Tuebingen, September 27, 2015 – Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company and a global leader in cancer immunotherapy, announced today the results of a pivotal phase 3 clinical trial with IMA901 in patients with metastatic renal cell carcinoma (RCC) in combination with sunitinib. Results were presented by Dr. Brian Rini, Professor of Medicine at the Cleveland Clinic Taussig Cancer Center and Chief Investigator of the phase 3 trial at the European Society of Medical Oncology (ESMO) Meeting in Vienna, Austria. The phase 3 trial did not meet its primary endpoint of showing an overall survival benefit of IMA901 in combination with sunitinib compared with sunitinib alone in this patient population.
The phase 3 trial had been designed to demonstrate an overall survival (OS) benefit in patients receiving IMA901 in combination with the standard first-line therapy sunitinib versus sunitinib alone, in patients with metastatic and/or locally advanced RCC. 339 patients were randomized 3:2 to receive or not up to 10 intradermal vaccinations of IMA901 plus 75 µg GM-CSF in addition to sunitinib; a single infusion of cyclophosphamide (300mg/m2) was given three days prior to the first vaccination to reduce the patient’s regulatory T cells. The primary endpoint of the phase 3 study was OS with progression free survival (PFS), overall response rate (ORR), safety, with biomarker and immune analyses being secondary endpoints.
No significant difference in OS was found when IMA901 was added to sunitinib standard first line treatment for patients with metastatic RCC. The study did not demonstrate an association between T-cell responses and clinical outcomes – in contrast to the phase 2 trial with IMA901, which demonstrated a clear link between the patient’s T cell response and OS. The intensity of the immune responses observed in the phase 3 trial when combined with sunitinib was shown to be 3-fold lower than those observed in the previous phase 2 trial, when IMA901 was investigated as single agent.
The trial confirmed that IMA901 had a favorable safety profile with transient injection-site reactions being the most frequent IMA901-related side effect.
Dr. Carsten Reinhardt, Chief Medical Officer of Immatics, said: “It is disappointing that the phase 3 trial did not generate the anticipated overall survival benefit. We will continue to review the data to gain a better understanding of these results. The observation that the magnitude of immune responses was significantly below expectations based on the previous results of IMA901, when acting as a single agent, may partly explain that clinical finding and asks for better means of mounting active immune cells against relevant cancer targets. Immatics remains committed to the validity of its discovery platform and technologies, which we believe will open up a range of indications for treatment with cancer immunotherapy. It is our intention to focus our development efforts from now on our novel Adoptive Cellular Therapies through our recently announced major collaboration with MD Anderson Cancer Center.”
For additional information please contact us via eMail or call +49 (7071) 5397-0.