Celldex Therapeutics Inc. stated that it would stop its late-stage study of its vaccine, Rintega, against brain cancer. This is after an independent interim analysis said it won't benefit patient survival compared to standard chemotherapy.
Rintega (rindopepimut) is a drug that stimulates the immune system to kill cancer. It targets genetically mutated tumor found in around a third of all glioblastoma multiforme (GBM) cases, which is roughly 4,000 patients in the country. GBM has no cure and it is the most deadliest and common form of brain cancer, as reported by Reuters.
GBM tumors are known to become immune to initial treatment quickly. Experts say that the newly-diagnosed patients have a median survival rate of 14-15 months once given a standard chemotherapy like Merck and Co's Temodar.
The study shows that the overall survival of patients using Rintega was consistent as seen in mid-stage studies. But the patient's survival on standard chemotherapy was quite higher than expected.
The company board recommends abandoning of the study. Too, the company does not expect "incurring substantial additional costs" regarding the drug's development at the moment.
"We are extremely disappointed for patients that the study was not successful," Anthony Marucci, co-founder, president and CEO of Celldex, said in a statement. "On behalf of Celldex, I want to express our gratitude to the 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," he added, according to Drug, Discovery and Development.
It's quite challenging for drug developers to find an effective therapy for GBM. At the moment, only Dendreon's sipuleucel-T vaccine or Provenge, a cell-based cancer immunotherapy for prostate cancer, has the approval of FDA. On the other hand, Northwest Biotherapeutics is currently working with its DCVax, a vaccine for GBM.
