Cerenome Completes Enrollment in Phase 2 ReSPECT-GBM Trial of REYOBIQ™ in Recurrent Glioblastoma
Key Highlights
- ➤Cerenome completed Phase 2 enrollment with 32 patients treated at the recommended dose
- ➤Topline Phase 2 data expected in mid-2027, followed by FDA End-of-Phase 2 discussions
- ➤Interim Phase 2 median overall survival reached 13 months versus approximately 8 months historically
- ➤Phase 1 median survival reached 17 months for tumors receiving at least 100 Gy
- ➤Phase 2 interim median progression-free survival reached 11 months versus approximately 4 months standard of care
Expert Statements
Eric J. Daniels, Chief Development Officer of Cerenome
“Completing enrollment in ReSPECT-GBM brings us an important step closer to understanding REYOBIQ’s potential in recurrent glioblastoma. We are very grateful to the patients, their families, and the investigators and study teams at each of our clinical sites.”
Eric J. Daniels, Chief Development Officer of Cerenome
“The Phase 1 and interim Phase 2 data reported so far show a consistent safety picture and response pattern: when REYOBIQ reaches the tumor at therapeutic doses, survival reliably exceeds controls in company sponsored, demographically matched synthetic controls.”
Eric J. Daniels, Chief Development Officer of Cerenome
“With enrollment complete, our focus moves to patient follow-up and final analysis. We look forward to reporting topline results in mid-2027 and discussing them with regulatory authorities.”
Andrew J. Brenner, Professor of Medicine at Mays Cancer Center at UT Health San Antonio and lead investigator of ReSPECT-GBM
“Patients with recurrent glioblastoma have very few treatment options, and median survival has held around eight months, despite multiple therapeutic approaches.”
Andrew J. Brenner, Professor of Medicine at Mays Cancer Center at UT Health San Antonio and lead investigator of ReSPECT-GBM
“In Phase 1, patients whose tumors received 100 Gy or more lived a median of 17 months.”
Andrew J. Brenner, Professor of Medicine at Mays Cancer Center at UT Health San Antonio and lead investigator of ReSPECT-GBM
“That finding gave us a clear delivery goal for Phase 2.”
Andrew J. Brenner, Professor of Medicine at Mays Cancer Center at UT Health San Antonio and lead investigator of ReSPECT-GBM
“Getting REYOBIQ to the tumor at therapeutic doses has been the focus of this trial, and the final Phase 2 data will show how well that approach holds up in a larger group of patients.”
Previously reported interim Phase 2 data showed a 63% improvement in median overall survival versus standard of care in recurrent glioblastoma (13 months vs. 8 months)
HOUSTON, Oct. 29, 2026 (GLOBE NEWSWIRE) -- Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), a CNS oncology company integrating diagnostics, therapeutics, and artificial intelligence, today announced that it has completed enrollment in the Phase 2 ReSPECT-GBM (NCT01906385) study. This multicenter, open-label trial is evaluating a single administration of REYOBIQ™ (rhenium Re186 obisbemeda), the Company's lead investigational radiotherapeutic, in adults with recurrent glioblastoma (GBM). The Phase 2 portion was designed to enroll 34 patients. Following a statistical review, the Company closed enrollment with 32 patients treated at the recommended Phase 2 dose, which it determined is sufficient to support the planned final statistical analysis with minimal effect on statistical power. The Company expects to report topline data in mid-2027 (to allow for appropriate patient follow-up and data maturity) and subsequently hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps for the program.
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