AbbVie’s imbruvica fails to meet pancreatic cancer trial objective

21st January 2019 (Last Updated January 21st, 2019 00:00)

AbbVie’s ibrutinib (imbruvica) has failed to meet the primary goal of improving progression-free survival (PFS) or overall survival (OS) in the Resolve trial (PCYC-1137) designed to treat patients with metastatic pancreatic adenocarcinoma.

AbbVie’s ibrutinib (imbruvica) has failed to meet the primary goal of improving progression-free survival (PFS) or overall survival (OS) in the Resolve trial (PCYC-1137) designed to treat patients with metastatic pancreatic adenocarcinoma.

Metastatic pancreatic adenocarcinoma is one of the most aggressive and difficult-to treat types of cancer. Chemotherapy is the most common treatment option.

The Phase III randomised, multi-centre Resolve trial evaluated imbruvica in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine for the treatment of the disease.

"We are passionately advancing our robust ibrutinib scientific development programme to continue to advance cancer standards of care."

However, the double-blind, placebo-controlled trial reported safety data similar to that observed in previous studies involving imbruvica.

AbbVie unit Pharmacyclics Clinical Science head Danelle James said: “We continue to evaluate the potential of imbruvicaas a cancer treatment alone or in combination for a variety of cancer types.

“We are passionately advancing our robust ibrutinib scientific development programme to continue to advance cancer standards of care, particularly in areas that have unmet medical need.”

The trial saw AbbVie examine the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine as a first-line treatment for metastatic pancreatic cancer patients.

Patients were randomised in 1:1 ratio to be treated with the study drug combination.

A total of 211 patients received ibrutinib and nab-paclitaxel and gemcitabine combination, while 213 patients received the placebo and nab-paclitaxel and gemcitabine combination treatment.