MIAMI - Summit Therapeutics Inc. (NASDAQ: NASDAQ:SMMT) has announced new data from its Phase II clinical trials of ivonescimab, a novel investigational bispecific antibody, showing significant efficacy in treating patients with advanced non-small cell lung cancer (NSCLC) who have brain metastases. The findings were presented today at the European Lung Cancer Congress in Prague, Czech Republic.
The trials, identified as AK112-202 and AK112-201, included 35 patients with asymptomatic brain metastases at baseline. Notably, the median intracranial progression-free survival was observed to be 19.3 months across the combined cohorts.
A 34% intracranial response rate was reported, with 23% of patients achieving a complete response by RANO criteria. Furthermore, all patients who did not achieve a response demonstrated stable disease or non-progression, with no cases of intracranial bleeding observed.
The safety and anti-tumor activity of ivonescimab, when used as a monotherapy or combined with chemotherapy, were highlighted in two posters at the congress. Dr. H. Jack West, Vice President of Clinical Development at Summit, expressed satisfaction with the favorable response rates and progression-free survival, as well as the promising safety profile in patients with brain metastases from NSCLC.
In a separate cohort of first-line advanced or metastatic squamous NSCLC patients, a median progression-free survival of 11.1 months was reported. Patients with non-squamous tumors experienced a median progression-free survival of 13.3 months.
The overall survival rate was not reached in either patient subset after a median follow-up of 22.1 months. Treatment-emergent adverse events leading to discontinuation of ivonescimab were relatively low, with the most frequent being anemia and decreased neutrophil counts.
Ivonescimab combines PD-1 immunotherapy with VEGF anti-angiogenesis effects in one molecule. It is designed to have higher binding affinity in the presence of both PD-1 and VEGF, potentially targeting tumor tissue more effectively than healthy tissue.
Summit is advancing ivonescimab's clinical development with ongoing Phase III trials, including the HARMONi trial for EGFR-mutated NSCLC patients and the HARMONi-3 trial for first-line metastatic squamous NSCLC patients. The drug is not yet approved by any regulatory authority.
The information in this article is based on a press release statement from Summit Therapeutics Inc.
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