Clinical Trials
Chinese biopharmaceutical company CANbridge Pharmaceuticals has announced positive long-term follow-up data from its clinical studies into a glioblastoma multiforme (GBM) drug.
The phase 1/2 study of CAN008 (asunercept) plus temozolomide/ radiotherapy (TMZ/RT) involved nine newly diagnosed GBM patients. At the five-year study point, four were still alive ‒ three years after the completion of the trial. All four were in the high-dose group, having received 400mg of CAN008 plus TMZ/RT.
The overall survival rate for the high-dose group was 83% at two years and 67% at three to five years. This raised the institutional database average, which at two years was 34.3%, 19.5% at three years, 16.1% at four years and 8.2% at five years. The high-dose cohort also saw a progression-free survivalrateof17.95months,compared to a historic median of 6.9 months for GBM patients just receiving TMZ/RT.
CAN008 is currently in a phase 2 trial, with interim data analysis expected in mid-2023.
James Xue PhD, CANbridge founder, chairman and CEO stated: “While this is a small study, we are extremely encouraged by the high fiveyear survival rate of patients in our CAN008 Phase 1/2 trial, three years after its completion, in GBM, a cancer with typically poor outcomes. We look forward to the continued development of lead candidate, CAN008, currently in a phase 2 GBM trial in China, and to bringing this potentially new and promising treatment to brain cancer patients.”
Gerry Cox MD PhD, chief medical officer and chief development strategist at CANbridge and a study author, commented: “We are pleased to see a median progression-free-survival of 17.95 months in CAN008 glioblastoma multiforme patients, more than double the historical median PFS for standard-of-care GBM patients, and that 67% of the CAN008 high-dose patients were alive after five years, in a cancer where patients typically progress very rapidly and survival rates are dismal. GBM is one of the deadliest cancers, with survival rates of less than 15 months, few treatment advances and a high unmet medical need.”