CANbridge Pharmaceuticals Inc. announced that long-term follow up data from the Phase 1/2 study of CAN008 (asunercept) plus temozolomide/radiotherapy (TMZ/RT) in newly diagnosed glioblastoma multiforme (GBM) showed a long-term survival rate of 67% at five years, three years after the trial ended. The data will be presented as a poster at the European Society of Medical Oncologists (ESMO) Sarcoma and Rare Cancers Annual Congress, March 20-22, in Lugano, Switzerland. The study was conducted at Chang Gung Memorial Hospital, Taoyuan, Taiwan, the site of the clinical study.

The principal investigator is Weiuo-Chen MD, Professor, formerly at Chang Gung Memorial Hospital and now at New Taipei City Tucheng Hospital. In the study, "Long term follow-up to the phase I/II study of CAN008 plus standard chemoradiotherapy treatment in patients with newly diagnosed glioblastomide multiforme," researchers reported that four out of the nine newly diagnosed gliob lastoma multiforme patients treated in the CAN008 Phase 1/2 trial at this lead site were alive at the five-year follow up, three years after the completion of the trial. All four of the surviving patients were in the high-dose cohort of the trial, which received 400 mg of CAN008 in addition to standardtemozolomide/rad iotherapy (TMZ/RT).

The overall survival rate of the high-dose CAN008 group was 83% at two years and 67% at three, four and five years. This compares to an overall survival rate in the institutional GBM database(1) (n=218) of 34.3% at two years, 19.5% at three years, 16.1% at four years and 8.2% at five years. In addition, the high-dose CAN008 cohort saw a median progression-free survival of 17.95 months.

This compares to a historical median progression-free survival of 6.9 months for GBM patients on standard-of-care (TMZ/RT) (Stuppet al, 2009). The researchers also reported that a high tumor mutation burden and DNAH family gene mutation were associated with a favorable response to CAN008 treatment. CAN008 is currently in an ongoing Phase 2 trial in glioblastoma multiforme (GBM) in China.

An interim data analysis is expected in mid-2023.