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Addition of ibrutinib to chemotherapy does not extend PFS in metastatic pancreatic cancer
A randomized phase 3 trial designed to assess the addition of ibrutinib to chemotherapy for patients with metastatic pancreatic cancer failed to meet its primary endpoint of prolonged PFS.
Ibrutinib (Imbruvica; Pharmacyclics, Janssen) is a Bruton’s tyrosine kinase inhibitor approved for treatment of certain patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, Waldenstrom’s macroglobulinemia, marginal zone lymphoma or graft-versus-host disease.
The RESOLVE trial — sponsored by Pharmacyclics, an AbbVie company — included 424 patients with metastatic pancreatic adenocarcinoma.
Researchers randomly assigned 211 patients to ibrutinib plus nab-paclitaxel and gemcitabine. The other 213 patients received chemotherapy plus placebo.
Results showed no statistically significant PFS or OS benefit with the addition of ibrutinib to chemotherapy.
Safety results appeared consistent with that observed in prior studies.
Full results from RESOLVE will be submitted for presentation at a future scientific conference or publication in 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,” Danelle James, MD, MAS, head of clinical science at Pharmacyclics, said in a press release. “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.”