IMBRUVICA® misses primary endpoint in pancreatic cancer trial

IMBRUVICA® misses primary endpoint in pancreatic cancer trial

AbbVie have released an update on the RESOLVE trial of IMBRUVICA® in combination with chemotherapy agents in metastatic pancreatic cancer. 

AbbVie, a research-based global biopharmaceutical company, has announced an update on the Phase 3 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 (cancer).

Metastatic pancreatic cancer is an aggressive and difficult-to-treat solid tumour primarily treated with chemotherapy. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialised by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech.

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.

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 randomised 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.

In 2018 Lynparza for pancreatic cancer was granted ODD by the FDA

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.

Danelle James, M.D., M.A.S., Head of Clinical Science at Pharmacyclics LLC, an AbbVie company said, “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.”