(1)
Positive first results from the complete dose-finding part of a phase Ib/II study of tumor-agnostic NBTXR3 (PEP503) activated by radiotherapy with concurrent chemotherapy for patients with rectal cancer show that intratumoral injection of the product candidate was feasible and it was well tolerated at all dose levels
An injection procedure-related dose-limiting toxicity of urinary tract infection was observed in the study, however there were no observed adverse events or severe adverse events associated with NBTXR3
More than 70% of patients showed objective tumor response after concurrent chemoradiation
Approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response