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Byondis ESMO Late-Breaking Presentation Confirms ADC [Vic-] Trastuzumab Duocarmazine (SYD985) Superior to Physician's Choice in Pre-treated Locally Advanced or Metastatic HER2-Positive Breast Cancer



Pivotal Phase III TULIP Study Showed SYD985 Provided 2.1 Month Increase in Progression-Free Survival Compared to Standard Treatment

NIJMEGEN, Netherlands, Sept. 19, 2021 /PRNewswire/ -- At a late-breaking oral presentation (LBA15) at the virtual 2021 ESMO Congress today, Byondis B.V., an independent, clinical stage biopharmaceutical company creating precision medicines, reported positive results from its pivotal Phase III TULIP study. The multi-center, open-label, randomized clinical trial compared the efficacy and safety of the company's antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) to physician's choice (PC) treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

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"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer" met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over PC – 7 months for SYD985 versus 4.9 months for PC. The study also demonstrated a trend towards better overall survival (OS) for patients treated with SYD985. TULIP results were presented by Cristina Saura, M.D., head, Vall d'Hebron University Hospital Breast Cancer Unit, Medical Oncology Department, and principal investigator, Vall d'Hebron Institute of Oncology Breast Cancer Research Group in Barcelona, Spain.

"We are satisfied with the results of the TULIP study, as it bodes well for the potential of SYD985 as a new treatment option for patients with HER2-positive metastatic breast cancer, a disease typically associated with a poor prognosis," said Dr. Saura.

"The TULIP results represent a significant milestone in our R&D efforts, and we hope to make this next generation ADC available as soon as possible to the patients whose lives we are dedicated to improve," said Byondis CEO Marco Timmers, Ph.D. "We want to thank our clinical trial sites and study participants and their families for their contributions to this important research."

Byondis is working to complete the SYD985 biological license application (BLA) and intends to submit it to the U.S. Food & Drug Administration (FDA) before the end of 2021. The company is exploring partnerships with pharma and biopharma companies in order to further develop and commercialize SYD985.

The therapy was granted fast track designation by the FDA in January 2018. The designation was based on promising data from heavily pre-treated last-line HER2-positive MBC patients participating in a two-part Phase I clinical trial (SYD985.001).[i]

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Nachrichtenquelle: PR Newswire (engl.)
19.09.2021, 13:30  |  165   |   |   

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Byondis ESMO Late-Breaking Presentation Confirms ADC [Vic-] Trastuzumab Duocarmazine (SYD985) Superior to Physician's Choice in Pre-treated Locally Advanced or Metastatic HER2-Positive Breast Cancer Pivotal Phase III TULIP Study Showed SYD985 Provided 2.1 Month Increase in Progression-Free Survival Compared to Standard Treatment NIJMEGEN, Netherlands, Sept. 19, 2021 /PRNewswire/ - At a late-breaking oral presentation (LBA15) at the virtual …

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