Key Takeaways:
The US Food and Drug Administration accepted Roche's New Drug Application under Priority Review for giredestrant, an oral selective estrogen receptor degrader that reduced the risk of invasive disease recurrence or death by 30% in early-stage breast cancer, with a decision expected by Nov. 30.
"Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest," Levi Garraway, chief medical officer and head of global product development at Roche, said.
The filing is based on the Phase III lidERA Breast Cancer study, which enrolled more than 4,100 patients with medium- or high-risk stage I-III estrogen receptor-positive, HER2-negative breast cancer. Adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy, with a hazard ratio of 0.70 (95% confidence interval 0.57-0.87, p=0.0014). At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the standard-of-care arm. The benefit was consistent across all clinically relevant subgroups. Overall survival data were immature but showed a positive trend, with follow-up continuing.
Giredestrant was well tolerated, with a treatment discontinuation rate of 5.3% versus 8.2% for standard-of-care endocrine therapy. Adverse events were manageable and consistent with the drug's known safety profile.
The drug is a next-generation selective estrogen receptor degrader designed to block estrogen from binding to the estrogen receptor, triggering its breakdown and slowing cancer cell growth. ER-positive breast cancer accounts for about 70% of all breast cancer cases, and more than 90% are diagnosed at an early stage. Globally, 2.3 million people are diagnosed with breast cancer each year. Up to a third of patients eventually experience recurrence on or after adjuvant endocrine therapy, and many discontinue treatment early due to tolerability issues.
Roche has five company-sponsored Phase III trials spanning multiple treatment settings. The FDA also recently accepted an NDA for giredestrant in combination with everolimus for ESR1-mutated, ER-positive advanced breast cancer based on the evERA study, with a decision expected in December.
The approval would make giredestrant the first oral SERD with positive Phase III data in the curative setting and the first significant advance in adjuvant endocrine therapy for ER-positive early breast cancer in more than 20 years. Investors will watch the Nov. 30 PDUFA date and the December decision on the advanced breast cancer indication for the drug's full commercial potential.
This article is for informational purposes only and does not constitute investment advice.
