Chronic Lymphocytic Leukemia

Two analyses of the phase II DUO trial show that modifying the dosage of duvelisib or interrupting treatment in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, does not compromise outcomes or increase toxicity.

Here's a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

David Bond, MD, discusses 2 key findings from a recent study investigating the risk of developing a second cancer in patients with chronic lymphocytic leukemia treated with a BTK inhibitor.

In an interview with Targeted Oncology, Alessandra Tedeschi, MD, discussed the 5-year data she presented at the 2019 EHA Meeting for frontline ibrutinib as a treatment for patients with CLL. She also highlighted other research that may also benefit elderly patients with CLL, including the emerging combination of venetoclax and obinutuzumab.

The FDA has granted a breakthrough therapy designation to acalabrutinib monotherapy for the treatment of adult patients with chronic lymphocytic leukemia. The breakthrough designation was given based on the results of interim analyses from 2 phase III trials: ELEVATE-TN and ASCEND. 

The initial pilot study of CTL019 in heavily pretreated CD19-positive hematologic malignancies demonstrated the feasibility of CAR T-cell therapy in patients with CLL. A presentation at the 2019 American Society of Gene & Cell Therapy Annual Meeting reported 2 cases of chemotherapy-resistant CLL, with ongoing follow- up at 8 years showing persistence of CAR-engineered T cells and sustained remission, as determined by flow cytometry and deep sequencing of immunoglobulin H rearrangements. 

In the phase I/II TRANSCEND CLL 004 study, chimeric antigen receptor T-cell therapy lisocabtagene maraleucel led to undetectable minimal residual disease in patients with relapsed/refractory chronic lymphocytic leukemia.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.

PF-05280586, a biosimilar for rituximab, has been approved by the FDA for use as a single-agent or in combination with chemotherapy for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma, or in combination with chemotherapy for patients with CD20-positive chronic lymphocytic leukemia.

At 3 years of follow-up, the combination of acalabrutinib and obinutuzumab continued to show benefit in patients with both newly diagnosed chronic lymphocytic leukemia and relapsed or refractory disease.

Addressing the need for treatments that are more effective and less toxic for patients with relapsed or refractory chronic lymphocytic leukemia, Paolo Ghia, MD, of the Universita Vita-Salute San Raffaele, and other researchers conducted a phase III randomized, multicentric ASCEND study, testing acalabrutinib monotherapy in comparison with physician’s choice of standard regimens in patients R/R CLL.

Significant activity was observed when ibrutinib was administered concurrently with CD19-directed CAR T-cell therapy compared with separately in patients with high-risk relapsed/refractory chronic lymphocytic leukemia who had progressed on or were intolerant of ibrutinib. Data presented at the 15th International Conference on Malignant Lymphoma show a high response rate with this concurrent treatment.