MIAMI - Summit Therapeutics Inc. (NASDAQ: NASDAQ:SMMT) announced that its Phase III clinical trial, HARMONi-2, met the primary endpoint of progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC). The trial compared ivonescimab monotherapy to pembrolizumab monotherapy in patients with PD-L1 positive expression. The trial, sponsored by Akeso, Inc. (HKEX Code: 9926.HK), was conducted in China and showed that ivonescimab had a statistically significant improvement in PFS.
The HARMONi-2 trial's results indicated a broad benefit across various patient subgroups, including those with different levels of PD-L1 expression and histologies. Ivonescimab, a PD-1/VEGF bispecific antibody, is designed to combine immunotherapy and anti-angiogenesis treatments into a single molecule, potentially offering a new approach to treating solid tumors.
This study is the first known Phase III clinical trial to demonstrate a statistically significant PFS benefit over pembrolizumab in NSCLC. Ivonescimab's differentiated mechanism and its potential impact on the standard of care for solid tumors, including lung cancer, are highlighted by Summit's CEO, Dr. Maky Zanganeh, and Chairman, Robert W. Duggan.
Summit plans to present the full data set at a major medical conference later this year and will discuss recent updates related to ivonescimab in a conference call scheduled for Monday, June 3, 2024, at 8:00am ET.
The investigational drug ivonescimab has been administered to over 1,600 patients in clinical studies globally. While not yet approved by regulatory authorities in Summit's license territories, including the United States and Europe, it received marketing authorization in China in May 2024.
NSCLC accounts for the majority of lung cancer cases, with a significant number of patients exhibiting EGFR-sensitizing mutations or squamous histology. Summit's development of ivonescimab includes ongoing Phase III trials, HARMONi and HARMONi-3, focusing on different NSCLC patient groups.
The safety profile of ivonescimab aligns with known risks of PD-1 and VEGF inhibiting drugs, with manageable side effects observed in trials. Summit Therapeutics, founded in 2003 and headquartered in Miami, is dedicated to developing therapies aimed at improving quality of life and addressing serious medical needs. This news is based on a press release statement.
InvestingPro Insights
As Summit Therapeutics Inc. (NASDAQ: SMMT) garners attention with its promising clinical trial results for ivonescimab, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Summit Therapeutics has an adjusted market capitalization of $2.06 billion. Despite the recent clinical successes, the company's stock has experienced significant volatility, with a one-week price total return showing a sharp decline of 32.06%. Additionally, the stock is currently trading at a high Price/Book multiple of 50.81, indicating a premium valuation relative to its book value.
InvestingPro Tips reveal that Summit Therapeutics has suffered from weak gross profit margins and has not been profitable over the last twelve months. Analysts are not anticipating the company will be profitable this year, which may be a point of concern for potential investors. However, it's worth noting that the company's liquid assets exceed short-term obligations, suggesting a level of financial stability.
For those seeking to delve deeper into Summit's financial and stock performance, there are additional InvestingPro Tips available at https://www.investing.com/pro/SMMT. For instance, while the stock has fared poorly over the last month, it has shown a high return over the last year, which could be of interest to long-term investors. Furthermore, the company operates with a moderate level of debt and does not pay a dividend to shareholders.
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