ERYTECH Pharma (NASDAQ: ERYP) has reported topline results from the third phase TRYbeCA-1 Clinical study evaluating eryaspase as a second-line metastatic pancreatic cancer treatment in 512 patients. Unfortunately, the study didn’t meet the primary goal of overall survival.
Eryaspase showed a median OS of 7.5 months
In the TRYbeCA-1 study, eryaspase showed a statistically significant improvement in the primary endpoint of OS when compared to chemotherapy alone, with a hazard ratio (HR) of 0.92 in the intent-to-treat population Patients treated with eryaspase and chemotherapy had a median OS of 7.5 months, compared to 6.7 months for chemotherapy alone.
Study principal co-investigator Pascal Hammel said, “While the results are disappointing, we congratulate the company for a very well managed trial in this difficult disease. With a median survival of 7.5 months, ERYTECH has created a new reference standard for clinical evaluation in second line pancreatic cancer.”
Also, Prof Manuel Hidalgo, a co-lead study investigator, said, I agree with Prof Hammel, and want to add that the results in the subgroup of fluoropyrimidine-based treatments are, with a median survival of 8 months, really remarkable and merit further investigation. Especially since this was also the better subgroup in the Phase 2b trial.”
Clinical benefit not confirmed in eryaspase phase 2 study
Commenting on the results, ERYTECH Chief Medical Officer said, “It is very disappointing that the clinical benefit eryaspase demonstrated in the Phase 2 trial was not confirmed; however, the study has addressed important questions in the management of pancreatic cancer patients. I want to thank the patients, their families and healthcare providers, our vendors, as well as our colleagues at ERYTECH, who overcame many obstacles, including the COVID-19 pandemic, to execute this important trial.”
CEO Gul Beyen added, “These results are highly disappointing, not only for the ERYTECH team, but also for patients and healthcare providers as there continues to be a major unmet medical need in pancreatic cancer.”
