Roche to present new giredestrant data at ASCO 2026
New giredestrant data from the lidERA study on its potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages
22 May 2026Industry news
At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 29 May to 2 June in Chicago, USA, Roche will showcase progress with bispecific antibodies, antibody-drug conjugates, brain-permeable molecules and targeted therapies designed to address cancers that impose the highest burden on patients and healthcare systems. In particular, Roche will present new clinical data on nine approved and investigational cancer medicines.
The data span more than 15 indications and focus on how Roche’s pipeline, including giredestrant, could address urgent unmet needs in breast, blood, lung, gastrointestinal and bladder cancers.
Advancing giredestrant in ER-positive, HER2-negative breast cancer
Roche’s ASCO 2026 programme is led by giredestrant, an investigational, oral, selective oestrogen receptor degrader (SERD) being studied in early and advanced oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This subtype represents around 70% of all breast cancer cases, with most diagnosed at an early stage.
Data from three phase III trials, lidERA Breast Cancer, persevERA Breast Cancer and evERA Breast Cancer, will explore giredestrant’s potential as a future standard of care endocrine therapy across multiple disease stages and treatment settings.
lidERA Breast Cancer: Consistency of benefit across menopausal stages
Building on the transformational lidERA Breast Cancer results shared in December 2025, which showed a 30% reduction in the risk of invasive disease recurrence or death, new ASCO 2026 data will assess whether the efficacy and safety of giredestrant are consistent in both pre- and post-menopausal patients with ER-positive, HER2-negative early breast cancer.
The lidERA data have been submitted to the U.S. Food and Drug Administration (FDA) to support the potential use of giredestrant as adjuvant therapy in early breast cancer across all menopausal stages.
Key ASCO 2026 presentation:
- Efficacy and safety of giredestrant (GIRE) in patients with estrogen receptor-positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the phase III lidERA BC clinical trial: Results by menopausal status.
persevERA Breast Cancer: First-line giredestrant plus palbociclib in advanced disease
Roche will present the primary results from the phase III persevERA Breast Cancer study, which evaluates giredestrant in combination with palbociclib as a first-line therapy in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
Although the study did not meet its primary endpoint, the giredestrant plus palbociclib combination showed a numerical improvement in progression-free survival in this endocrine-sensitive, first-line setting. These findings suggest that giredestrant is active in advanced ER-positive, HER2-negative disease and provide important context for future treatment strategies.
Key ASCO 2026 presentation:
- Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the phase III persevERA Breast Cancer (BC) trial.
evERA Breast Cancer: Post-progression outcomes and regulatory progress
New analyses from the phase III evERA Breast Cancer trial will examine post-progression treatment patterns and sustained clinical benefit for patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
The study evaluates giredestrant plus everolimus in the post-CDK4/6 inhibitor setting. Positive evERA data supported the recent acceptance of the New Drug Application for giredestrant by the U.S. FDA, underscoring its potential role in endocrine-resistant advanced breast cancer.
Key ASCO 2026 presentation:
- Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i).
Evolving treatment for HER2-positive metastatic breast cancer
Roche will also present new data in HER2-positive metastatic breast cancer:
- Safety and efficacy of ZN-A-1041, a highly blood–brain barrier (BBB)-permeable HER2 tyrosine kinase inhibitor (TKI), + trastuzumab deruxtecan (T-DXd) or pertuzumab-trastuzumab (PH) in HER2-positive metastatic breast cancer (HER2+ mBC): Phase Ic expansion results from the ZN-A-1041-101-US trial.
Expanding precision oncology in lung cancer with divarasib
Roche will share new data on divarasib, a next-generation oral KRAS G12C inhibitor, in non-small cell lung cancer (NSCLC). Divarasib is currently being assessed in three pivotal phase III studies as a monotherapy or in combinations that do not include chemotherapy.
Novel combinations in diffuse large B-cell lymphoma
Roche will present updated data on Lunsumio® (mosunetuzumab) and Polivy® (polatuzumab vedotin) in diffuse large B-cell lymphoma (DLBCL), focusing on chemotherapy-free regimens and outcomes in relapsed or refractory disease.
Additional breast cancer data at ASCO 2026
Beyond giredestrant and ZN-A-1041, Roche will discuss new data on Itovebi® (inavolisib) and Kadcyla® (trastuzumab emtansine) in breast cancer.
Tecentriq-based regimens in lung, gastrointestinal and bladder cancers
Roche will present multiple analyses of Tecentriq® (atezolizumab)-based regimens across lung, gastrointestinal and bladder cancers, focusing on clinical outcomes, quality of life and biomarker-driven insights.