A late-stage trial testing AbbVie's Imbruvica (ibrutinib) in combination with chemotherapy for metastatic pancreatic adenocarcinoma (cancer) has failed to meet its primary endpoint.
The Phase RESOLVE III trial evaluated the efficacy of Imbruvica in combination with Abraxane (nab-paclitaxel) and Gemzar (gemcitabine) as first-line treatment of patients with metastatic pancreatic cancer.
211 received the Imbruvica combination treatment, and 213 received the placebo with Abraxane and Gemzar combination treatment.
Unfortunately, the randomised, multicenter, double-blind, placebo-controlled study did not meet its primary endpoint of improving progression-free survival (PFS) or overall survival (OS) benefit among the study population.
"We continue to evaluate the potential of Imbruvica as a cancer treatment alone or in combination for a variety of cancer types. We are passionately advancing our robust ibrutinib scientific development program to continue to advance cancer standards of care, particularly in areas that have unmet medical need," said Danelle James, head of Clinical Science at Pharmacyclics LLC, an AbbVie company.
Metastatic pancreatic cancer is an aggressive and difficult-to-treat solid tumour that is currently primarily treated with chemotherapy.
The therapy mainly works by blocking a protein called Bruton's tyrosine kinase (BTK), making it a first-in-class BTK inhibitor, which has been available in the US 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.