ADC Therapeutics puts clinical trial enrollment on hold following patient deaths

Betsy Goodfellow | July 12, 2023 | News story | Medical Communications ADC Therapeutics, DLBCL, Oncology, clinical trial 

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.”

Betsy Goodfellow

Related Content

Nuvectis Pharma initiates phase 1a NXP900 clinical trial

Clinical stage biopharmaceutical company Nuvectis Pharma has announced the initiation of a phase 1a dose …


Neurocrine Biosciences begins phase 1 study assessing NBI-1117570 in healthy adults

Sosei Heptares has announced that its partner, Neurocrine Biosciences, has initiated its phase 1 first-in-human …

AstraZeneca and Daiichi Sankyo share positive results from DESTINY-Lung02 phase 2 trial

AstraZeneca and Daiichi Sankyo have announced results from the primary analysis of the DESTINY-Lung02 phase …

Latest content