ERYTECH Pharma enrols first patients in Phase lll trial of eryaspase

21st September 2018 (Last Updated September 21st, 2018 00:00)

ERYTECH Pharma has enrolled the first three patients in the TRYbeCA1 trial, a Phase lll clinical study investigating eryaspase for the treatment of second-line metastatic pancreatic cancer.

ERYTECH Pharma enrols first patients in Phase lll trial of eryaspase
Histopathogic image of pancreatic adenocarcinoma arising in the pancreas head region. Credit: KGH.

ERYTECH Pharma has enrolled the first three patients in the TRYbeCA1 trial, a Phase lll clinical study investigating eryaspase for the treatment of second-line metastatic pancreatic cancer.

The open-label, multicentre, randomised trial aims to enrol around 500 patients with second line metastatic pancreatic cancer across 120-130 clinical sites across Europe and the US.

The enrolled patients are expected to be randomised one-to-one and will be treated with eryaspase in combination with standard chemotherapy or chemotherapy alone until disease progression.

ERYTECH Pharma plans to conduct an interim analysis when approximately two-thirds of events will occur.

The primary endpoint of the trial is overall survival, while the secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and others.

"Our first three enrolled patients mark the initiation of the trial in Europe. Early next year, we expect sites in the US will begin enrolling as well."

The TRYbeCA1 trial is based on the positive results reported in September last year from a Phase llb trial that included same patient population as the TRYbeCA1 study.

The Phase llb trial was an open-label, multi-centre, two-to-one randomised study that included 141 patients.

Results from the trial showed significant improvement in both overall survival and progression-free survival.

ERYTECH Pharma chief medical officer Iman El-Hariry said: “The results from our landmark Phase llb study are highly promising and underscore the importance of targeting tumour metabolism pathways in pancreatic cancer.

“Our first three enrolled patients mark the initiation of the trial in Europe. Early next year, we expect sites in the US will begin enrolling as well.”

In patients with pancreatic cancer, malignant cells are found in the tissues of the pancreas.

Every year, around 150,000 new cases of pancreatic cancer are diagnosed in Europe and the US.