LAUSANNE - ADC Therapeutics SA (NYSE: ADCT), a biotechnology firm specializing in antibody drug conjugates (ADCs), has reported positive preliminary results from a clinical trial assessing the combination of its drug ZYNLONTA with glofitamab for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Despite the optimistic data, the company's shares fell sharply by over 20%.
The LOTIS-7 Phase 1b trial is a global, multicenter study involving patients with r/r B-cell non-Hodgkin lymphoma (B-NHL). As of November 20, 2024, a total of 29 patients across various dose levels were treated and assessed for safety.
The trial's efficacy analysis focused on 18 patients with 2L+ DLBCL who received ZYNLONTA® in combination with glofitamab, revealing a best overall response rate (ORR) of 94% based on Lugano criteria, with a complete response rate of 72%.
ADC Therapeutics' Chief Medical (TASE:PMCN) Officer, Mohamed Zaki, MD, PhD, expressed confidence in the data, highlighting the additive or synergistic efficacy of the drug combination, as well as its manageable safety profile.
The initial safety data indicated that the combination therapy was generally well tolerated, with no dose-limiting toxicities (DLTs) reported. Treatment emergent adverse events of Grade 3 or higher were limited to neutropenia, lymphopenia, and hypokalemia.
The study also observed cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), though all cases were low-grade and resolved with standard treatment. No Grade 3 or higher CRS or ICANS, nor Grade 5 treatment emergent adverse events, were reported.
Ameet Mallik, Chief Executive Officer of ADC Therapeutics, stated that the initial results support the potential of ZYNLONTA® plus glofitamab to become a leading combination in the competitive market. The company anticipates completing enrollment for the dose expansion phase of the trial in the first half of 2025 and plans to discuss the path forward with regulatory authorities as more data becomes available.
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