Summit Therapeutics Inc. has recently reported positive topline results from the phase III clinical trial, Harmoni, evaluating Ivonescimab in combination with 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 met the progression-free survival (PFS) primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS with a hazard ratio of 0.52. This represents a 48% reduction in the risk of disease progression or death compared to chemotherapy alone. The study also showed a positive trend in the other primary endpoint, overall survival (OS), with a hazard ratio of 0.79.
The safety profile of Ivonescimab in combination with chemotherapy was found to be acceptable and manageable in the context of the observed clinical benefit. There were no new safety signals noted, and the incidence of grade 3 or higher treatment-emergent adverse events (TEAEs) was reported as 56.9% for patients in the Ivonescimab + chemotherapy arm versus 50.0% in those receiving chemotherapy alone.
Summit intends to file a biologics license application (BLA) based on the results of the trial, with discussions with the FDA ongoing to determine the timing of the filing. The company also plans to share a more complete data presentation from the clinical study at a future major medical conference.
Ivonescimab, also known as SMT112 in Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody that combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. The therapy has shown promising results, and Summit is optimistic about its potential to make a meaningful difference in the lives of patients.
Summit Therapeutics Inc. has shown conviction in the promise of this therapy, with plans to continue its clinical development in non-small cell lung cancer. The company has begun enrollment for other phase III clinical trials, including Harmoni-3 and Harmoni-7, to further evaluate the potential of Ivonescimab in different patient populations and treatment settings.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-friendly medicinal therapies intended to resolve serious unmet medical needs. The company's shares are listed on the NASDAQ Global Market under the symbol "SMMT" and it is headquartered in Miami, Florida, with additional offices in Menlo Park, California, and Oxford, UK. Today the company's shares have moved -30.5% to a price of $18.215. For more information, read the company's full 8-K submission here.
