secwatch.observer — SEC 8-K summary
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Issuer:     Xencor Inc (XNCR)
CIK:        0001326732
Form:       8-K
Filed at:   2025-10-24T23:59:59+00:00
Accession:  0001326732-25-000082
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Xencor reports 25% ORR for XmAb819 in ccRCC Phase 1; dose-expansion cohort selected
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- XmAb819 (ENPP3 x CD3) Phase 1: 25% ORR (5/20 PRs) and 70% DCR in target dose range in heavily pre-treated ccRCC.
- All 5 responders remain on treatment; 50% (10/20) of evaluable patients in target range remain on treatment as of Sep 19, 2025.
- Safety: CRS (Grade 3 in 4% with correct priming dose), no ICANS, no Grade 5 events; priming dose errors identified and remediated.
- First dose-expansion cohort enrolled; expect Phase 3 dose selection in 2026, pivotal study start in 2027.
- Early XmAb541 (CLDN6 x CD3) data also presented in ovarian, endometrial, and germ cell tumors.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1326732/000132673225000082/0001326732-25-000082-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1326732/000132673225000082/xncr-20251024.htm
  HTML page:      https://secwatch.observer/filing/0001326732-25-000082

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