Is Balixafortide safe?
Phase 1 and phase 3 adverse event data
In the phase 1 trial, the most common adverse events were fatigue (79% of patients) and neutropenia, a low white cell count (57%). Infusion-related reactions followed (48%). Hair loss, constipation and nausea were also common. Serious adverse events hit 38% of patients. Two died during treatment, one of septic shock and one of pneumonia. The investigators judged the safety profile similar to eribulin alone. FORTRESS reported no new safety signals before it closed. Polyphor stopped development after FORTRESS. Long-term safety data do not exist. The only trial registered since is an investigator-led phase 1 study in pancreatic cancer, not yet recruiting at its last update. 124
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Citations
- Pernas 2018, Lancet Oncology: balixafortide plus eribulin in HER2-negative metastatic breast cancer, phase 1 trial pubmed.ncbi.nlm.nih.gov
- Clinical Trials Arena: Polyphor's balixafortide fails phase 3 FORTRESS breast cancer study clinicaltrialsarena.com
- OncLive, June 2021: balixafortide plus eribulin fails to improve response rate in the FORTRESS trial onclive.com
- ClinicalTrials.gov: NCT06981806, balixafortide with cosibelimab in pancreatic cancer clinicaltrials.gov
Reference information only, not medical advice. Drawn from the Balixafortide article, fact-checked against the cited sources. No dosing anywhere on this site.