Summit Therapeutics has completed enrollment in the multi-regional Phase III HARMONi trial, evaluating ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced, or metastatic non-small cell lung cancer (NSCLC). This patient population has historically shown poor response to PD-1 antibodies.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ivonescimab in combination with chemotherapy for treating locally advanced or metastatic NSCLC patients with EGFR mutations who have progressed on EGFR tyrosine kinase inhibitors (TKIs).
Fast Track designation aims to accelerate the development and review of drugs that address serious medical needs. This designation allows for more frequent interactions with the FDA, written communication, and a rolling review process, facilitating earlier submission and review of the Biologic License Application (BLA).
The optimistic belief in ivonescimab’s potential has contributed to the successful enrollment completion of the HARMONi trial. Summit’s goal is to bring this drug to patients to enhance the quality of life for those with severe unmet medical needs.
The HARMONi trial’s topline data is anticipated in mid-2025. The FDA’s Fast Track designation provides an expedited review process, potentially leading to earlier approval and access to ivonescimab for patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
