Prima BioMed updates CVac development program

Clinical trial focus on second-remission ovarian cancer patient

13-Nov-2013 - Australia

Prima BioMed Ltd provided significant updates to its CVac™ clinical development program.

Prima previously reported all progression-free survival data from its CAN-003 protocol, a 63-patient phase 2 trial of CVac for the treatment of epithelial ovarian cancer in remission after standard first-or second-line treatment. In 20 patients in second remission on the CAN-003 trial, CVac conferred approximately a 50% increase in progression free survival as compared to observation only (7.69 months versus 5.14 months; HR=0.41; p=0.09).

Prima will move forward with a 210-patient phase 2, multicentre, randomized, and controlled trial of CVac for the maintenance treatment of platinum sensitive, epithelial ovarian cancer patients who achieve remission after second-line platinum-based treatment. This trial will be conducted as an amendment to the CAN-004 protocol. The primary endpoint for this study will be Overall Survival (OS); secondary endpoints include progression-free survival (PFS), adverse events, and immune monitoring. Prima will also move forward with a 40-patientpilot, multicentre, single-arm trial of CVac for the maintenance treatment of resected pancreatic cancer patients. This trial will assess OS, PFS, adverse events, and immune monitoring.

Matthew Lehman, Prima’s CEO: “Though based on a small cohort of 20 patients, we are pleased to see a strong clinical signal in the second-remission ovarian cancer patient population from the CAN-003 trial. Ovarian cancer has proven a very difficult cancer to treat. We are excited to move forward with our 210-patient trial of this second-remission patient population. If we are able to confirm similar results as the CAN-003 trial, we would have compelling proof of clinical concept for CVac to treat ovarian cancer.”

The Company further advised that it will not enrol additional first-remission ovarian cancer patients onto the CAN-004 trial and that it will not commence trials of triple-negative breast and colorectal cancers. There are currently 76 randomized patients in first-remission on the CAN-004 trial; these patients will be allowed to continue on the protocol and will be analysed separately to the second-remission cohort.

https://www.bionity.com/en/news/145786/prima-biomed-updates-cvac-development-program.html