Ivonescimab HARMONi-A Trial Results Published in JAMA

Summit Therapeutics Inc. recently announced that the Journal of the American Medical Association (JAMA) has published a paper entitled "Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer with EGFR Variant: A Randomized Clinical Trial." The publication is based on the results of the HARMONi-A Phase III clinical trial, which was conducted in China and sponsored by Akeso, Inc.

The HARMONi-A trial investigated the efficacy of ivonescimab combined with platinum-doublet chemotherapy in patients suffering from non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations. These patients had previously progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI). Ivonescimab, a PD-1/VEGF bispecific antibody, was compared against a placebo combined with the same chemotherapy regimen. Previous global Phase III trials had shown that PD-1 monoclonal antibodies were ineffective in this patient population, highlighting the potential significance of ivonescimab's differentiated mechanism of action.

Summit Therapeutics also announced a conference call scheduled for June 3, 2024, to discuss updates related to ivonescimab, including data presented at the ASCO 2024 meeting. The call will feature a live webcast accessible through Summit's website, with dial-in options available for U.S. and international attendees.

Ivonescimab, commercially known as SMT112 in certain regions, is a novel bispecific antibody that combines the effects of blocking PD-1 and VEGF. This dual mechanism aims to improve targeting of tumor tissues over healthy tissues, leveraging higher expression levels of PD-1 and VEGF in the tumor microenvironment. The molecule's tetravalent structure allows for enhanced binding affinity, potentially increasing its efficacy in treating cancer.

Ivonescimab was developed by Akeso Inc. and is currently undergoing multiple Phase III clinical trials. Over 1,600 patients have participated in global clinical studies involving ivonescimab. Summit Therapeutics has initiated its own clinical development of the drug in NSCLC, starting enrollment in 2023 for two Phase III trials: HARMONi and HARMONi-3. The HARMONi trial focuses on ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have not responded to third-generation EGFR TKIs like osimertinib. The HARMONi-3 trial compares ivonescimab combined with chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic squamous NSCLC patients.

It is important to note that ivonescimab is still an investigational therapy and has not been approved by regulatory authorities in Summit's licensed territories, including the United States and Europe. However, it received marketing authorization in China in May 2024.

Lung cancer remains a significant health issue, affecting approximately 600,000 individuals across several countries, including the United States, the United Kingdom, and Japan. NSCLC accounts for 80% to 85% of all lung cancer cases, with a subset having EGFR mutations. These mutations are particularly prevalent among non-squamous NSCLC patients, who represent a substantial portion of the overall lung cancer patient population.

Summit Therapeutics, founded in 2003, is dedicated to developing medicinal therapies aimed at improving quality of life and addressing unmet medical needs. The company's shares are traded on the Nasdaq Global Market under the symbol "SMMT." Summit has offices in Miami, Florida, Menlo Park, California, and Oxford, UK.

This announcement underscores Summit Therapeutics' commitment to advancing innovative treatments for life-threatening conditions like NSCLC, demonstrating the potential of ivonescimab to improve outcomes for patients who have limited treatment options.