ADC Therapeutics SA announced that ZYNLONTA® (loncastuximab tesirine-lpyl) and camidanlumab tesirine (Cami) abstracts have been accepted for presentation at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022), which will be held in Houston, Texas from September 28October 1, 2022. LOTIS-5 Initial Safety Run-In Results: LOTIS-5 is a Phase 3, randomized, open-label, two-part, two-arm, multicenter study of loncastuximab tesirine in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Twenty patients were enrolled in part 1 in a nonrandomized safety run-in.
In part 2, approximately 330 patients will be randomized 1:1 to receive Lonca-R or rituximab-gemcitabine-oxaliplatin (R-GemOx). The 20 patients in the safety run-in were a median age of 74.5 years (range 35-93) and received a median of 1 previous therapy (range 1-6). As of the February 28, 2022, data cutoff: The overall response rate by central review was 15/20 (75%).
A total of 8/20 (40%) and 7/20 (35%) patients attained complete response and partial response, respectively. The most common all-grade TEAEs, regardless of the relationship to the study treatment, were rash (5 [25%]), fatigue (4 [20%]), and increased gamma-glutamyl transferase (4 [20%]). The most common grade =3 TEAEs were increased gamma-glutamyl transferase (3 [15%]), increased alanine aminotransferase (2 [10%]), and neutropenia (2 [10%]).
These data will be presented in the following poster: Initial Safety Run-In Results of the Phase 3 LOTIS-5 Trial: Novel Combination of Loncastuximab Tesirine With Rituximab (Lonca-R) Versus Immunochemotherapy in Patients With R/R DLBCL; Poster Number: ABCL-320; Details of ADC Therapeutics' other poster presentations: A Phase 2, Open-Label Study of Loncastuximab Tesirine in Combination with Rituximab (Lonca-R) in Previously Untreated Unfit/Frail 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 Loncastuximab Tesirine Treatment in a Phase 2 Clinical Trial (LOTIS-2); Poster Number: ABCL-316; Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Encore data, first time as presentation); Poster Number: ABCL-334; Camidanlumab Tesirine: Updated Efficacy and Safety in an Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore); Poster Number: HL-339. Details of ADC Therapeutics' oral presentation: Camidanlumab Tesirine: Updated Efficacy and Safety in an Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore); Date and Time: September 30, 5:48-5:58 p.m. CT; Location: Grand Ballroom G-L, 4th floor; Presenter: Alex Herrera, MD, City of Hope, Duarte, California, USA; Session XII: Hodgkin Lymphoma.