TRYbeCA-1: Eryaspase + chemotherapy does not meet primary endpoint in pancreatic cancer

Eryaspase plus chemotherapy did not significantly outperform chemotherapy alone in the second-line treatment for patients with advanced pancreatic adenocarcinoma. However, the phase 3 TRYbeCA-1 study did suggest an advantage of additional eryaspase for resectable patients and patients with low or normal CA19-9 levels at baseline [1].

A phase 2 trial showed promising activity of eryaspase, an L-asparaginase within red blood cells, when added to FOLFOX or gemcitabine chemotherapy as a second-line therapy for patients with advanced pancreatic cancer [2]. Prof. Pascal Hammel (Université Paris VII, France) presented the results of the phase 3 TRYbeCA-1 trial (NCT03665441), in which 512 patients with stage III or IV pancreatic cancer, who underwent 1 previous line of chemotherapy, were randomised 1:1 to chemotherapy alone (gemcitabine + nab-paclitaxel, or FOLFIRI), or chemotherapy plus eryaspase. The primary endpoint was overall survival (OS).

The median OS for patients receiving the eryaspase plus chemotherapy regimen was not significantly longer than the median OS for patients receiving chemotherapy alone (7.5 vs 6.7 months; P=0.469). The median progression-free survival was 3.7 months and 3.4 months for patients in the eryaspase arm and patients in the chemotherapy alone arm, respectively. The disease control rate was higher in the eryaspase arm compared with the chemotherapy alone arm (57.6% vs 49.0%; P=0.047). Notably, a trend in the OS analysis suggested that patients on FOLFIRI chemotherapy may benefit from additional eryaspase (median OS of 8.0 vs 5.7 months). In addition, subgroup analyses revealed that resectable patients (HR 0.53; 95% CI 0.32–0.87) or patients with low or normal CA19-9 levels (HR 0.49; 95% CI 0.27–0.90) may benefit more from the addition of eryaspase to chemotherapy. Future studies should investigate whether these biologically favourable subgroups indeed benefit from eryaspase.

Eryaspase did not significantly increase adverse events. However, haematologic events, such as neutropenia (25.4% vs 20.3%) and anaemia (17.3% vs 12.2%) were more common in the eryaspase arm. Dr Hammel concluded that the addition of eryaspase did not elevate the toxicity of chemotherapy.

1. Hammel P, et al. A Randomized Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-line Treatment in Patients with Pancreatic Adenocarcinoma – TRYbeCA-1 Study. Abstract 518, ASCO GI 2022, 20–22 January.
2. Hammel P, et al. Eur J Cancer. 2020;124:91–101.

 

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Posted on 21 March 202217 May 2024