Abstract 1421
Background
Triple Negative Breast Cancer (TNBC) represents approximately 15% of all breast cancer. It confers a poorer prognosis relative to the other breast cancer subtypes, with an increased likelihood of recurrence and death within 5 years of diagnosis. There is no standard of care specifically for patients presenting with TNBC. Altered amino acid metabolism have been shown to play a role in TNBC. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. In a recent randomized phase 2b study, eryaspase has demonstrated evidence of improved overall survival (OS) and progression free survival (PFS) and acceptable safety when combinedwith gemcitabine or FOLFOX therapyinpatients with advanced pancreatic cancer whose disease progressed following first-line treatment (NCT02195180). The demonstration of ASNase activity of eryaspase in combination with chemotherapy including DNA-damaging agents in both preclinical and clinical settings provide a rationale to further test combination in TNBC.
Trial design
TRYbeCA-2 is an international, randomized, open-label phase 2/3 trial (N = 64 for phase 2) of eryaspase combined with chemotherapy in patients with locally recurrent or metastatic TNBC who have not received prior systemic therapy for locally recurrent or metastatic disease. Patients are randomized in a 1:1 ratio to receive gemcitabine/carboplatin with or without eryaspase, administered as IV infusion on Day 1 and Day 8 of each 3-week cycle. Key eligibility criteria include measurable lesion(s), performance status 0 or 1, and adequate organ function. The primary endpoint is the objective response rate (ORR) as determined by an independent radiological review. Key secondary endpoints include ORR as determined by the investigator’s assessment, clinical benefit rate, overall survival, progression-free survival, safety, biomarker research, pharmacokinetics and pharmacodynamics.
Clinical trial identification
NCT03674242.
Editorial acknowledgement
Legal entity responsible for the study
Erytech.
Funding
Erytech.
Disclosure
J. Bertrand: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. A. Clermont: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. R. Pollard: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. R. Chrestia-Blanchine: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. N. Biswas-Baldwin: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. I. El-Hariry: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. All other authors have declared no conflicts of interest.
Resources from the same session
3082 - Prognostic and predictive role of body mass index (BMI) in metastatic colorectal cancer (mCRC): a pooled analisys of TRIBE and TRIBE-2 studies by GONO
Presenter: Emanuela Dell'Aquila
Session: Poster Display session 2
Resources:
Abstract
3618 - Drug holidays and overall survival in patients treated for metastatic colorectal cancer
Presenter: Silvio Ken Garattini
Session: Poster Display session 2
Resources:
Abstract
6111 - Quality of life during 1st-line FOLFOXIRI+/- panitumumab in RAS wild-type metastatic colorectal cancer: Results from the randomized VOLFI trial (AIO KRK-0109)
Presenter: Michael Geissler
Session: Poster Display session 2
Resources:
Abstract
1042 - A biomarker combination indicating resistance to FOLFOX plus bevacizumab in metastastic colorectal cancer : results of phase I of the PERMAD trial
Presenter: Thomas Seufferlein
Session: Poster Display session 2
Resources:
Abstract
3291 - Microsatellite Instability (MSI) status and prognosis in colorectal cancer: meta-analysis
Presenter: James Toh
Session: Poster Display session 2
Resources:
Abstract
2046 - Choosing the right strategy based on individualized treatment effect predictions: Combination versus sequential chemotherapy in patients with metastatic colorectal cancer.
Presenter: Miriam Koopman
Session: Poster Display session 2
Resources:
Abstract
2589 - Noninferiority on overall survival of every-2-weeks vs weekly schedule of cetuximab for first-line treatment of RAS wild-type metastatic colorectal cancer
Presenter: Stefan Kasper
Session: Poster Display session 2
Resources:
Abstract
4944 - POLAF study: Efficacy and safety of FOLFIRI/aflibercept in a phase II trial in patients with metastatic colorectal cancer: Results of plasmatic prognostic and predictive markers
Presenter: Maria Elena Elez Fernandez
Session: Poster Display session 2
Resources:
Abstract
2042 - The accuracy of the clinical PCI score in patients with peritoneal carcinomatosis of colorectal cancer
Presenter: Nadine De Boer
Session: Poster Display session 2
Resources:
Abstract
2667 - The impact of late-line treatment on overall survival (OS) from the initiation of first-line chemotherapy (CT) for patients (pts) with metastatic colorectal cancer (mCRC).
Presenter: Takeshi Kawakami
Session: Poster Display session 2
Resources:
Abstract