ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
Objective: Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with M...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2021-11-01
|
| Series: | Hematology, Transfusion and Cell Therapy |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2531137921011226 |
| _version_ | 1818567369049505792 |
|---|---|
| author | Mehmut TURGUT Roman HAJEK Tomas JELÍNEK Philippe MOREAU Thomas MARTIN Ludek POUR Gabor MIKALA Argiris SYMEONIDIS Sara BRINGHEN Andreea RAWLINGS Marie Laure RISSE Helgi VAN DE VELDE Ivan SPICKA |
| author_facet | Mehmut TURGUT Roman HAJEK Tomas JELÍNEK Philippe MOREAU Thomas MARTIN Ludek POUR Gabor MIKALA Argiris SYMEONIDIS Sara BRINGHEN Andreea RAWLINGS Marie Laure RISSE Helgi VAN DE VELDE Ivan SPICKA |
| author_sort | Mehmut TURGUT |
| collection | DOAJ |
| description | Objective: Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with MM with 1–3 prior lines and in EU for those with ≥1 prior therapy. This post-hoc analysis evaluated efficacy and safety of Isa-Kd vs Kd in relapsed MM pts with pre-existing soft-tissue plasmacytomas (STP). Methodology: Pts (N=302) were randomized (3:2) to Isa-Kd (n=179; 12 had STP) or Kd (n=123; 7 had STP). Doses: Isa: 10 mg/kg IV QW for 4 weeks, then Q2W; K 20 mg/m² days 1–2, then 56 mg/m² twice-weekly 3 of 4 weeks; d: 20 mg twice-weekly. Independent review committee assessed response based on central radiology review and central lab M-protein using International Myeloma Working Group criteria. Median (range) duration of exposure in STP pts (Isa-Kd vs Kd) was 41.9 (2–87) vs 29.9 (4–83) weeks. Results: In STP sub-group, PFS (95% CI) improved in Isa-Kd vs Kd: HR 0.574 (0.125–2.640); median PFS was Isa-Kd: 18.76 months (4.435–not calculable [NC]) vs Kd: NC (0.986–NC). Response rates improved in Isa-Kd vs Kd: overall (50.0% vs 28.6%), ≥VGPR (33.3% vs 14.3%), CR (25.0% vs 0%, all with MRD negativity). TEAE rates (n [%]; Isa-Kd vs Kd) were: Grade ≥3: 12 (100%) vs 4 (57.1%); Grade 5: 2 (16.7%) vs 1 (14.3%); serious: 9 (75.0%) vs 4 (57.1%); discontinuation: 0 (0%) vs 1 (14.3%). Conclusion: Baseline characteristics in STP subgroup were similar to overall ITT population, except ISS stages II, III, and renal function impairment, which were more prevalent in STP subgroup vs ITT. Isa-Kd vs Kd improved PFS and depth of response in pts with relapsed MM and STP, with manageable safety profile, consistent with the benefit observed in IKEMA overall population. Isa-Kd is a new treatment option for pts with relapsed MM and STP. |
| first_indexed | 2024-12-14T06:22:31Z |
| format | Article |
| id | doaj.art-3c2d6faeced74604914a15ac633f598e |
| institution | Directory Open Access Journal |
| issn | 2531-1379 |
| language | English |
| last_indexed | 2024-12-14T06:22:31Z |
| publishDate | 2021-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Hematology, Transfusion and Cell Therapy |
| spelling | doaj.art-3c2d6faeced74604914a15ac633f598e2022-12-21T23:13:46ZengElsevierHematology, Transfusion and Cell Therapy2531-13792021-11-0143S18ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSISMehmut TURGUT0Roman HAJEK1Tomas JELÍNEK2Philippe MOREAU3Thomas MARTIN4Ludek POUR5Gabor MIKALA6Argiris SYMEONIDIS7Sara BRINGHEN8Andreea RAWLINGS9Marie Laure RISSE10Helgi VAN DE VELDE11Ivan SPICKA12Ondokuz Mayıs UniversityDepartment of Hemato-Oncology, University Hospital Ostrava and University of OstravaDepartment of Haemato-Oncology, University Hospital Ostrava and Faculty of Medicine, University of OstravaDepartment of Hematology, University Hospital Hôtel-DieuDepartment of Hematology, University of California at San FranciscoDepartment of Internal Medicine, Hematology and Oncology, University Hospital BrnoNational Institute for Hematology and Infectious Diseases, Department of Hematology and Stem Cell Transplantation, South Pest Central HospitalHematology Division, Department of Internal Medicine, University of Patras Medical SchoolAzienda Ospedaliero-Universitaria Città della Salute e della Scienza di TorinoSanofi Research & DevelopmentSanofi Research & DevelopmentSanofi Research & Development1st Department of Medicine – Department of Hematology, 1st Faculty of Medicine, Charles University and General Hospital in PragueObjective: Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with MM with 1–3 prior lines and in EU for those with ≥1 prior therapy. This post-hoc analysis evaluated efficacy and safety of Isa-Kd vs Kd in relapsed MM pts with pre-existing soft-tissue plasmacytomas (STP). Methodology: Pts (N=302) were randomized (3:2) to Isa-Kd (n=179; 12 had STP) or Kd (n=123; 7 had STP). Doses: Isa: 10 mg/kg IV QW for 4 weeks, then Q2W; K 20 mg/m² days 1–2, then 56 mg/m² twice-weekly 3 of 4 weeks; d: 20 mg twice-weekly. Independent review committee assessed response based on central radiology review and central lab M-protein using International Myeloma Working Group criteria. Median (range) duration of exposure in STP pts (Isa-Kd vs Kd) was 41.9 (2–87) vs 29.9 (4–83) weeks. Results: In STP sub-group, PFS (95% CI) improved in Isa-Kd vs Kd: HR 0.574 (0.125–2.640); median PFS was Isa-Kd: 18.76 months (4.435–not calculable [NC]) vs Kd: NC (0.986–NC). Response rates improved in Isa-Kd vs Kd: overall (50.0% vs 28.6%), ≥VGPR (33.3% vs 14.3%), CR (25.0% vs 0%, all with MRD negativity). TEAE rates (n [%]; Isa-Kd vs Kd) were: Grade ≥3: 12 (100%) vs 4 (57.1%); Grade 5: 2 (16.7%) vs 1 (14.3%); serious: 9 (75.0%) vs 4 (57.1%); discontinuation: 0 (0%) vs 1 (14.3%). Conclusion: Baseline characteristics in STP subgroup were similar to overall ITT population, except ISS stages II, III, and renal function impairment, which were more prevalent in STP subgroup vs ITT. Isa-Kd vs Kd improved PFS and depth of response in pts with relapsed MM and STP, with manageable safety profile, consistent with the benefit observed in IKEMA overall population. Isa-Kd is a new treatment option for pts with relapsed MM and STP.http://www.sciencedirect.com/science/article/pii/S2531137921011226 |
| spellingShingle | Mehmut TURGUT Roman HAJEK Tomas JELÍNEK Philippe MOREAU Thomas MARTIN Ludek POUR Gabor MIKALA Argiris SYMEONIDIS Sara BRINGHEN Andreea RAWLINGS Marie Laure RISSE Helgi VAN DE VELDE Ivan SPICKA ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS Hematology, Transfusion and Cell Therapy |
| title | ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS |
| title_full | ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS |
| title_fullStr | ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS |
| title_full_unstemmed | ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS |
| title_short | ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS |
| title_sort | isatuximab plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma and soft tissue plasmacytomas ikema subgroup analysis |
| url | http://www.sciencedirect.com/science/article/pii/S2531137921011226 |
| work_keys_str_mv | AT mehmutturgut isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT romanhajek isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT tomasjelinek isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT philippemoreau isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT thomasmartin isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT ludekpour isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT gabormikala isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT argirissymeonidis isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT sarabringhen isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT andreearawlings isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT marielaurerisse isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT helgivandevelde isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis AT ivanspicka isatuximabpluscarfilzomibanddexamethasoneinpatientswithrelapsedmultiplemyelomaandsofttissueplasmacytomasikemasubgroupanalysis |