Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

@article{Attal2019IsatuximabPP,
  title={Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study},
  author={Michel Attal and Paul G. Richardson and S. Vincent Rajkumar and Jesus F F San-Miguel and M Sinan Beksac and Ivan {\vS}pi{\vc}ka and Xavier Leleu and F. Schjesvold and Philippe Moreau and Meletios- Athanasios Dimopoulos and Jeffrey Shang-Yi Huang and Jiř{\'i} Minař{\'i}k and Michele Cavo and Henry Miles Prince and Sandrine Mac{\'e} and Kathryn Penkus Corzo and Frank Campana and Solenn Le-Guennec and Franck Dubin and Kenneth C. Anderson and Paul G. Richardson and Vincent S. Rajkumar and Meletios- Athanasios Dimopoulos and Henry Miles Prince and Kathryn Penkus Corzo and Kenneth C. Anderson and Simon James Harrison and Wojt Janowski and Ian Kerridge and Andrew Spencer and Michel Delforge and Karel Fostier and Philip Vlummens and Ka Lung Wu and Richard LeBlanc and Michel Pavic and Michael Sebag and Roman H{\'a}jek and Vladim{\'i}r Maisnar and Ludek Pour and Henrik Gregersen and Lotfi B Benbouker and Denis Caillot and Martine Escoffre-Barbe and Thierry Facon and Laurent Frenzel and Cyrille Hulin and Lionel Karlin and Brigitte Kolb and Brigitte P{\'e}gouri{\'e} and Aurore Perrot and Mourad Tiab and Laure Vincent and Dietger Niederwieser and Achilles Anagnostopoulos and Sosana Delimpasi and Marie-Christine Kyrtsonis and Anargyros Symeonidis and {\'A}rp{\'a}d Ill{\'e}s and G{\'a}bor Mikala and Zsolt Nagy and Sara Bringen and Paolo Corradini and Ciceri Fabio and Roberto Massimo Lemoli and Anna Marina Liberati and Chiara Nozzoli and Renato Zambello and Shinsuke Iida and Takashi Ikeda and Satoshi Iyama and Morio Matsumoto and Chihiro Shimazaki and Kazutaka Sunami and Kenshi Suzuki and Michihiro Uchiyama and Youngil Koh and Kihyun Kim and Jae Hoon Lee and Chang-Ki Min and Hillary Blacklock and Hugh J. B. Goodman and Annette J. Neylon and David Simpson and Sebastian Grosicki and Artur Jurczyszyn and Adam Walter-Croneck and Krzysztof Warzocha and Luis Araujo and Cl{\'a}udia Moreira and Vadim A Doronin and Larisa P. Mendeleeva and Vladimir I. Vorobyev and Andrej Vranovsk{\'y} and Adri{\'a}n Alegre and Mercedes Gironella and Marta Sonia Gonz{\'a}lez P{\'e}rez and Carmen Montes and Enrique Mar{\'i}a Ocio and Paula Rodriguez and Mats Hardling and Birgitta Lauri and Ming-chung Wang and Su-Peng Yeh and Mutlu Arat and Fatih Demirkan and Zafer Gulbaş and Sevgi Beşışık and Ihsan Karadoğan and Tulin Firatli Tuglular and Ali Unal and Filiz Vural and Jonathan Sive and Matthew Streetly and Kwee L. Yong and Jason Tache},
  journal={The Lancet},
  year={2019},
  volume={394},
  pages={2096-2107}
}

Figures and Tables from this paper

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TLDR
Overall response rate was 62%; median duration of response was 18.7 months; median progression-free survival was 17.6 months; and the 10 mg/kg QW/Q2W isatuximab dose was selected for future studies, demonstrating potential meaningful clinical activity and a manageable safety profile.
Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA Phase III study design.
TLDR
The design of the Phase III ICARIA-MM study is described which will evaluate isatuximab in combination with pomalidomide (Pom) and low-dose dexamethasone (dex) (Poms/Dex) versus Pom/dex alone in RRMM.
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The data suggest that isatuximab combined with lenalidomide and dexamethasone is active and tolerated in heavily pretreated patients with RRMM.
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POM+LoDEX was effective and generally well tolerated and provides an important new treatment option for RRMM patients who have received multiple prior therapies.
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Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies, and deep, durable responses were observed in heavily treated patients.
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The baseline characteristics and demographic data from stage 2 at the selected dosing scheme from stage 1 are reported, and the full efficacy and safety data will be presented at the meeting.
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