Genentech's Giredestrant Posts Positive Phase 3 Data Ahead Of November, December FDA Dates
(RTTNews) - Genentech, a member of the Roche Group (RHHBY), announced that detailed Phase 3 evERA study results published in the New England Journal of Medicine showed that giredestrant combined with everolimus significantly improved progression-free survival in patients with ER-positive advanced breast cancer.
Estrogen receptor (ER)-positive breast cancer is the most common form of breast cancer. While many patients initially benefit from endocrine therapy and cyclin-dependent kinase (CDK)4/6 inhibitors, tumors can eventually become resistant to treatment, creating a need for new therapeutic options.
The Phase 3 evERA trial evaluated investigational oral selective estrogen receptor degrader (SERD) giredestrant in combination with everolimus in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed or recurred following treatment with a CDK4/6 inhibitor and endocrine therapy.
According to the company giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intent-to-treat (ITT) population, and by 62% in patients with ESR1-mutated tumors compared with standard endocrine therapy plus everolimus.
In the overall study population, median progression free survival was 8.8 months with the giredestrant combination compared with 5.5 months for the comparator regimen. Among patients with ESR1-mutated disease, median progression-free survival was 10.0 months versus 5.5 months, respectively.
The company also reported a positive trend in overall survival, although the data were still immature at the time of analysis. Follow-up is ongoing.
Giredestrant is an investigational oral SERD, designed to block and degrade the estrogen receptor, a key driver of many breast cancers. The therapy is being studied across multiple breast cancer settings.
The safety profile of the combination was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.
Upcoming Milestones
The U.S FDA has set a PDUFA goal date of November 30, 2026, for giredestrant in early-stage breast cancer and December 18, 2026, for advanced breast cancer.
The evERA results represent the first positive head-to-head Phase 3 study of an all-oral SERD-containing regimen versus a standard-of-care combination in this treatment setting.
RHHBY has traded between $40.07 and $60.85 over the past year. The stock closed Wednesday's trading at $51.88, down 0.71%.
