Summit Therapeutics has concluded subject enrolment in the Phase III HARMONi clinical trial of ivonescimab, along with platinum-doublet chemotherapy for the treatment of a certain type of non-small cell lung cancer (NSCLC).
Patients from North America, Europe, and China are part of the multi-regional trial.
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The trial includes individuals with epidermal growth factor receptor-mutated (EGFRm), locally advanced or metastatic non-squamous NSCLC, whose disease advanced following third-generation EGFR tyrosine kinase inhibitor (TKI) therapy.
This patient population is said to have previously seen unsuccessful results from PD-1 monoclonal antibodies in Phase III global trials, the company noted.
The HARMONi trial will compare the efficacy of ivonescimab plus platinum-doublet chemotherapy against a placebo plus platinum-doublet chemotherapy.
Designed with dual primary endpoints, the HARMONi trial aims to evaluate progression-free survival and overall survival.
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By GlobalDataThe company anticipates topline data from the HARMONi trial in mid-2025.
Furthermore, the US Food and Drug Administration (FDA) has granted fast track designation to ivonescimab for use in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with an EGFR mutation, who have experienced disease progression following EGFR-TKI therapy.
Summit Therapeutics chairman and CEO Robert Duggan said: “Completing enrolment in the HARMONi study represents another step towards our goal of bringing to patients a drug that is intended to improve the quality and potential duration of life for those facing serious unmet medical needs.
“As our belief in the potential for ivonescimab to make a meaningful, positive difference continues to grow, we are pleased that the FDA has granted fast track designation for ivonescimab.”
In May, the company revealed that its Phase III HARMONi-2 (AK112-303) trial of ivonescimab in patients with PD-L1 positive NSCLC in China met the primary endpoint.
