Treatment with Copiktra (duvelisib) doubles response rates compared with Arzerra (ofatumumab), and significantly extends the time until disease progression or death in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two previous therapies, a Phase 3 trial revealed.
The findings were presented at the Lymphoma & Myeloma 2019 International Congress, held Oct. 23-26 in New York, in a poster titled “An improved benefit‐risk profile of duvelisib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who received 2 prior therapies.”
Copiktra, developed by Verastem Oncology, is the first dual inhibitor of the enzymes PI3K-delta and PI3K-gamma to be approved by the U.S. Food and Drug Administration. Those two enzymes are known to support the growth and survival of malignant immune B-cells.
The medication’s approval for CLL/SLL patients was based on data from the DUO Phase 3 clinical trial (NCT02004522). That trial compared Copiktra’s efficacy to that of Novartis‘ Arzerra in 319 people with CLL/SLL who had received at least one prior therapy.
At the conference, researchers now presented updated data from a subset of 191 heavily treated patients for whom the treatment was approved — those with at least two previous lines of therapy. The participants’ median number of prior treatments was three, with a range from 2 to 10.
The data showed that individuals on Copiktra lived significantly longer without signs of disease progression than those receiving Arzerra — 16.4 months vs. 9.1 months. Copiktra also doubled the proportion of patients who responded to treatment (78.9% vs. 38.6%).
Adverse events were reported by more than a quarter of participants on Copiktra, and included diarrhea, fever, infections, pneumonia, fatigue, and low numbers of a type of immune cell called neutrophils. Most of these adverse events were successfully managed either by reducing the treatment dose or by discontinuing it.
In total, 23% of patients discontinued Copiktra due to treatment-related adverse events, most commonly diarrhea and pneumonia, and 12% died due to adverse events, most commonly stroke and pneumonia. Adverse events related to Arzerra were similar to what has been previously reported, which includes diarrhea, rash, nausea, and fatigue.
“The data presented at this year’s Lymphoma & Myeloma Congress reflect the utility of duvelisib in patients with relapsed or refractory CLL/SLL after at least two prior therapies, including in patients with advanced disease or at high-risk of recurrence,” Hagop Youssoufian, MSc, MD, the head of medical strategy at Verastem Oncology, said in a press release.
“Further, the research supports the approach to management of adverse events through dose interruptions or dose reductions without an impact on the patient’s response, which could allow patients who are benefitting to stay on therapy longer,” he said.
The treatment had been approved by the FDA in September 2018.
“Findings from the DUO study demonstrated that patients taking duvelisib who have received two or more prior therapies experienced improved clinical outcomes and a manageable safety profile,” said Matthew S. Davids, MD, of the Dana-Farber Cancer Institute, a co-investigator of the study. “These results with duvelisib are important for this patient population, which is in need of targeted therapies to control their disease.”
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