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Combination therapy with Aliqopa and rituximab improved progression-free survival in patients with relapsed indolent non-Hodgkin lymphoma.
Aliqopa (copanlisib) in combination with rituximab demonstrated a clinically and statistically significant progression-free survival improvement in patients with relapsed indolent non-Hodgkin lymphoma, according to data published in Lancet Oncology.
“This combination could, therefore, be a potential substitute for rituximab backbone treatment in this patient population,” the study authors wrote.
Previously, Aliqopa alone showed efficacy and safety in patients with indolent non-Hodgkin lymphoma, so researchers sought to compare it in combination with rituximab or placebo with rituximab, with a focus on progression-free survival (time during and after treatment when the patient lives without disease progression).
“Results from the (previously) published literature showed that the combination of rituximab plus a PI3K inhibitor has been suggested as a potentially promising combination in patients with indolent non-Hodgkin lymphoma owing to unique mechanisms of action; however, safety concerns have been identified with the combination of rituximab and orally administered PI3Kinhibitors,” the study authors
Researchers assessed data from 458 patients with confirmed CD20-positive indolent B-cell lymphoma relapsed after the last anti-CD20 monoclonal antibody therapy. These patients also were progression free and treatment free for at least 12 months, or at least six months for those unwilling or unfit to receive chemotherapy.
Patients either received 60 mg of Alipoqa (307 patients) on days one, eight, 15 and 22 in a 28-day cycle) or placebo (151 patients). Both treatment groups also received 375 mg/m2 of rituximab on days one, eight, 15 and 22 during the first cycle and on the first day of cycles three, five, seven and nine.
With a median follow up of 19.2 months, median progression-free survival was significantly improved in patients who received Aliqopa plus rituximab compared with those who received placebo plus rituximab (21.5 months versus 13.8 months).
“The median progression free survival of 13.8 months with placebo plus rituximab … presumably reflects the rituximab-sensitive nature of the population, with 80% of patients having not received rituximab for more than 12 months,” the study authors explained.
Objective response rate (or the rate of a measurable response to treatment) was achieved in 81% of patients in the Aliqopa group versus 48% in the placebo group. In addition, complete response rates (or the disappearance of cancer as a response to treatment) were observed in 34% and 15%, respectively, and partial responses (a decrease in tumor size or the amount of cancer in the body as a response to treatment) were achieved in 45% and 29% of patients, respectively.
The most common severe to life-threatening side effects in the Aliqopa and placebo groups were high blood sugar (56% and 8%, respectively) and high blood pressure (40% and 9%). Serious side effects related to the treatment occurred in 47% of patients assigned Aliqopa plus rituximab and 18% of those assigned placebo plus rituximab. One patient assigned Aliqopa with rituximab died from pneumonitis compared with no deaths in patients assigned placebo with rituximab.
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