Summit Therapeutics Inc. (NASDAQ: SMMT) is making significant strides in the development of ivonescimab, a novel investigational bispecific antibody, through a strategic collaboration with Pfizer Inc. (NYSE: PFE) and continued advancement of its Phase III clinical trials in non-small cell lung cancer (NSCLC). These efforts aim to address unmet needs in oncology and improve patient outcomes.
Pfizer Collaboration to Expand Ivonescimab's Potential
Summit Therapeutics and Pfizer have entered into a clinical trial collaboration to evaluate ivonescimab in combination with several of Pfizer’s antibody drug conjugates (ADCs) across multiple solid tumor settings. This collaboration seeks to accelerate the development of potentially transformative therapeutic combinations. According to Dave Gancarz, Chief Business & Strategy Officer at Summit, the collaboration involves multiple ADCs from Pfizer in various solid tumor settings beyond non-small cell lung cancer.
Under the agreement, Summit will provide ivonescimab for use in the studies, while Pfizer will manage the clinical trial operations and associated costs. Both companies will jointly oversee the studies, retaining their respective rights to their products. Initial studies are likely to be Phase Ib2 level trials, with studies planned to begin in mid-2025. Allen Yang, Chief Medical Officer at Summit, noted that the collaboration aims to enhance therapeutic options beyond lung cancer, leveraging ADCs' potential across solid tumors, focusing on expanding Ivonescimab's application outside lung cancer.
HARMONi Trial Completion and FDA Fast Track Designation
Summit Therapeutics has completed enrollment in its HARMONi clinical trial, a multi-regional Phase III study evaluating ivonescimab plus platinum-doublet chemotherapy versus placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Top-line results from the HARMONi trial are expected in mid-2025.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ivonescimab in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutation, who have experienced disease progression following EGFR-TKI therapy. This designation is intended to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs.
HARMONi-3 Trial Expansion and HARMONi-7 Trial Activation
In the fourth quarter of 2024, Summit amended the HARMONi-3 protocol to include patients with both squamous and non-squamous histologies, significantly increasing the eligible patient population. HARMONi-3 is a Phase III clinical trial designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
Summit has also begun activating clinical trial sites in the United States for the HARMONi-7 trial, a Phase III study evaluating ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression. This trial aims to assess the efficacy and safety of ivonescimab as a monotherapy compared to pembrolizumab in this patient population.
Financial Position
As of December 31, 2024, Summit Therapeutics reported aggregate cash and cash equivalents and short-term investments of $412.3 million, compared to $186.2 million at December 31, 2023. GAAP R&D expenses were $150.8 million for the full year of 2024, compared to $59.4 million for the full year of 2023.
About Ivonescimab
Ivonescimab (SMT112/AK112) is an investigational bispecific antibody that combines the effects of immunotherapy via PD-1 blockade with the anti-angiogenesis effects of VEGF blockade into a single molecule. It exhibits unique cooperative binding to PD-1 and VEGF, potentially directing it to the tumor microenvironment with higher affinity compared to normal tissue. Ivonescimab was engineered by Akeso Inc. and is currently in multiple Phase III clinical trials globally, with over 2,300 patients treated to date.
