Atossa Therapeutics has amended its Phase II EVANGELINE study of (Z)-endoxifen for premenopausal women with breast cancer to support New Drug Application (NDA) activities.
This trial is intended for women with newly diagnosed early-stage Estrogen Receptor-positive (ER+)/ Human Epidermal Growth Factor Receptor 2-negative (HER2-) breast cancer.
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The amended non-registrational design aims to expedite objective outcomes while also lowering anticipated future trial costs.
In 2026, Atossa will focus its resources on immediate activities that support the NDA for the investigational (Z)-endoxifen.
Atossa chairman and CEO Steven Quay said: “This amendment is about efficiency, focus and financial discipline.
“By streamlining EVANGELINE, we are rationalising study spending and concentrating our strong balance sheet on the NDA-enabling package we plan to advance in 2026, without changing our safety oversight or commitment to rigorous data.”
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By GlobalDataThe open-label, single-arm Phase II trial involving premenopausal women with ER+/HER2– breast cancer in the pre-surgical context comprises two cohorts.
Cohort A employs a signal-seeking, two-stage futility design, evaluating the week-4 Ki-67 rate of 10% or lower to facilitate an early termination if the results are not promising.
Meanwhile, Cohort B concentrates on the week-24 objective response, utilising RECIST 1.1 with central review.
The initial design of the EVANGELINE trial comprised 214 participants. However, this amendment revises the total number of participants to between 40 and 65.
The collection of subject safety data and the oversight by the Data Safety Monitoring Committee will remain unchanged following this amendment.
Data from the EVANGELINE run-in, which was previously presented at the 2024 San Antonio Breast Cancer Symposium, indicated a Ki-67 rate of 86% at week four.
