Thomas J. Prior

Teclistamab and Daratumumab Immune-Based Doublet Therapy for Relapsed/Refractory Multiple Myeloma: the TRIMM-2 Study

Paula Rodríguez‐Otero, Daniel Morillo, Anita D'Souza, Donna Ellen Reece et autres

Teclistamab is the first approved B-cell maturation antigen×CD3 bispecific antibody with weight-based dosing for triple-class-exposed relapsed/refractory multiple myeloma (RRMM). We evaluated the safety and efficacy of teclistamab combined with the anti-CD38 monoclonal antibody daratumumab in the phase 1b TRIMM-2 study. Eligible patients …

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Evaluating Safety Rules in Ongoing Dose‐Escalation Trials Using BOIN : A Comparative Analysis of Criteria and Their Impact on Dose‐Level Safety Assessments

Stefan Englert, Thomas J. Prior, Anirban Mitra, Busola O. Sanusi et autres

Ongoing dose-escalation trials present unique challenges in assessing safety, all with the goal to establish the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D). Due to the extended duration of trials, it is common to declare doses as safe …

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Updated results of JNJ-5322, a next-generation BCMA x GPRC5D x CD3 trispecific antibody, in patients with relapsed/refractory multiple myeloma

Rakesh Popat, Amrita Y. Krishnan, Martin Kaiser, Jeffrey Matous et autres

Clinical pharmacology strategies to support dose optimization of the recommended Phase 2 dose regimen of JNJ-5322, a BCMA×GPRC5D×CD3 trispecific antibody, in Relapsed/Refractory multiple myeloma

Ashley T. Nguyen, Jie Zhou, Thomas J. Prior, Joseph J. Weidman et autres

Abstract Introduction JNJ-5322 is a next-generation trispecific antibody that contains novel B-cell maturation antigen (BCMA), G protein–coupled receptor class C group 5 member D (GPRC5D), and CD3 binding domains, and has shown potent and selective T-cell mediated antitumor activity against BCMA and …

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Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study

Ajai Chari, Niels W.C.J. van de Donk, Bhagirathbhai Dholaria, Katja Christina Weisel et autres

ABSTRACT: Talquetamab, a G protein-coupled receptor class C group 5 member D-targeting bispecific antibody for relapsed/refractory multiple myeloma (R/R MM), plus daratumumab, may lead to deeper and more durable responses than either therapy alone. In the phase 1b TRIMM-2 study, patients with …

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Patient-Reported Outcomes (PROs) and Safety in Patients (Pts) With NDMM Achieving MRD Negativity and ≥CR (MRDneg) in the Phase 3 PERSEUS and CEPHEUS Trials

Jesús F. San Miguel, Saad Z. Usmani, Sonja Zweegman, Philippe Moreau et autres

POSTER: MM-906 First-in-Human Study of JNJ-79635322 (JNJ-5322), a Novel Next-Generation Trispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma: Initial Phase 1 Results

Hans C. Lee, Rakesh Popat, Cyrille Touzeau, Aurore Perrot et autres

MM-906: First-in-Human Study of JNJ-79635322 (JNJ-5322), a Novel Next-Generation Trispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma: Initial Phase 1 Results

Hans C. Lee, Rakesh Popat, Cyrille Touzeau, Aurore Perrot et autres

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ORAL ABSTRACT: MM-906 First-in-Human Study of JNJ-79635322 (JNJ-5322), a Novel Next-Generation Trispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma: Initial Phase 1 Results

Hans C. Lee, Rakesh Popat, Cyrille Touzeau, Aurore Perrot et autres

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Measurable residual disease (MRD) as a surrogate end point for clinical drug approval in acute myeloid leukemia (AML): Perspectives from the MRD Partnership and Alliance in AML Clinical Treatment Consortium

Michael M. Boyiadzis, Andrew H. Wei, Bruno Paiva, Sylvie D. Freeman et autres

Despite advances in acute myeloid leukemia (AML) treatment, significant unmet medical needs remain. Surrogate end points for overall survival can accelerate the approval of novel therapies. Measurable residual disease (MRD) is a promising surrogate end point candidate, providing a sensitive and quantitative …

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Figure 6 from Modeling MRD Changes in Myeloma to Understand Treatment Effects, Predict Outcomes, and Investigate Curative Potential

Walter Martin Gregory, Thomas J. Prior, J. Blake Bartlett, Pieter Sonneveld et autres

Model validation from the MAIA trial: PFS predictions from original data compared with actual results from updated data. CI, confidence interval. Kaplan–Meier curves are shown with censoring ticks removed.

Figure 3 from Modeling MRD Changes in Myeloma to Understand Treatment Effects, Predict Outcomes, and Investigate Curative Potential

Walter Martin Gregory, Thomas J. Prior, J. Blake Bartlett, Pieter Sonneveld et autres

Minimum time spent below the LOD (months) by whether values increased above the LOD again or not. aLOD group 3, values go below the LOD and stay below the LOD (≥2 values below the LOD). bLOD group 4, values at or below …