ADC Therapeutics Voluntary Pauses Patients Enrolment in the P-II Study (LOTIS-9) of Zynlonta and Rituximab for Diffuse Large B-Cell Lymphoma
Shots:
- The company has decided to halt the new patient enrolment in the P-II study (LOTIS-9) of Zynlonta (loncastuximab tesirine-lpyl) & rituximab (Lonca-R) due to TRAEs in unfit or frail patients
- The decision was based on a recent review of aggregate data from the 40 patients & consultation with the DMC that relieved excessive respiratory-related events. The results showed 7 patient deaths & 5 grade 3 or 4 respiratory-related TEAEs
- The investigators concluded 11 of the 12 events, incl. 6 of the 7 grade 5 fatal events that led to the patients’ deaths as unlikely or unrelated to the study drug & 4 of the 5 nonfatal AEs have resolved & those patients completed their treatment regimen. The company is not expected to report additional data at the end of 2023
Ref: ADC | Image: ADC
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
