Roche (OTCQX:RHHBY) unit Genentech announced on Tuesday that giredestrant, a selective estrogen receptor degrader (SERD), reached the main goal in a Phase 3 trial for breast cancer, boosting the shares of Olema Pharmaceuticals (OLMA), which is advancing a similar treatment.
Shares of the Swiss drugmaker rose ~6% in Zürich, while Olema (OLMA) added ~123% in the premarket after the announcement. The San Francisco, California-based biotech is advancing its lead asset palazestrant, a complete estrogen receptor antagonist (CERAN) and a SERD, in multiple clinical studies for breast cancer in partnership with Novartis (NVS) (OTCPK:NVSEF) and Pfizer (PFE).
Citing an interim analysis, Roche (OTCQX:RHHBY) said that its lidERA Breast Cancer study for giredestrant met the primary endpoint, indicating a statistically significant and clinically meaningful improvement in invasive disease-free survival.
The trial involving more than 4,000 patients was designed to evaluate giredestrant versus standard-of-care endocrine therapy in an adjuvant setting for estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer.
Roche (RHHB) noted there was a favorable trend for overall survival, a key secondary endpoint of lidERA, even though data were not mature enough at the time of the analysis. As for tolerability, the company said that giredestrant was well tolerated, with a safety profile consistent with prior data.
Roche (OTCQX:RHHBY) expects to present the results at a future medical event and share with global regulatory authorities seeking giredestrant’s commercialization.
The company said that lidERA is the first late-stage trial of a SERD to indicate a significant benefit in an adjuvant setting and highlighted giredestrant’s potential to become a new standard-of-care endocrine therapy in early-stage breast cancer.