Erytech Could Launch Several New Studies Following Pancreatic Cancer PhII Success
Executive Summary
Erytech's lead therapy has shown strong anti-cancer activity in pancreatic cancer, on top of the hematological indications it is already targeting in late-stage trials, spelling good news for the French firm to pursue more studies in other oncology indications such as ovarian cancer.
French biotech Erytech Pharma SA is likely to pursue expedited regulatory submissions for its second-line pancreatic cancer therapy, eryaspase, on the back of strong topline Phase IIb data; as well as assess its options in other solid tumor indications now that the treatment has demonstrated positive effects in oncological and hematological cancers.
Analysts at Jefferies are predicting peak worldwide sales of $500m for eryaspase and have given the therapy an 80% probability rating for a successful approval.
Erytech's treatment, known as Graspa in the EU, met both co-primary endpoints in the Phase IIb second-line pancreatic cancer study, significantly improving progression-free survival (PFS) and overall survival (OS) in patients with low asparagine synthetase (ASNS) expression.
Jefferies analysts noted that "importantly the benefit was irrespective of ASNS expression." Median OS was 26.1 weeks versus 19.0 weeks (HR=0.57; p=0.034) in the entire patient population, with similar results for PFS.
"Given this impressive result we envisage regulatory discussions to potentially lead to expedited filings," Jefferies analysts said in a March 27 note. In the Phase IIb study eryaspase was used in combination with chemotherapy (gemcitabine or FOLFOX).
Not Just An Anti-Leukemic Therapy
The positive Phase IIb data, announced on Mar. 27 but discussed in a conference call by Erytech the following day, were described as "striking" by Bryan, Garnier & Co analyst Mickael Chane Du. He highlighted that the strong data in pancreatic cancer would help broaden investors' awareness of the product. "Most investors and potential industrial partners probably perceived it as anti-leukemic rather than a compound with potentially a broader range of applications," Chane Du said.
Eryaspase is also in development for acute myelogenous leukemia (AML), for which the company is awaiting results from a pivotal Phase IIb study, and acute lymphocytic leukemia (ALL). Data from the Phase IIb ENFORCE-1 trial in AML patients are expected in the second half of 2017.
Erytech had submitted eryaspase for market authorization in Europe for use in ALL patients, but it withdrew this application in Nov. 2016 after the European Medicines Agency's scientific committee, the CHMP, requested more data for the application. The company plans to resubmit this application in the third quarter of 2017.
Following positive proof-of-concept Phase II results in pancreatic cancer, analysts now expect Erytech to consider the initiation of additional clinical studies to evaluate the potential of eryaspase in other solid tumors. Chane Du put ovarian cancers and hepatocellular carcinomas at the top of the list for further exploration of eryaspase.
Chair and CEO of Erytech Gil Beyen said in a statetment: "We will now explore the path forward with clinicians and regulators to bring eryaspase to patients with metastatic pancreatic cancer as soon as possible. The results of this study not only reinforce the role of eryaspase in the treatment of this disease, they also provide further rationale for its evaluation in other tumor types.”
Pancreatic cancer is a particularly aggressive and deadly 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. Eryaspase, which consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells, has been granted orphan drug designations in the US and Europe for the treatment of ALL, AML and pancreatic cancer. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells, from circulating blood plasma.
In addition to eryaspase, Erytech is developing two other product candidates using encapsulated enzymes to induce tumor starvation. The company is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies.