ADC Therapeutics Completes Enrollment for LOTIS-7 Clinical Trial with ZYNLONTA®
ADC Therapeutics Completes Enrollment for LOTIS-7 Clinical Trial with ZYNLONTA®
ADC Therapeutics SA, listed on the New York Stock Exchange as ADCT, is making significant strides in the fight against diffuse large B-cell lymphoma (DLBCL). The company announced today that it has successfully completed the enrollment of patients in the LOTIS-7 Phase 1b open-label clinical trial. This pivotal study evaluates the safety and efficacy of ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with glofitamab (COLUMVI®), a bispecific antibody designed to treat patients with relapsed or refractory (r/r) DLBCL.
In total, the trial has dosed 100 participants with r/r DLBCL at a dose of 150 µg/kg of ZYNLONTA, in tandem with glofitamab. The trial took place at 30 sites, with 70% of the participants from the United States and 30% from Europe. The trial cohort reflects a balance between relapsed (46%) and primary refractory patients (54%), with a median age of 66 years.
Goals of LOTIS-7
The trial has established primary endpoints focusing on safety and tolerability among patients undergoing treatment. Moreover, the secondary endpoints encompass various critical measures such as overall response rate, duration of response, complete response rate, relapse-free survival, progression-free survival, and overall survival. Pharmacokinetics and immunogenicity assessments are also integral to the study's design. All participants undergoing treatment are recommended to receive anti-infective prophylaxis, alongside intravenous immunoglobulin for those experiencing B-cell loss, which elevates infection risk.
Dr. Mohammed Zaki, the Chief Medical Officer at ADC Therapeutics, expressed enthusiasm regarding the data shared from the trial, which highlighted an impressive 89.8% overall response rate and 77.6% complete response rate among the patients that were evaluable for efficacy, following a minimum of six months of follow-up. He noted, "We believe this combination of ZYNLONTA holds the potential to emerge as a leading bispecific antibody-based therapeutic for patients suffering from second-line or greater DLBCL. With enrollment now finalized, we look forward to sharing comprehensive findings from LOTIS-7 in the upcoming months."
Future Perspectives
Building on the already promising clinical data indicated by the ongoing LOTIS-7 trial, ADC Therapeutics plans to deliver complete results at an upcoming medical conference and subsequently submit these findings for publication by the end of 2026. The company is also looking into regulatory pathways that could advance the approval process for the ZYNLONTA and glofitamab combination.
Understanding the LOTIS-7 Framework
The LOTIS-7 trial is a global multicenter study, categorized into two distinct parts — Part 1 addressing dose escalation and Part 2 focused on dose expansion. Within this framework, three dosing arms are being studied: ZYNLONTA in combination with polatuzumab vedotin, ZYNLONTA paired with glofitamab, and ZYNLONTA supplemented by mosunetuzumab. Enrollment across the study signifies Part 1's conclusion, which utilized a 3+3 dose escalation approach for heavily pre-treated patients, initially administering ZYNLONTA at 90 µg/kg, escalating to 120 µg/kg and finally 150 µg/kg. Part 2 entails additional expansion doses for large B-cell lymphoma utilizing the established dosing from Part 1.
More About ZYNLONTA®
ZYNLONTA® is a cutting-edge antibody-drug conjugate that targets CD19 expressed on B cells. It operates by binding to CD19-positive cells and facilitating internalization. Once inside, the conjugate releases its potent payload, resulting in cell cycle arrest and subsequent tumor cell death. Both the U.S. FDA and the European Medicines Agency (EMA) have granted approval for ZYNLONTA in treating adults with relapsed or refractory DLBCL after two or more systemic therapy lines.
In summary, ADC Therapeutics is not only setting the pace in clinical advancements with ZYNLONTA but is also dedicated to addressing the complex needs of patients with difficult-to-treat B-cell malignancies. The robust data expected from the LOTIS-7 trial may soon provide a new lifeline for those in need of innovative and effective therapies.
For those seeking additional details about the LOTIS-7 study, further information can be accessed via clinicaltrials.gov (NCT04970901).
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.