AbbVie , a research-based global biopharmaceutical company, today 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 tumor primarily treated with chemotherapy today. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. (Janssen). 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 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 (PFS) or overall survival (OS) benefitamong 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.
“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, M.D., M.A.S., Head of Clinical Science at Pharmacyclics LLC, an AbbVie company.
About the IMBRUVICA (ibrutinib) Clinical Program
IMBRUVICA has a robust clinical oncology development program with more than 130 ongoing clinical trials. IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 135,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.
About the RESOLVE Study (PCYC-1137)
PCYC-1137 is a Pharmacyclics, an AbbVie company, sponsored randomized, multicenter, double-blind, placebo-controlled, Phase 3 study of the Bruton’s tyrosine kinase (BTK) 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 (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
- IMBRUVICA was first approved for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in adult chronic lymphocytic leukemia (CLL) patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for adult patients with Waldenström’s Macroglobulinemia (WM) in January 2015.
- In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with CLL/ small lymphocytic lymphoma (SLL).
- In January 2017, IMBRUVICA was approved for adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
- In August 2017, IMBRUVICA was approved for adult patients with chronic graft versus host disease (cGVHD) that failed to respond to one or more lines of systemic therapy.
- In August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.3 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.