Revolution Medicines' RASolute 302 trial is an OS event-driven Phase III study targeting metastatic pancreatic cancer, with top-line data and database lock expected in the first half of 2026. The exact OS event thresholds remain confidential until data unblinding.
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For RASolute 302, can you confirm the exact OS event threshold and the expected calendar window for database lock and top-line disclosure in H1 2026?
1. OS Event-Driven Analysis and Threshold
2. Expected Calendar Window for Database Lock and Readout
3. Interim Analysis and Disclosure Policy
Summary Table
| Aspect | Detail | Citation(s) |
|---|---|---|
| Trial Name | RASolute 302 | 4 |
| Trial Design | OS event-driven, hierarchical testing in core and expanded populations | 412 |
| OS Event Threshold Disclosure | Not publicly disclosed; unknown exact number | 123 |
| Expected Readout/Database Lock | First half (H1) of 2026 | 4 |
| Interim PFS Analysis | Possible but no guarantee; disclosure dependent on data results | 1 |
| Status at Q4 2025 Call | Enrollment complete; no OS event threshold met to trigger interim analysis yet | 3 |
This cautious communication style is consistent with the company’s prioritization of data integrity and regulatory compliance in their pivotal clinical programs.
References:
This comprehensive analysis relies entirely on the disclosed official company statements in their Q4 2025 earnings call transcript and related excerpts.
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