Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genmab A/S has unveiled data showing that clinical and metabolic response was demonstrated with HuMax-EGFr in a phase I/II study in refractory head and neck cancer.
Subscribe to our email newsletter
In the trial, 27 patients who had previously failed standard therapies were divided into six dose groups receiving IV infusions of HuMax-EGFr at doses of 0.15, 0.5, 1, 2, 4, or 8mg/kg. Twenty patients received all five infusions and the primary objective of the study was safety.
Results, as assessed by a FDG-PET scan, showed that seven of 18 evaluable patients achieved partial metabolic response and four had stable metabolic disease one week after their fifth and last infusion.
Clinical response evaluated by computerized tomography (CT scan) supported the positive FDG-PET results. Two of 19 evaluable patients achieved partial response and nine patients had stable disease according to RECIST criteria.
The partial response was maintained at week 12 by one of the two patients. The other patient’s disease progressed five weeks after the last treatment, but following additional HuMax-EGFr treatment at 8mg/kg on a compassionate use basis, the patient re-obtained the partial response.
The most frequent adverse event was acneiform rashes demonstrating biological activity of HuMax-EGFr reported in 56% of the patients. The occurrence increased with dose, with ten of 11 patients in the 4 and 8mg/kg dose groups reporting the rash. Other adverse events included rigors, fatigue, pyrexia, nausea, flushing and increased sweating.
One patient reported a serious adverse event considered related to treatment with HuMax-EGFr, grade 2 pyrexia, which developed during the first infusion. The patient recovered, however, and completed the study.