Summit Therapeutics provides update on development of ivonescimab

Summit Therapeutics announced updates to the development of ivonescimab, as well as near-term corporate catalysts that it will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9 in San Francisco, California. AK112-201 is an open-label Phase II study evaluating ivonescimab plus chemotherapy across three cohorts of patients. In part, data generated from this trial has supported Summit’s decision to advance ivonescimab into two global Phase III clinical trials. Updated data includes patients from Cohorts 1 & 2 of this study: Cohort 1: Patients with first line advanced or metastatic non-small cell lung cancer, or NSCLC, without actionable genomic alterations. The updated data centers on the 63 patients whose tumors are of squamous histology. Cohort 2: Patients with second or third line advanced or metastatic NSCLC whose tumors are positive for EGFR mutations and have progressed following an EGFR tyrosine kinase inhibitor. Notably, the estimated one-year overall survival rate was 85.6%, and the two-year overall survival rate was 64.8% for patients in Cohort 1 with squamous histology NSCLC. After a median follow-up time of 21 months, the median overall survival, or OS, was not reached. The frequency of treatment-related adverse events, or TRAEs, leading to discontinuation of ivonescimab was 11%; there were no TRAEs leading to the death of a patient. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and decreased white-blood cell counts. The 19 patients in Cohort 2, primarily second or third line patients with EGFRm NSCLC, demonstrated a median overall survival of 22.5 months. After a median follow-up time of 25.8 months, the estimated one-year overall survival rate was 74%. Ivonescimab had an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with advanced or metastatic NSCLC who had progressed following an EGFR-TKI. There were no TRAEs leading to permanent discontinuation of therapy or patient death. AK112-201 is a clinical trial that is sponsored and conducted in China by our collaboration and licensing partner, Akeso. The aforementioned data related to AK112-201 was generated and analyzed by Akeso. Summit is enrolling patients in two global Phase III clinical trials involving ivonescimab: HARMONi intends to evaluate ivonescimab combined with chemotherapy compared to a placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI and HARMONi-3 is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with 1L metastatic squamous NSCLC.