Pixuvri: new option in the treatment of non-Hodgkin's B-cell lymphoma

1 December 2013

Pixuvri (pixantrone) is indicated as monotherapy in the treatment of multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma.

The licensed adult dose of pixantrone is 50mg/m2 by intravenous infusion on days 1, 8 and 15 of each 28-day cycle for up to six cycles

PHARMACOLOGY

Pixantrone is a cytotoxic aza-anthracenedione. It has shown minimal cardiotoxicity in animal models compared with doxorubicin or mitoxantrone.¹

CLINICAL STUDIES

Salvage treatment

The safety and efficacy of pixantrone were evaluated in a phase III open-label trial involving 140 patients with aggressive non-Hodgkin's lymphoma who had relapsed after two or more previous chemotherapy regimens including at least one standard anthracycline-containing regimen with a response that lasted at least 24 weeks.²

Patients were randomised to receive pixantrone (85mg/m² by intravenous infusion over one hour on days 1, 8 and 15 of a 28-day cycle for up to six cycles, n=70) or their investigator’s choice of comparator agent at pre-specified standard doses and schedules (n=70).²Comparator agents included vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone, gemcitabine and rituximab.²

Complete responses

In the ITT population, significantly more patients achieved a complete or unconfirmed complete response at the end of treatment with pixantrone than with a comparator agent (14 [20%, 95% CI 11.4-31.3] vs 4 [5.7%, 95% CI 1.6-14.0], p=0.021).²

In addition, the overall number of responses (complete, unconfirmed complete or partial) was significantly greater in the pixantrone group than in the comparator group (26 [37.1%, 95% CI 25.9-49.5] vs 10 [14.3%, 95% CI 7.1-24.7]; p=0.003).²

Median progression-free survival was significantly longer in the pixantrone group than in the comparator group (5.3 months vs 2.6 months, p=0.005).²

Median overall survival was also greater in the pixantrone group than in the comparator group although the difference was not significant.²

Safety profile

The most commonly observed grade 3 or 4 adverse events in the pixantrone group were neutropenia, leucopenia and thrombocytopenia, all of which occurred at a greater rate than in the comparator group.²

The incidence of cardiac adverse events was also higher in the pixantrone group than in the comparator group (35.3% vs 20.9%, respectively); however, these were predominantly asymptomatic grade 1 or 2 declines in left ventricular ejection fraction and did not increase with increasing pixantrone exposure.²

References: