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IMMagine-1: Preliminary phase II results of anitocabtagene autoleucel in patients with triple-class exposed RRMM
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IMMagine-1 (NCT05396885) is a phase II, single-arm, open-label study investigating the efficacy and safety of the BCMA-directed CAR T-cell therapy anitocabtagene autoleucel (anito-cel; formerly known as CART-ddBCMA) in patients who have received ≥3 prior lines of therapy, including a prior proteasome inhibitor, immunomodulatory agent, and CD38-targeted therapy, and are refractory to their most recent therapy.1 The primary endpoint is ORR per 2016 IMWG criteria.1 Preliminary findings from the safety evaluable (n = 98) and efficacy evaluable (n = 86) populations were presented at the 66th ASH Annual Meeting and Exposition by Freeman.1 |
| Key learnings |
| At a median follow-up of 9.5 months the ORR was 97%, with 93.1% of evaluable patients achieving MRD negativity at a minimum sensitivity of 10−5. The OS rate was 96.5% at both 6 and 12 months. |
| 83% of patients had CRS of any grade, with a median onset of 4 days and a median duration of 3 days. 86% of patients had CRS of Grade ≤1, including 17% of patients with no CRS. |
| Only 9% of patients developed ICANS, with no Grade 4 or 5 cases, and all cases resolved. The most common Grade ≥3 TEAEs were cytopenias, with Grade 3/4 neutropenia in 54% of patients, anemia in 22%, and thrombocytopenia in 20%. |
| Anito-cel demonstrated deep, durable responses in this triple-class exposed RRMM patient population with a manageable safety profile. Recruitment to the IMMagine-1 study is ongoing, with an estimated trial completion date of May 2025. |
Abbreviations: anito-cel, anitocabtagene autoleucel; ASH, American Society of Hematology; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; IMWG, International Myeloma Working Group; ORR, overall response rate; MRD, measurable residual disease; RRMM, relapsed/refractory multiple myeloma; TREAE, treatment-emergent adverse event.
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