Phase I/II trial shows promising activity of invikafusp alfa in PD-1–resistant GI cancers

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Published: 18 Aug 2025
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Dr Elena Élez - Vall d'Hebron Institute of Oncology, Barcelona, Spain

Dr Elena Élez speaks to ecancer about results from a phase I/II trial testing invikafusp alfa, a first-in-class bispecific antibody that targets the TCR-beta chain. The study looks at its use as monotherapy in patients with antigen-rich gastrointestinal (GI) cancers who had already developed resistance to anti-PD(L)1 therapy.

The findings are encouraging: invikafusp showed meaningful anti-tumour activity across several GI cancers, with particularly strong signals in colorectal cancer. The trial reported an overall response rate of 23–25% and a disease control rate of 63%.

Looking ahead, researchers plan to refine patient selection and expand the trial to include individuals with specific molecular profiles, with the goal of better identifying who may benefit most from this treatment