Janssen Biotech, Inc. and partner Pharmacyclics, Inc. announced that an Independent Data Monitoring Committee determined that its late-stage trial, evaluating Imbruvica in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) met its primary endpoint.
According to the companies, during a pre-planned interim analysis of the Phase III HELIOS study, the committee determined that the study met its primary endpoint of progression-free survival (PFS), and recommended that, based on the clinically meaningful and statistically significant treatment benefit in the Imbruvica arm, the study be unblinded.
The Phase III HELIOS trial evaluated the combination of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory CLL or SLL. In the trial, treatment with Imbruvica demonstrated a statistically significant PFS. Based on the results, the independent data monitoring committee said that patients receiving placebo plus BR should be offered the option to receive Imbruvica as their next treatment.
“This is the second randomized, controlled study in patients with previously treated CLL or SLL to show a significant improvement in progression-free survival, further underscoring the potential of Imbruvica,” said Sen Zhuang, MD, PhD, Vice President, Oncology Clinical Research, Janssen. “The data form the Phase 3 RESONATE trial demonstrated that Imbruvica as a single agent significantly improved both progression-free and overall survival compared to ofatumumab. Now, the interim data from HELIOS demonstrate that Imbruvica may be incorporated into a regimen with bendamustine and rituximab to improve outcomes for patients.”
The HELIOS trial included 578 CLL or SLL patients who had received at least one line of prior systemic therapy. The primary endpoint was PFS, with secondary endpoints including safety, overall response rate, overall survival, rate of minimal residual disease-negative responses and other improvements in hematologic values, disease-related symptoms and patient-reported outcome scores. Topline results are planned to be submitted for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, as well as publication in a peer-reviewed journal.
“We are delighted by the superior efficacy observed in CLL and SLL patients treated with Imbruvica in combination with BR compared to patients in the placebo-controlled BR arm and look forward to sharing these results with the scientific community and U.S. regulators,” said Danelle James, MD, MS, Head of Oncology at Pharmacyclics. “These results build upon early results in the Phase I/II program and are very encouraging as we continue to explore the benefits Imbruvica provides to patients when it is combined with other treatments.”
Sources: Janssen Research & Development, LLC; Pharmacyclics, Inc.
Last updated: 3/16/15; 3:55pm EST