Clinical TrialJun 1, 2026, 07:02 AM
Summit Therapeutics Ivonescimab Phase III OS Benefit HR 0.66 in NSCLC
AI Summary
Summit Therapeutics announced positive overall survival (OS) results from the Phase III HARMONi-6 trial for ivonescimab in first-line squamous non-small cell lung cancer (NSCLC), conducted by its partner Akeso in China. Ivonescimab plus chemotherapy reduced the risk of death by 34% (HR 0.66) compared to tislelizumab plus chemotherapy, with 24-month OS rates of 64.7% vs. 48.6%. Additionally, encouraging global Phase II data for ivonescimab in first-line metastatic colorectal cancer (mCRC) from the AK112-206 trial showed an objective response rate (ORR) of 70.8% and a manageable safety profile. The company will discuss these results in a conference call.
Key Highlights
- Ivonescimab plus chemotherapy reduced the risk of death by 34% (HR 0.66) in the HARMONi-6 Phase III NSCLC trial.
- The HARMONi-6 trial showed 24-month overall survival rates of 64.7% for ivonescimab vs. 48.6% for tislelizumab.
- HARMONi-6 achieved a statistically significant overall survival benefit (p=0.0017) in 1L squamous NSCLC.
- The AK112-206 Phase II trial in 1L metastatic colorectal cancer (mCRC) reported an Objective Response Rate (ORR) of 70.8%.
- The 9-month progression-free survival rate in the AK112-206 20 mg/kg ivonescimab arm was 76.1%.
- Both ivonescimab trials demonstrated an acceptable and manageable safety profile with no new safety signals.
- The HARMONi-6 clinical trial results were simultaneously published in The Lancet.
- Summit Therapeutics will host a conference call on June 1, 2026, to discuss the ivonescimab data.
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