Pharmacyclics Presents Interim Results From Ongoing Phase Ib/II PCYC-1129 Study

(RTTNews) - Pharmacyclics LLC (PCYC) reported interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease, or cGVHD, who were either refractory to steroid treatment or were steroid-dependent. The company said, in a preliminary analysis, data show all five evaluable patients who had received at least three months of ibrutinib achieved a partial response, and two patients who were evaluable at six months maintained a partial response.

The ongoing Phase Ib/II study evaluated the safety and efficacy of ibrutinib for the treatment of patients with steroid-dependent or refractory cGVHD. The Phase Ib portion of the study was open-label and designed to determine the recommended Phase II dose of ibrutinib, starting at 420 mg. As a result of the preliminary evaluation of the available data, researchers determined the Phase II dose of ibrutinib to be 420 mg. The Phase II study is currently ongoing.