Summit: Phase III Trial Of Ivonescimab Plus Chemotherapy Shows Positive Results In EGFR-Mutant NSCLC

(RTTNews) - Summit Therapeutics Inc. (SMMT) announced Friday positive topline results from the Phase III clinical trial, HARMONi, evaluating ivonescimab plus chemotherapy in patients with EGFR-Mutant non-small cell lung cancer or NSCLC.

Based on the results of the HARMONi clinical trial, Summit said it intends to file a Biologics License Application or BLA in order to seek approval for ivonescimab plus chemotherapy in this setting.

The company noted that the first global Phase III study evaluating ivonescimab plus chemotherapy showed statistically significant and clinically meaningful improvement in progression-free survival or PFS primary endpoint and showed a positive trend in the other primary endpoint, overall survival.

The U.S. Food & Drug Administration noted that a statistically significant overall survival benefit is necessary to support marketing authorization, which will weigh into Summit's considerations regarding the timing of a potential BLA filing.

Ivonescimab is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Summit noted that HARMONi represents the first phase III trial to evaluate Ivonescimab in a multiregional setting. It is a double-blinded, placebo-controlled, Phase III study sponsored by Summit, evaluating ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy.

The trial is in patients with epidermal growth factor receptor or EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI).

In the trial, the company noted that Ivonescimab in combination with chemotherapy reduces the risk of disease progression or death by 48% compared to chemotherapy alone.

Around 38% of patients were randomized from western countries, consistent with other recent multiregional Phase III studies in patients with EGFR-mutated NSCLC.

A clinically meaningful hazard ratio was observed in both Asia and ex-Asia sub-populations.

Ivonescimab was engineered by Akeso Inc. and is currently engaged in multiple Phase III clinical trials.

The drug is known as SMT112 in Summit's license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia.

Robert Duggan, Chairman and Co-Chief Executive Officer of Summit, said, "The evidence of a consistent benefit in PFS for both Asian and western patients, as well as the consistent overall survival results between the single-region HARMONi-A study and our global HARMONi study demonstrates the potential benefit ivonescimab has to bring to patients around the world, including the United States."

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