November 8, 2012
biotechnologies GmbH, a biopharmaceutical company developing rationally designed therapeutic vaccines that are active against cancer, announced today that it has completed patient recruitment into the pivotal phase 3 trial evaluating its lead cancer vaccine IMA901 for renal cell carcinoma (RCC). The trial has completed patient inclusion and it is expected that around 345 patients will be randomized across 10 countries in the US and
. The first (interim) overall survival results are expected during the first half of 2014.
The phase 3 IMPRINT trial* is designed to show an overall survival benefit with IMA901 in combination with sunitinib (Sutent®, Pfizer), standard first-line therapy in comparison to sunitinib alone in patients with metastatic and/or locally advanced RCC. The secondary endpoints include immune response to the peptides contained in IMA901, progression-free survival, safety and tolerability.
The study aims to build on the promising survival and immune response data observed in the phase 2 study with IMA901 in advanced RCC patients. These data show that patients who produced an immune response to two or more of the tumor-associated peptides (TUMAPs) contained in IMA901 had a significantly longer survival. Key data from the scientific and clinical development of IMA901 were recently published in
Chief investigator of the trial is Professor
, Lerner College of Medicine, Department of Solid Tumor Oncology at the Cleveland Clinic Taussig Cancer Institute,
. The European lead investigator is Professor
, Clinical Director of Medical Oncology at Addenbrooke's Hospital,
University of Cambridge
, CMO of
, said: "We have achieved another key milestone in
development. The rate of patient recruitment in this pivotal trial with IMA901 reflects a very high level of interest in this novel cancer vaccine for the treatment of renal cell carcinoma both by investigators and also patients. IMA901, which contains multiple highly relevant tumor peptides, has already indicated the potential to extend patient survival and we look forward to this being confirmed in this pivotal trial."
US orphan drug designation for IMA901