Byondis Announces Positive Topline Results of Phase 3 TULIP Study Evaluating (ADC) [vic-]trastuzumab duocarmazine in Patients with HER2+ Breast Cancer

Byondis Announces Positive Topline Results of Phase 3 TULIP Study Evaluating (ADC) [vic-]trastuzumab duocarmazine in Patients with HER2+ Breast Cancer

Byondis announced positive topline results from the Phase III TULIP study, which compared the efficacy and safety of the company’s antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) to physician's choice treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer. The study met the primary endpoint, confirming that ADC [Vic-]Trastuzumab Duocarmazine (SYD985) is superior to Physician’s Choice in delaying disease progression. 

The multi-center, open-label, randomized clinical trial enrolled 436 female patients aged 18 and over, at 83 sites across the United States, Canada, Europe and Singapore. To qualify, patients had either: (1) progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease; or (2) progression during or after ado-trastuzumab emtansine treatment. Patients were randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression or unacceptable toxicity. The trial met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over physician’s choice. PFS ...

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