secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2023-10-13T23:59:59+00:00
Accession:  0001193125-23-255616
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Nuvalent reports Phase 1 ALKOVE-1 data: NVL-655 shows 39% ORR in heavily pre-treated ALK+ NSCLC
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- ORR 39% (20/51) in response-evaluable NSCLC patients; 44% (18/41) at ≥50 mg QD dose levels.
- Activity in CNS metastases subgroup: ORR 52% (15/29); all responders continued without CNS progression.
- Patients with ALK G1202R mutations had 71% ORR (12/17); compound mutations ORR 56% (9/16).
- Favorable safety: 2% discontinuations, 5% dose reductions; no TRK-related neurotoxicities; MTD not reached.
- 100% clearance of ALK resistance mutations in 14/16 patients with G1202R or I1171X mutations by ctDNA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000119312523255616/0001193125-23-255616-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000119312523255616/d558552d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-255616

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer