Relay Therapeutics, Inc. Form 8-K Summary
Business Context and Reporting Period
This Current Report on Form 8-K was filed by Relay Therapeutics, Inc. on March 16, 2026. The filing discloses the announcement of clinical trial data for zovegalisib (RLY-2608) presented at the European Society for Medical Oncology Targeted Anticancer Therapies Congress 2026. The data pertains to the Phase 1/2 ReDiscover trial evaluating zovegalisib in combination with fulvestrant for patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
Key Financial Metrics
The filing text does not provide specific financial metrics such as revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on clinical development updates and regulatory disclosures.
Material Changes and Clinical Data
The primary material event is the release of interim data from the ReDiscover trial as of the January 13, 2026 data cut-off date. Key findings include:
- Study Population: 60 patients received the 400mg twice daily (BID) fed regimen. The efficacy population consisted of 57 patients without PTEN or AKT co-mutations. All patients had prior exposure to CDK4/6 inhibitors and endocrine therapy.
- Pharmacokinetics: The 400mg BID fed regimen achieved exposures comparable to the previously evaluated 600mg BID fasted dose, with mean concentrations approaching IC90 in the majority of patients.
- Efficacy Results:
- Median progression-free survival (PFS) was 11.1 months (95% CI: 7.3–13.0 months).
- Median PFS was 11.2 months in patients with kinase mutations and 11.0 months in those with non-kinase mutations.
- Confirmed objective response rate (ORR) was 43% (15/35) among patients with measurable disease.
- ORR was 52% (11/21) in second-line only patients.
- Safety Profile: The regimen was generally well tolerated. Adverse events were primarily low-grade, manageable, and reversible. Hyperglycemia events were mostly Grade 1, with no Grade 4-5 events observed. Only four patients discontinued due to treatment-related adverse events.
Guidance, Outlook, and Risks
Management indicated that the 400mg BID fed dose is the recommended Phase 3 dose. The filing includes standard forward-looking statements regarding the potential therapeutic benefits, regulatory interactions, and commercialization of zovegalisib. Risks highlighted include the uncertainty of clinical trial results, potential delays in development, regulatory approval outcomes, and global economic or geopolitical factors. The company disclaims any obligation to update forward-looking statements.
Investor Verification Checklist
- Verify the full text of the press release (Exhibit 99.1) for detailed statistical tables and subgroup analyses not fully summarized in the 8-K.
- Confirm the timeline for the initiation of the Phase 3 trial and any regulatory meetings planned following this data release.
- Review the company's most recent Form 10-K or 10-Q for updated financial position, cash runway, and burn rate, as this 8-K contains no financial data.
- Monitor subsequent filings for any changes in the safety profile as the patient follow-up period extends beyond the 12.0-month median reported.