The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Adding eryaspase to chemotherapy does not improve survival outcomes for patients with advanced pancreatic cancer, according to phase 3 results presented at the ASCO Gastrointestinal Cancers Symposium 2022.1

A prior phase 2b trial suggested that adding eryaspase to chemotherapy could improve both overall survival (OS) and progression-free survival (PFS) in patients with advanced pancreatic cancer.2 However, results from the phase 3 TRYbeCA-1 trial showed no significant improvement in OS or PFS when eryaspase was added to chemotherapy.

TRYbeCA-1 (ClinicalTrials.gov Identifier: NCT03665441) enrolled 512 patients with stage III-IV pancreatic adenocarcinoma who had progressed on 1 prior line of systemic therapy. 


Continue Reading

The patients were randomly assigned to receive chemotherapy alone (257 patients) or in combination with eryaspase (255 patients). Chemotherapy consisted of gemcitabine plus nab-paclitaxel (58% in each arm) or leucovorin, irinotecan, and fluorouracil (FOLFIRI; 42% in each arm).

Baseline characteristics were well balanced between the treatment arms. The median age was 63 years in both arms (overall range, 30-85 years). About 99% of patients in each arm had stage IV disease, and the median time from advanced disease diagnosis to random assignment was 9 months.

Results

More than 90% of patients in each arm discontinued study treatment, most due to progressive disease. Half of patients received subsequent anticancer therapy.

The researchers found no significant difference in median OS between the eryaspase arm and the chemotherapy-alone arm — 7.5 months and 6.7 months, respectively (hazard ratio [HR], 0.92; 95% CI, 0.76-1.11; P =.469).

The researchers did note a trend toward an OS benefit with eryaspase among patients who received FOLFIRI. The median OS was 8.0 months with eryaspase-FOLFIRI and 5.7 months with FOLFIRI alone (HR, 0.81; log rank P =.238).

However, there was no such trend among patients who received gemcitabine plus nab-paclitaxel. In this group, the median OS was 7.0 months with eryaspase and 6.9 months with the chemotherapy regimen alone (HR, 1.01; log rank P =.967).

Likewise, there was no significant difference in median PFS between the eryaspase arm and the chemotherapy-alone arm — 3.7 months and 3.4 months, respectively (HR, 0.89; 95% CI, 0.73-1.07; P =.178).

On the other hand, the disease control rate was significantly higher in the eryaspase arm than the chemotherapy-alone arm — 57.6% and 49.0%, respectively (P =.047).

The most common grade 3 to 4 adverse events (in the eryaspase and chemotherapy-alone arms, respectively) were neutropenia (25.4% and 20.3%), anemia (17.3% and 12.2%), asthenia (16.9% and 13.8%), and thrombocytopenia (11.3% and 9.8%).

Disclosures: This research was supported by ERYtech Pharma. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Read more of Cancer Therapy Advisor’s coverage of ASCO GI 2022 by visiting the conference page.

References

  1. Hammel P, El-Hariry I, Macarulla T, et al. Trybeca-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with advanced pancreatic adenocarcinoma (NCT03665441). Presented at ASCO GI 2022; January 20-22, 2022. Abstract 518.
  2. Hammel P, Fabienne P, Mineur L, et al. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized phase IIb trial. Eur J Cancer. 2020;124:91-101. doi:10.1016/j.ejca.2019.10.020