- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Novel Cancer Vaccine Receives Orphan Drug Designation for Renal Carcinoma
Patient recruitment completed for phase III trial (Nov. 8)
An experimental cancer vaccine (IMA901, Immatics Biotechnologies) has been granted orphan drug designation from the FDA for the treatment of patients with renal cell carcinoma (RCC) who are positive for human leukocyte antigen (HLA)-A*02. The FDA grants orphan drug designation to novel drugs aimed at treating rare diseases or conditions.
In addition, patient recruitment has been completed for a pivotal phase III trial evaluating IMA901 in patients with RCC. It is anticipated that approximately 345 patients will be enrolled into the trial in the U.S. and Europe. The first (interim) overall survival results are expected during the first half of 2014, and final data will be reported in 2015.
The IMA901 vaccine contains multiple tumor-associated peptides.
The phase III IMPRINT (IMA901 MultiPeptide vaccine Randomized INTernational) trial is designed to demonstrate an overall survival benefit with IMA901 in combination with sunitinib (Sutent, Pfizer) in comparison with sunitinib alone in patients with metastatic and/or locally advanced RCC. The study’s secondary endpoints include the patients’ immune response to the peptides contained in IMA901, progression-free survival, safety, and tolerability.
The study aims to build on survival and immune-response data from a phase II trial of IMA901 in patients with advanced RCC. These data showed that patients who produced an immune response to two or more of the tumor-associated peptides contained in IMA901 had significantly longer survival.
Key data from the scientific and clinical development of IMA901 were recently published in Nature Medicine.
Source: Immatics Biotechnologies; November 8, 2012.