Roche Holding AG (RHHBY.OB) has announced positive results from its phase 3 trial of its investigational oral selective estrogen receptor, Giredestrant, in patients with early-stage ER+/HER2- breast cancer, dubbed lidERA.
The lidERA trial enrolled more than 4,100 patients with stage I-III ER+/HER2-breast cancer. At a pre-planned interim analysis, giredestrant met its primary endpoint, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) versus standard endocrine therapy.
Giredestrant, which is designed to block estrogen binding, trigger receptor degradation, and slow or stop cancer cell growth, is the first oral selective estrogen receptor degrader (SERD) to show superior invasive disease-free survival in early breast cancer.
A clear positive trend in overall survival was observed, though data remain immature, and the drug was well tolerated, with adverse events consistent with its known safety profile, according to the company.
Genentech's chief medical officer Levi Garraway, called the results "unprecedented," noting the potential for giredestrant to become a new standard of care in early-stage ER+/HER2-breast cancer.
The positive results of Roche's Giredestrant seem to have a domino effect on the shares of Olema Pharmaceuticals (OLMA), which are up over 220% to $27 in premarket trading. Olema is developing its own oral SERD candidate, Palazestrant, which is currently in late-stage development for ER+/HER2-metastatic breast cancer.
Roche plans to present full lidERA data at upcoming medical meetings and engage regulators globally.
RHHBY.OB has traded in a range of $34.10 to $48.45 over the past year. The stock closed yesterday's trading at $44.59, down 0.71%.
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