Phase III trial of Imbruvica + chemo fails to meet endpoint in pancreatic cancer.- AbbVie

AbbVie announced an update on the Phase III RESOLVE trial (PCYC-1137) of Imbruvica (ibrutinib) in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma (cancer). PCYC-1137 evaluated the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with metastatic pancreatic cancer.

Patients were randomized 1:1 to receive ibrutinib and nab-paclitaxel and gemcitabine combination treatment arm (n=211 study patients) versus the placebo and nab-paclitaxel and gemcitabine combination treatment arm (n=213 study patients). At conclusion, the study did not meet its primary endpoint of improving progression-free survival (PFS) or overall survival (OS) benefit among the study population. Safety data collected from the study were consistent with the existing safety information for the study therapies. The full results from this trial will be submitted for publication to a future scientific conference and/or a peer-reviewed medical journal.