Summit Therapeutics Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for ivonescimab, the novel, first-in-class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced and metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib).
Detailed results of the study were provided in September 2025, and a Biologics License Application ("BLA") was submitted to the United States Food and Drug Administration (F FDA) for marketing authorization in the fourth quarter of 2025. HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimib combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCL C, irrespective of PD-L1 expression. HARMONi-7 is a Phase III clinical trial that is intended to evaluate ivonesC monotherapy compared to pembrolizUMab monotherapy in patients with first-line prostate NSCLC whose tumors have high PD-L1 expression.ARMONi-GI3 is a Phase III clinical study evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first- line unresectable metastatic CRC.
In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined With chemotherapy compared to placebo plus chemotherapy In patients with EGFR-mutate, locally advanced or metastatic non the tumors have positive PD-L1 expression. Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary tract cancer, colorectal cancer, breast cancer, pancreatic cancer, small cell lung cancer, and head and neck cancer.
