TuHURA Biosciences Provides First Look at Data from its Open-Label Study of IFx-2.0 as an Adjunctive Therapy to Keytruda® in First Line Treatment of Patients with Deep Seated Metastatic Merkel Cell Carcinoma
PR Newswire•26/10/2026•07:30 ET
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Key Highlights
- ➤Three patients achieved partial responses under RECIST v.1.1 at six months
- ➤All three tumor responses remained ongoing at the protocol-specified six-month assessment
- ➤IFx-2.0 was safely administered via CT or ultrasound-guided injection into deep-seated tumors
- ➤TuHURA may expand enrollment and discuss supplementing its Phase 3 trial with FDA
- ➤Phase 1b/2a study initially plans to enroll nine patients with visceral tumors
Expert Statements
James Bianco, President and Chief Executive Officer at TuHURA Biosciences
“While preliminary and only reported in 3 patients, these results highlight that it is feasible to utilize CT or ultrasound guided administration of IFx-2.0 safely to patients with large bulky and or deep-seated tumors.”
James Bianco, President and Chief Executive Officer at TuHURA Biosciences
“This is also the first time we have administered IFx-2.0 with Keytruda® in the front line treatment setting of patients with metastatic MCC and may serve as a proxy to the potential response rates in the ongoing randomized placebo controlled Phase 3 trial, which is also being conducted in the front line treatment of patients with advanced or metastatic MCC as an adjunct with Keytruda®”
James Bianco, President and Chief Executive Officer at TuHURA Biosciences
“Approximately 30% of patients with metastatic MCC present without cutaneous or superficial nodal involvement.”
James Bianco, President and Chief Executive Officer at TuHURA Biosciences
“If we continue to see this high response rate in patients in this trial, we will explore the potential to expand the number of patients in the trial and discuss with the FDA its potential to supplement the ongoing Phase 3 trial, should that study successfully meet the primary endpoint.”
James Bianco, President and Chief Executive Officer at TuHURA Biosciences
“We look forward to additional patient data in the coming months, and we will seek to present the data at an appropriate scientific conference next year.”
TuHURA Biosciences Provides First Look at Data from its Open-Label Study of IFx-2.0 as an Adjunctive Therapy to Keytruda® in First Line Treatment of Patients with Deep Seated Metastatic Merkel Cell Carcinoma PR Newswire
Preliminary results demonstrate major objective tumor responses in first 3 patients at 6 months
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