2023-07-11 08:14:36 ET
ADC Therapeutics ( NYSE: ADCT ) lost ~16% pre-market Tuesday after announcing a voluntary pause in enrollments in a Phase 2 trial for a drug regimen containing its lymphoma therapy Zynlonta due to treatment-emergent adverse events (TEAEs).
The study, LOTIS-9, involved unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). It was designed to assess Zynlonta with rituximab (Lonca-R), sold as Rituxan by Biogen ( BIIB ) and Roche ( OTCQX:RHHBY ).
After a review of data from 40 patients, the investigators have found respiratory-related TEAEs, including seven Grade 5 fatal events and five Grade 3 or Grade 4 TEAEs.
However, 11 out of 12 TEAEs (including six of seven fatal events) were found to be unlikely or unrelated to Zynlonta, the Swiss biotech said, adding that four out of five Grade 3 or Grade 4 events have also been resolved since then, and patients have completed the treatments.
The "decision to pause enrollment enables time to evaluate data around the TEAEs and determine next steps," ADC Therapeutics ( ADCT ) said.
The cause of the events remains under investigation. Zynlonta is conditionally approved in the U.S. and Europe as a late-line option for adults with relapsed or refractory (r/r) large B-cell lymphoma, including DLBCL.
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ADC Therapeutics falls after pausing mid-stage trial for lead asset