---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-065254"
form_type: "8-K"
ticker: "BDTX"
cik: "0001701541"
company_name: "Black Diamond Therapeutics, Inc."
filed_at: "2026-05-21T21:19:10+00:00"
generated_at: "2026-05-21T21:23:54.207839+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Black Diamond reports positive Phase 2 silevertinib results; mPFS 15.2 months in EGFR-NCM NSCLC

## Summary
- Preliminary mPFS 15.2 months (95% CI: 10.8, NE); median DOR not reached; 53% of patients remain on therapy.
- CNS ORR 86%; no de novo brain metastases observed; 19 patients with brain metastases at baseline.
- ORR 60%, DCR 91%; VAF reduction in all evaluable patients across 25 unique EGFR-NCMs including PACC.
- No new safety signals; TRAEs > Grade 3 reduced to 28% after dose reduction; 150 mg QD selected for pivotal development.
- Company plans to meet with FDA later this year to discuss pivotal development plan.

## SEC filing metadata
- accession: 0001104659-26-065254
- form_type: 8-K
- ticker: BDTX
- cik: 0001701541
- company_name: Black Diamond Therapeutics, Inc.
- filed_at: 2026-05-21T21:19:10+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701541/000110465926065254/0001104659-26-065254-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701541/000110465926065254/tm2615293d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-065254
- JSON: https://secwatch.observer/filing/0001104659-26-065254.json
- Plain text: https://secwatch.observer/filing/0001104659-26-065254.txt

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