Category: Chronic Lymphocytic Leukemia

AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia

Shots: The P-III CLL14 trial assessing the efficacy & safety of a combined regimen of Venclyxto/Venclexta + obinutuzumab vs obinutuzumab and chlorambucil in 432 patients with previously untreated CLL Results: @median follow-up of 52.4 mos., PFS rate (74% vs 35.4%) after 1 yr. fixed-duration treatment, 67% reduction in risk of disease progression or death; OS […]

AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III Head-to-Head ELEVATE-RR Trial for Chronic Lymphocytic Leukemia

Shots: The P-III head-to-head ELEVATE-RR trial evaluating Calquence (100mg, PO, bid) vs ibrutinib (420mg, PO, qd) in a ratio (1:1) in 533 patients with previously treated CLL The trial met its 1EPs i.e PFS non-inferiority with an m-PFS of 38.4 mos. @median follow up (40.9mos.). The 2EPs include lower incidence of all-grade atrial fibrillation (9.4% […]

TG Therapeutics Reports the US FDA’s Acceptance of BLA for Ublituximab + Ukoniq (umbralisib) to Treat Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Shots: The BLA submission is based on P-III UNITY-CLL trial evaluating ublituximab + Ukoniq (U2) vs obinutuzumab + chlorambucil in a ratio (1:1) in 420 patients with treatment-naive and r/r CLL. The 1EP of the study was PFS The trial is being conducted under a SPA agreement with the US FDA. The FDA also notified […]

Janssen to Present Results of Imbruvica (ibrutinib)-based Combination Regimen as 1L Treatment for Chronic Lymphocytic Leukemia at ASCO

Shots: Janssen to present new data from the fixed-duration cohort of P-II CAPTIVATE study, demonstrating 95% of patients treated with combined Imbruvica + Venetoclax were alive and progression-free @2yrs. with deep remissions were seen across all subgroups, including patients with high-risk CLL Additionally, Janssen will present 7yrs. data from the RESONATE-2 study on PFS and […]

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III Head-to-Head APSEN Trial for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: The P-III head-to-head APSEN trial involves assessing Brukinsa (160 mg, PO, bid) vs ibrutinib (420 mg, PO, qd) in 652 patients with r/r CLL or SLL, until disease progression or unacceptable toxicity The interim analysis of the trial met its 1EP & pre-specified 2EPs i.e superior ORR & lower risk of atrial fibrillation or […]