An open‐label, first‐in‐human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma

Author:

Kapoor Prashant1,Nathwani Nitya2,Jelinek Tomas3,Pour Ludek4,Perrot Aurore5,Dimopoulos Meletios‐Athanasios6ORCID,Huang Shang‐Yi7,Spicka Ivan8,Chhabra Saurabh9,Lichtman Eben1011,Mateos Maria‐Victoria12,Kanagavel Dheepak13,Zhao Liang14,Guillemin‐Paveau Helene13,Macé Sandrine13,van de Velde Helgi15,Richardson Paul G.16ORCID

Affiliation:

1. Division of Hematology Mayo Clinic Rochester Minnesota USA

2. Judy and Bernard Briskin Center for Multiple Myeloma Research City of Hope Comprehensive Cancer Center California USA

3. Department of Hematooncology University Hospital Ostrava and University of Ostrava Ostrava Czech Republic

4. Department of Internal Medicine, Hematology and Oncology University Hospital Brno Brno Czech Republic

5. Department of Hematology Institut Universitaire du Cancer de Toulouse Toulouse France

6. Department of Clinical Therapeutics National and Kapodistrian University of Athens Athens Greece

7. Department of Hematology National Taiwan University Hospital Taipei Taiwan

8. First Department of Medicine, Department of Hematology, First Faculty of Medicine Charles University and General Hospital Prague Czech Republic

9. Division of Hematology and Oncology, Department of Medicine Mayo Clinic Arizona Phoenix Arizona USA

10. Lineberger Comprehensive Cancer Center University of North Carolina at Chapel Hill Chapel Hill North Carolina USA

11. Department of Medicine, Division of Hematology University of North Carolina at Chapel Hill Chapel Hill North Carolina USA

12. Hospital Universitario de Salamanca, Instituto de Investigacion Biomedica de Salamanca (IBSAL) University of Salamanca Salamanca Spain

13. Research and Development Sanofi, Research and Development Vitry‐sur‐Seine France

14. Research and Development Sanofi, Research and Development Shanghai China

15. Research and Development Sanofi, Research and Development Cambridge Massachusetts USA

16. Department of Medical Oncology, Dana‐Farber Cancer Institute Jerome Lipper Multiple Myeloma Center Boston Massachusetts USA

Abstract

AbstractObjectivesCluster of differentiation 38 (CD38) is a key target on multiple myeloma (MM) cells. This multi‐centre, Phase 1, single‐agent study (NCT04000282) investigated SAR442085, a novel fragment crystallisable (Fc)‐modified anti‐CD38 monoclonal antibody (mAb), with enhanced affinity towards Fc‐gamma receptor on effector cells in patients with relapsed and/or refractory (RR) MM.MethodsThis study comprised two parts: Part‐A (dose‐escalation involving anti‐CD38 mAb pre‐treated and naïve patients) and Part‐B (dose expansion). Primary endpoints were maximum tolerated dose and recommended Phase 2 dose (RP2D).ResultsThirty‐seven heavily pre‐treated patients were treated in Part A. Part‐B (dose‐expansion) was not studied. Seven dose‐limiting toxicities were reported at DL3, DL5, DL6, and DL7. RP2D was determined to be 5–7·5 mg/kg. Most common treatment‐emergent adverse events were infusion‐related reactions in 70·3% (26/37) patients. Grade ≥3 thrombocytopenia was reported in 48·6% (18/37). Overall response rate was 70% in anti‐CD38 mAb naïve and 4% in anti‐CD38 pre‐treated patients, with a median progression‐free survival of 7·62 (95%CI: 2·858; not calculable) months and 2·79 (95%CI: 1·150; 4·172) months and, respectively.ConclusionsThe efficacy of SAR442085 was promising in anti‐CD38 mAb naïve patients but did not extend to the larger cohort of anti‐CD38 mAb pre‐treated patients. This observation, along with transient high‐grade thrombocytopenia, could potentially limit its clinical use.

Publisher

Wiley

Reference38 articles.

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