Artiva Biotherapeutics presented longer-term Phase 1/2 data for its AlloNK® (AB-101) therapy in combination with rituximab at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting in New Orleans. The results demonstrate impressive efficacy and durability in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), positioning the therapy as a potential alternative to CAR-T treatments.
The data revealed a 64% complete response rate (9/14) in heavily pretreated patients who were naïve to prior CAR-T cell therapy. This response rate is comparable to approved autologous CAR-T therapies in similar patient populations, which showed complete response rates of 58% for Yescarta, 53% for Breyanzi, and 40% for Kymriah in their respective registrational trials.
"We are thrilled to see continuing durability, now with an ongoing median duration of response of at least 19 months. These data are maturing as one of the data sets with the highest activity and durability for any allogeneic cell therapy in heavily pretreated, aggressive B-NHL patients and in line with approved auto-CAR-T therapies," said Fred Aslan, M.D., Chief Executive Officer of Artiva.
Durable Responses Comparable to CAR-T Therapies
The median duration of response has not yet been reached and extends beyond 19.4 months as of the March 7, 2025 data cut. This durability compares favorably with approved CAR-T therapies, which showed median durations of response of 11.1 months for Yescarta, 23.1 months for Breyanzi, and a not-reached median at 40.3 months follow-up for Kymriah.
The study population included patients who had received a median of three prior lines of therapy, with 13 out of 14 patients having aggressive B-NHL. Complete responses were sustained in the majority of patients treated with the AlloNK and rituximab combination.
David G. Maloney, M.D., Ph.D., Professor Emeritus of Translational Science and Therapeutics at the Fred Hutch Cancer Center, who dosed the first patient with rituximab in 1997, commented, "It is encouraging to see AlloNK demonstrate robust responses and meaningful durability in tough to treat late-line patients with aggressive NHL that are comparable to those with autologous CAR-T cell therapies."
Favorable Safety Profile Supports Outpatient Use
A key advantage of AlloNK therapy appears to be its safety profile. Among the 45 patients dosed, the treatment was well-tolerated with no reported cases of immune effector cell associated neurotoxicity syndrome (ICANS) or graft-versus-host disease. No deaths related to AlloNK or trial discontinuations due to AlloNK-related adverse events have been reported.
Initially reported cytokine release syndrome (CRS) events were re-classified as infusion-related reactions (IRRs) based on analysis of cytokines, which showed an absence of elevated IL-6 and other cytokines typically associated with CRS. These events occurred within 24 hours of cell infusion and resolved without specialized treatment.
The most common treatment-emergent adverse events were hematologic, including neutropenia (84%), leukopenia (82%), and lymphopenia (71%), which are consistent with the use of lymphodepletion regimens. Infusion-related reactions and febrile neutropenia (7% each) were the only related serious adverse events reported in more than one patient.
Implications for Autoimmune Disease Treatment
The robust efficacy and safety profile of AlloNK in B-NHL patients has significant implications for its potential use in autoimmune diseases. The deep B-cell depletion and prolonged duration of response observed in heavily pretreated cancer patients suggests that AlloNK could deliver effective B-cell depletion in refractory autoimmune populations.
"AlloNK has now demonstrated its ability to significantly enhance the activity of both anti-CD20 rituximab and Affimed's CD30-directed NK cell engager AFM13 in late line, cancer populations. These findings reinforce the potential of AlloNK to drive deep and durable responses in autoimmune diseases through the enhancement of standard of care monoclonal antibodies and robust B-cell depletion," added Dr. Aslan.
The absence of severe cell therapy-related toxicities, even in older patients with aggressive disease, supports the potential for outpatient administration in community settings. This could represent a significant advantage over current cellular therapies that typically require specialized centers and inpatient monitoring.
Ongoing Clinical Development
Artiva is currently evaluating AlloNK in three ongoing clinical trials for B-cell driven autoimmune diseases. These include two company-sponsored trials—one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases including rheumatoid arthritis and Sjögren's disease—as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.
In addition to the clinical data presentation, Artiva also featured a poster at ASGCT highlighting the scalability and consistency of the AlloNK manufacturing process, an important consideration for broader clinical application.
AlloNK is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. The therapy was developed as part of a strategic partnership with GC Cell (formerly GC Lab Cell Corporation), a leading healthcare company in the Republic of Korea.
As the data continues to mature, AlloNK's combination of efficacy, durability, and safety could position it as a significant advancement in both oncology and autoimmune disease treatment landscapes, potentially offering an alternative to more complex and costly cellular therapies.
