Artiva Biotherapeutics announces new, long-term data for AlloNK combination

Artiva Biotherapeutics (ARTV) announced new longer-term Phase 1/2 data demonstrating durable responses for AlloNK in combination with rituximab in patients with relapsed/refractory B-cell non-Hodgkin lymphoma at the American Society of Gene & Cell Therapy annual meeting. The study had a 64% complete response rate for AlloNK + RTX with patients who were naive to prior CAR-T cell therapy. Patients received a median three prior lines and 13 out of 14 patients had aggressive B-NHL. Comparable to outcomes with approved auto-CAR-T cell therapies in a similar heavily pretreated, later line patient population with aggressive B-NHL, which in registrational studies showed a 58% CR rate with Yescarta, 53% CR rate with Breyanzi and 40% CR rate with Kymriah Median duration of response not yet reached and is at least 19.4 months as of the March 7, 2025, data-cut in patients following treatment with AlloNK + RTX. Complete responses sustained in the majority of patients treated with AlloNK + RTX. Comparable to outcomes with approved auto-CAR-T cell therapies in a similar heavily pretreated, later line patient population with aggressive B-NHL, which in registrational studies showed an 11.1 month mDoR with Yescarta, 23.1 month mDOR with Breyanzi and mDOR not reached at 40. Three months follow up with Kymriah AlloNK + RTX was well-tolerated among the 45 patients dosed. All cytokine release syndrome events were re-classified as infusion-related reactions based on: analysis of cytokines of the three patients with reported low-grade CRS, demonstrating an absence of elevated IL-6 and other cytokines; timing of reported events, all occurring within 24 hours of cell infusion; and resolution of symptoms without specialized treatment. These re-classifications support AlloNK’s potentially well-tolerated profile, suitable for outpatient community administration No immune effector cell associated neurotoxicity syndrome, no graft-versus-host disease, no deaths related to AlloNK, and no trial discontinuations due to AlloNK related adverse events have been reported to date. In line with the usage of lymphodepletion regimens, the most common treatment-emergent adverse events were hematologic, including neutropenia, leukopenia and lymphopenia. IRRs and febrile neutropenia were the only related serious TEAEs reported in more than 1 patient Deep B-cell depletion and prolonged duration of response for over 19 months in heavily pretreated R/R B-NHL patients supports a potent mechanism of action with potential to deliver deep B-cell depletion in a refractory autoimmune population Lack of cell-therapy driven acute toxicities like CRS and ICANS in heavily pretreated patients with aggressive disease, including older patients, supports the potential for outpatient administration.