EU approves Imbruvica plus Gazyva for untreated chronic lymphocytic leukemia

The EU has announced that Imbruvica (ibrutinib), from Janssen Biotech, can be used in combination with Gazyva (obinutuzumab) from Roche, in previously untreated chronic lymphocytic leukemia (CLL), based on Phase III data from the iLLUMINATE study.

The Phase III iLLUMINATE (PCYC-1130) study showed the combination of Imbruvica plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Patients treated in the Imbruvica arm experienced a 77 percent reduction in risk of progression or death compared to the chlorambucil plus obinutuzumab arm. The chemotherapy-free, anti-CD20 combination regimen also showed an 85 percent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab (HR 0.15; 95% CI: 0.09-0.27) when evaluating PFS in patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV).

The data were presented in an oral session at the 2018 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The Lancet Oncology.