2022 ASCO GI Sneak Peek | Can the innovative drug eraspase break through the fog of pancreatic cancer treatment?

The 2022 American Society of Clinical Oncology Symposium on Gastrointestinal Oncology (ASCO-GI) will be held from January 21 to 23, local time. Recently, the content of the 2022 ASCO-GI abstract was officially announced, and a number of blockbuster studies will be announced soon. Pancreatic cancer is a malignant tumor of the digestive tract with a high degree of malignancy, difficult to diagnose and treat, and there are currently several new generations of drugs trying to treat pancreatic cancer by restoring damaged apoptosis signaling pathways. The results of a randomized Phase 3 study (Trybeca-1) of ERYASPASE plus chemotherapy versus chemotherapy alone as second-line treatment for patients with advanced pancreatic cancer will be presented at this ASCO GI conference.

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Eryaspase consists of L-asparaginase encapsulated in donor-derived red blood cells that act on cancer cell-altered asparagine and glutamine metabolism. An early stage IIb study in patients with advanced pancreatic cancer showed that eryaspase combined with chemotherapy improved overall survival (OS) and progression-free survival (PFS).

method:

TRYbeCA-1 is a randomized, open-label Phase III trial in which eryaspase is combined with chemotherapy for patients with advanced pancreatic adenocarcinoma who have previously received only one systemic anticancer therapy, randomized 1:1 with gemcitabine/albumin-binding paclitaxel or irinotecan/fluorouracil (depending on the first-line treatment received), with or without eryaspase, given in ivy every 4 weeks for 1 cycle on days 1 and 15. Admission criteria include progression on or after first-line systemic therapy, ECOG fitness status 0 or 1, stage III-IV disease, documentary evidence of disease progression, effective tumor tissue, and adequate organ function. The main endpoint is os.

outcome:

A total of 512 patients were included in the study. Baseline features are balanced between treatment groups. The study did not achieve the primary endpoint for OS [HR:0.92 (95% confidence interval (CI), 0.76-1.11), p=0.375]. The median OS in patients receiving eryaspase plus chemotherapy was 7.5 months (95% CI, 6.5 to 8.3), compared with 6.7 months (95% CI, 5.4 to 7.5) in the chemotherapy group alone. Compared with 109 patients in the control group, 107 patients treated with eryaspase and irinotecan-5FU had a trend of OS benefit, with median OS being 8.0 months and 5.7 months [HR: 0.81 (95% CI: 0.60-1.09)]. The efficacy of various prognostic factors is consistent. The median PFS of eryaspase and control groups was 3.7 months and 3.5 months, respectively [HR: 0.89 (95% CI: 0.73-1.07), p=0.215]. The disease control rates of eryaspase and control groups were 57.6% and 49.0%, respectively (p=0.047). The most common adverse events in the eryaspase group were weakness, diarrhoea, and anaemia (incidence rates of grades 3 to 4 were 16.9%, 7.66%, and 17.3%, respectively). Eryaspase does not appear to enhance the toxicity of chemotherapy.

conclusion:

This large prospective study did not achieve the primary endpoint for improving OS in patients. However, the well tolerated and encouraging survival benefits shown in the eryaspase combined irinotecan/5FU subgroup warrant further study.

bibliography:

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).2022 ASCO GI.