immatics to receive support from Pfizer for its pivotal Phase III study (IMPRINT) with IMA901
immatics biotechnologies GmbH announced that Pfizer has agreed to support its pivotal Phase III trial (IMPRINT = IMA901 Multi-Peptide vaccine Randomized INTernational study) with IMA901, its therapeutic cancer vaccine for advanced renal cell carcinoma.
The pivotal Phase III study will evaluate as the primary endpoint the overall survival of advanced renal cell carcinoma patients treated with IMA901 in combination with Pfizer’s Sutent® (sunitinib malate) versus Sutent® alone. The study is expected to enroll approximately 330 patients across Europe and in the US.
Pfizer will support the trial by supplying Sutent® for all the patients enrolled in the pivotal study. The first patients are expected to start treatment in April 2011.
Paul Higham, CEO of immatics, said: “We are extremely pleased that Pfizer has committed to supporting our pivotal Phase III trial with IMA901 with the supply of Sutent. Their decision reflects the growing interest in IMA901 and its potential to be an important breakthrough in the treatment of renal cell carcinoma patients.”
IMA901 has generated encouraging overall survival data, which compare favorably with historical comparisons of currently available treatments, in a Phase II trial in advanced renal cell carcinoma patients. Importantly, the Phase II study also showed an association between survival and the patient’s immune response to IMA901, as well as confirming the favorable safety profile observed in an earlier Phase I study.
Other news from the department research and development
