UV1 Vaccination Plus Nivolumab/Ipilimumab Falls Short in Metastatic Melanoma
Source: OncLive, March 2024
The addition of the universal cancer vaccine UV1 to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) did not improve progression-free survival (PFS) compared with nivolumab plus ipilimumab alone in the first-line treatment of patients with unresectable or metastatic melanoma, failing to meet the primary end point of the phase 2 INITIUM trial (NCT04382664).
Topline findings showed that at a minimum follow-up of 18 months, the median PFS was not reached in either arm (HR, 0.95). Furthermore, differences in overall survival (OS) and overall response rate (ORR) were not observed between the 2 arms.
“Ultimovacs had set a very high bar for UV1 by comparing it to the ipilimumab and nivolumab combination, currently considered the most effective treatment for this patient population. Nevertheless, we are disappointed that UV1 did not add further clinical benefit for these [patients with] late-stage melanoma in the INITIUM trial. Looking forward, our first objective is to complete the analysis of the full data set in depth to gain further insights on UV1’s effects,” Jens Bjørheim, chief medical officer of Ultimovacs, stated in a news release. “We wish to thank the patients for their trust and the investigators for their collaboration with us.”