Tuesday, XBiotech Inc (NASDAQ: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 versus 120 days).
Subjects receiving the Natrunix combination also reported a 22% reduction in fatigue, 32% improved appetite, and 41% reduction in pain.
The incidence of severe diarrhea was twofold (9% versus 19%) lower during the 24-week treatment regimen for patients receiving the Natrunix + ON+5FU+LV combination compared to placebo + ON+5FU+LV.
Overall Survival (OS) is one of the secondary endpoints for the Phase 2 study. The data highlights the observation that no subjects in the placebo ON+5FU+LV group (n=32) survived for longer than 330 days, whereas eight subjects in the Natrunix ON+5FU+LV arm (n=33) were still alive as of day 330.
Considering the small sample size, the borderline statistically significant p-value of p = 0.096 suggests prolonged survival for subjects receiving the Natrunix regimen.
Price Action: XBIT shares are down 9.54% at $5.50 at last check Tuesday.
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