#Switzerland #ADC Therapeutics #ZYNLONTA #Lausanne #DLBCL

ADC Therapeutics Completes Enrollment for Phase 3 Trial of ZYNLONTA®

ADC Therapeutics SA, a notable name in the development of antibody-drug conjugates (ADCs), recently announced that it has successfully completed the enrollment process for its ongoing Phase 3 confirmatory trial, named LOTIS-5. This trial is centered on evaluating the efficacy of ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with Rituximab for patients suffering from relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

The announcement, made from Lausanne, Switzerland, sheds light on the promising nature of this inquiry. Previously, in 2021, ZYNLONTA received accelerated approval from the FDA for intended use post two or more systemic therapies. Following this progress, the completion of the LOTIS-5 trial demonstrates a significant milestone in the pursuit of innovative treatment options for DLBCL.

Doctor Mohamed Zaki, Chief Medical Officer at ADC Therapeutics, expressed optimism regarding this achievement, stating, "This milestone for LOTIS-5 brings us a step closer to providing a potential combination treatment in the 2L+ DLBCL setting that we believe will offer competitive efficacy with favorable safety and a convenient dosing schedule, well-suited for use in patients across care settings."

The trial has a somewhat structured design, divided into two parts. Part one, which involved a non-randomized safety run-in, included the enrollment of 20 participants. Notably, results from this segment indicated an overall response rate of 80%, with half of the participants achieving a complete response. Additionally, this phase reported no unexpected safety concerns.

In the second part of the study, participants diagnosed with 2L+ DLBCL will be randomized to receive either the fixed dose of ZYNLONTA in tandem with Rituximab or standard treatment comprising Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx). The primary focus of LOTIS-5 is the progression-free survival endpoint, with secondary outcomes revolving around overall survival rates, overall response rates, complete response rates, duration of response, and the frequency and severity of adverse effects.

Anticipating completion, ADC Therapeutics expects to publicly share the topline results from the primary endpoint analysis by the end of 2025. If successful, plans are in place to submit a supplemental Biologics License Application (BLA) to the FDA in the early months of 2026, with hopes of potentially gaining approval by the end of 2026.

About ZYNLONTA®

ZYNLONTA® is an innovative therapeutic modality targeting CD19, specifically designed for patients grappling with B-cell malignancies. Once the drug binds to a CD19-expressing cell, it triggers internalization, which subsequently releases a potent payload that leads to cell cycle arrest and triggers cellular apoptosis, effectively aiding in tumor cell death.

This FDA-approved antibody-drug conjugate has emerged as a game-changer for patients who have previously exhausted significant therapeutic options. The a critical element to note here is that ZYNLONTA's current approval paths are predicated on broad safety and efficacy data.

Moreover, it's vital to note that ADC Therapeutics continues exploring ZYNLONTA in various combination trials for other B-cell malignancies as well as potential applications in earlier treatment lines.

Conclusion

ADC Therapeutics is firmly positioned at the forefront of revolutionizing cancer treatment paradigms. With ongoing clinical trials and innovative therapies such as ZYNLONTA, the company underpins its mission to improve patient outcomes in oncology. As the Phase 3 trial progresses toward its anticipated milestones, the lymphoma community eagerly awaits the subsequent results that could redefine therapeutic approaches against DLBCL. For further details on the clinical trial, interested individuals can visit clinicaltrials.gov and reference identifier NCT04384484.