Erytech reports positive results from Phase II trial of ERY-ASP in pancreatic cancer patients

The trial showed positive Data Safety Monitoring Board (DSMB) safety review following the treatment of the first 24 patients with ERY-ASP.

Around 90 people were included in this multicenter, randomized Phase II trial of ERY-ASP, which was carried out as second-line treatment in patients with metastatic pancreatic cancer.

In the trial, conducted in France, ERY-ASP in addition to the standard of care (Gemcitabine or Folfox regimen) is being compared to the standard of care alone in a 2-to-1 randomization.

The trial’s primary endpoint is progression-free survival (PFS) at four months.

An independent DSMB has performed a pre-planned safety analysis of the first 24 patients treated and it raised no safety concerns, and recommended the continuation of enrollment in the trial.

The company noted that two earlier DSMB reviews recommended proceeding with the combination of ERY-ASP with Gemcitabine and Folfox after safety evaluation of the first three patients in each treatment regimen.

Erytech chief medical officer Iman El-Hariry said: "Our earlier Phase I study in pancreas cancer with ERY-ASP in monotherapy had already suggested a favorable safety profile of the product candidate.

"We are pleased that this DSMB raised no safety concerns for the combination of ERY-ASP with the current standard of care.

"If this safety profile can be confirmed and signals of efficacy can be observed, we believe that the results of this Phase II clinical trial could pave the way for treatment of other solid tumors."