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Posted by on Aug 25, 2018 in Leukemia | 0 comments

In a nutshell

This study evaluated the effectiveness and safety of duvelisib in patients with chronic lymphocytic leukemia (CLL). This study concluded that duvelisib may be an effective new therapy with manageable side effects.

Some background

CLL is the most common type of leukemia in adults in the U.S. Although therapy options have increased, many patients with CLL relapse. In particular, patients with an abnormal gene (TP53 mutation) have a poorer prognosis. New treatments are needed for these patients.

Duvelisib is a targeted therapy. This type of treatment blocks cancer cell survival without affecting healthy cells. This leads to cancer cell death. The effectiveness and safety of duvelisib in patients with CLL remain under investigation. 

Methods & findings

This study involved 210 patients with CLL. Only 73 patients were included in the current analysis. All patients received duvelisib. 75.3% of patients had relapsed (cancer recurrence) or refractory (does not respond to treatment) disease. 24.7% of patients were previously untreated. 52.0% of patients had a TP53 or 17p mutation. Patients were treated for an average of 24 – 62.3 weeks.

Of the patients with relapsed/refractory (RR) disease, 56.4% responded to treatment. Of the previously untreated (PU) group, 83.3% responded to treatment. The average progression-free survival (patients still alive without a return of disease) was 15.7 months (RR). The probability of the disease not progressing 1 year later was 57.1% (RR) and 94% (PU). The probability of survival at 1 year was 65.5% (RR) and 100% (PU).

Most side effects were mild to moderate. The most common included low white blood cell count (53.4%), diarrhea (54.8%), and low red blood cell count (32.9%). Low platelet count (23.2%) was also reported.

Severe to life-threatening side effects were also reported. These included low white blood cell count (32.9% – RR and 8.22% – PU), low platelet count (13.7% – RR. and 2.74% – PU), and diarrhea (6.85% – RR and 5.48% – PU). 27.3% (RR) and 8.22% (PU) of patients stopped treatment due to side effects.

The bottom line

This study concluded that duvelisib may be an effective new therapy option for patients with CLL.

The fine print

This study received funding support from Verastem Oncology, the developer of duvelisib.

This was a phase 1 study with a small patient population. More studies are needed to establish the role of duvelisib in the treatment of chronic lymphocytic leukemia.

Published By :

American Journal of Hematology

Date :

Aug 10, 2018

Original Title :

Duvelisib, an oral dual PI3K-δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a Phase 1 study.

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