ADC Therapeutics will terminate the Phase II LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and Rituxan (rituximab) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
The decision comes after the US Food and Drug Administration’s (FDA) decision to place a partial clinical hold on the trial, stopping enrolment. ADC had previously announced a pause on new patent enrolment, citing an increase in observed adverse events.
Several patients enrolled in the open-label, non-randomised Phase II LOTUS-9 trial (NCT05144009) reported respiratory-related adverse events.
Following the trial termination, the current patients will be asked to consent again to continue to receive the combination therapy.
Zynlonta has been approved by the US FDA and the European Medicines Agency for treating adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy.
Sobi has exclusive rights for marketing Zynlonta in the EU and other international markets, except the US, Greater China, Singapore, and Japan.
Zynlonta is also under investigation in combination with imvotamab, a bispecific antibody, for the treatment of R/R B cell non-Hodgkin’s lymphoma (NHL). The trial is being conducted in partnership with IGM Biosciences.
Other ADC pipeline drugs include ADCT-602 for the treatment of B-cell acute lymphoblastic leukaemia, ADCT-601 in solid tumours for targeting AXL tyrosine kinase receptors, ADCT-901 for ovarian, triple-negative breast cancer and advanced solid tumours, and ADCT-701 for the treatment of neuroblastomas, hepatocellular carcinoma, small cell lung cancer, and myeloid leukaemia.