- Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus
- By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes
- The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of November 30, 2026 and in advanced disease of December 18, 2026
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--$RHHBY--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that detailed results from the evERA Breast Cancer study, showing investigational giredestrant in combination with everolimus significantly improved progression-free survival (PFS) versus standard endocrine therapy plus everolimus, were published in The New England Journal of Medicine. The evERA trial is evaluating giredestrant, an investigational oral selective estrogen receptor degrader (SERD), in combination with everolimus in people with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer who had disease progression or recurrence following treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy.
“Despite advancements with CDK4/6 inhibitor treatment in the first-line setting, many people with advanced breast cancer will eventually experience disease progression as their tumors become resistant to endocrine therapy,” said Dr. Erica L. Mayer, medical oncologist at Dana-Farber Cancer Institute. “The evERA trial demonstrated that the giredestrant combination significantly delayed disease progression, potentially offering a promising all-oral treatment option in a setting where there remains a need for additional treatments to improve patient outcomes.”
In the ESR1-mutated population, the median PFS was 10.0 months with giredestrant plus everolimus compared with 5.5 months in the comparator arm (stratified hazard ratio [HR]=0.38, 95% CI: 0.27-0.54, p<0.001). In the intent-to-treat (ITT) population, the median PFS was 8.8 months compared with 5.5 months in the giredestrant and comparator arms, respectively (HR=0.56, 95% CI: 0.44-0.71, p<0.001). Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02). Follow-up for OS will continue to the next analysis. Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines. No unexpected safety findings were observed, including no photopsia and low rates of bradycardia.
“The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Together with the positive Phase III lidERA results in early breast cancer, these findings reinforce the potential of giredestrant to redefine care in both metastatic and early disease settings.”
Additional evERA analyses were presented at the 2026 American Society of Clinical Oncology Annual Meeting, showing that giredestrant plus everolimus prolongs PFS2 (time from randomization to disease progression following second-line therapy) and chemotherapy-free survival compared with standard endocrine therapy, suggesting that the clinical benefit may be sustained beyond initial progression.
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer accounts for approximately 70% of breast cancer cases. Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes.
evERA was the first positive Phase III readout for giredestrant, followed by the lidERA Breast Cancer study in the early-stage setting. Based on these evERA data, the U.S. Food and Drug Administration (FDA) accepted Genentech’s New Drug Application (NDA) for giredestrant in combination with everolimus for the treatment of people with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease has recurred during or after completing endocrine-based adjuvant therapy, or who have progressed on at least one endocrine-based regimen in the metastatic setting. The FDA is expected to decide on the application by December 18, 2026. The FDA also accepted an NDA under Priority Review for giredestrant as an adjuvant treatment for adults with ER-positive, HER2-negative, stage I, II and III breast cancer based on the lidERA results. The FDA has set a Prescription Drug User Fee Act goal date of November 30, 2026.
Genentech’s expanding giredestrant clinical development program spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with HR-positive breast cancer as possible.
About the evERA Breast Cancer study
evERA Breast Cancer [NCT05306340] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard endocrine therapy in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.
The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomization to the time when the disease progresses or a patient dies from any cause. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations. Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.
About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.
Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.
Giredestrant has an extensive clinical development program including five company-sponsored Phase III clinical trials to address the needs of patients across multiple treatment settings and lines of therapy:
- Giredestrant versus standard endocrine therapy as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
- Giredestrant plus everolimus versus standard endocrine therapy plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
- Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
- Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
- Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)
About hormone receptor (HR)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.
HR-positive, human epidermal growth factor receptor 2-negative breast cancer accounts for approximately 70% of breast cancer cases and the majority are diagnosed in the early-stage. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to hormones like estrogen, which can contribute to tumor growth.
Despite treatment advances, HR-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.
About Genentech in Breast Cancer
Genentech has revolutionized the breast cancer landscape for more than 30 years. From pioneering backbone therapies for HER2+ care to developing new approaches to target resistance in HR+ disease, our goal is to deliver transformational therapies from early- to late-stage disease to help as many people living with breast cancer as possible. By collaborating across the oncology ecosystem, delivering groundbreaking science and applying advanced technologies, we are committed to achieving the best outcomes and building a future where people with cancer can thrive, in spite of their diagnosis.
About Genentech
Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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