Roche’s oral selective oestrogen receptor degrader (SERD) has failed to meet its primary endpoint in a Phase III breast cancer trial.
In the persevERA Breast Cancer study (NCT04546009), giredestrant was investigated in combination with Pfizer’s Ibrance (palbociclib) for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
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The study did not meet its primary objective of a statistically significant improvement in progression-free survival (PFS) when compared to letrozole plus Ibrance, but Roche said that a numerical improvement was observed.
Dr Levi Garraway, Roche’s chief medical officer and head of global product development, said: “While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer. We believe there is a path forward for combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting and we are conducting further studies.”
The adverse events (AEs) for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment. The full results from persevERA will be presented at an upcoming medical meeting.
The drug has been investigated in other Phase III trials, including the evERA study (NCT05306340), which was the first positive Phase III readout for giredestrant in September 2025.
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By GlobalDataThe drug also showed success in the lidERA trial (NCT04961996), which enrolled patients in the early-stage setting.
“The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development programme,” Garraway added.
persevERA is the first of two distinct Phase III trials of giredestrant in the first-line setting. The second study, pionERA, which is investigating giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer, is expected to readout in 2027.
The US Food and Drug Administration (FDA) recently accepted the New Drug Application (NDA) for giredestrant based on the evERA data. In the coming weeks, Roche will submit the giredestrant Phase III lidERA data in early-stage breast cancer to the FDA. A filing with the European Medicines Agency (EMA) is expected in 2026.
According to GlobalData analyst consensus forecast, giredestrant could reach $1.7bn in sales in 2031. In a research note, Citi analysts said that the persevERA results did not affect its estimated peak forecast in adjuvant breast cancer given “compelling positive results of lidERA already reported 4Q25.”
Beyond Roche’s candidate, the oral SERD field is highly competitive. AstraZeneca’s camizestrant is in the pre-registration stage with the FDA and sales are expected to reach $1.8bn; Olema Pharmaceuticals’ palazestrant is currently in Phase III and is projected to gain $1.3bn in 2031.
