Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open‐label Phase II study

British Journal of Haematology - Tập 192 Số 5 - Trang 869-878 - 2021
Ajai Chari1, Paula Rodríguez‐Otero2, Helen O. McCarthy3, Kenshi Suzuki4, Vânia Hungria5, Anna Sureda6, Aurore Perrot7, Cyrille Hulin8, Hila Magen9, Shinsuke Iida10, Vladimír Maisnar11, Lionel Karlin12, Luděk Pour13, Dolly A. Parasrampuria14, Tara Masterson14, Michele Kosh14, Shiyi Yang14, Maria Delioukina14, Ming Qi14, Robin Carson14, Cyrille Touzeau15
1Icahn School of Medicine at Mount Sinai, New York, NY, USA.
2Clínica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain
3Royal Bournemouth Hospital, Bournemouth, UK
4Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan
5Clinica Medica São Germano, São Paulo, Brazil
6Hematology Department Institut Català d'Oncologia – Hospitalet IDIBELL University of Barcelona Barcelona Spain
7CHU de Toulouse IUCT‐O Université de Toulouse UPS Service d'Hématologie Toulouse France
8Department of Hematology, Hôpital Haut Lévêque, University Hospital, Pessac, France
9Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
10Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
114th Department of Medicine – Haematology Charles University Hospital Hradec Králové Czech Republic
12Department of Hematology Centre Hospitalier Lyon Sud Hospices Civils de Lyon Pierre‐Bénite France
13University Hospital Brno, Brno, Czech Republic
14Janssen Research & Development, LLC Spring House PA USA
15Hematology Department University Hospital Hôtel‐Dieu Nantes France

Tóm tắt

SummaryDaratumumab is a CD38‐targeting monoclonal antibody approved for intravenous (IV) infusion for multiple myeloma (MM). We describe the Phase II PLEIADES study of a subcutaneous formulation of daratumumab (DARA SC) in combination with standard‐of‐care regimens: DARA SC plus bortezomib/lenalidomide/dexamethasone (D‐VRd) for transplant‐eligible newly diagnosed MM (NDMM); DARA SC plus bortezomib/melphalan/prednisone (D‐VMP) for transplant‐ineligible NDMM; and DARA SC plus lenalidomide/dexamethasone (D‐Rd) for relapsed/refractory MM. In total, 199 patients were treated (D‐VRd, n = 67; D‐VMP, n = 67; D‐Rd, n = 65). The primary endpoints were met for all cohorts: the ≥very good partial response (VGPR) rate after four 21‐day induction cycles for D‐VRd was 71·6% [90% confidence interval (CI) 61·2–80·6%], and the overall response rates (ORRs) for D‐VMP and D‐Rd were 88·1% (90% CI 79·5–93·9%) and 90·8% (90% CI 82·6–95·9%). With longer median follow‐up for D‐VMP and D‐Rd (14·3 and 14·7 months respectively), responses deepened (ORR: 89·6%, 93·8%; ≥VGPR: 77·6%, 78·5%), and minimal residual disease–negativity (10‒5) rates were 16·4% and 15·4%. Infusion‐related reactions across all cohorts were infrequent (≤9·0%) and mild. The median DARA SC administration time was 5 min. DARA SC with standard‐of‐care regimens demonstrated comparable clinical activity to DARA IV–containing regimens, with low infusion‐related reaction rates and reduced administration time.

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British Journal of Haematology

Tập 192 Số 5

869-878

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