Summit Therapeutics Inc. (NASDAQ: SMMT) has announced a significant milestone in the development of its novel investigational drug, ivonescimab. The phase III clinical trial, harmoni-2 or AK112-303, conducted in China, evaluated the efficacy of ivonescimab in comparison to pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) expressing positive PD-L1.
The trial demonstrated that ivonescimab decisively outperformed pembrolizumab in terms of progression-free survival (PFS), achieving a statistically significant superiority over its competitor. This is a groundbreaking achievement as it marks the first time a drug has shown a clinically meaningful benefit over pembrolizumab in a randomized phase III clinical trial in NSCLC.
The data revealed that ivonescimab's PFS improvement was observed broadly across various patient subgroups, including those with low PD-L1 expression, high PD-L1 expression, squamous and non-squamous histologies, and other high-risk patients. These results are particularly noteworthy as there are no known phase III clinical trials in NSCLC that have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.
Summit's Chief Executive Officer, Dr. Maky Zanganeh, expressed the significance of these results, emphasizing that ivonescimab represents the next generation in PD-1 directed immunotherapy and has the potential to make a significant difference in the lives of patients with lung cancer and other tumors. The company's Chairman and CEO, Robert W. Duggan, also emphasized the historic nature of this achievement, heralding it as the beginning of a paradigm change for cancer treatment options.
The safety profile of ivonescimab was also highlighted, with the drug demonstrating a manageable safety profile consistent with known risks for PD-1 and VEGF inhibiting drugs. Notably, ivonescimab's approval in China in combination with chemotherapy based on the results of the harmoni-a trial further supports the differentiated mechanism of action of the drug and its potential to improve existing standards of care for solid tumors.
Ivonescimab's unique cooperative binding to its intended targets, PD-1 and VEGF, with higher affinity in the presence of both targets, sets it apart as a potential first-in-class investigational bispecific antibody. The drug's tetravalent structure enables higher avidity in the tumor microenvironment, with the intent to improve efficacy thresholds and safety profiles associated with these targets.
Summit Therapeutics Inc. plans to host a conference call to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday, June 3, 2024, before the market opens.
The development of ivonescimab represents a significant step forward in the treatment of NSCLC, with potential implications for other types of cancer as well. As the company continues to advance its clinical development of ivonescimab in NSCLC and other tumors, these results mark a pivotal moment in the pursuit of improved treatment options for cancer patients. As a result of these announcements, the company's shares have moved 272.1% on the market, and are now trading at a price of $10.92. Check out the company's full 8-K submission here.
