Fulgent Genetics (FLGT) announced preliminary clinical data as of September 25, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in less than or equal to 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma, or R/M HNSCC. This preliminary data will be presented on October 20, 2025, at the European Society for Medical Oncology, or ESMO, held October 17th to the 21st in Berlin, Germany. 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: 39 patients with R/M HNSCC have been randomized, of which 36 have received at least one dose of study treatment; 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, or 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, or 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, or SAE, rate in the 36 patients evaluated for safety. Overall grade 3 and worse treatment-related adverse events were observed in greater than or equal to 5% of patients and consisted of lymphocyte count decreased, neutrophil count decreased, anemia, dermatitis acneiform, white blood cell count decreased, rash , hypomagnesaemia, and pneumonia. Grade 1-2 peripheral neuropathy was reported in 31% of the patients. No grade 3 and above peripheral neuropathy has been reported to date.
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