Shots:
- The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regions
- Trial showed reduced VMS frequency (1EP), with mean changes of −6.5 vs −3.0 at Wk. 4 & −7.8 vs −4.2 at Wk. 12 from baseline
- Trial also showed significant improvements across 2EPs at Wk. 12, with mean change in PROMIS SD SF 8b (−10.6 vs −4.1) & MENQOL total score (−1.3 vs −0.5) from baseline; reduced VMS frequency at Wk. 1 & severity at Wks. 4 & 12 were also observed. Data was published in The NEJM
Ref: Businesswire| Image: Bayer | Press Release
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