Data presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid shows that Erytech Pharma’s eyraspase (graspa) could potentially be an effective treatment in patients with metastatic pancreatic adenocarcinoma.
The open-label, multi-center, randomized Phase 2b clinical study conducted in France assessed the efficacy of eryaspase, a drug which consists of L-asparaginase (L-ASP) encapsulated in red blood cells, as a second-line treatment in combination with chemotherapy in 141 patients with metastatic pancreatic cancer.
L-ASP is an enzyme that degrades asparagine, an amino acid essential for the survival and proliferation of cancer cells.
While metastatic pancreatic cancer is rare, it is currently the 4th
leading cause of all cancer-related deaths in the country. Per the National Cancer Institute, there are an estimated 46,000 new cases of pancreatic cancer in the United States annually, and about 40,000 deaths.
Symptoms of pancreatic cancer don’t present until well after the disease has progressed, often causing a delayed diagnosis and difficulty as it pertains to treatment.
In the study, the drug was added to the current standard of care [gemcitabine or Folfox (leucovorin + fluorouracil + oxaliplatin)] and compared to the standard of care alone in a 2-to-1 randomization. The clinical trial met its co-primary endpoints and established substantial improvement in overall survival (OS) and progression-free survival (PFS).
More specifically, OS and PFS were 26.1 weeks and 8.6 weeks in the eryaspase + standard care group compared to 19.0 weeks and 7.0 weeks in the standard care group. Both endpoints were shown to be statistically significant.
“The full results of this study are highly encouraging and support eryaspase as a potential treatment option for patients with metastatic pancreatic cancer in the second-line setting,” said Professor Pascal Hammel, gastroenterologist-oncologist, lead investigator of the study, and the head of the Oncology Unit at Beaujon Hospital in Paris in a press release
Currently, therapeutic options for pancreatic cancer are inadequate, thus emphasizing the need to develop new strategies and rational drug combinations with the intention of improvement in both patient outcomes and quality of life.
“Despite intense research efforts, limited progress has been made toward increased overall survival and metastatic pancreatic cancer remains a high unmet medical need,” said Dr. Iman El-Hariry, Chief Medical Officer of Erytech. We are quite impressed with this study outcome, particularly with the overall survival advantage demonstrated in the eryaspase arm. These results underscore the importance of targeting the metabolic pathways in pancreatic cancer and potentially other solid tumors.”
Overall, treatment in the study was well-tolerated, with asthenia, nausea and vomiting, and myelosuppression being the most common adverse events (AE) in both arms..
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