Results
Fulgent Genetics Inc.
10/20/2025 | Press release | Distributed by Public on 10/20/2025 04:05
Fulgent Shares Preliminary Data from Poster Presentation at ESMO 2025 Conference (Form 8-K)
Fulgent Shares Preliminary Data from Poster Presentation at ESMO 2025 Conference
EL MONTE, CA, 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, today announced 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), held October 17th to the 21st in Berlin, Germany.
"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: https://fulgentgenetics.gcs-web.com/news-events/presentations.
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.
About Fulgent Pharma
Fulgent Pharma (a wholly-owned, indirect subsidiary of Fulgent Genetics, Inc.) has developed and possesses a novel nanoencapsulation technology, which includes over 40 patents and a targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of both new and existing cancer drugs. Fulgent Pharma began as Fulgent Therapeutics in Temple City, California, in June 2011. As the company progressed into the realm of personalized medicine, it also started delving into clinical genetic testing - a natural complement. In 2016, Fulgent Therapeutics split into two separate entities, Fulgent Pharma and Fulgent Genetics, which enabled each to better pursue their independent objectives. In 2022, Fulgent Pharma merged with Fulgent Genetics and is now focused exclusively on perfecting drug candidates for treating a broad range of cancers. Its partners in this endeavor include the University of Southern California, Moffitt Cancer Center, and the City of Hope Cancer Center, among others.
About Fulgent
Fulgent is a technology-based company with a well-established laboratory services business and a therapeutic development business. Fulgent's laboratory services business includes technical laboratory and testing services and professional interpretation of laboratory results by licensed physicians. Fulgent's therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a diagnostic business into a fully integrated precision medicine company.
Fulgent Genetics Inc. published this content on October 20, 2025, and is solely responsible for the information contained herein. Distributed via EDGAR on October 20, 2025 at 10:05 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]