Date: 2017-12-08
Type of
information: Results
phase: 2b
Announcement: completion of patient enrollment
Company: Erytech Pharma (France)
Product: Ery-asp®/Graspa® (eryaspase - L-asparaginase loaded erythrocytes)
Action
mechanism:
- enzyme. Ery-asp®/Graspa® is a new formulation of L-asparaginase encapsulated inside donor-derived red blood cells through Erytech’s proprietary ERYCAPS technology platform. The enzyme degrades asparagine, an amino acid that is essential for the tumor cells to grow and multiply, which starves and eventually kills the cancer cells.
- In February 2013, the European Medicines Agency (EMA) granted Graspa® the orphan drug status for the treatment of acute myeloid leukemia.
Disease: acute myeloid leukemia
Therapeutic
area: Cancer - Oncology
Country: 38 European countries
Trial
details:
- This study is a multicentre randomized controlled Phase IIb trial evaluating efficacy and tolerability of Graspa® in the treatment of newly diagnosed AML patients over 65 years old that are unfit for intensive chemotherapy. In this 123 patients study one-third of the patients receive the current standard treatment (low-dose cytarabine) and two-thirds receive low-dose cytarabine plus Graspa®. The study was initiated in March 2013 and is performed in collaboration with Orphan Europe (Recordati Group) Erytech’s partner for the commercialization of Graspa® in 38 pays European countries (NCT01810705)
Latest
news:
- • On December 8, 2017, Erytech Pharma announced topline results from its Phase 2b clinical study evaluating eryaspase (Graspa®) for the treatment of acute myeloid leukemia. The open-label, randomized, multi-center clinical study, evaluated eryaspase in newly diagnosed acute myeloid leukemia patients over the age of 65 and unfit for intensive chemotherapy. The study enrolled a total of 123 patients at 30 European sites. The median age of the patients was 78 years.
- Patients were randomized two-to-one to receive eryaspase in combination with low-dose cytarabine (LDAC) versus LDAC alone. The primary endpoint in this proof-of concept study was overall survival (OS). The key secondary endpoints included progression free survival, overall response and toxicity. The study was performed in collaboration with Orphan Europe (Recordati Group), Erytech's partner for the anticipated commercialization of Graspa® for the treatment of ALL and AML in Europe.
- The study did not meet its primary endpoint of overall survival (OS). The OS Hazard Ratio (HR) was 1.06 (95% CI; 0.70, 1.61). When adjusting for minor imbalances in the main prognostic factors at baseline (age, karyotype and FAB status), the OS HR was 0.98 (95% CI; 0.64, 1.50). The median number of months on treatment was less then 2 months in both treatment arms. The toxicity profile was acceptable and consistent with previously reported data for eryaspase. "These data reflect the complexity of this disease, particularly in the older age group." commented Iman El-Hariry, MD, PhD, Chief Medical Officer of Erytech. The full dataset will be discussed at a scientific congress in 2018.
- • On August 29, 2016, Erytech Pharma announced that it has reached full patient enrollment in the Phase 2b trial of eryaspase for the treatment of acute myeloid leukemia.The open-label, randomized, multi-center clinical trial, which is being conducted at more than 20 sites in Europe, has completed enrollment of a total of 123 patients and is on track for reporting of primary data in the second half of 2017. Patients enrolled in the trial are over the age of 65, newly-diagnosed with AML, and unable to receive intensive chemotherapy. The primary endpoint is overall survival (OS) at one year.
- • On January 6, 2016, Erytech Pharma announced that an independent Data and Safety Monitoring Board (DSMB) completed its third safety assessment of the company’s Phase 2b ENFORCE 1 study in acute myeloid leukemia and that enrollment will continue until completion. The study is a multinational, randomized, controlled Phase 2b trial evaluating the efficacy and tolerability of Graspa® in the treatment of newly diagnosed AML patients over 65 years of age and unfit for intensive chemotherapy. The primary endpoint of the study is overall survival (OS) following a recently approved protocol amendment, changing the endpoint from progression free survival (PFS) to OS. OS is considered a more robust endpoint in this indication.
- Today, more than 90% out of a total of 123 patients to be treated have been enrolled in the study in over 20 active centers in France, Spain, Finland, Norway and Italy.
- The third DSMB safety review, now with 105 patients treated, again raised no safety concerns. The DSMB noted that their observations regarding the main endpoints are unlikely to change with the additional patients, although the statistical power should be improved. Based on the DSMB comments, Erytech decided to continue enrolment into the trial until completion, which is expected during the first quarter of 2016. Primary results are expected in 2017.
- • On August 27, 2014, Erytech Pharma announced that an independent Data and Safety Monitoring Board (DSMB) completed its second safety assessment of the company’s Phase IIb study in acute myeloid leukemia and unanimously recommended continuation of the trial without modification. This second DSMB assessment was based on a pre-planned safety analysis on the first 60 patients included in the study and with a minimum of 1 month follow-up. The next step will be another DSMB analysis, this time for safety and futility, when 60 patients will have experienced an event in the study. This analysis is anticipated towards the end of this year.
- • On January 15, 2014, Erytech Pharma has announced it received authorizations for its Phase IIb GRASPA-ML clinical trial in acute myeloid leukemia in Finland and Spain. The study was first launched in France in March 2013, where to-date more than one third of the patients (out of a total of 123 patients to be recruited to complete the study) have been enrolled. The opening of centers in additional countries is adding international credibility and visibility to the study and is expected to further accelerate the pace of patient recruitment. Next to France, Spain and Finland, additional countries are expected to be authorized in the coming months.
- • On November 11, 2013, Erytech Pharma has announced that an independent Data and Safety Monitoring Board (DSMB) completed its first assessment of the company’s Phase IIb study in acute myeloid leukemia study and unanimously recommended continuation of the trial without modification. The DSMB assessment was based on a pre-planned safety analysis on the first 30 patients included in the study and with a minimum of 1 month follow-up. A second DSMB review is planned when 60 patients will be treated in the study.
- • On July 4, 2013, Erytech Pharma has announced a fast take-off of its Phase IIb study in acute myeloid leukemia. The study, a multicentre, open, randomized, controlled Phase IIb trial evaluating efficacy and tolerability of Graspa® in the treatment of newly diagnosed acute myeloid leukemia patients, over 65 years, unfit for intensive chemotherapy, was initiated in March 2013. In the mean time and in line with the planning, all 21 French investigation sites have been authorized to participate in the study. With 13 of these sites having been initiated and opened so far, already 12 out of a total of 123 patients have been enrolled in the study. The current pace of inclusion shall enable Erytech to recruit the last patient in the study before the end of 2014. In parallel to the patient recruitments realized in France, it is foreseen to open other specialized centers in different European countries in view of internationalizing the study and further accelerating patient enrollment.
- The study is performed in collaboration with Orphan Europe (Recordati Group), Erytech’s partner for the commercialization of GRASPA® in 38 pays European countries, under a licensing and distribution agreement that was signed at the end of 2012.
Is
general: Yes
