LocoMMotion: A prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma (RRMM) receiving ≥3 prior lines of therapy.

person Maria-Victoria Mateos Hospital Clinico Universitario de Salamanca, Salamanca, Spain info_outline Maria-Victoria Mateos, Katja Weisel, Valerio De Stefano, Aurore Perrot, Niels W.C.J. van de Donk, Hartmut Goldschmidt, Martin F. Kaiser, Ravi Vij, Francesca Gay, Annemiek Broijl, Anna Potamianou, Caline Sakabedoyan, Vadim Strulev, Jordan Mark Schecter, Martin Vogel, Tonia Nesheiwat, Robert Wapenaar, Michel Delforge, Hermann Einsele, Philippe Moreau

Authors person Maria-Victoria Mateos Hospital Clinico Universitario de Salamanca, Salamanca, Spain info_outline Maria-Victoria Mateos, Katja Weisel, Valerio De Stefano, Aurore Perrot, Niels W.C.J. van de Donk, Hartmut Goldschmidt, Martin F. Kaiser, Ravi Vij, Francesca Gay, Annemiek Broijl, Anna Potamianou, Caline Sakabedoyan, Vadim Strulev, Jordan Mark Schecter, Martin Vogel, Tonia Nesheiwat, Robert Wapenaar, Michel Delforge, Hermann Einsele, Philippe Moreau Organizations Hospital Clinico Universitario de Salamanca, Salamanca, Spain, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, Section of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France, Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands, University Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT), Heidelberg, Germany, Institute of Cancer Research, London, United Kingdom, Washington University School of Medicine, St. Louis, MO, Division of Hematology, University of Torino, Torino, Italy, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands, Janssen-Cilag, Neuss, Germany, EMEA Medical Affairs, Janssen-Cilag, Beirut, Lebanon, EMEA Medical Affairs, Janssen Pharmaceutica NV, Beerse, Belgium, Janssen R&D, Raritan, NJ, Janssen Global Services, LLC, Raritan, NJ, Medical Affairs, Legend Biotech USA Inc, Piscataway, NJ, Janssen-Cilag BV, Breda, Netherlands, Department of Hematology, University Hospitals (UZ) Leuven, Leuven, Belgium, Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany, Hematology, University Hospital Hotel-Dieu, Nantes, France Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Janssen-Cilag International NV, Pharmaceutical/Biotech Company Background: Multiple myeloma (MM) remains incurable despite advances in medical treatment that have improved survival. Even with these improvements, most patients with MM eventually progress through standard drug classes of proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), anti-CD38 monoclonal antibodies (mAbs), and others. There are currently no prospective data on real-world standard-of-care (SOC) in patients who progress after PIs, IMiDs, and anti-CD38 mAbs. Here, we present interim results from LocoMMotion (NCT04035226), the first prospective efficacy and safety study of real-life SOC in patients with RRMM. Methods: Eligible patients (aged ≥18 years [y]) with a diagnosis of MM were enrolled between August 2019 and October 2020 from 75 sites across 9 European countries and the US. Patients were included if they received ≥3 prior lines of therapy or were double-refractory to a PI and IMiD, had measurable disease at screening, received at least a PI, an IMiD, and anti-CD38 mAb with documented progressive disease since their last line of therapy, and had an ECOG PS score of 0 or 1. Responses were assessed per International Myeloma Working Group response criteria. A Response Review Committee assessed the overall response rate (ORR, primary objective) of real-life current SOC. Secondary objectives of the study included additional efficacy and safety evaluation of real-life SOC. Results: The data cut-off was November 4, 2020 for the first interim analysis of 225 patients with a median follow-up of 3.7 months (range: 0–12.7), 22 (9.8%) patients were from the US and 203 (90.2%) were from Europe. Median age was 68 y (range: 41–89), 124 (55.1%) were male, 162 (72.0%) had a baseline ECOG PS score of 1, and median time since initial MM diagnosis was 6.0 y (range: 0.3–22.8). Patients had received a median of 4.0 (range: 2–13) prior lines of therapy; all patients were triple-class exposed, 166 (73.8%) were triple-class refractory, and 208 (92.4%) were refractory to last line of therapy. The ORR with real-life SOC salvage therapy was 20.1% (95% CI: 15.0–26.0) in the response-evaluable population (n = 219). Treatment-emergent adverse events (TEAEs) were reported in 148 (65.8%) patients, 95 (42.2%) were grade ≥3. The most common grade ≥3 TEAEs were anemia, thrombocytopenia, and neutropenia. Fifteen deaths (6.7%) occurred due to TEAEs during the study. Treatment is ongoing in 121 (53.8%) patients. Conclusions: The interim results of this first, prospective study of real-life SOC treatment in heavily pretreated, triple-class exposed patients with RRMM demonstrate that patients continue to progress after multiple lines of therapy and have poor outcomes. Therefore, there is a need for new treatments with novel mechanisms of action for this patient population. Clinical trial information: NCT04035226