interim analysis, demonstrating statistically significant superiority over the standard durvalumab plus chemotherapy regimen as a first-line treatment. This marks the first positive Phase III outcome for ivonescimab outside of lung cancer indications, where the drug has previously shown strong efficacy.
In non-small cell lung cancer with EGFR mutations, ivonescimab combined with chemotherapy reduced the risk of disease progression by approximately half compared with placebo, yielding a hazard ratio of 0.52. Summit separately published the primary analysis of its HARMONi Phase III trial in The Lancet Oncology, reinforcing the clinical profile of the therapy.
The stock has traded between $12.07 and $29.23 over the past 52 weeks, with broader markets mixed as the NASDAQ slipped 0.2% and the S&P 500 remained little changed. Analysts have also weighed in: Guggenheim maintained a Buy rating with a $38 price target, while Bernstein SocGen upgraded Summit from Underperform to Market Perform and lifted its target to $11.90 from $9.80.
Investors are now focused on a November FDA decision as the next major catalyst for the company.
