1. Zovegalisib shows 10.3-month median PFS in all patients. 2. Subset analyses reveal robust activity in PI3Kα-mutated breast cancer. 3. Ongoing Phase 3 ReDiscover-2 trial aims to determine treatment efficacy. 4. Zovegalisib could address 500,000 patients in the U.S. 5. Overall tolerability is consistent with mutant-selective PI3Kα inhibition.
FAQ
Why Bullish?
Positive clinical data suggests strong treatment efficacy, potentially boosting RLAY stock value, similar to previous oncology breakthroughs in clinical trials that led to stock surges.
How important is it?
The article's focus on zovegalisib's promising clinical outcomes supports Relay Therapeutics’ growth potential, making it a strong influence on stock performance.
Why Long Term?
As the clinical data matures and if regulatory approvals are secured, the long-term outlook for RLAY could significantly improve due to the unmet medical need in targeted cancer treatments.
Relay Therapeutics Presents Positive Efficacy Data for Zovegalisib (RLY-2608) in Breast Cancer at SABCS 2025
CAMBRIDGE, Mass., December 12, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a leader in precision medicine focused on cancer treatment, announced promising efficacy results from a subset analysis of zovegalisib (RLY-2608) at the 2025 San Antonio Breast Cancer Symposium (SABCS). This investigational treatment is currently being evaluated for its effectiveness in patients with HR+/HER2- metastatic breast cancer.
Key Findings from Zovegalisib Study
The analysis presented consistent efficacy with prior disclosures, highlighting a median progression-free survival (PFS) of 10.3 months across all patients. For those who had previously undergone second-line treatment, the median PFS was noted at 11.4 months. The subset evaluations revealed remarkable activity among patients with PI3Kα mutations, regardless of prior treatments with fulvestrant or other SERDs, and ESR1 mutation status.
Clinical Insights from the ReDiscover Trial
The ongoing Phase 3 ReDiscover-2 trial aims to examine the combination of zovegalisib and fulvestrant in a patient cohort pre-treated with CDK4/6 inhibitors. As of the latest update on October 15, 2025, a total of 118 patients were enrolled in this arm of the trial. Notably, 44% of patients had previously undergone two or more lines of therapy, and 29% showed detectable ESR1 mutations at baseline.
Efficacy Analysis and Patient Subgroups
The data from this subset analysis reveal:
- Overall median PFS for patients receiving zovegalisib + fulvestrant was 10.3 months.
- Among those with measurable disease (31 patients), the objective response rate (ORR) was reported at 39%.
- For second-line (2L) patients, median PFS was 11.4 months with an ORR of 47%.
- In the group with prior SERD exposure, median PFS was also 11.4 months, and an ORR of 44% was observed.
- Patients with detectable ESR1 mutations had a median PFS of 8.8 months and an ORR of 60%.
Ongoing Clinical Developments
Relay Therapeutics is committed to advancing the development of zovegalisib. Upcoming steps include:
- Enhanced enrollment in the Phase 3 ReDiscover-2 trial to assess zovegalisib in diverse breast cancer populations.
- Progress in dose escalation within the ReDiscover Phase 1/2 study, focusing on combination therapies that may inform future treatment protocols.
- Enrollment into the Phase 1/2 ReInspire clinical trial targeting vascular malformations connected to PIK3CA mutations.
About Zovegalisib and Relay Therapeutics
Zovegalisib represents Relay Therapeutics’ foundational asset aimed at targeting PI3Kα mutations, relevant for approximately 500,000 patients in the United States. This allosteric inhibitor is positioned to provide more effective treatments with fewer side effects compared to traditional inhibitors. It marks a significant advancement in precision oncology, addressing a large population in need of targeted therapies.
Conclusion
As Relay Therapeutics continues to innovate within the realms of precision medicine, the encouraging results regarding zovegalisib (RLY-2608) pave the way for potential new standards of care in breast cancer treatment. Investors and stakeholders can follow the progress made in clinical trials through the company’s official communications and updates.
Contact Information
For detailed presentations from SABCS and more about zovegalisib, visit the Relay Therapeutics publication section at Relay Therapeutics Publications.