ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that the MTD has been declared in a Phase I investigator sponsored clinical trial (IST), named rESPECT, of its lead product candidate eryaspase for the first-line treatment of pancreatic cancer, defining the recommended dose for future clinical trials in this indication at 100 U/kg (Press release, ERYtech Pharma, OCT 4, 2021, View Source [SID1234590814]).

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After review of the safety data, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no DLT. Consequently, the MTD has been declared at a dose of 100 U/kg eryaspase. Interestingly, all six patients evaluated for response achieved disease control, four patients with objective response and two with stable disease.
The trial will continue to enroll additional patients at the 100 U/kg dose level to further assesss the safety and clinical activity. The declared MTD of 100 U/kg eryaspase corresponds with the dose currently being used in clinical trial in second-line patients and it can now be taken forward into future late-stage clinical studies in first-line pancreatic patients.
Full disclosure of both safety and efficacy information will be made at a future medical congress. Dr Marcus Noel, Associate Professor of Medicine at Georgetown University, Washington DC, USA, commented: "As an oncologist, one of my biggest challenges is the ability to add treatments to existing backbone chemotherapies, such as mFOLFIRINOX, which are already difficult for patients to tolerate. It is highly encouraging that this study has demonstrated the possibility to add a novel treatment, eryaspase, to mFOLFIRINOX without observing DLT. Furthermore, whilst the trial is not designed to answer if eryaspase is efficacious, partial responses in four out of the six patients with imaging are clearly encouraging."
Dr Iman El-Hariry, ERYTECH’s Chief Medical Officer, added: "We are delighted to be working alongside Dr Noel at the University of Georgetown and reaching the important milestone of declaring the MTD of eryaspase in first-line pancreatic patients. We look forward to discussing future study designs with Dr Noel and other Key Opinion Leaders so that we can bring this potentially valuable therapy to first-line pancreatic patients at the earliest opportunity. In the fourth quarter of this year , we also expect top-line results from the TRYbeCA-1 Phase 3 clinical trial in second-line pancreatic cancer. If that trial confirms the survival benefit we observed in the earlier Phase 2 trial, we will plan to launch a pivotal trial in first-line pancreatic cancer and potentially other settings such as locally advanced pancreatic cancer."
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030. Every year, there are approximately 185,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Approximately half of patients are diagnosed with metastatic disease and approximately 30% of patients are diagnosed with locally advanced disease. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate below 10%. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug
combinations with the aim of improving overall patient outcomes and quality of life.