Roche Announces Positive Phase III evERA Trial Results for Oral SERD Giredestrant in HR+/HER2- Advanced Breast Cancer

Sep 22, 2025 14:03 CST Updated 14:03

Roche

Oncology Drug Research, Development, and Manufacturing

On September 22, Roche announcedPhase III clinical trial of evERA has achieved positive results.

Source: Roche Official Website

evERA is aPhase III, Randomized, Open-label, Multicenter Study Designed to EvaluateGiredestrant Efficacy and Safety of Everolimus in Combination with Standard Endocrine Therapy for HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Patients Previously Treated with CDK 4/6 Inhibitors and Endocrine Therapy.

The press release also pointed out that this isThe FirstComparison of All-Oral Selective Estrogen Receptor Degrader Regimens with Standard-of-Care CombinationsPositive Head-to-HeadPhase III Clinical Trial.

The co-primary endpoints of the study areInvestigator-Assessed Progression-Free Survival in the Intention-to-Treat Population and the ESR1 Mutation Population（PFS）, defined as the time from randomization to disease progression or death from any cause. Key secondary endpoints include overall survival.（OS）, objective response rate, duration of response, clinical benefit rate, and safety.

The results showed that the studyAchieved Two Co-Primary Endpoints, indicating that compared with standard endocrine therapy combined with everolimus, the intention-to-treat group and ESR1 mutation group patientsPFS was significantly prolonged, and is clinically significant. OS data is not yet mature, but observedClear positive trend. Subsequent studies will continue with OS analysis.

In addition, the combination therapy of Giredestrant was well tolerated, with adverse events consistent with the known safety profiles of the respective study treatments, and no new safety signals were observed.

Giredestrant is an emerging oral selective estrogen receptor degrader.（SERD）Class of drugs. According to the Insight database, there are currently 6 Phase III trials underway for this drug, with indications including HR-positive, HER2-negative breast cancer first-line therapy, maintenance/consolidation therapy, adjuvant treatmentetc.

Source: Insight Database

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Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If needed, please consult and contact正规医疗机构.

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