A late-stage study for a brain cancer vaccine has been discontinued, Celldex Therapeutics Inc. announced Monday.
The drug manufacturing company said the results from a preplanned independent analysis found that the vaccine, Rintega, did not appear to boost a patient's survival rate from glioblastoma multiforme (GBM) any more than standard chemotherapy did.
The Data Safety and Monitoring Board's analysis reported that the overall survival rate in patients recently diagnosed with GBM, who were being treated with Rintega in the Phase 3 ACT IV study, was not significantly higher than the survival rate seen in the control group that involved standard chemotherapy treatment.
The experts stated that the Phase 3 results were consistent with the findings from the Phase 2 studies that had reported survival rates at 20.4 months for the Rintega group and 21.1 months for the control group. Based from these findings, the board recommended the company to end the study.
"We are extremely disappointed for patients that the ACT IV study was not successful," Anthony Marucci, Co-founder, president and CEO of Celldex Therapeutics, said in a press release. "On behalf of Celldex, I want to express our gratitude to the ACT IV investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment."
GBM is the deadliest and most common form of brain cancer that affects fewer than 200,000 people within the United States per year. The tumor, which grows and spreads very quickly, can lead to symptoms that include headache, drowsiness, seizures, nausea, blurred vision and personality changes. There is currently no cure for the disease, but treatments, such as chemotherapy and surgery, can help.
Rintega, which is a part of a class of drugs that works by triggering the immune system to recognize and attack cancerous cells, was developed to target a specific genetic mutation that can be found in roughly one-third of all GBM cases.
Celldex currently heads seven clinical trials. The company stated that it expects to report the results from many of these trials over the next three to 18 months.