Eryaspase, a novel drug candidate, is being evaluated in patients with second-line metastatic pancreatic cancer and those with metastatic triple-negative breast cancer.
A novel drug candidate, eryaspase, is being evaluated to target cancer cells’ altered amino acid metabolism – particularly in metastatic pancreatic and triple-negative breast cancer (TNBC).
In the phase 3 TRYbeCA1 trial, researchers are evaluating the agent in combination with standard chemotherapy – either gemcitabine, nab-paclitaxel or an irinotecan-based regimen – compared to chemotherapy alone in patients with second-line metastatic pancreatic cancer. In April, more than 75% of the approximately 500 patients to be enrolled in the trial have been assigned to either the new treatment group or the standard chemotherapy group. The primary end point of the trial is overall survival.
ERYTECH Pharma, the agent’s manufacturer, noted that an interim superiority analysis will be conducted by an independent data monitoring committee when two-thirds of the events have occurred. They added that this is expected to take place by the end of 2020 and the final analysis in the second half of 2021.
The independent data monitoring committee reviewed the safety data for the first 320 patients enrolled in April, and found no safety issues in the trial.
“The third independent safety review has once again confirmed the favorable safety profile of our lead product candidate eryaspase, and the trial has now surpassed 75% of the planned target enrollment,” Gil Beyen, CEO of ERYTECH, said in a press release. “…In addition, and unrelated to COVID-19, the average time to events appears longer than originally expected.”
In April, the Food and Drug Administration granted fast track designation to eryaspase for this indication, potentially expediting its development and review as it is intended to treat a serious or life-threatening condition and address an unmet medical need.
Previously, in an open-label, randomized, multicenter phase 2b trial, eryaspase significantly improved overall survival, reducing the risk of death by 40%, and progression-free survival (the time from treatment to disease progression or worsening). Moreover, in the trial, the agent was well tolerated, showing a safety profile comparable to that of standard chemotherapy.
“This clinical trial represents the first time an asparaginase-based therapy has been reported to have a survival benefit in a solid tumor indication,” according to ERYTECH. “This trial forms the basis for our strategy to explore the further development of eryaspase for the treatment of pancreatic cancer and other solid tumor indications.”
Triple-Negative Breast Cancer
Following the positive data in patients with pancreatic cancer, ERYTECH expanded evaluation of eryaspase to TNBC.
“TNBC is an aggressive and metabolically active form of breast cancer with high rates of symptomatic metastases,” noted ERYTECH.
For this indication, eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in the first-line setting is being evaluated in the ongoing phase 2/3 TRYbeCA2 trial among patients with metastatic TNBC. The researchers aim to enroll 64 patients in phase 2 of the trial, with a primary end point of objective response rate.