Summit Therapeutics Inc. (NASDAQ: SMMT) has announced the completion of patient enrollment in its HARMONi clinical trial. This multi-regional Phase III study evaluates ivonescimab combined with platinum-doublet chemotherapy versus placebo with platinum-doublet chemotherapy for patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The trial successfully enrolled participants from sites across North America, Europe, and China, targeting a patient population where PD-1 monoclonal antibodies have previously shown limited success in Phase III trials.
“I want to express my heartfelt thanks to the investigators, site coordinators, Team Summit, and especially the patients participating in the HARMONi study,” said Dr. Maky Zanganeh, CEO and President of Summit. “Completing enrollment in this first global study for ivonescimab highlights the growing belief in its potential to significantly impact patient lives.”
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ivonescimab combined with platinum-based chemotherapy for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations, following disease progression after EGFR-TKI therapy. This designation is aimed at expediting the development and review of drugs addressing serious conditions and unmet medical needs.
“Completing enrollment in HARMONi is a crucial step toward delivering a drug that may enhance the quality and duration of life for patients with serious unmet needs,” stated Robert W. Duggan, Chairman & CEO of Summit. “We are pleased that the FDA has recognized the potential of ivonescimab by granting it Fast Track status.”
The HARMONi analysis will include patients from the HARMONi-A trial, which evaluated ivonescimab in a similar setting. This earlier trial, sponsored by Akeso, demonstrated positive outcomes and received marketing authorization in China.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s territories, is a novel bispecific antibody that targets PD-1 and VEGF, aiming to improve efficacy and safety compared to existing therapies. It has shown promising binding properties in the tumor microenvironment and is currently undergoing multiple Phase III trials.
Summit has begun its clinical development of ivonescimab in NSCLC, with ongoing trials HARMONi, HARMONi-3, and plans for HARMONi-7.
About Summit Therapeutics
Summit Therapeutics Inc. is focused on developing therapies to improve quality of life and address unmet medical needs in oncology. Established in 2003 and headquartered in Miami, Florida, Summit is listed on the Nasdaq Global Market under the symbol “SMMT.”
