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Tuesday, XBiotech Inc XBIT announced data from its Phase 1/Phase 2, 1-BETTER Study for advanced pancreatic cancer . The study examined the Natrunix (anti-interleukin-1alpha) antibody in combination with an established chemotherapy regimen (ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV)), which is already widely used for treating pancreatic cancer but is associated with difficult toxicities and less-than-ideal survival outcomes. Natrunix was being evaluated as an anti-cancer agent for use in cytotoxic chemotherapy combinations where the company believes it might potentially also improve tolerability of the chemotherapy.
The Phase 1 portion was a dose escalation study in metastatic pancreatic cancer patients to determine if dose-limiting toxicities occurred in combination with the ON+5FU+LV regimen in a second- or third-line setting. DLTs were not expected with Natrunix and none were seen. The Natrunix dose in the Phase 2 portion was thus the highest dose used in the Phase 1 portion.
The primary endpoint for the Phase 2 study was to assess the safety and tolerability of Natrunix when used with the ON+5FU+LV combination. Overall, there were fewer adverse events (AEs) during the 24-week treatment period for the Natrunix arm compared to placebo (297 vs 336), with markedly fewer events in specific categories of adverse events during that time. Subjects receiving the Natrunix ON+5FU+LV regimen also had about a 33% reduction in hospitalization (80 days ve.