Summit Therapeutics PLC’s shares rose 8.5% in pre-market trading on Wednesday after the company reported positive interim data from a Phase III trial of its experimental drug ivonescimab.
The HARMONi-GI1 study, conducted in partnership with Akeso, met its primary endpoint of overall survival at a pre-specified interim analysis. The treatment demonstrated statistically significant superiority over a standard regimen of durvalumab plus chemotherapy as a first-line therapy for patients with advanced biliary tract cancer. This marks the first positive Phase III outcome for ivonescimab outside of lung cancer indications.
Separately, Summit published primary analysis results from the HARMONi Phase III trial in The Lancet Oncology. The data showed that ivonescimab combined with chemotherapy reduced the risk of disease progression by roughly half compared with placebo in patients with EGFR-mutated non-small cell lung cancer. The hazard ratio was reported at 0.52, indicating a 48% reduction in progression risk.
The company’s stock, which has traded between $12.07 and $29.23 over the past 52 weeks, moved against broader market trends. The NASDAQ Composite declined 0.2% while the S&P 500 remained nearly flat during the same session.
Analysts at Guggenheim maintained a Buy rating and set a price target of $38, while Bernstein SocGen upgraded Summit from Underperform to Market Perform and raised its target to $11.90 from $9.80.
Investor focus is now turning to a November decision by the U.S. Food and Drug Administration as the next major binary catalyst for the company’s pipeline, particularly given the progression of ivonescimab across multiple cancer indications.
