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Etentamig combined with daratumumab/dexamethasone for RRMM: Results from the phase I Kilimanjaro trial
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Etentamig (ABBV-383) is a BCMA- and CD3-directed bispecific antibody with previously demonstrated efficacy in treating heavily pretreated patients with RRMM as a monotherapy. At the 66th ASH Annual Meeting and Exposition, Rodriguez presented results from Arm C of Kilimanjaro (NCT05259839), an open-label, phase I dose-escalation and expansion trial.1 Arm C examined etentamig in combination with daratumumab and dexamethasone in patients with R/R MM who had received ≥3 prior lines of therapy. A total of 86 patients were treated with the triplet combination, with doses of etentamig of 20 mg (n = 37), 40 mg (n = 35), and 60 mg (n = 14).1 |
| Key learnings |
| In the dose escalation phase, 12 patients experienced a DLT, most commonly thrombocytopenia. Disease progression was the most common reason for treatment discontinuation (22%). |
| The most common hematologic TEAE was neutropenia, affecting 35% of patients in the 20 mg group and 57% in the 40 mg and 60 mg groups. Infections occurred in 67% of patients overall. |
| With a median follow-up of 7 months, the ORR was 71% overall and 83% in the 40–60 mg dose, with a median time to first response of 1 month. 28% of patients achieved sCR/CR, with the highest CR rate observed in the 40 mg group (40%). |
| In a heavily pretreated patient population, etentamig in combination with daratumumab and dexamethasone led to high ORR, with no unexpected safety signals compared with monotherapy, warranting further investigation in earlier lines of therapy. |
Abbreviations: AE, adverse event; ASH, American Society of Hematology; BCMA, B cell maturation antigen; CR, complete response; DLT, dose-limiting toxicity; MM, multiple myeloma; ORR, overall response rate; R/R, relapsed/refractory; sCR, stringent complete response; TEAE, treatment-emergent adverse event.
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