ERYTECH Announces Positive Full Results from Phase 2b Study of Eryaspase in Combination with Chemotherapy for Treatment of Metastatic Pancreatic Cancer in Second-Line
- Full data demonstrates statistically significant improvement in both overall survival and progression-free survival for eryaspase as second-line treatment of metastatic pancreatic cancer
-
Data to be presented at the
European Society for Medical Oncology (ESMO) Annual Meeting inMadrid (September 8-12 ) -
Meeting with U.S.
FDA upcoming to discuss the design of Phase 3 study -
Company to host Investor & Analyst Event with live webcast,
Monday, September 11 ,6:15 p.m. CEST /12:15 p.m. EDT
The Phase 2b study evaluated eryaspase, L-asparaginase encapsulated in
red blood cells, as a second-line treatment in combination with
chemotherapy in 141 patients suffering from metastatic pancreatic
cancer. In this study, conducted in
As reported in topline results earlier this year, the study met its co-primary endpoints of OS and PFS with Hazard Ratios (HR) below 0.85 in patients with no or low asparagine synthetase expression (ASNS 0/1), approximately 70% of the study population, and demonstrated statistically significant improvements of OS and PFS in the entire patient population. The associated sensitivity analyses and subgroup evaluations indicate the consistent treatment benefit with eryaspase across the treated populations.
Principal Investigator Professor
Highlights of the study results include:
-
Co-primary endpoints met:
- HR of 0.65 for OS and 0.72 for PFS in the ASNS 0/1 patient population
-
Statistically significant improvement of OS and PFS in the entire
patient population:
-
HR of 0.60 for OS (95% CI; 0.40, 0.88) (p=0.009)
- median OS of 26.1 weeks (95% CI; 21.0, 28.4) in the eryaspase arm vs. 19.0 weeks (95% CI; 12.3, 26.3) in the standard of care arm
- one-year survival of 14.8% vs. 3.0%, respectively
-
HR of 0.59 for PFS (95% CI; 0.40, 0.89) (p=0.011)
- median PFS of 8.6 weeks (95% CI; 7.6, 14.6) in the eryaspase arm vs. 7.0 weeks (95% CI; 6.1, 7.6) in the standard of care arm
- 16.9% of patients without disease progression at 24 weeks vs. 5.8%, respectively
-
Improved objective response rate (ORR) and disease control rate
(DCR) in the entire patient population:
- ORR of 11.6% in the eryaspase arm vs. 6.5% in the standard of care arm
- DCR of 47.4% in the eryaspase arm vs. 23.9% in the standard of care arm
-
Patients with high ASNS-expressing tumors (ASNS2/3) had a worse
prognosis, but also a better relative treatment benefit:
- HR of 0.45 for OS and 0.38 for PFS
- DCR of 51.7% in the eryaspase arm vs. 7.1% in the standard of care arm
-
The toxicity profile was similar in the two treatment arms:
- The percentage of patients with at least one Grade 3 or 4 adverse event (AE) was 77% in the eryaspase-treated arm compared to 86% in the control arm. The most common Grade 3 or 4 AEs were: increased gamma-glutamyl transferase (17% vs. 25%), neutropenia (13% vs. 11%), general health deterioration (13% vs. 2%), and thrombocytopenia (10% vs. 7%), respectively.
- The percentage of patients with at least one serious adverse events (SAE) was 45% in the eryaspase-treated arm compared to 50% in the control arm. The most common SAEs were: general health deterioration (9% each), gastro-intestinal hemorrhage (2% vs. 7%, respectively).
-
HR of 0.60 for OS (95% CI; 0.40, 0.88) (p=0.009)
Dr.
“We are very pleased by the results from this landmark study. The
full picture emerging from these data shows a robust clinical benefit in
this particularly difficult-to-treat and highly morbid form of cancer,”
said
The full poster presentation will be accessible on
ERYTECH will also host an investor and analyst event on
For those unable to attend, a live webcast will be accessible at the
start of the event starting at
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
approximately 150,000 new cases of pancreatic cancer diagnosed in
About ERYTECH and eryaspase (GRASPA®): www.erytech.com
Founded
in
The company’s lead product, eryaspase, also known under the trade name GRASPA®, consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase degrades asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells. L-asparaginase has been a standard component of multiagent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.
Eryaspase demonstrated positive efficacy and safety results in different
studies in ALL, including in a Phase 2 study in elderly patients with
ALL, and a Phase 2/3 study in children and adults with relapsed or
refractory ALL. The positive results of its Phase 2b clinical trial in
second line metastatic pancreatic cancer mark a first step in solid
tumors. ERYTECH also has an ongoing Phase 1 clinical study of eryaspase
in
ERYTECH produces eryaspase at its own GMP-approved and operational
manufacturing site in
In addition to eryaspase, ERYTECH is developing two other product candidates that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies.
ERYTECH is listed on
Forward-looking information
This press release contains forward-looking statements, forecasts and
estimates with respect to the clinical development plans, business and
regulatory strategy, and anticipated future performance of ERYTECH and
of the market in which it operates. Certain of these statements,
forecasts and estimates can be recognized by the use of words such as,
without limitation, “believes”, “anticipates”, “expects”, “intends”,
“plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar
expressions. They include all matters that are not historical facts.
Such statements, forecasts and estimates are based on various
assumptions and assessments of known and unknown risks, uncertainties
and other factors, which were deemed reasonable when made but may or may
not prove to be correct. Actual events are difficult to predict and may
depend upon factors that are beyond ERYTECH's control. There can be no
guarantees with respect to pipeline product candidates that the
candidates will receive the necessary regulatory approvals or that they
will prove to be commercially successful. Therefore, actual results may
turn out to be materially different from the anticipated future results,
performance or achievements expressed or implied by such statements,
forecasts and estimates. Documents filed by
View source version on businesswire.com: http://www.businesswire.com/news/home/20170907006616/en/
Source:
ERYTECH
Naomi Eichenbaum, +1-917-312-5151
Director
of Investor Relations
naomi.eichenbaum@erytech.com
or
The
Ruth Group
Lee Roth, +1-646-536-7012
Investor
relations
lroth@theruthgroup.com
or
Kirsten
Thomas, +1-508-280-6592
Media relations
kthomas@theruthgroup.com
or
NewCap
Julien
Perez, +33 1 44 71 98 52
Investor relations
or
Nicolas
Merigeau, +33 1 44 71 98 52
Media relations
erytech@newcap.eu