Chronic Lymphocytic Leukemia

The positive opinion for the BCL-2 inhibitor has been sent to the European Commission, which usually issues its final approval decision within 2 to 3 months of the CHMP recommendation.

Steve Coutre, MD, discusses how he determines which CLL treatment option is best for which patient, the advantage of treating patients with ibrutinib over chemoimmunotherapy, and new oral agents currently being investigated in the space.

William G. Wierda, MD, PhD, medical director of the Leukemia Center at The University of Texas MD Anderson Cancer Center, discusses the management of CLL treatment in the frontline setting.

William G. Wierda, MD, PhD, discusses which groups of CLL patients may benefit from ibrutinib versus chemoimmunotherapy and clinical trials that may provide further clarification.

Jennifer Brown, MD, PhD, discusses the status of targeted therapy agents for the treatment of patients with CLL.

Jennifer Woyach, MD, offers her expert insight into the practical clinical use of CLL treatments.

Nitin Jain, MD, assistant professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, discusses the checkpoint inhibitors under investigation in chronic lymphocytic leukemia (CLL).

Focusing primarily on the therapeutic categories of PI3K and BTK inhibitors, O’Brien, associate director for clinical science at the Chao Comprehensive Cancer Center, acknowledged efforts to build on existing success but said the hoped-for progress and advances await definitive data.

Bruce Cheson, MD, outlines the treatment choices for each of the 3 patient categories of CLL, noting that, regardless of the treatment, “a clinical trial is always the preferred option.”

Results from the phase Ib M13-365 study showed combining the BCL-2 inhibitor venetoclax (Venclexta) with the anti-CD20 agent rituximab (Rituxan) led to objective responses in 86% of patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

The FDA has approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia (CLL). The approval was based on an improvement in progression-free survival (PFS) in the phase III COMPLEMENT-2 study.

Survivors of acute myeloid leukemia (AML) produce antibodies that kill leukemia cells following allogeneic hematopoietic stem cell transplantation (HSCT) that can be used to treat other patients with AML.

Patients with chronic phase chronic myeloid leukemia (CML) can safely conclude treatment of tyrosine kinase inhibitors (TKIs) following a maintained deep molecular remission, according to findings from the large EURO-SKI trial presented at the 2016 European Hematology Association (EHA) Congress.

Final data from a phase III trial of CPX-351 (Vyxeos) in older patients with high-risk, secondary acute myeloid leukemia (AML) revealed that CPX-351 reduced the mortality risk by 31% compared with cytarabine and daunorubicin (7+3), according to findings presented at the 2016 ASCO Annual Meeting.

The FDA has lifted a clinical hold placed on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Ibrutinib (Imbruvica) continued to demonstrate impressive antitumor activity in a pooled analysis of 243 patients with deletion 17p chronic lymphocytic leukemia.

Infusion with 19-28z chimeric antigen receptor (CAR) modified T-cells led to complete response (CR) rates of 77% to 90% and minimal residual disease (MRD)-CR rates of 68% to 70% in adult patients with relapsed or refractory B-cell acute lymphocytic leukemia (B-ALL).

The treatment paradigm for relapsed/refractory chronic lymphocytic leukemia (CLL) is slowly expanding, with clinical trials starting and a new generation of drugs being ushered in, says Susan M. O'Brien, MD.

Despite the RESONATE-2 trial having demonstrated the efficacy of ibrutinib (Imbruvica) in treatment-naive elderly patients with chronic lymphocytic leukemia (CLL), Jennifer Brown, MD, explains that oncologists should carefully select patients to receive the drug depending on their age, comorbidities, and risk.

CPX-351 (Vyxeos) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

Extended follow-up data continue to demonstrate the efficacy and tolerability of ibrutinib in previously treated patients with chronic lymphocytic leukemia, including those with high-risk gene mutations and prognostic features.

The FDA has updated the label for ibrutinib to include new overall survival data, an indication for the BTK inhibitor in combination with bendamustine/rituximab, and a new indication for patients with small lymphocytic lymphoma with a 17p deletion.

The FDA has granted a priority review to a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

With nearly a dozen new PI3K and BTK inhibitors currently in development for patients with relapsed chronic lymphocytic leukemia it is challenging to know which therapies are truly "next-generation" agents and which are "me too" products.

Jeffrey Jones, MD, discusses treatment options for patients with chronic lymphocytic leukemia (CLL) who progress on, or become intolerant of, idelalisib or ibrutinib during their treatment.