ESMO 2025 | Initial Phase II activity of invikafusp alfa in ICB-resistant solid tumors
Antoine Italiano, MD, PhD, Institute Bergonié, Bordeaux, France, discusses the Phase II expansion of START-001 trial (NCT05592626), evaluating invikafusp alfa, a first-in-class T cell receptor β-chain-targeted bispecific antibody, as monotherapy in patients with antigen-rich, immune checkpoint blockade-resistant solid tumors. In patients with high tumor mutational burden or microsatellite instability-high tumors, invikafusp demonstrated clinically meaningful antitumor activity across gastrointestinal, non-small cell lung, and head and neck cancers, with manageable safety. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
This phase 2 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 2 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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