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ESMO 2025 | Evaluating invikafusp alfa in high TMB & microsatellite instable solid tumors

Antoine Italiano, MD, PhD, Institute Bergonié, Bordeaux, France, comments on the results from a Phase II expansion of START-001 trial (NCT05592626), which assessed invikafusp alfa in patients with high tumor mutational burden (TMB) and microsatellite instability. Clinically meaningful responses were observed, even in indications considered refractory to immune checkpoint inhibitors, such as MSS colorectal cancer. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

This Phase II study investigated invikafusp alfa first in a population of patients characterized by high tumor mutational burden and microsatellite instability. So what we observed in this study was a very significant response rate of about 20% in this population of highly refractory disease and disease control rate of about 60%. We observed clinically and meaningful responses, even in indications that are considered refractory to immune checkpoint inhibitors, such as MSS colorectal cancer...

This Phase II study investigated invikafusp alfa first in a population of patients characterized by high tumor mutational burden and microsatellite instability. So what we observed in this study was a very significant response rate of about 20% in this population of highly refractory disease and disease control rate of about 60%. We observed clinically and meaningful responses, even in indications that are considered refractory to immune checkpoint inhibitors, such as MSS colorectal cancer.

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