ADC Therapeutics SA announced that two ZYNLONTA® (loncastuximab tesirine-lpyl) abstracts have been accepted for presentation at the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023), which will be held in Houston, Texas from September 6-9, 2023. LOTIS-5 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). It is the confirmatory trial for accelerated approval for 3L+ and would also support potential label expansion into 2L+ in combination with rituximab.
Twenty patients were enrolled in part 1 of a non-randomized safety run-in. In part 2, approximately 330 patients will be randomized 1:1 to receive fixed-dose Lonca-R or rituximab-gemcitabine-oxaliplatin (R-GemOx). The 20 patients in the safety run-in were a median age of 74.5 years and had previously received a median of five cycles of Lonca-R and one previous therapy.
As of the April 10, 2023, data cutoff: Seven patients completed treatment and five continue in follow-up. The overall response rate by central review was 16/20 (80%). A total of 10/20 (50%) and 6/20 (30%) patients attained complete and partial response, respectively.
The median duration of response was 8.0 months and the median progression-free survival was 8.3 months. A total of 11 (55%) patients had grade =3 treatment-emergent adverse events (TEAEs). The most common grade =3 TEAEs were increased gamma-glutamyltransferase (5 patients [25%]) and neutropenia (3 patients [15%]).
LOTIS-7 is a multicenter and multi-arm study that will enroll approximately 200 patients with relapsed or refractory B-cell non-Hodgkin lymphoma in part 1 (dose escalation in approximately 60 patients) and part 2 (dose expansion in approximately 120 patients). Dosing arms include ZYNLONTA (loncastuximab tesirine-lpyl) plus polatuzumab vedotin, as well as ZYNLONTA (loncastuximab tesirine-lpyl) plus glofitamab and mosunetuzumab, t-cell-engaging bispecific monoclonal antibodies (BsAbs). The bispecific combination arms of the LOTIS-7 trial are now actively enrolling patients with DLBCL, including transformed follicular lymphoma (FL), high-grade B-cell lymphoma (HGBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Combining these agents with different mechanisms of action has the potential to have increased activity compared to either agent alone.
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