Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

Brief summary public domain (ClinicalTrials.gov)

This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

Detailed description public domain (ClinicalTrials.gov)

Patients who meet all inclusion and exclusion criteria will be randomized in a 1:1 ratio to one of the following treatment arms (see figure below): * Arm A (investigational arm): eryaspase in combination with either gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI \[FOLinic acid-Fluorouracil-IRInotecan regimen\] or Onivyde®/5 fluorouracil/leucovorin), or * Arm B (control arm): gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI or Onivyde/5-FU/leucovorin) The chemotherapy will be investigator's choice and based on what patient has received in first line treatment. Treatment will continue until disease progression, unacceptable toxicity, or the patient's withdrawal of consent. An End of Treatment visit should occur within approximately 30 days from last dose of eryaspase or chemotherapy regimen. A survival follow-up period will include the collection of survival, progression of disease if applicable, treatment updates, and quality of life assessments every 8 weeks.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [~12 months]. Median, months (95% Confidence Interval). Eryaspase Plus Chemotherapy (n=255): 7.5 (6.5 to 8.3); Chemotherapy Alone (n=257): 6.7 (5.4 to 7.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [~24 weeks]. Median, months (95% Confidence Interval). Eryaspase Plus Chemotherapy (n=255): 3.7 (3.4 to 4.1); Chemotherapy Alone (n=257): 3.4 (2 to 3.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) [~24 weeks]. Count Of Participants, Participants. Eryaspase Plus Chemotherapy (n=255): 41; Chemotherapy Alone (n=257): 32.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response (DoR) [~24 weeks]. Median, months (95% Confidence Interval). Eryaspase Plus Chemotherapy (n=255): 5.7 (3.9 to 7.4); Chemotherapy Alone (n=257): 6.8 (2.8 to 7.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR) [~24 weeks]. Count Of Participants, Participants. Eryaspase Plus Chemotherapy (n=255): 147; Chemotherapy Alone (n=257): 126.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0 [~9 months]. Number, participants. Number of patients with treatment emergent adverse events (TEAE): Eryaspase Plus Chemotherapy (n=248): 248; Chemotherapy Alone (n=246): 246. number of patients with TEAE >= Grade 3: Eryaspase Plus Chemotherapy (n=248): 195; Chemotherapy Alone (n=246): 176. Number of patients with TE SAE: Eryaspase Plus Chemotherapy (n=248): 122; Chemotherapy Alone (n=246): 105. Number of patients with TEAEs leading to study drug discontinuation: Eryaspase Plus Chemotherapy (n=248): 46; Chemotherapy Alone (n=246): 41. Number of patients with TE SAE with outcome of death: Eryaspase Plus Chemotherapy (n=248): 14; Chemotherapy Alone (n=246): 9.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis [~1 year]. Median, months (95% Confidence Interval). Eryaspase Plus Chemotherapy (n=228): 4.0 (3.1 to 5.1); Chemotherapy Alone (n=229): 3.6 (2.8 to 4.7).