Atossa Therapeutics (ATOS) announced that three posters involving pharmacokinetic and tolerability data from the Phase 2 EVANGELINE trial will be presented at the 2024 San Antonio Breast Cancer Symposium, SABCS 2024. The first poster, “Neoadjuvant Z-Endoxifen for Premenopausal Estrogen Receptor (ER)+, Human Epidermal Receptor- Breast Cancer: Evaluation of the Pharmacokinetic Run-in for the EVANGELINE Study,” discusses findings from the pharmacokinetic run-in phase of the trial. Primary Endpoint Achieved: 50 percent of patients in the group that received 80 mg of (Z)-endoxifen with goserelin met the target steady-state plasma concentrations of 500-1000 ng/mL. The second poster, “Evaluation of Quality of Life Measures in the EVANGELINE Study,” focuses on patient-reported outcomes from (Z)-endoxifen treatment in patients enrolled onto the PK run-in. The QOL data presented supports (Z)-endoxifen as generally well-tolerated. The third poster, “A Randomized Phase 2 Non-inferiority Trial of (Z)-endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women with ER+/HER2- Breast Cancer.” Based on adverse events reported in 80 mg/day groups, as well as the findings reported on (Z)-endoxifen tissue and plasma Css, overall tolerability, and antitumor activity, EVANGELINE is expected to proceed based on an amended protocol as a randomized trial that compares (Z)-endoxifen 40 mg/day plus OFS to exemestane plus OFS, using the 4-week Ki-67 reduction as the primary endpoint.
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