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Follow-up data from a phase I/II clinical trial with INTUVAX in eleven patients with metastatic kidney cancer have been announced by Immunicum, a Swedish biopharmaceutical company. The trial was started in February 2012, and 5 patients are still alive. The median overall survival for the entire patient group has more than doubled, and the median overall survival for patients with poor prognosis has more than tripled compared to published historical data for newly diagnosed patients who received standard treatment. The follow up study is ongoing and the final median overall survival has not yet been reached for any of the patient groups.
INTUVAX is an immune primer that is injected directly into the tumour (intratumoural injection), and which is designed to stimulate the immune system to specifically attack the patient’s own tumour cells.
In the phase I/II study, patients with metastasised renal cell carcinoma (RCC) were treated with two doses of INTUVAX before the primary tumour was surgically removed. Median overall survival for the entire patient population currently stands at about 37 months versus expected 15.2 months for sunitinib. For the group with high-risk prognosis (6 patients), the median overall survival is currently at about 31 months versus 9 months for sunitinib. The purpose of the phase I/II study was to document the safety profile and immunological effects, as well as to follow the survival of patients with metastatic renal cell cancer after two INTUVAX treatments.