Roche Holdings AG (OTC:RHHBY) on Monday shared results from the phase 3 persevERA Breast Cancer study of giredestrant combined with palbociclib in advanced cancer patients.
Trial Misses Primary Goal
The trial included patients with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer.
The study did not meet its primary objective of a statistically significant improvement in progression-free survival versus letrozole plus palbociclib.
The study showed a numerical improvement.
The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each treatment.
Roche Sees Path Forward
"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 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," said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
Earlier Trials Show Promise
evERA was the first positive phase 3 readout for giredestrant, followed by lidERA in the early-stage setting.
The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting.
Another Phase 3 Readout Expected in 2027
persevERA is the first of two distinct phase 3 studies in the first-line setting.
The pionERA study of giredestrant combined with cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer is expected to read out in 2027.
The U.S. Food and Drug Administration (FDA) recently accepted the New Drug Application based on the evERA data. The FDA has set a Prescription Drug User Fee Act date of 18 December.
Roche Shares Slide
Roche Holding AG's shares fell as much as 5% in early Zurich trading. The Swiss drugmaker's main listing trades on the SIX Swiss Exchange under the ticker ROG, while its shares also trade in the U.S. over-the-counter as RHHBF and RHHBY.
The results follow disappointing data last week from an experimental obesity drug being developed by Roche and Zealand Pharma. Genentech, a Roche unit, reported Phase 2 results showing up to 10.7% weight loss—lagging those of treatments from Novo Nordisk A/S (NYSE:NVO) and Eli Lilly and Co. (NYSE:LLY).
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