Lumoxiti to treat hairy cell leukaemia

October 10, 2018 0 By CH Unnikrishnan

The US Food and Drug Administration gave its nod to Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL).

Lumoxiti was approved under FDA’s Priority Review. The approval is based on data from the phase III, single-arm, open-label ‘1053’ trial of Lumoxiti monotherapy in 80 patients who have received at least two prior therapies, including a purine nucleoside analog.

The primary endpoint of the trial was durable complete response, AstraZeneca and MedImmune said in joint press communication.

The median time to haematologic remission was 1.1 months. At data cut-off, the median duration of complete response was not yet reached after a median 16.7 months of follow-up.

Capillary leak syndrome (CLS) and haemolytic uraemic syndrome (HUS), including life-threatening cases of each, have been reported among patients treated with Lumoxiti. In the combined safety database of 129 HCL patients treated with Lumoxiti, Grade 3 or 4 CLS occurred in 1.6% and 2% of patients, respectively. Grade 3 or 4 HUS occurred in 3% and 0.8% of patients, respectively.

In the ‘1053’ trial of 80 patients, the most common Grade 3 or 4 adverse reactions were hypertension, febrile neutropenia, and HUS. HUS was the most common adverse reaction leading to discontinuation.

Lumoxiti, which targets CD22 transmembrane protein, is AstraZeneca’s first antibody-drug conjugate (ADC).