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Oxford Biomedica and Sanofi-Aventis report new TroVax Phase II trial results in renal cancer

05 Jun 2007 - Oxford BioMedica and sanofi-aventis announced new data from two Phase II trials of TroVax® in renal cancer. TroVax® is Oxford BioMedica's lead cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. The Phase II data were presented by Oxford BioMedica and its clinical collaborators from the Methodist Hospital in Houston, Texas, at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
 
Fifty-three patients with progressive metastatic renal cell cancer (RCC) have been enrolled and 48 patients are currently evaluable in the Methodist Hospital's two non-randomised Phase II trials of TroVax®. The trials are designed to evaluate TroVax® either as a single agent, or in combination with either interleukin-2 or interferon-alpha. The treatment regimen in the two trials comprises seven intramuscular injections of TroVax® over 41 weeks. The patients had previously failed various anti-cancer treatments before entering the trials.
 
TroVax® was well tolerated with no serious adverse events attributable to the treatment. TroVax® induced anti-5T4 antibody responses in 91% of patients. In patients with clear cell RCC, which is the most common subtype of renal cancer and is the patient group for the Phase III TRIST study, 24 of 35 (68%) evaluable patients showed disease control. Two patients had complete responses, three had partial responses and 19 had stable disease for periods exceeding three months, including three patients that have been stable for more than 17 months. Preliminary analysis of clinical benefit shows a statistically significant relationship between reduction in tumour burden (biologic response) in patients with clear cell RCC and patients' anti-5T4 antibody responses (p = 0.028). This is particularly encouraging since it supports the rationale that the 5T4-specific immune response induced by TroVax® has therapeutic benefit.