---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-347400"
form_type: "8-K"
ticker: "CGEM"
cik: "0001789972"
company_name: "Cullinan Therapeutics, Inc."
filed_at: "2026-08-12T23:35:50+00:00"
generated_at: "2026-08-13T10:05:31.353716+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Cullinan's zipalertinib combo meets PFS endpoint in Phase 3 REZILIENT3 trial

## Summary
- REZILIENT3 Phase 3 trial (285 patients) met primary endpoint of PFS at planned interim analysis; statistically significant and clinically meaningful improvement.
- Zipalertinib plus platinum-based chemotherapy vs chemo alone in first-line EGFR exon 20 insertion NSCLC; safety manageable.
- Independent Data Monitoring Committee recommended unblinding; trial continues for efficacy/safety monitoring.
- Taiho and Cullinan plan to pursue U.S. FDA approval for the combination in first-line setting pending discussions.
- Full results to be submitted for presentation at an upcoming international medical conference.

## SEC filing metadata
- accession: 0001193125-26-347400
- form_type: 8-K
- ticker: CGEM
- cik: 0001789972
- company_name: Cullinan Therapeutics, Inc.
- filed_at: 2026-08-12T23:35:50+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1789972/000119312526347400/0001193125-26-347400-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1789972/000119312526347400/cgem-20260812.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-347400
- JSON: https://secwatch.observer/filing/0001193125-26-347400.json
- Plain text: https://secwatch.observer/filing/0001193125-26-347400.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.