ADC Therapeutics Announce Voluntary Pause Of Patient Enrollment In Phase 2 LOTIS-9 Trial Of ZYNLONTA

(RTTNews) - ADC Therapeutics SA (ADCT) announced Tuesday a voluntary pause in the enrollment of new patients in the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

The voluntary action was taken by the Company after a recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events.

These respiratory-related treatment-emergent adverse events (TEAEs) included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs. The cause of these events remains under further investigation.

The Company's decision to pause enrollment enables time to evaluate data around the TEAEs and determine next steps.

The Company has notified all study investigators and regulatory authorities including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) of the Company's decision to pause enrollment. The Company does not expect to report additional data from the trial by the end of the year.