On October 20, 2025 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported preliminary clinical data as of September 25, 2025, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in ≤ 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This preliminary data will be presented on October 20, 2025, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held October 17th to the 21st in Berlin, Germany.

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"We believe this preliminary data reinforces our mission to build a holistic platform that delivers comprehensive solutions across the cancer care continuum — from early detection, diagnostics, and monitoring to drug discovery and development," said Ming Hsieh, Chairman and CEO of Fulgent Genetics and co-founder of Fulgent Therapeutics. "We are encouraged by the steady advancement of FID-007 in oncology indications to date, while our precision diagnostics business continues to provide strong momentum as the primary driver of revenue for Fulgent."

Poster title: "A Randomized Phase 2 Study of FID-007 Plus Cetuximab in Patients with Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma"

Observations in the Poster include:

As of a September 25, 2025 preliminary data cutoff date:

39 patients with R/M HNSCC have been randomized, of which 36 have received at least one dose of study treatment (FID-007 at 75 mg/m2 or 125 mg/m2 IV on Days 1, 8, 15 Q4W and cetuximab 500 mg/m2 IV biweekly).
FID-007 combined with cetuximab demonstrated meaningful anticancer efficacy at both dose levels for the 1L – 2L treatment of R/M HNSCC. Of the 35 patients evaluable for efficacy, the objective response rate (ORR) for the 75 mg/m2 arm and the 125 mg/m2 arm were 44% and 59% respectively, and 51% overall when both arms are combined. The median progression-free survival (PFS) for the 75 mg/m2 arm and the 125 mg/m2 arm were 9.2 months and 7.8 months, respectively. The overall PFS was 7.8 months, compared to the historical 2.3 months of the standard-of-care therapies.
FID-007 exhibited a favorable safety and tolerability profile, with a 6% overall treatment-related serious adverse event (SAE) rate in the 36 patients evaluated for safety. Overall grade 3 and worse treatment-related adverse events were observed in ≥ 5% of patients and consisted of lymphocyte count decreased (19%), neutrophil count decreased (17%), anemia (8%), dermatitis acneiform (8%), white blood cell count decreased (8%), rash (6%), hypomagnesaemia (6%) and pneumonia (3%). Grade 1-2 peripheral neuropathy was reported in 31% of the patients. No grade 3 and above peripheral neuropathy has been reported to date.
An optimal dose of FID-007 will be determined after data maturation to support further development of this combination therapy.
The poster will be available on the Investor Relations section of the company’s website at: View Source

About FID-007

FID-007 is designed to improve the pharmacokinetics of paclitaxel (PTX), increase its water solubility, reduce formulation-related toxicity, and enhance therapeutic efficacy by encapsulating PTX with a clinically safe polyethyloxazoline (PEOX) polymer excipient. Importantly, the smaller size of FID-007 nanoparticles compared to solvent-based PTX micelles in plasma enables efficient penetration and reduced clearance within the tumor due to the enhanced permeability and retention effect, thus resulting in higher accumulation of FID-007 in the tumor tissue.

(Press release, Fulgent Genetics, OCT 20, 2025, View Source [SID1234656847])