ADC Therapeutics puts clinical trial enrollment on hold following patient deaths
ADC Therapeutics has announced a voluntary pause in the enrollment of patients for its phase 2 LOTIS-9 clinical trial which aimed to assess Zynlonta (loncastuximab tesirine-lpyl) and rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
This decision was made following a recent review of the aggregate data of 40 patients in the trial and consultation with the Data Monitoring Committee which noted potentially excessive respiratory-related events. The respiratory-related treatment-emergent adverse events (TEAE) comprised seven grade 5 fatal events, five grade 3 or 4 respiratory-related TEAEs. Of these twelve events, eleven were individually assessed as unlikely or unrelated to the study drug; four of the grade 3 or 4 events have been resolved and the patients have completed treatment. The investigation into the causes of these events is ongoing.
All patients with fatal events are reported as having at least one significant active underlying respiratory and/or cardiac co-morbidity including severe chronic obstructive pulmonary disease, pulmonary edema, chronic bronchiectasis, idiopathic pulmonary fibrosis and recent COVID-19 infection. These patients were all also over the age of 80.
The company decided to pause enrollment in order to give it some time to evaluate the data surrounding the TEAEs and determine its next steps.
Ameet Mallik, CEO of ADC Therapeutics, commented: “Our top priority is the safety of every patient who participates in our clinical trials. Given the aggregate of the respiratory-related events seen in the trial, we implemented a voluntary pause of enrollment to allow for a thorough investigation of the data set. This trial includes a very difficult-to-treat patient population with limited treatment options, and we will provide an update on next steps when available.”
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