ERYTECH Pharma announced top-line results from its Phase 3 TRYbeCA-1 clinical trial evaluatingeryaspase as second-line treatment in 512 patients with metastatic pancreatic cancer. The trial did not meet its primary endpoint of overall survival (OS). In the TRYbeCA-1 trial, eryaspase demonstrated an improvement in the primary endpoint of OS compared to chemotherapy alone with a hazard ratio (HR) of 0.92 (95% confidence interval (CI), 0.76-1.11) in the intent-to-treat population, and the difference was not statistically significant (p-value 0.375). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months (95% CI, 6.5-8.3), compared to 6.7 months (95% CI, 5.4-7.5) for chemotherapy alone. Interestingly, while the patients treated with gemcitabine plus nabpaclitaxel did not experience a survival benefit from the addition of eryaspase, patients treated with eryaspase and an irinotecan-based chemotherapy regimen showed nominal survival benefit with a HR of 0.77 (95% CI, 5.7-1.05) over those treated with chemotherapy alone. This prespecified subgroup had a median OS of 8.0 months in the eryaspase-treated arm versus 5.7 months in the control arm (per protocol population). Key secondary endpoints of the trial, including progression-free survival, disease control rate and objective response rate, showed benefit in favor of eryaspase.
The safety profile of eryaspase observed in the TRYbeCA-1 trial was consistent with earlier observations and previous safety reviews by the trial?s independent data monitoring committee (IDMC). ERYTECH will now focus on its late-stage program in acute lymphoblastic leukemia (ALL) and pursue a path to approval in hypersensitive ALL based on positive results of NOPHO-sponsored Phase 2 trial. The Company reiterates its intention to submit a BLA before the end of the year.