Efficacy, Safety, and Determination of RP2D of ABBV-383, a BCMA Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Summary:
The phase 1 trial of ABBV-383, a BCMA bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM) has demonstrated promising activity. ABBV-383, with its unique design and convenient dosing schedule, has shown efficacy and safety in RRMM patients. The optimal therapeutic dose of 60mg every 4 weeks (Q4W) was determined based on safety, efficacy, and exposure-response analyses. This dosing regimen resulted in a lower incidence of cytokine release syndrome (CRS) compared to other dosing schedules. Neutropenia, anemia, thrombocytopenia, and infections were the most common adverse events observed. The overall response rate (ORR) and very good partial response (VGPR) rate were similar across the different dosing regimens. The findings from this trial support further investigation of ABBV-383 at the recommended dose in a phase 3 trial for RRMM. If successful, ABBV-383 could provide a new therapeutic option for patients with relapsed/refractory multiple myeloma.

Key Points:
• ABBV-383 is a next-generation BCMA x CD3 bispecific antibody designed to reduce cytokine release syndrome (CRS) risk and allow convenient dosing.
• The phase 1 trial enrolled RRMM patients who had received at least 3 prior lines of therapy.
• ABBV-383 regimens explored in the trial included 60mg Q4W and 40 or 60mg Q3W.
• The modified premedication schedule and shortened CRS monitoring period were implemented in the 60mg Q4W cohort for cycle 1.
• Common treatment-emergent adverse events (TEAEs) included CRS, neutropenia, anemia, thrombocytopenia, and infections.
• The incidence of CRS was lower in the 60mg Q4W cohort compared to the Q3W cohorts.
• The overall response rate (ORR) and very good partial response (VGPR) rate were similar across the different dosing regimens.
• Exposure-response (ER) analyses and correlative analyses supported the determination of the recommended phase 2 dose (RP2D) as 60mg Q4W.

Authors:
Katja Weisel, Cesar Rodriguez-Valdes, Peter Voorhees, Anita D'Souza, Alfred Chung, Sascha Tuchman, Hana Safah, John Mckay, Raphael Teipel, Neha Korde, Ravi Vij, Orlando Bueno, Tanya Rosenberg, Rajvineeth Kumar Pothacamury, Akshanth Polepally, Aarif Ahsan, Shane Lee, Ziyi Jin, Chetasi Talati, Shaji Kumar

EHA Abstract: S211


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