Roche’s Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial

Roche announced that its oral selective estrogen receptor degrader (SERD), giredestrant, achieved the primary endpoint of significantly improving progression-free survival (PFS) in a pivotal Phase III breast cancer study compared to standard endocrine therapy59.

The positive results come from the Phase III evERA study, where giredestrant in combination with everolimus was tested in patients with estrogen receptor (ER)-positive, advanced breast cancer who had previously received endocrine therapy95.

The therapy showed a statistically significant improvement in PFS, meeting the co-primary endpoints, and represents a potential new oral endocrine treatment option for patients75.

This marks a turnaround for giredestrant after previous setbacks in earlier phase trials, and supports Genentech's (a Roche company) plans to file for regulatory approval based on these results71.

Oral SERDs are seen as an important development in breast cancer, particularly for patients with ESR1 mutations, offering convenience and the potential to overcome resistance seen with other endocrine therapies68.

Sources:

1. https://pharmaphorum.com/news/roches-oral-serd-comes-good-2nd-line-breast-cancer-trial

5. https://firstwordpharma.com/story/6094461

6. https://www.oncologynewscentral.com/breast-cancer/a-challenge-for-community-practices-big-news-in-breast-cancer-comes-with-questions

7. https://www.clinicaltrialsarena.com/news/genentech-to-file-for-oral-serd-approval-on-phase-iii-breast-cancer-win/

8. https://www.onclive.com/view/oral-serds-and-pi3k-inhibitors-move-the-needle-beyond-cdk4-6-inhibitors-in-metastatic-breast-cancer

9. https://trial.medpath.com/news/d0ec45005293c393/roche-s-giredestrant-combination-meets-phase-iii-endpoints-in-advanced-breast-cancer