AbbVie announced an update on the phase III RESOLVE trial (PCYC-1137) of ibrutinib (Imbruvica) in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma.
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 or overall survival 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.
PCYC-1137 is a Pharmacyclics sponsored randomized, multicenter, double-blind, placebo-controlled, phase III study of the Bruton’s tyrosine kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first-line treatment of patients with metastatic pancreatic adenocarcinoma.
Imbruvica is a first-in-class Bruton’s tyrosine kinase inhibitor jointly developed and commercialized by Pharmacyclics LLC. Imbruvica has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as in chronic graft-versus-host-disease for a total of nine FDA-approved indications.
