Summit Therapeutics: FDA Grants Fast Track Designation for Ivonescimab with Platinum-Based Chemotherapy in EGFRm NSCLC Treatment

Summit Therapeutics Inc. Completes Enrollment in HARMONi Clinical Trial

Summit Therapeutics Inc. has announced the successful completion of patient enrollment in its HARMONi clinical trial, a Phase III study evaluating the efficacy of ivonescimab in combination with platinum-doublet chemotherapy compared to a placebo combined with the same chemotherapy regimen. This trial targets patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after receiving a 3rd generation EGFR tyrosine kinase inhibitor (TKI). Patient enrollment was successfully achieved across multiple sites in North America, Europe, and China, focusing on a demographic where previous treatments with PD-1 monoclonal antibodies have not yielded positive results in Phase III trials.

Dr. Maky Zanganeh, Chief Executive Officer and President of Summit, expressed gratitude towards the investigators, site coordinators, Team Summit, and the participating patients. He emphasized the significance of completing enrollment in this landmark global study for ivonescimab and its potential impact on patients worldwide.

Additionally, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the proposed use of ivonescimab in conjunction with platinum-based chemotherapy for adult patients with EGFR mutation-positive, locally advanced or metastatic NSCLC who have experienced disease progression following previous treatment with an EGFR-TKI. The Fast Track designation is intended to expedite the development and review process for drugs addressing serious conditions and unmet medical needs, thereby facilitating earlier access to vital new therapies.

Robert W. Duggan, Chairman and CEO of Summit, highlighted that reaching this enrollment milestone is a step towards the objective of delivering a drug that may enhance both the quality and potential longevity of life for patients with significant unmet medical needs. He also conveyed his optimism regarding the FDA’s Fast Track designation for ivonescimab.

The analysis of the HARMONi trial will incorporate all patients from the prior HARMONi-A trial, which evaluated ivonescimab in a similar context. HARMONi-A, sponsored by collaboration partner Akeso, was designed to assess progression-free survival as its main endpoint. In contrast, HARMONi focuses on dual primary endpoints: progression-free survival and overall survival.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s territories and AK112 in China and Australia, is a novel investigational bispecific antibody that combines immunotherapy via PD-1 blockade with anti-angiogenic effects associated with blocking VEGF. This innovative design allows ivonescimab to bind more effectively to its targets, potentially increasing its efficacy in the tumor microenvironment compared to normal tissues.

The bispecific antibody’s advanced binding capability showcases its unique tetravalent structure, enhancing its ability to interact with PD-1 and VEGF, which are often present in higher concentrations in tumors compared to healthy tissue. Ivonescimab’s design aims to improve established efficacy thresholds while potentially mitigating adverse effects associated with traditional therapies.

Ivonescimab is in Phase III clinical trials, and over 1,800 patients globally have received treatment with this investigational therapy. Summit is progressing the development of ivonescimab in NSCLC, with ongoing clinical trials HARMONi and HARMONi-3, and plans to initiate HARMONi-7 soon.

HARMONi evaluates ivonescimab combined with chemotherapy against a placebo plus chemotherapy for EGFR-mutated NSCLC patients. HARMONi-3 is structured to compare ivonescimab plus chemotherapy with pembrolizumab plus chemotherapy for first-line treatment in squamous NSCLC. HARMONi-7 aims to assess ivonescimab monotherapy against pembrolizumab monotherapy in first-line treatment for NSCLC with high PD-L1 expression.

In addition to the ongoing HARMONi studies, Akeso has also reported positive results from two other Phase III clinical trials for ivonescimab in NSCLC conducted in China. This investigational therapy is not yet approved by regulatory authorities in Summit’s regions, except for marketing authorization granted in China in May 2024. Ivonescimab has received Fast Track designation from the FDA for its use in the HARMONi clinical trial setting.