Roche, fresh from an all-comers win with its oral SERD giredestrant in second-line ER-positive, HER2-negative breast cancer, is now claiming success in the adjuvant setting. The company has toplined a victory in the Lidera study, testing giredestrant versus endocrine therapy, on its primary endpoint of invasive disease-free survival. A positive OS trend was also seen, although data were immature. Roche didn’t give more details, with results being reserved for an upcoming medical meeting. The Swiss group is the first oral SERD developer to prevail in adjuvant breast cancer, but others have ambitions here. AstraZeneca’s camizestrant could be next to yield pivotal data, with the Cambria-1 and 2 trials set to read out after 2026, although Lilly might not be far behind with the Ember-4 study of Inluriyo, due to complete in 2027. There are some differences between trials, with Lidera notably not allowing prior endocrine therapy. Lidera also included a substudy testing giredestrant plus Lilly’s CDK4/6 inhibitor Verzenio, but Roche made no mention of this in its press release. The next big giredestrant readout will be from the first-line Persevera trial, delayed from 2025 to 2026, while a second-line FDA filing is slated for next year. Phase 3 studies of oral SERDs in adjuvant breast cancerProject/productCompanyTrialRegimenNoteGiredestrantRocheLideraMonotx, vs endocrine therapy (also includes substudy testing giredestrant + Verzenio)Toplined positive Nov 2025; no prior endocrine therapyCamizestrantAstraZenecaCambria-1Monotx, vs endocrine therapy2-5yrs prior adjuvant endocrine therapy; data due >2026CamizestrantAstraZenecaCambria-2+ Verzenio, vs endocrine therapy + VerzenioUp to 12wks prior endocrine therapy; data due >2026InluriyoLillyEmber-4Monotx, vs endocrine therapy2-5yrs prior adjuvant endocrine therapy; completes Oct 2027OrserduMenariniElegantMonotx, vs endocrine therapy2-5yrs prior adjuvant endocrine therapy; completes Aug 2029Source: OncologyPipeline.
Roche, fresh from an all-comers win with its oral SERD giredestrant in second-line ER-positive, HER2-negative breast cancer, is now claiming success in the adjuvant setting. The company has toplined a victory in the Lidera study, testing giredestrant versus endocrine therapy, on its primary endpoint of invasive disease-free survival. A positive OS trend was also seen, although data were immature. Roche didn’t give more details, with results being reserved for an upcoming medical meeting. The Swiss group is the first oral SERD developer to prevail in adjuvant breast cancer, but others have ambitions here. AstraZeneca’s camizestrant could be next to yield pivotal data, with the Cambria-1 and 2 trials set to read out after 2026, although Lilly might not be far behind with the Ember-4 study of Inluriyo, due to complete in 2027. There are some differences between trials, with Lidera notably not allowing prior endocrine therapy. Lidera also included a substudy testing giredestrant plus Lilly’s CDK4/6 inhibitor Verzenio, but Roche made no mention of this in its press release. The next big giredestrant readout will be from the first-line Persevera trial, delayed from 2025 to 2026, while a second-line FDA filing is slated for next year.
Phase 3 studies of oral SERDs in adjuvant breast cancer
| Project/product | Company | Trial | Regimen | Note |
|---|
| Giredestrant | Roche | Lidera | Monotx, vs endocrine therapy (also includes substudy testing giredestrant + Verzenio) | Toplined positive Nov 2025; no prior endocrine therapy |
| Camizestrant | AstraZeneca | Cambria-1 | Monotx, vs endocrine therapy | 2-5yrs prior adjuvant endocrine therapy; data due >2026 |
| Camizestrant | AstraZeneca | Cambria-2 | + Verzenio, vs endocrine therapy + Verzenio | Up to 12wks prior endocrine therapy; data due >2026 |
| Inluriyo | Lilly | Ember-4 | Monotx, vs endocrine therapy | 2-5yrs prior adjuvant endocrine therapy; completes Oct 2027 |
| Orserdu | Menarini | Elegant | Monotx, vs endocrine therapy | 2-5yrs prior adjuvant endocrine therapy; completes Aug 2029 |
