Phase III breast cancer trial meets primary endpoint

pharmafile | June 10, 2021 | News story | |   

Byondis has revealed positive Phase III results for (ADC) [vic-]trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer.

The Phase III TULIP study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over physician’s choice.

PFS is defined as the time from the date of randomisation 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.

Jan Schellens, Byondis Chief Medical Officer, said: “There is considerable unmet medical need in patients with HER2-positive metastatic breast cancer and [vic-]trastuzumab duocarmazine represents a promising potential clinical advance.

“We are excited by the topline results of TULIP and indebted to all patients who participated in the clinical studies.”

Byondis CEO Marco Timmers, said: “A large trial involving breast cancer patients with advanced disease is difficult in the best of times, but it is especially challenging during a global pandemic.

“The completion of TULIP is a testament to the dedication of all involved, especially the patients, their families, and participating clinical sites.”

SYD985 was granted fast track designation by the U.S. Food & Drug Administration 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.

Lilly Subbotin

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