Initial results from the safety testing phase of the LOTIS-5 Phase 3 trial demonstrate an overall response rate of 75% and a clinical recovery rate of 40%, with no new safety concerns
Key Phase 2 data for Cami will be highlighted in additional oral and poster presentations
LAUSANNE, Switzerland, September 22, 2022–(BUSINESSWIRE)–ADC Therapeutics SA (NYSE:ADCT) announced today that abstracts of ZYNLONTA® (loncastuximab tesirine-lpyl) and camidanlumab tesirine (Cami) have been accepted for presentation at the 10th Annual Meeting of the Society for Hematologic Oncology (SOHO 2022), taking place in Houston, Texas, from September 28 to October 1 of 2022.
“We look forward to sharing the encouraging early results from the safety trial phase of our phase 3 clinical trial LOTIS-5 at SOHO 2022, evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma,” said Joseph Camardo, MD, medical director of ADC Therapeutics. “This is one of several clinical studies of ZYNLONTA in combination with other drugs to evaluate ZYNLONTA in previous lines of treatment. »
Initial results from the “safety roll-in” phase of LOTIS-5
LOTIS-5 is a randomized, open-label, two-arm, multicenter phase 3 study of loncastuximab tesirine-lpyl in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Twenty patients were recruited into part 1 as part of a non-randomized ‘safety test’ phase. In Part 2, approximately 330 patients will be randomized 1:1 to receive either Lonca-R or R-GemOx (rituximab + gemcitabine + oxaliplatin).
The 20 patients who participated in the safety trial phase had a median age of 74.5 years (range: 35-93) and received a mean of 1 prior treatment (range: 1-6). February 28, 2022, deadline for data collection:
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The centrally controlled overall response rate was 15/20 (75%). A total of 8/20 (40%) and 7/20 (35%) patients achieved a complete response or a partial response, respectively.
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The most common treatment-emergent adverse reactions (TEAEs), all grades combined and regardless of relationship to study treatment, were: rash (5 [25 %]), fatigue (4 [20 %]) and increased gamma-glutamyltransferase (4 [20 %]). The most common grade ≥3 TEAEs were: increased gamma-glutamyltransferase (3 [15 %]), increased alanine aminotransferase (2 [10 %]) and neutropenia (2 [10 %]).
These data will be presented in the following poster:
Early Preliminary Safety Results from the Phase 3 LOTIS-5 Trial: New Combination of Loncastuximab Tesirin with Rituximab (Lonca-R) Versus Immunochemotherapy in Patients with DLBCL R/R
Poster number: ABCL-320
Details of other ADC Therapeutics poster presentations:
An open-label phase 2 study of loncastuximab tesirine in combination with rituximab (Lonca-R) in previously untreated frail/unfit patients with diffuse large B-cell lymphoma (DLBCL) (LOTIS-9) (Encore data, first time as presentation )
Poster number: ABCL-272
Health-related quality of life and tolerability in patients with/without skin toxicity during treatment with loncastuximab tesirin in a phase 2 clinical trial (LOTIS-2)
Poster number: ABCL-316
Long-term survival projections of patients treated with loncastuximab tesirin in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Encore data, first time as presentation)
Poster number: ABCL-334
Camidanlumab Tesirin: Updated Efficacy and Safety in an Open-label, Multicenter, Phase 2 Study of Patients With Relapsed/Refractory Classical Hodgkin’s Lymphoma (R/R cHL) (Encore)
Poster number: HL-339
All posters will be displayed on Wednesday, September 28 between 5:05 pm and 6:30 pm Central Time in the Ballroom of Americas, Level 2 of the Hilton-Americas Houston hotel. The posters will remain in the Poster Lobby, where they can be viewed all day on Thursdays and Fridays. Online access to posters for registered participants will begin on Thursday, September 29.
ADC Therapeutics Oral Presentation Details:
Camidanlumab Tesirin: Updated Efficacy and Safety in an Open-label, Multicenter, Phase 2 Study of Patients With Relapsed/Refractory Classical Hodgkin’s Lymphoma (R/R cHL) (Encore)
Date and time: Friday, September 30 from 5:48 p.m. to 5:58 p.m. (Central Time)
Venue: GL Grand Ballroom, 4me scenery
Presenter: Alex Herrera, DM, City of Hope, Duarte, CA, USA
Session XII: Hodgkin lymphoma
About ZYNLONTA® (loncastuximab tesirin-lpyl)
ZYNLONTA® it is an antibody-drug conjugate (ADM) directed at CD19. Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where the enzymes release a pyrrolobenzodiazepine (PBD) payload. This powerful payload binds to the minor groove of DNA with low distortion, thus remaining less visible to DNA repair mechanisms. Ultimately, this results in cell cycle arrest and death of tumor cells.
The FDA approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma to two or more lines of systemic therapy, including unspecified DLBCL, resulting low-grade DLBCL lymphoma, as well as high-grade B-cell lymphoma. The trial included a wide range of intensively pretreated patients (median number of prior treatments was three) and with difficult-to-treat diseases, including patients who did not respond to first-line treatment, refractory to all previous first-line therapies, patients with a double/triple genetic event disease and patients who underwent stem cell transplantation and CAR-T cell therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under the accelerated approval procedure based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefits seen in a confirmatory trial.
ZYNLONTA is also being evaluated in combination with previous therapeutic lines and in other B-cell malignancies.
About camidanlumab tesirine (Cami)
Camidanlumab tesirin (Cami) is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated with the pyrrolobenzodiazepine dimer (PBD) payload, tesirin. Once bound to a CD25-expressing cell, Cami is internalized into the cell, where enzymes release the PBD-based warhead, leading to cell death. This applies to CD25-expressing tumor cells as well as CD25-expressing Treg cells. Intratumoral release of its PBD-based warhead can also lead to the death of neighboring tumor cells. PBDs have also been shown to induce immunogenic cell death. All these properties of Cami are likely to enhance immune-mediated antitumor activity.
Cami is being evaluated in a pivotal phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma, and in a phase 1b clinical trial, as monotherapy and in combination with pembrolizumab in the treatment of solid tumors.
About ADC Therapeutics
ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company improving the quality of life for people with cancer through its next-generation antibody-targeted drug conjugates (ADCTs). The Company leverages its proprietary PBD-based CAM technology to transform the therapeutic paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-targeting CAM ZYNLONTA (loncastuximab tesirine-lpyl) is FDA-approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma after at least two lines of systemic therapy. ZYNLONTA is also being developed in combination with other agents. Cami (cadidanlumab tesirine) is in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial for the treatment of various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has several CAMs in preclinical and clinical development.
ADC Therapeutics is headquartered in Lausanne (Biopôle), Switzerland, with offices in London, the San Francisco Bay Area and New Jersey. For more information, you can visit the website https://adctherapeutics.com/ and follow the Company on Twitter Y LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
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