The Phase III TULIP study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement of its [Vic-]Trastuzumab Duocarmazine (SYD985) over physician’s choice, said the developer.
PFS is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurred earlier. The study also demonstrated preliminary supportive overall survival (OS) results, reported Byondis.
The Nijmegen, Netherlands headquartered company did not provide detailed data along with the topline results of the trial today but confirmed it would release further information from the TULIP study at scientific conferences in due course.
“There is considerable unmet medical need in patients with HER2-positive metastatic breast cancer and [vic-]trastuzumab duocarmazine represents a promising potential clinical advance,” said Byondis Chief Medical Officer, Jan Schellens. “We are excited by the topline results of TULIP.”
Meanwhile, it is finalizing its biological license application (BLA) on SYD985 and said it intends to submit that before the end of 2021.
In addition, given the positive study outcome, Byondis said it is now planning to explore partnerships with pharma and biopharma companies in order to commercialize SYD985.
SYD985 was granted fast track designation by the US Food and Drug Administration (FDA) in January 2018 based on promising data from heavily pre-treated last-line HER2-positive MBC patients participating in a two-part Phase I clinical trial.