---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-271664"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2022-10-28T23:59:59+00:00"
generated_at: "2026-06-22T22:55:09.889431+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Nuvalent reports preliminary Phase 1 data for NVL-520: 48% ORR in heavily pre-treated ROS1+ NSCLC

## Summary
- 48% ORR (10/21) in heavily pre-treated ROS1+ NSCLC; 78% (7/9) in G2032R mutation patients.
- Intracranial PRs in 100% (3/3) with measurable CNS mets; 73% (8/11) with CNS history.
- No DLTs, treatment-related SAEs, dizziness, or AEs leading to dose reduction/discontinuation in 35 patients.
- Dose levels 25-125 mg QD achieved exposures above target thresholds; half-life supports once-daily dosing.
- Phase 1 enrollment ongoing; 76% (16/21) of response-evaluable patients continue treatment.

## SEC filing metadata
- accession: 0001193125-22-271664
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2022-10-28T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000119312522271664/0001193125-22-271664-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312522271664/d377694d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-271664
- JSON: https://secwatch.observer/filing/0001193125-22-271664.json
- Plain text: https://secwatch.observer/filing/0001193125-22-271664.txt

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