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Ultimovacs adjusts guidance on timeline for INITIUM readout

Carlos de Sousa

Ultimovacs has adjusted guidance from the first half of 2023 to the second half of 2023 for communication of topline progression free survival (PFS) data from the INITIUM Phase II trial in malignant melanoma patients.

“We are encouraged that disease progression in the INITIUM trial is slower than anticipated when compared with historical data. This is positive for patients, though we do not know if UV1-related efficacy is responsible for this extended time to expected readout since both Ultimovacs and the investigators remain blinded.  We look forward to learning to what degree UV1 may have contributed to the clinical outcome for patients,” says Carlos de Sousa, Chief Executive Officer of Ultimovacs.

INITIUM

INITIUM is an Ultimovacs-sponsored comparative, randomized Phase II trial for first-line treatment of patients with advanced or metastatic malignant melanoma. The first patient was enrolled in the trial in June 2020, and the study completed enrollment of 156 patients in June 2022. Half of the patients enrolled have been dosed with UV1 plus the PD-1 checkpoint inhibitor nivolumab and the CTLA-4 checkpoint inhibitor ipilimumab, while the other half received nivolumab and ipilimumab only.

According to INITIUM’s event-driven design, topline progression free survival results will be disclosed after progression of cancer or death has been verified in 70 patients. Based on published historical data for the combination of ipilimumab and nivolumab, progression was estimated to occur in 70 patients by the first half of 2023. The last update from the INITIUM trial shows that it is taking longer than anticipated to observe the required number of patients showing progression. With this shift in timeline, the topline results will not be announced before the second half of 2023.

Photo of Carlos de Sousa: Ultimovacs

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