Roche's Oral Breast Cancer Drug Shows 30% Drop In Recurrence In Patients With Early Disease

On Wednesday, Roche Holdings AG (OTC:RHHBY) shared data from the phase 3 lidERA Breast Cancer study.

The study evaluated giredestrant as an adjuvant endocrine treatment for oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer.

The lidERA results were presented at the 2025 San Antonio Breast Cancer Symposium.

Roche, in a press release on Wednesday, said 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 3 readout for giredestrant following the evERA Breast Cancer results in the metastatic setting.

Also Read: Roche Targets Top Spot In Weight Loss Drug Market

Data

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).

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. The iDFS benefit was consistent across all clinically relevant subgroups.

Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed.

Follow-up for OS will continue to the next analysis.

Giredestrant also demonstrated a 31% risk reduction of distant recurrence-free interval– another key secondary endpoint.

Giredestrant was well tolerated, and adverse events were manageable and consistent with its known safety profile.

Reuters noted that the results suggest giredestrant could become a new standard in adjuvant endocrine therapy, though it remains unclear which patients might still require add-on CDK4/6 inhibitors such as Novartis AG's (NYSE:NVS) Kisqali.

Roche Chief Medical Officer Levi Garraway told Reuters that a 30% improvement in disease-free survival means patients are 30% less likely to experience a recurrence compared with standard care.

JPMorgan analysts previously estimated the adjuvant indication could generate about $5 billion in annual revenue if approved.

Read Next:

• Semiconductor Stocks Sell Off After Oracle's Results Spoil AI Party

Photo by OleksSH via Shutterstock