Contributions
Abstract: EP987
Type: E-Poster Presentation
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Despite advances in medical treatments that have improved patient survival, multiple myeloma (MM) remains an incurable disease. 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 in patients who progress after PIs, IMiDs, and anti-CD38 mAbs.
Aims
To describe the interim results from LocoMMotion (NCT04035226), the first prospective study on the efficacy and safety of real-life standard of care in patients with relapsed/refractory MM.
Methods
Between August 2019 and October 2020, eligible patients who were aged ≥18 years and had a diagnosis of MM were enrolled in 75 sites across 9 European countries and the US. Patients were included if they had received 3 or more 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 Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. All patients provided informed consent prior to enrollment in the study. Responses were assessed per International Myeloma Working Group response criteria. The overall response rate (ORR) of real-life current standard of care (primary objective of the study) was assessed by a Response Review Committee. Secondary objectives of the study included additional efficacy and safety evaluation of real-life standard of care.
Results
The data cut-off was November 4, 2020 for the first interim analysis of 225 patients (203 [90.2%] from Europe and 22 [9.8%] from the US) with a median follow-up of 3.7 months (range: 0–12.7). The median age was 68 years (range: 41–89), 124 (55.1%) patients were male, 162 (72.0%) had a baseline ECOG PS score of 1, and median time since initial MM diagnosis was 6.0 years (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 their last line of therapy. The ORR with real-life standard of care 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 or higher. 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.
Conclusion
The interim results of this first, prospective study of real-life standard of care treatment demonstrate that heavily pretreated, triple-class exposed patients with relapsed/refractory MM continue to progress after multiple lines of therapy and have poor outcomes. Therefore, new treatments with novel mechanisms of action are needed for this patient population.
Keyword(s): Multiple myeloma, Refractory, Relapse, Treatment
Abstract: EP987
Type: E-Poster Presentation
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Despite advances in medical treatments that have improved patient survival, multiple myeloma (MM) remains an incurable disease. 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 in patients who progress after PIs, IMiDs, and anti-CD38 mAbs.
Aims
To describe the interim results from LocoMMotion (NCT04035226), the first prospective study on the efficacy and safety of real-life standard of care in patients with relapsed/refractory MM.
Methods
Between August 2019 and October 2020, eligible patients who were aged ≥18 years and had a diagnosis of MM were enrolled in 75 sites across 9 European countries and the US. Patients were included if they had received 3 or more 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 Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. All patients provided informed consent prior to enrollment in the study. Responses were assessed per International Myeloma Working Group response criteria. The overall response rate (ORR) of real-life current standard of care (primary objective of the study) was assessed by a Response Review Committee. Secondary objectives of the study included additional efficacy and safety evaluation of real-life standard of care.
Results
The data cut-off was November 4, 2020 for the first interim analysis of 225 patients (203 [90.2%] from Europe and 22 [9.8%] from the US) with a median follow-up of 3.7 months (range: 0–12.7). The median age was 68 years (range: 41–89), 124 (55.1%) patients were male, 162 (72.0%) had a baseline ECOG PS score of 1, and median time since initial MM diagnosis was 6.0 years (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 their last line of therapy. The ORR with real-life standard of care 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 or higher. 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.
Conclusion
The interim results of this first, prospective study of real-life standard of care treatment demonstrate that heavily pretreated, triple-class exposed patients with relapsed/refractory MM continue to progress after multiple lines of therapy and have poor outcomes. Therefore, new treatments with novel mechanisms of action are needed for this patient population.
Keyword(s): Multiple myeloma, Refractory, Relapse, Treatment