ERYTECH Announces Poster Presentations at ASCO 2020 Annual Meeting
LYON, France and CAMBRIDGE, Mass., June 01, 2020 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, announces the presentation of two posters at the American Society of Clinical Oncology (ASCO) 2020 Virtual Meeting.
1. Trial in Progress Poster for the ongoing Phase 3 TRYbeCA1 trial (Abstract # TPS4666)
TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients in approximately 100 clinical sites in Europe and the U.S. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival (OS). The trial is designed to identify a OS hazard ratio (HR) of 0.72 with close to 90% power. An interim efficacy analysis is planned for when approximately two- thirds of events have occurred. To date, approximately 80% of the patients have been enrolled.
Prof Pascal Hammel, MD, PhD, gastroenterologist-oncologist at Beaujon Hospital in Paris and co-principal investigator of the study, commented, “Patients with advanced pancreatic cancer need new treatment options, particularly in second line treatments after failure of gemcitabine-Nab-paclitaxel or FOLFIRINOX combinations. The Trial-in-Progress poster demonstrates that we are making excellent progress toward completing enrolment of this important international study and I look forward to the outcome of the planned interim analysis for superiority towards the end of 2020.”
2. ctDNA is prognostic and potentially predictive of eryaspase efficacy in patients with advanced pancreatic adenocarcinoma (Abstract #4617)
Eryaspase is composed of L-asparaginase encapsulated in erythrocytes and has demonstrated significant efficacy in a randomized Phase 2 trial1. Prognostic and predictive value of circulating tumor DNA (ctDNA) investigated in this trial.
The analysis from this prospective randomized trial confirmed that the presence of ctDNA at baseline is a strong prognostic factor, and that the early change of ctDNA correlates with treatment outcome. ctDNA could therefore be a potential predictive biomarker of eryaspase efficacy.
Dr Bachet from Sorbonne Université, UPMC Université, IUC, Paris France commented, “The feasibility of this approach and its potential prognostic value provides a rationale for stratifying patients in future clinical trials. Our results suggest that presence of ctDNA could be a predictive biomarker of eryaspase efficacy which needs to be confirmed from the ongoing phase 3 clinical trial.”
“We are excited about this state-of-the art ctDNA analysis. We will continue our endeavour to investigate ctDNA and other biomarker platforms in the ongoing Phase 3 trial to further understand the efficacy of eryaspase in different patient subsets,” said Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH Pharma. “We continue to be encouraged by the progress of our Phase 3 trial, despite the unprecedented times due to COVID-19. We are thankful to all our investigators who continued to enrol patients in the study and adhere to our guidelines dealing with potential COVID-19 impact.”
Both posters are available to view online at the ASCO Virtual meeting website: https://meetings.asco.org/am/virtual-format
About pancreatic cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year there are about 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10% and is currently the fourth most common cause of cancer death in the EU for men and women.
About ERYTECH and eryaspase
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.
The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of first-line triple-negative breast cancer. An investigator-sponsored Phase 2 study in second-line acute lymphoblastic leukemia is ongoing in the Nordic countries of Europe.
ERYTECH produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France, and for patients in the United States at its GMP manufacturing site in Princeton, New Jersey, USA.
ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
For more information, please visit www.erytech.com
- ERYTECH Pharma
- ERYTECH Pharma