Roche’s giredestrant reduced risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer

Rhea-AI Summary

Roche (OTCQX: RHHBY) announced positive phase III lidERA results showing investigational oral SERD giredestrant reduced the risk of invasive disease recurrence or death by 30% versus standard-of-care endocrine therapy (HR=0.70, 95% CI 0.57-0.87, p=0.0014) in ER-positive, HER2-negative early-stage breast cancer (pre-specified interim analysis).

At three years, 92.4% of patients on giredestrant were alive and free of invasive disease versus 89.6% with SoC ET. Giredestrant also cut distant recurrence risk by 31% (HR=0.69). Overall survival data are immature; safety was described as manageable. Results will be presented at the 2025 San Antonio Breast Cancer Symposium.

Positive

• iDFS risk reduced by 30% (HR=0.70, p=0.0014)
• Three-year iDFS 92.4% with giredestrant vs 89.6% SoC
• Distant recurrence risk reduced by 31% (HR=0.69)
• First oral SERD to show superior iDFS in adjuvant setting

Negative

• Overall survival data are immature at interim analysis
• Regulatory approvals not yet secured

News Market Reaction – RHHBY

+3.55%

1 alert

+3.55% News Effect

On the day this news was published, RHHBY gained 3.55%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

iDFS risk reduction: 30% reduction Hazard ratio (iDFS): HR=0.70 (95% CI 0.57–0.87) p-value (iDFS): p=0.0014 +5 more

8 metrics

iDFS risk reduction 30% reduction Phase III lidERA; giredestrant vs standard endocrine therapy

Hazard ratio (iDFS) HR=0.70 (95% CI 0.57–0.87) Phase III lidERA invasive disease-free survival

p-value (iDFS) p=0.0014 Statistical significance for primary iDFS endpoint

3-year iDFS giredestrant 92.4% Patients alive and free of invasive disease at three years

3-year iDFS SoC ET 89.6% Standard-of-care endocrine therapy arm at three years

DRFI risk reduction 31% reduction Distant recurrence-free interval secondary endpoint

Hazard ratio (DRFI) HR=0.69 (95% CI 0.54–0.89) Distant recurrence-free interval in lidERA

ER+ breast cancer share 70% of cases Proportion of breast cancers that are ER-positive

Market Reality Check

Price: $59.55 Vol: Volume 5,370,502 is 2.05x...

high vol

$59.55 Last Close

Volume Volume 5,370,502 is 2.05x the 20-day average of 2,619,116, indicating elevated interest ahead of this update. high

Technical Shares at 50.43 are trading above the 200-day MA of 41.66 and sit just below the 52-week high of 50.67.

Peers on Argus

RHHBY gained 3.55% on high volume, while key pharma peers showed mixed, modest m...

RHHBY gained 3.55% on high volume, while key pharma peers showed mixed, modest moves (e.g., ALPMY +0.13%, DSNKY -1.9%), suggesting a stock-specific reaction to Roche’s news.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Diagnostic approval	Positive	-0.4%	CE Mark for cobas BV/CV PCR assay expanding sexual health diagnostics.
Dec 09	Regulatory approval	Positive	-0.4%	EC approval of Gazyva/Gazyvaro for adults with active lupus nephritis.
Dec 08	Clinical data update	Positive	-0.4%	Lunsumio data suggesting efficacy earlier in lymphoma treatment lines.
Dec 08	Clinical data update	Positive	-0.4%	Genentech Lunsumio results with high complete response and durable outcomes.
Dec 08	Clinical trial follow-up	Neutral	+0.8%	Columvi combo three-year OS/PFS benefit in DLBCL alongside a US CRL.

Pattern Detected

Recent positive clinical and regulatory headlines often saw flat-to-negative one-day moves, so today’s positive reaction to strong trial data marks a shift toward alignment between news and price.

Recent Company History

Over the past few days, Roche reported several oncology and diagnostic advances. On Dec 8, Columvi phase III data in DLBCL showed longer OS and PFS but also an FDA Complete Response Letter. On Dec 8–9, multiple Lunsumio datasets and a new CE-marked vaginitis PCR test were highlighted, alongside an EC approval for Gazyva in lupus nephritis. Despite largely positive content, shares moved little or slightly negative, making today’s strong breast cancer trial readout more aligned with the underlying momentum in Roche’s pipeline.

Market Pulse Summary

This announcement highlights phase III lidERA results where giredestrant reduced invasive disease re...

Analysis

This announcement highlights phase III lidERA results where giredestrant reduced invasive disease recurrence or death by 30% and delivered a three-year iDFS of 92.4% versus 89.6% for standard endocrine therapy. The data add to Roche’s recent stream of oncology updates, underscoring a broad pipeline. Investors may monitor longer-term overall survival follow-up, additional safety data, and regulatory interactions to assess how this therapy could fit across early-stage and advanced ER-positive breast cancer settings.

Key Terms

invasive disease-free survival, hazard ratio, confidence interval, overall survival, +4 more

8 terms

invasive disease-free survival medical

"superior invasive disease-free survival in the adjuvant setting"

Invasive disease-free survival is a clinical trial measure that tracks how long patients live without the original cancer returning in an invasive form or spreading after treatment. Think of it like timing how long a repaired roof stays leak-free — longer periods suggest the repair worked. For investors, longer invasive disease-free survival signals a treatment’s effectiveness, boosting chances of regulatory approval, broader use, and potential commercial value.

hazard ratio medical

"(hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

confidence interval medical

"HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

overall survival medical

"Overall survival (OS) data were immature at the time of this analysis"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

distant recurrence-free interval medical

"31% risk reduction of distant recurrence-free interval (HR=0.69"

Distant recurrence-free interval is the length of time after initial cancer treatment during which the disease does not come back in a different part of the body (metastasis). For investors, it’s a key measure of a therapy’s ability to delay or prevent serious relapse—longer intervals suggest stronger clinical benefit, which can improve a drug’s regulatory prospects, adoption by doctors, and commercial value. Think of it like the warranty period before a major problem reappears.

selective oestrogen receptor degrader medical

"first and only oral selective oestrogen receptor degrader (SERD) to show"

A selective oestrogen receptor degrader (SERD) is a type of drug that binds to oestrogen receptors in cells and triggers their removal, effectively turning off a pathway some cancers and other diseases use to grow. For investors, SERDs matter because their success in clinical trials, regulatory approval, and adoption can drive large prescription markets and affect the value of companies developing them—think of taking away and destroying a machine’s key so it can no longer be restarted.

phase III medical

"positive data from the phase III lidERA Breast Cancer study"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

p-value medical

"HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014"

A p-value is a number that helps determine how likely it is that a result or pattern happened by chance rather than because of a real effect. For investors, a low p-value suggests that the findings in a study or analysis are probably meaningful and not just random noise—like noticing a pattern in coin flips that’s unlikely to occur by chance. This helps in assessing the reliability of information used to make financial decisions.

AI-generated analysis. Not financial advice.

12/10/2025 - 08:15 AM

• Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years^1-3
• Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease¹
• ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or after adjuvant endocrine therapy treatment^4-7
• Data will be featured in an oral presentation at the 2025 San Antonio Breast Cancer Symposium and included in the official press programme

Basel, 10 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive data from the phase III lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer.¹ At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (invasive disease-free survival [iDFS]) compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014).¹ The lidERA results are being presented at the 2025 San Antonio Breast Cancer Symposium and are included in the official press programme.

“In early ER-positive breast cancer, challenges with disease recurrence and treatment adherence mean there is an urgent need for more effective, tolerable endocrine therapies,” said Aditya Bardia, M.D., M.P.H, Director, Breast Oncology Program, Professor of Medicine at the David Geffen School of Medicine at University of California, Los Angeles (UCLA), Director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center, and lidERA principal investigator. “After almost 25 years, a new medicine –  giredestrant – has demonstrated superiority over existing endocrine therapies in the curative setting, highlighting its potential as a new standard-of-care endocrine therapy for patients with breast cancer.”

“The substantial efficacy observed with giredestrant in the lidERA trial underscores its potential to become a new standard-of-care endocrine therapy in ER-positive early-stage breast cancer, where the chance for cure is highest,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to sharing these results with health authorities around the world with the aim of bringing this new treatment option to patients as soon as possible.”

At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm.¹ The iDFS benefit was consistent across all clinically relevant subgroups.¹ Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed.¹ Follow-up for OS will continue to the next analysis. Giredestrant also demonstrated a 31% risk reduction of distant recurrence-free interval (HR=0.69, 95% CI 0.54-0.89) – another key secondary endpoint.¹ Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile.¹

ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage.^4,5 Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer.^5-7 Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death.^8,9 These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

Giredestrant is the first and only oral selective oestrogen receptor degrader (SERD) to show superior iDFS in the adjuvant setting and lidERA is the second positive phase III readout for giredestrant following the evERA Breast Cancer results in the metastatic setting.^1,10 The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels).¹¹ This growing body of evidence supports the potential of giredestrant to meaningfully improve outcomes compared with standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.^1,10,11

Roche’s extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the lidERA Breast Cancer study
lidERA Breast Cancer [NCT04961996] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.¹²  Over 4,100 patients were enrolled in the study.¹²

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers).¹² Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.¹²

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.¹³

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.¹⁴

Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

• Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)¹²
• Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)¹⁵
• 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)¹⁶
• Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) 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)¹⁷
• Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)¹⁸ 

About oestrogen receptor (ER)-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.¹⁹ Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.²⁰

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.⁴  A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.²¹

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.²² Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.^5-9,22,23 There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.^5,8,22,23

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.

By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Bardia A, et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial. Presented at: San Antonio Breast Cancer Symposium (SABCS); 2025 December 9-12; San Antonio, Texas, United States. #GS1-10.
[2] Baum M, et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359(9324):2131-9.
[3] Thürlimann B, et al. A Comparison of Letrozole and Tamoxifen in Postmenopausal Women with Early Breast Cancer. N Engl J Med; 2005;353:2747-57.
[4] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI
Cancer Spectrum; 2022;6(5):pkac060.
[5] Shaughnessy J, et al. Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy
in patients with stage II-III HR+/HER2- early breast cancer. Breast. 2025;81:104437.
[6] Pan H, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. NEJM.
2017;377:1836–46.
[7] Khatpe AS, et al. Nexus between PI3K/AKT and Estrogen Receptor Signaling in Breast Cancer. Cancers (Basel).
2021;13(3):369.
[8] Hershman DL, et al. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with
increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011;126:529–37.
[9] Rosso R, et al. Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients. Curr Oncol. 2023;30(2):1461-72.
[10] Mayer E, et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial. Presented at: European Society for Medical Oncology (ESMO) Annual Meeting; 2025 October 17-21; Berlin, Germany. LBA #16.
[11] Hurvitz SA, et al. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24:1029–1041.
[12] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With
Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-
Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2025 December]. Available from: https://clinicaltrials.gov/study/NCT04961996.
[13] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts)
with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2,
randomised, open-label acelERA BC study. Presented at: ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.
[14] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable
mechanistic and pre-clinical DMPK attributes. Presented at: SABCS; 2018 December 4-8; San Antonio, Texas, United States. Abstract #P5-04-07.
[15] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With
the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive,
HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2025
December]. Available from: https://clinicaltrials.gov/study/NCT05306340.
[16] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib
Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-
Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2025
December]. Available from: https://clinicaltrials.gov/study/NCT04546009.
[17] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a
CDK4/ 6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant
Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2025 December]. Available from: https://clinicaltrials.gov/study/NCT06065748.
[18] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo
(Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or
Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2025 December]. Available from: https://clinicaltrials.gov/study/NCT05296798.
[19] World Health Organization. Breast Cancer [Internet; cited 2025 December]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.
[20] World Health Organization. Cancer Today [Internet; cited 2025 December]. Available from: https://gco.iarc.fr/today/en/dataviz/bars?mode=cancer&types=1&group_populations=1&sexes=2&key=asr&age_end=14.
[21] Cleveland Clinic. Estrogen Receptor-Positive Breast Cancer (ER+) [Internet; cited 2025 December]. Available
from: https://my.clevelandclinic.org/health/diseases/er-positive-breast-cancer.
[22] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020;37(4):496–513.
[23] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic
breast cancer. Cancer Treat Rev. 2018;63:144-55. 

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

• Media Investor Release lidERA giredestrant English

FAQ

What did Roche announce about giredestrant in early-stage breast cancer on December 10, 2025 (RHHBY)?

Roche reported lidERA interim results showing giredestrant reduced invasive disease recurrence or death by 30% versus standard endocrine therapy (HR=0.70, p=0.0014).

How did giredestrant perform at three years in the lidERA trial (RHHBY)?

At three years, 92.4% of patients on giredestrant were alive and free of invasive disease versus 89.6% on standard-of-care endocrine therapy.

Did giredestrant affect distant recurrence in the lidERA study (RHHBY)?

Yes; giredestrant showed a 31% reduction in distant recurrence-free interval (HR=0.69, 95% CI 0.54-0.89).

Are overall survival results available from the lidERA interim analysis (RHHBY)?

No; overall survival data were described as immature at the time of the interim analysis and follow-up will continue.

When and where will Roche present the lidERA results for giredestrant (RHHBY)?

The lidERA results will be presented orally at the 2025 San Antonio Breast Cancer Symposium and are in the official press programme.

What did Roche report about giredestrant safety in lidERA (RHHBY)?

Roche reported giredestrant was well tolerated and adverse events were manageable and consistent with its known safety profile.