Summit Therapeutics Reports Positive Phase III Results

By Tamara Parker • Sunday, June 01 16:17 • Permanent Link

Summit Therapeutics Inc. (NASDAQ: SMMT) has released the topline results from the phase III clinical trial, Harmoni, evaluating ivonescimab in combination with chemotherapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI).

The results show that ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), with a hazard ratio of 0.52, representing a 48% reduction in the risk of disease progression or death compared to chemotherapy alone.

Furthermore, the study also indicated a positive trend in overall survival (OS) with a hazard ratio of 0.79, though it did not achieve statistical significance. The safety profile of ivonescimab plus chemotherapy was deemed acceptable and manageable.

The trial encompassed a multiregional, double-blinded, placebo-controlled design and involved patients from both Asian and Western countries. Notably, there were no new safety signals observed during the study.

Summit intends to file a biologics license application (BLA) based on the results of the Harmoni trial, with the timing of the filing to be determined in collaboration with the United States Food & Drug Administration (FDA).

Ivonescimab, also known as SMT112 in Summit’s license territories, 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. It has been developed by Akeso Inc. and is currently engaged in multiple phase III clinical trials, with over 2,300 patients treated in clinical studies globally.

Summit Therapeutics, a biopharmaceutical oncology company, plans to present a more comprehensive data analysis from the Harmoni trial at an upcoming major medical conference.

The market has reacted to these announcements by moving the company's shares -30.5% to a price of $18.215. Check out the company's full 8-K submission here.

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