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January 21, 2019

AbbVie’s imbruvica fails to meet pancreatic cancer trial objective

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.”

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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.

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