The late-breaking data were presented by Nicholas Butowski, M.D., a principal investigator on the trial and Professor of Neurological Surgery at the University of California San Francisco Weill Institute for Neurosciences, on November 22 at the Society for Neuro-Oncology annual meeting in Phoenix.
Glioblastoma multiforme (GBM) represents 15-20% of all primary intracranial neoplasm, with death typically occurring within the first 15 months after diagnosis. The median age of diagnosis is 64 years old. Since agents from various drug classes have failed in clinical trials, there is an urgent need for a more effective and less toxic GBM therapy.
RRx-001, EpicentRx’s lead program, is a small molecule immunotherapy targeting the CD47 – SIRPα axis and has been evaluated in multiple clinical studies.
In the G-FORCE trial, 18 patients with histologically verified glioblastoma received RRx-001 plus radiotherapy and temozolomide. After a six-week break, patients in cohorts 1-3 received temozolomide maintenance therapy, while patients in cohorts 4-6 received temozolomide plus RRx-001 maintenance therapy.
RRx-001 combination therapy led to an overall survival (OS) of 21.9 months, compared with historical OS data of 15-20 months. The RRx-001 combo also led to a progression-free survival (PFS) of 13 months, compared with historical PFS data of 6-7 months.
The combination therapy was well tolerated, with no serious adverse events considered related to treatment with RRx-001.
“Patients diagnosed with glioblastoma have poor prognosis and very limited treatment options,” said Corey A. Carter, M.D., President & CEO of EpicentRx.
“The results from this Phase 1 G-FORCE study and our ongoing Phase 3 REPLATINUM trial in small cell lung cancer (SCLC) validate RRx-001 as a viable therapy for multiple cancer types. We plan to begin a Phase 0 trial of RRx-001 for GBM in the near future to gain further insight into the mechanism of action in brain tumors before starting Phase 3 studies,” added Dr. Carter.
“I am very excited to begin the Phase 0 trial,” said Howard Fine, M.D., Director of Neuro-oncology at Weill Cornell Medical Center and principal investigator for the upcoming Phase 0 trial. “This is a high priority project and collaboration for both Weill Cornell and EpicentRx, and an important step in our efforts to bring safe, effective and minimally toxic therapeutics to GBM patients,” Dr. Fine said.
RRx-001 has Orphan Drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma, and from EMA for SCLC.
Source: Company Press Release