Pharmacyclics and Janssen Biotech's Imbruvica trial in CLL and SLL meets primary endpoint

US biopharma company Pharmacyclics (Nasdaq: PCYC) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech have announced that a Phase III trial of Imbruvica (ibrutinib) has been reviewed by an independent monitoring committee.

The committee assessed the HELIOS trial which evaluated Imbruvica in combination with bendamustine and rituximab (BR) versus placebo in combination with BR in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL). It unanimously recommended that the study be unblinded based on clinically meaningful and statistically significant treatment benefit in the Imbruvica arm. The study has met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS). The safety profile of the drug in combination with BR was consistent with prior clinical experience.

Danelle James, head of oncology at Pharmacyclics, said: “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 US regulators. 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.”