Roche Claims Its SERD Is Most Potent After Positive Breast Cancer Data Presented at ESMO 2025

Roche presented phase 3 clinical data at ESMO 2025 showing its oral SERD, giredestrant, significantly delayed tumor progression in people with ER-positive, HER2-negative breast cancer who had progressed on standard therapies2 3 8 11.

The evERA trial combined giredestrant with everolimus, and this combination lowered the risk of disease progression or death by approximately two thirds (nearly 66%) compared to standard treatment in an all-comers population2 8 11.

Giredestrant met its primary endpoints, with the data indicating it achieved a notable improvement in progression-free survival over current standard options like hormone therapy alone11 14.

These results distinguish Roche’s SERD from its existing competitors, including Eli Lilly’s Inluriyo and Menarini’s Orserdu, which have shown risk reductions of 38% and 45%, respectively2.

Roche now asserts giredestrant is the most potent SERD in the class, specifically referencing its broad effectiveness across all ER-positive, HER2-negative patients rather than just those with ESR1 mutations1 13.

Roche intends to pursue regulatory approval for giredestrant based on these findings, further staking its claim for leadership in the oral SERD space8 12.

The oral SERD field has seen recent setbacks and successes, but these positive phase 3 data restore competitive momentum for Roche after a previous trial failure in 20228 9.