Relay Therapeutics (RLAY), a clinical-stage, small molecule precision medicine company, announced plans to move Zovegalisib plus Atirmociclib, Pfizer's investigational, potential CDK4 inhibitor, into Phase 3 development for frontline patients with PI3Ka-mutated, HR+/HER2- metastatic breast cancer.
The planned study, subject to regulatory feedback, is a randomised Phase 3 trial evaluating Zovegalisib in combination with Atirmociclib and aromatase inhibitor (AI) in frontline endocrine sensitive patients with PIK3CA-mutated, HR+/HER2- advanced or metastatic breast cancer.
The trial is expected to commence in early 2027, subject to regulatory feedback.The key endpoints include median progression-free survival as the primary endpoint and overall survival as the secondary endpoint.
For the planned study, Pfizer has agreed to supply Atirmociclib for the experimental arm, in combination with Zovegalisib, and palbociclib for the control arm.
Zovegalisib is currently being evaluated in ReDiscover, an ongoing first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of Zovegalisib in combination with Fulvestrant and CDK inhibitors in patients with PI3Ka-mutated, HR+/HER2- metastatic breast cancer.
As of the April 13, 2026 data cut-off date, 69 patients were enrolled, and 34 were evaluable for response, and the Objective response rate (ORR) was 44% (15/34) and was also 44% in both kinase and non-kinase patients. Nearly 85% of patients experienced tumour reduction.
"While PI3Ka inhibition has demonstrated meaningful benefit in breast cancer, its use in the frontline setting has been limited by tolerability challenges with earlier agents," said Don Bergstrom at Relay Therapeutics.
RLAY has traded between $2.67 and $17.32 over the last year. The stock closed Friday's trade at $15.13, up 0.27%.
In the pre-market, RLAY is up 0.13% at $15.15.
For More Such Biotech Stock News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.