After seeing an overall survival benefit in a mid-stage study of eryaspase in pancreatic cancer, Erytech Pharma likely thought a phase 3 would be in the bag.
But the results are out (PDF) and the late-stage trial did not confirm the earlier result. The French biopharmaceutical company will now shift focus to developing the therapy in acute lymphoblastic leukemia, or ALL.
Shares of the company were sent sliding downwards 36% to $3.47 as the markets opened Monday, compared to a prior close of $5.48.
Eryaspase was being studied in a phase 3 trial called TRYbeCA-1 for 512 patients with second-line advanced pancreatic cancer. The company was hoping to see improvement in overall survival among the patients who received the therapy, but that main endpoint was unsuccessful. Erytech said there was an improvement on this measure, but the results were not statistically significant. Patients treated with eryaspase plus chemotherapy had a median overall survival of 7.5 months compared to 6.7 for chemotherapy alone.
The therapy did, however, demonstrate “an interesting trend of survival benefit,” according to Erytech, which “merits further investigation.”
Erytech also saw a slight improvement in overall survival in a subgroup of patients who received eryaspase plus an irinotecan-based chemotherapy regimen. This group had an overall survival of eight months compared to 5.7 months in the group that received just chemotherapy with gemcitabine plus nabpaclitaxel.
Other secondary endpoints, including progression-free survival, disease control rate and objective response rate “showed benefit in favor of eryaspase,” according to Erytech. Safety was consistent with previous studies.
Additional analysis will be conducted on the data with results presented at an upcoming medical meeting.
Erytech still has hope for eryaspase and will move forward with a filing in the ALL indication before the end of the year. The company previously reported positive results in a phase 2 clinical trial in this type of cancer.
“Pancreatic cancer is a very challenging, heterogeneous disease, and the results of the TRYbeCA-1 phase 3 trial have now also encountered this significant hurdle,” said Erytech Chief Medical Officer Iman El Hariry, M.D., Ph.D. “It is very disappointing that the clinical benefit eryaspase demonstrated in the phase 2 trial was not confirmed.”
That phase 2b trial showed an improvement in overall survival and progression-free survival in patients who took eryaspase. Patients also saw a 40% reduction in death rate. The study was similarly sized to the phase 3.
The therapy flopped a phase 2b trial in acute myeloid leukemia back in 2017 shortly after the company made its debut on the public markets.
CEO Gil Beyen said the company will provide a corporate update after evaluating “our strategic and partnering options” following the late-stage failure.
Eryaspase aims to treat pancreatic cancer by disrupting metabolic pathways that can lead to disease. The therapy is believed to break down asparagine, an amino acid that serves as a nutrient for cancer cells.