On May 21, 2026 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established laboratory services business and a therapeutic development business, reported that its full abstract has been released on the ASCO (Free ASCO Whitepaper) 2026 website. The abstract will be presented within the Head and Neck Cancer Track of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Rapid Oral Abstract Session on June 1, 2026, from 4:30pm to 6:00pm (CDT) in Hall D1 of McCormick Place, Chicago.
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The abstract is entitled "FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020". It presents interim data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study was designed to evaluate the efficacy of two different dosing regimens and to characterize the pharmacokinetics (PK) and safety and tolerability of FID-007 in combination with cetuximab in patients with disease progression after treatment with PD-1-based immune checkpoint inhibitor. As of the data cut-off date of December 20, 2025, FID-007 exhibited meaningful clinical activity and a favorable safety profile when combined with cetuximab in target patient population.
Key observations in the abstract include:
FID-007 combined with cetuximab demonstrated anticancer activity at both dose levels for the 1L–2L treatment of R/M HNSCC. Of the 42 patients evaluable for efficacy, the objective response rate (ORR) was 60% (58% in Arm A, 61% in Arm B), and the median progression-free survival (mPFS) was 7.2 mo [6.7 mo in Arm A (95% CI: 2.0-12.8), and 7.2 mo in Arm B (95% CI: 4.0-NR)]. The median duration of response (DoR) was 7.4 mo (7.4 mo in Arm A, NR in Arm B) with 56% (14/25) of responders continuing to respond at the time of data cut-off. The overall survival data (OS) are immature at present.
FID-007 exhibited a favorable safety and tolerability profile consisting mostly of grade 1-2 treatment-related adverse events (TRAEs). Grade 3-4 TRAEs occurring in ≥ 2 patients included neutropenia (3 in Arm A, 5 in Arm B), anemia (2 in Arm A, 4 in Arm B), leukopenia (3 in Arm B), acneiform dermatitis (2 in Arm A), maculo-papular rash and other rash (2 in Arm B). There was 1 Grade 5 TRAE (pneumonia in Arm B).
The full abstract is now available on the ASCO (Free ASCO Whitepaper) website, as well as on Fulgent’s investor relations website.
The final presentation slides with updated data will be available on Fulgent’s investor relations website at the start of the session on June 1, 2026.
Dr. Ray Yin, Co-Founder and President of Fulgent Pharma, said, "Based on available estimates, there are approximately 73,000 new head and neck Squamous Cell Carcinoma (HNSCC) cases in the U.S. and 930,000 worldwide each year, with 50% to 60% progressing to the recurrent or metastatic stage. We are encouraged by the clinical progress achieved so far and believe in the potential of FID-007 to serve as a meaningful treatment for R/M HNSCC patients, particularly given that the current standard of care offers a historical objective response rate (ORR) of just 5.8% to 19.1% and a progression-free survival (PFS) of only 2.3 to 3.7 months."
(Press release, Fulgent Genetics, MAY 21, 2026, View Source [SID1234665967])