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Investing.com -- Summit Therapeutics plc (NASDAQ:SMMT) stock rose as much as 15% before paring gains to 2% after Akeso announced positive interim results from its HARMONi-A clinical trial for ivonescimab.
In Akeso’s first half 2025 earnings report, the company disclosed that ivonescimab plus chemotherapy achieved a statistically significant and clinically meaningful overall survival (OS) benefit in the China-only HARMONi-A trial. The study evaluated the combination therapy against chemotherapy alone in second-line or later EGFR-mutated non-small cell lung cancer (NSCLC) patients.
The positive OS data from HARMONi-A follows an earlier update presented at ASCO 2024, where the OS hazard ratio was 0.80 at 52% maturity. Akeso plans to present the updated data at an upcoming medical conference.
While this development represents positive news for Summit Therapeutics, analysts note its impact on Summit’s overall prospects may be limited. Cantor analyst Eric Schmidt pointed out that the second-line EGFR+ NSCLC market represents a smaller opportunity compared to the first-line wild-type patient population, where ivonescimab is also being evaluated.
The HARMONi-A results may not directly translate to U.S. approval prospects, as the separate HARMONi trial narrowly missed statistical significance for overall survival. However, the favorable maturation of survival data over time could be viewed positively.
TD Cowen analyst Tyler Van Buren reiterated a Buy rating on Summit Therapeutics, noting that the positive HARMONi-A results "could derisk the additional exploratory analyses that Summit plans to run on the HARMONi trial, as the initial results just barely missed statistical significance."
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