E Celldex Announces Discontinuation Of Phase 3 Trial In Patients With Brain Cancer

Today shares of Celldex Therapeutics (CLDX) fell 53% after the company announced the discontinuation of their phase 3 trial due to insufficient efficacy. The phase 3 trial known as the ACT IV trial recruited up to 745 patients with newly diagnosed Glioblastoma — GBM — who had the EFGRvlll-positive mutation. 

Patients in the trial underwent surgery that removed the tumor, and were then given standard of care. The standard of care was chemotherapy and radiation across the board. Once that was completed, patients were randomized to either receive Celldex’s drug Rintega along with chemotherapy or a control injection along with chemotherapy. 

The trial was stopped after the Data Safety and Monitoring Board — DSMB — concluded that the trial would not reach its clinical endpoint if continued to completion. Therefore this body recommended that the trial be stopped early. Although, patients will be given the option to continue treatment on a compassionate use basis if they choose to do so. 

The trial failed to reduce the death rate in patients. Rintega along with chemotherapy only reduced the risk of death by 1%, which is not a substantial amount. In addition the primary endpoint of the trial was Overall survival — OS. Celldex failed on this clinical endpoint because Rintega increased overall survival by 20.4 months, but the control arm performed better with overall survival of 21.1 months. Because patients in the control arm performed better than Rintega, the drug did not produced statistically significant results to merit completion. 

The  company will save money as they will no longer incur costs for this phase 3 trial. Investors are disappointed by the clinical outcome, but the good news is that Celldex still has a pretty decent pipeline. The company has seven other clinical trial utilizing five other drug candidates that may yield positive results. While still risky, considering the company has multiple shots on goal it wouldn’t be too bad to gamble on one of those trials yielding successful results. The company expect to report out on all these trials over the next 3 to 18 months, and any one of them being positive might help shareholders recoup some losses.