Fn14 is over-expressed in at least 30% of several solid tumours, including pancreatic cancer, breast cancer, non-small cell lung cancer and malignant melanoma.
From July 2011, Dr Lassen and his colleagues recruited 38 patients with treatment-refractory solid tumours to the phase I trial. All patients had tumours expressing the Fn14 receptor. They received an intravenous dose of the drug either once weekly or once every three weeks, with a dose range of 200 to 3600 mg.
Dr Lassen said: "Several of the patients continue to receive study treatments, and encouraging signs of clinical benefit have already been observed. A patient with heavily pre-treated, metastatic melanoma with no mutation in the BRAF gene has shown evidence of tumour regression when scanned using computerised tomography (CT) and remains on study after more than 30 weeks of treatment. Four other patients have had partial metabolic responses confirmed by positron emission tomography (PET) scans.
"Prolonged stable disease has been seen in several patients. Overall, 11 of the 38 patients (29%) have received more than 12 weeks of study treatment, with several receiving 18 or more weeks of RG7212 therapy, including those with refractory NSCLC, melanoma, mesothelioma, breast cancer, renal cell carcinoma, and biliary tract cancer.
"We found that RG7212 has an excellent safety profile across a broad dose range on each schedule. We saw no dose-limiting toxicities and no patient discontinued study treatments for treatment-related adverse side-effects. The phase I data show that RG7212 is quite safe for multi-cycle administration in patients with advanced cancer. Results from tests of blood and tumour samples suggest that it would be feasible to administer the drug over a prolonged period of time.
"There are encouraging pharmacodynamic data (effects of the drug on
|Contact: Emma Mason|
ECCO-the European CanCer Organisation