secwatch.observer — SEC 8-K summary
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Issuer:     PMV Pharmaceuticals, Inc. (PMVP)
CIK:        0001699382
Form:       8-K
Filed at:   2023-10-12T23:59:59+00:00
Accession:  0001193125-23-255083
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PMV Pharma: PC14586 Phase 1 shows 38% ORR at RP2D; registrational Phase 2 planned early 2024
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- Confirmed ORR 38% (6/16) at RP2D 2000 mg daily in TP53 Y220C/KRAS wild-type patients; median DoR 7 months.
- Responses across ovarian, breast, prostate, lung, endometrial cancers; 34% ORR in efficacious dose range (13/38).
- Well tolerated: most TRAEs Grade 1-2 (nausea, vomiting, creatinine increase); only 3% discontinuation due to TRAE.
- RP2D selected after End of Phase 1 meeting with FDA in Q3 2023; Phase 2 registrational trial to start early 2024.
- Study enrolled heavily pretreated patients (median 3 prior lines); no approved therapies targeting p53 currently exist.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1699382/000119312523255083/0001193125-23-255083-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1699382/000119312523255083/d534012d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-255083

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