LOTIS-9 trial targets unfit, frail and elderly patients with previously untreated DLBCL representing a significantly underserved patient population
ADC Therapeutics SA (NYSE: ADCT) today announced the first patient has been dosed in LOTIS-9, a Phase 2 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in unfit and frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
“Unfit, elderly, and frail DLBCL patients represent a growing population for which new treatments are greatly needed. These patients are often unable to tolerate the standard of care R-CHOP or even a modified R-CHOP regimen and they are excluded from many first-line studies,” said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “Following results from the safety run-in of our LOTIS-5 Phase 3 confirmatory trial that demonstrated the tolerability and additive efficacy of ZYNLONTA in combination with rituximab, we are pleased to be assessing the combination in the LOTIS-9 trial in the first-line DLBCL setting for these particular patients. We look forward to the continued advancement of our clinical program designed to maximize the potential of ZYNLONTA and address significant unmet medical needs for patients with lymphoma around the world.”
The initial exploratory stage of the LOTIS-9 open-label Phase 2 trial is evaluating the efficacy and tolerability of Lonca-R in approximately 80 unfit or frail patients aged 80 years or older with previously untreated DLBCL. The simplified geriatric assessment (sGA) developed by the Fondazione Italiana Linfomi identifies three distinct categories (fit, unfit, and frail) based on age, activities of daily living, instrumental activities of daily living and the Cumulative Illness Rating Scale for Geriatrics. Trial participants will be assigned to either Cohort A (unfit) or Cohort B (frail) using the sGA. For more information about the LOTIS-9 trial, please visit www.clinicaltrials.gov (identifier NCT05144009).