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Persevera

All articles tagged with #persevera

health4 hours ago•5 min saved

Roche bets on adjuvant promise after giredestrant’s first-line miss

Roche’s oral SERD giredestrant failed to achieve statistical significance in the persevERA first-line trial for HR+/HER2- metastatic breast cancer when combined with palbociclib, but the company remains optimistic about its adjuvant potential and is designing a new CDK4/6–giredestrant study for early-stage disease. Earlier lidERA showed an adjuvant iDFS benefit; OS data are immature. Roche is pursuing ESR1-mutant labeling in second-line work and exploring additional adjuvant combos, with an FDA decision target around late 2026.

via Fierce Biotech|

#adjuvant #breast-cancer #giredestrant

healthcare2 months ago•2 min saved

Roche's oral SERD giredestrant misses first-line breast cancer target

Roche’s phase 3 persevERA trial of the oral SERD giredestrant in first-line ER-positive, HER2-negative locally advanced or metastatic breast cancer did not meet its primary endpoint, showing no statistically significant progression-free survival benefit versus letrozole plus Ibrance (though a numerical improvement was noted). Adverse events were manageable, and Roche plans to pursue FDA filing based on second-line and adjuvant data while continuing the pionERA trial in endocrine-resistant disease. The setback adds cautiousness to the outlook for oral SERDs in first-line settings and prompts analysts to temper earlier multi-billion-dollar sales expectations.

via Fierce Biotech|

#breastcancer #giredestrant #healthcare