2019 ASCO Annual Meeting!
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Type: Oral Abstract Session
Time: Sunday June 2, 9:45 AM to 12:45 PM
A phase III randomized, open label, multicenter study comparing isatuximab, pomalidomide, and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM).
Hematologic Malignancies—Plasma Cell Dyscrasia
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 8004)
Author(s): Paul G. Richardson, Michel Attal, S. Vincent Rajkumar, Jesus San Miguel, Meral Beksac, Ivan Spicka, Xavier Leleu, Fredrik Schjesvold, Philippe Moreau, Meletios A. Dimopoulos, Jeffrey SY. Huang, Jiri Minarik, Michele Cavo, H. Miles Prince, Sandrine Macé, Kathryn Penkus Corzo, Frank Campana, Solenn Le-Guennec, Franck Dubin, Kenneth Carl Anderson, on behalf of the ICARIA-MM Study Group; Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; IUCT-Oncopole, Toulouse, France; Mayo Clinic, Rochester, MN; Clínica Universidad de Navarra, Navarra, Spain; Ankara University, Ankara, Turkey; Vseobecna Fakultni Nemocnice V Praze, Prague, Czech Republic; CHRU Lille, Lille, France; Oslo University Hospital, Oslo, Norway; CHU de Nantes-Hôtel Dieu, Nantes, France; National and Kapodistrian University of Athens, Athens, Greece; National Taiwan University Hospital, Taipei, Taiwan; University Hospital Olomouc, Olomouc, Czech Republic; Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy; Epworth Healthcare and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sanofi R&D, Oncology, Vitry-Sur-Seine, France; Sanofi, Cambridge, MA; Sanofi US, Cambridge, MA; Sanofi R & D, Vitry-Alfortville, France; Sanofi, Vitry-Sur-Seine, France
Background: The primary objective of this phase 3 trial was to demonstrate progression free survival (PFS) improvement of isatuximab (Isa), a novel anti-CD38 monoclonal antibody, combined with pomalidomide (P)/dexamethasone (d) versus (vs) Pd. Methods: Patients (pts) with RRMM who received ≥2 prior lines, including lenalidomide (len) and a proteasome inhibitor (PI), refractory to last therapy were enrolled. IsaPd arm received Isa 10 mg/kg IV weekly for first 4 weeks (wks), then every 2 wks. Both arms received approved schedules of pom and dex (4mg PO days 1-21; 40mg [20mg if >75 yrs] PO or IV weekly) every 28 days until progression or unacceptable toxicity. Results: 307 pts (154 IsaPd, 153 Pd) were randomized and analyzed (ITT). Patient characteristics were well balanced across arms. Median age: 67 (36-86) yrs; median prior lines of therapy: 3 (2-11); estimated GFR: <60ml/min in 33.9% pts; 92.5% refractory to len, 75.9% to PI; and 19.5% pts had high-risk cytogenetics. At median follow-up of 11.6 months (mos), median PFS was 11.5 mos IsaPd vs 6.5 mos Pd; HR 0.596 (95% CI 0.44-0.81), P=0.001. PFS benefit was consistent across all major subgroups. ORR (≥PR) was 60.4% IsaPd vs 35.3% Pd, P<0.0001. VGPR rate or better was 31.8% IsaPd vs 8.5% Pd, and MRD negativity (NGS, 10-5) was seen in 5.2% IsaPd pts vs 0% Pd. At analysis date, overall survival (OS) was immature (99 events) but a trend to OS improvement in IsaPd (vs Pd) was observed (HR 0.687; 95% CI 0.461-1.023). Median treatment duration was 41 wks IsaPd vs 24 wks Pd; median Isa infusion (inf.) duration was 3.3h at 1st inf. and 2.8h at subsequent inf. Grade ≥3 AEs were observed in 86.8% IsaPd vs 70.5% Pd; 7.2% IsaPd and 12.8% Pd pts discontinued due to AEs; 7.9% IsaPd and 9.4% Pd pts died due to AEs. Inf. reactions were reported in 38.2% (2.6% grade 3-4) IsaPd. Grade ≥3 infections were seen in 42.8% IsaPd and 30.2% Pd, grade ≥3 neutropenia in 84.9% (febrile 11.8%) IsaPd and 70.1% (febrile 2.0%) Pd. Conclusions: IsaPd significantly improved PFS and ORR vs Pd, with a manageable safety profile. IsaPd is an important new treatment option for the management of RRMM. Clinical trial information: NCT02990338
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