Celgene is testing Abraxane (nab-paclitaxel), which is approved to treat metastatic pancreatic cancer, as an adjuvant therapy in a late-stage trial, and will need to show superior overall survival (OS) data compared to what doctors currently use as standard of care.
Experts interviewed at the recently concluded ASCO annual meeting agreed with analyst reports that the outcome of the Phase III APACT trial testing Abraxane plus the chemotherapy gemcitabine is tough to call, given there is only data from metastatic disease for the duo of drugs. And even if the trial is positive, how the combination -- called gemabraxane -- stacks up against the competition will be unclear. Data comparisons will be challenging, considering APACT has different primary endpoints compared to trials of the standards of care (SOCs), and each study used gemcitabine monotherapy as the active comparator and not any of the SOCs. It is possible that the differentiating factor between gemabraxane and SOCs could come down to side effects, which could have varying impact between countries and patients.
However, there are some doubts if it is worth investigating gemabraxane in the adjuvant setting to start with, a gastrointestinal (GI) oncologist said. Using therapies approved to treat metastatic disease in an earlier setting could mean limited options if a patient’s disease progresses, the GI oncologist explained.