The strong efficacy and clean safety profile at a lower, food-affected dose de-risks the Phase 3 ReDiscover-2 trial. Breakthrough Therapy designation may accelerate approval timeline. Monitor upcoming enrollment updates and next data readout for confirmatory signals.
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Executive Summary
Relay Therapeutics announced updated Phase 1/2 data for zovegalisib (400mg BID fed) in PI3Kα-mutated HR+/HER2- metastatic breast cancer, showing a median progression-free survival (PFS) of 11.1 months and a 43% confirmed objective response rate. The FDA has granted Breakthrough Therapy designation for this indication, supporting the ongoing Phase 3 ReDiscover-2 trial.
Key Facts
- Zovegalisib 400mg BID fed regimen showed 11.1-month median PFS in heavily pre-treated patients with PI3Kα-mutated HR+/HER2- metastatic breast cancer
- Confirmed objective response rate (ORR) was 43% (15/35) in patients with measurable disease, rising to 52% in second-line only patients
- Safety profile was favorable, with only four patients discontinuing due to treatment-related adverse events
- FDA granted Breakthrough Therapy designation for zovegalisib in the ReDiscover-2 trial population
- Pharmacokinetic data show 400mg fed achieves exposures comparable to 600mg fasted, supporting dosing strategy
Financial Impact
Potential blockbuster opportunity; targets ~140,000 US patients with PI3Kα-mutated HR+/HER2- breast cancer
Risk Factors
- Phase 3 trial may not replicate Phase 1/2 results
- Competitive landscape includes capivasertib (being tested in the same trial arm) and other AKT/PI3K inhibitors
- Forward-looking statements are subject to clinical and regulatory uncertainty
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3256120 |
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Sep 9, 2026 23d ago | Insider Cluster | $18.66 $18.84 | ▲ +0.96% | ▲ +1.62% | $18.96 (+1.61%) |
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May 21, 2026 19w ago | 8-K | $13.53 $14.26 | ▼ −5.40% | ▼ −3.74% | $18.96 (−40.13%) |
May 21, 2026 19w ago | Press Release | $13.66 $14.05 | ▼ −2.86% | ▼ −1.01% | $18.96 (−38.80%) |
May 19, 2026 19w ago | 424B5 | $13.02 $13.90 | ▼ −6.76% | ▼ −4.96% | $18.96 (−45.62%) |
May 19, 2026 19w ago | Press Release | $13.02 $14.43 | ▼ −10.83% | ▼ −9.59% | $18.96 (−45.62%) |
US Market Status
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