New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA ® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia

ATLANTA, Ga., December 11, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from two studies evaluating the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax (I+V) as a potential fixed-duration treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These data were both featured today during the American Society of Hematology (ASH) 2021 Annual Meeting. New secondary endpoint data from the Phase 3 GLOW study (NCT03462719) showed that fixed-duration treatment with I+V resulted in undetectable minimal residual disease (uMRD) responses that were deeper compared to patients treated with chlorambucil plus obinutuzumab (Clb+O), and an additional analysis showed that uMRD responses were better sustained during the first year post-treatment.[1] Updated results from the Phase 2 CAPTIVATE study (NCT02910583) of the same investigational regimen, now with a median 38 months of follow-up, further demonstrated sustained uMRD and disease-free survival (DFS).[2] There were no new MRD relapses, clinical progressions or deaths with an additional year of study follow-up in patients with confirmed uMRD following 12 cycles of combined I+V who were randomized to placebo or continued IMBRUVICA®.2 “GLOW and CAPTIVATE are part of a comprehensive development program continuing to evaluate the potential of IMBRUVICA-based therapy in patients with previously untreated CLL ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news