Roche’s Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial
Roche's oral selective estrogen receptor degrader (SERD) giredestrant succeeded in a large Phase 3 trial (lidERA) for early-stage ER-positive, HER2-negative breast cancer, delaying recurrences longer than standard hormone therapies when administered after surgery135.
In the trial, giredestrant significantly improved invasive disease-free survival (iDFS), becoming the first oral SERD to show this benefit as adjuvant therapy in early breast cancer15.
A positive trend was also seen in overall survival, although it remains too early to confirm a statistically significant improvement in this endpoint1.
The lidERA trial enrolled over 4,100 patients with medium- or high-risk stage I-III disease9.
Compared with standard treatments, giredestrant reduced the risk of disease progression or recurrence, supporting its potential as a new standard after surgery in the ER-positive, HER2-negative population1356.
Roche plans to share full results with regulators, including the FDA, and more detailed data will be presented at upcoming medical meetings17.
This result distinguishes giredestrant from other oral SERDs, some of which have approval in later-stage or ESR1-mutated populations but did not show as robust a benefit in broader, earlier-stage settings4.
Sources:
1. https://www.biopharmadive.com/news/roche-giredestrant-serd-adjuvant-breast-cancer-study-results/805768/
3. https://www.oncologypipeline.com/apexonco/roche-touts-early-giredestrant-success
4. https://www.biopharmadive.com/news/roche-giredestrant-evera-breast-cancer-esmo-2025-study-results/803151/
5. https://www.onclive.com/view/giredestrant-becomes-first-oral-serd-to-show-idfs-benefit-as-adjuvant-therapy-in-early-er-her2-negative-breast-cancer
6. https://www.morningstar.com/news/dow-jones/2025101817/roche-says-breast-cancer-drug-beats-standard-treatment-in-late-stage-trial
7. https://www.gene.com/media/press-releases/15090/2025-11-17/genentechs-giredestrant-becomes-the-firs