Fulgent Presents Updated Phase 2 FID-007 + Cetuximab Data at ASCO Showing 61.9% ORR

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Fulgent Genetics presented updated Phase 2 data at ASCO for FID-007 combined with cetuximab in recurrent/metastatic head and neck squamous cell carcinoma. The regimen showed a 61.9% objective response rate, 63.4% one-year overall survival, and manageable safety. Fulgent plans to initiate a Phase 3 study based on these results.

Fulgent presented updated Phase 2 data showing a 61.9% objective response rate for FID-007 combined with cetuximab in R/M HNSCC.

Key Highlights:

  • Presented updated preliminary Phase 2 (NCT06332092) data in ASCO Rapid Oral session for FID-007 + cetuximab.
  • As of Apr 16, 2026 cutoff: objective response rate 61.9%, median PFS 6.7 months, median DOR 7.4 months.
  • One-year overall survival reported at 63.4% and activity seen in HPV‑related and unrelated HNSCC.
  • Study evaluated two dosing regimens and assessed PK, safety and tolerability; safety described as manageable.
  • Company plans a Phase 3 study; updated presentation slides posted on investor site after the June 1 presentation.

Original SEC Filing: Fulgent Genetics, Inc. [ FLGT ] - 8-K - Jun. 01, 2026

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