LOTIS-9 study update
On the 20th of July 2023, Sobi’s partner ADC Therapeutics announced that it plans to discontinue 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). Given the challenges of defining the addressable segment of the difficult-to-treat unfit or frail naïve DLBCL patient population, the benefit-risk profile does not support continuation of the LOTIS-9 trial.
Following a meeting with the U.S. Food and Drug Administration (FDA), a partial clinical hold was placed on the trial for new patient enrolment but will allow patients already on therapy who are deriving clinical benefit to remain on therapy after being reconsented. Following treatment of any reconsenting patients, ADC Therapeutics will conduct the necessary steps to conclude the trial and does not plan to continue studying this regimen in the unfit or frail previously untreated DLBCL patient population.
Sobi firmly believes in the potential of loncastuximab tesirine to help DLBCL patients and remains committed to making loncastuximab tesirine available to as many patients as possible. Patient safety remains Sobi’s top priority. Please reach out to Sobi’s Global Medical Information ([email protected]) or your local Sobi affiliate in case of any questions (contact details are posted on www.sobi.com/en/contacts).
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