The FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the part 2 scientific trial of ERC1671 together with granulocyte-macrophage colony-stimulating issue (GM-CSF), and cyclophosphamide for the remedy of glioblastoma be terminated, in keeping with a press launch from ERC-USA and the College of California, Irvine.1
In place of the present research, the FDA recommends that ERC-USA conduct a part 3 confirmatory research, from which information may help the longer term submitting of a Biologics License Software and probably result in an FDA approval.
“We’re extremely reassured that the FDA shares our view that ERC1671 ought to enter a registration trial and transfer towards an NDA as quickly as potential,” stated Daniela A. Bota, MD, PhD, vice dean for Scientific Analysis, College of California, Irvine College of Medication, and medical Director, UCI Well being Complete Mind Tumor Program and principal investigator of the part 2 research, within the press launch.
The cell-based immunotherapy ERC1671 was displaying promise as remedy of recurrent glioblastoma primarily based on interim outcomes from the part 2 research. A complete of 10 sufferers had been included within the first evaluation and a 6-month total survival price of 100% was achieved as a nicely as a 12-month OS price of 40% with the mix of ERC1671, GM-CSF, and cyclophosphamide. The median OS noticed with the mix within the research was 10.5 months. It was famous in a 2020 press launch that the interim outcomes had been higher than historic controls which confirmed a 6-month OS price of solely 33% and a median OS of solely 5.3 months (P < .0001).2
The trial was double-blinded and placebo-controlled. 84 sufferers had been randomized 1:1in the research obtain both ERC1671 plus GM-CSF and cyclophosphamide or placebo plus bevacizumab (Avastin). The secondary finish factors explored had been progression-free survival price, immune response, the share of grade 3 by 5 opposed occasions, and the speed of radiographic response.
Sufferers had been eligible to enroll in the event that they had been not less than 18 years of age with a histologic prognosis of glioblastoma or gliosarcoma, a Karnofsky Efficiency rating ≥ 70%, a life expectancy of not less than 12 weeks, measurable illness, ample organ operate, and who’re of their first or second relapse of glioblastoma. When it comes to prior remedy, sufferers had been eligible for the research given that they had prior surgical procedure for glioblastoma and systemic corticosteroid remedy of ≤ 4 mg of dexamethasone or equal.
People who had been unable to endure an MRI with distinction had been excluded from the research together with those that had the presence of diffuse leptomeningeal illness, historical past, presence, or threat of metastatic illness, important vascular illness, and different circumstances that will have interfered with on-study remedy. As well as, the research excluded those that acquired immunosuppressive medication lower than 2 weeks earlier than the primary dose of ERC1671, bevacizumab, bevacizumab biosimilars, different VEGF-targeted brokers, and people with hypersensitivity to bevacizumab.
Following the early success of ERC1671, ERC-USA considers the response from the FDA to be useful for the longer term improvement of the agent, which can fill a remedy hole for sufferers with recurrent glioblastoma who at present don’t have any efficient remedy choices.
“We’re thrilled that the FDA now acknowledges the potential of ERC1671 to deal with this intractable illness and main unmet medical want. We consider ERC1671 offers important hope to sufferers with recurrent glioblastoma and we’re grateful to the FDA’s encouragement to aggressively enter right into a registration trial, stated Apostolos Stathopoulos, MD, PhD, president and chief govt workplace of ERC Belgium, father or mother firm to ERC-USA, in a press release.
1. ERC-USA pronounces FDA advice for early termination of part 2 scientific trial of ERC1671 (Gliovac or Sitoiganap) and utility for registration trial for remedy of glioblastoma. Information launch. ERC-USA. April 7, 2021. Accessed April 7, 2021.
2. ERC pronounces interim outcomes from part 2 trial of immunotherapy ERC1671 in recurrent glioblastoma sufferers. Information launch. ERC Belgium. August 19, 2020. Accessed April 7, 2021.