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Attend this session at the
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

Location: E451

First clinical (phase 1b/2a) study of iberdomide (CC-220; IBER), a CELMoD, in combination with dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM).

Sub-category:
Multiple Myeloma

Category:
Hematologic Malignancies—Plasma Cell Dyscrasia

Meeting:
2019 ASCO Annual Meeting

Abstract No:
8006

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 8006)

Author(s): Sagar Lonial, Niels W.C.J. van de Donk, Rakesh Popat, Jeffrey A. Zonder, Monique C. Minnema, Jeremy Larsen, Tuong Vi Nguyen, Min S. Chen, Amine Bensmaine, Mariana Cota, Pieter Sonneveld; Winship Cancer Institute of Emory University, Atlanta, GA; Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Amsterdam, Netherlands; NIHR UCLH Clinical Research Facility, University College London Hospitals NHS Foundation Trust, London, United Kingdom; Karmanos Cancer Institute, Detroit, MI; University Medical Center Utrecht, Utrecht, Netherlands; Mayo Clinic, Phoenix, AZ; Celgene Corporation, Summit, NJ; Erasmus Medical Center Rotterdam, Rotterdam, Netherlands

Abstract Disclosures

Abstract:

Background: IBER is a novel cereblon E3 ligase modulator (CELMoD) with enhanced tumoricidal and immunostimulatory activities. Preclinically, IBER overcomes immunomodulatory drug (IMiD) resistance and has synergy with daratumumab (DARA), bortezomib (BORT), and DEX. Methods: A phase 1b/2a multicenter, open-label, dose-escalation study evaluated the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, and preliminary efficacy of IBER. Eligible pts had RRMM and must have received ≥ 2 prior regimens including lenalidomide (LEN) and/or pomalidomide (POM), and a proteasome inhibitor (PI). All pts had progressed on or within 60 days of last MM therapy. Escalating doses of IBER were given on days 1–21, in combination with DEX 40 mg (20 mg in pts age > 75 years) on days 1, 8, 15, and 22, of each 28-day cycle. Dose escalation was reviewed by a dose escalation committee. Results: As of Jan 2019,58 pts received IBER + DEX. Median age was 64.5 years (range 33–79), and median number of prior regimens was 5 (2–12). Prior therapies included autologous stem cell transplant (79%), LEN (100%), POM (69%), PIs (100%), and DARA (66%). IBER dose ranged from 0.3 to 1.2 mg; MTD/RP2D was not reached. Median duration of therapy was 12+ weeks (range 4–109). Grade 3–4 adverse events (AEs) were reported in 41 (72%) pts and were not related to dose. Grade 3–4 neutropenia, thrombocytopenia, neuropathy, and fatigue occurred in 26%, 11%, 2%, and 0% pts, respectively. Three pts discontinued treatment due to AEs. Clinical activity occurred early and was observed across all dose levels (Table); 20 of 51 pts remain on treatment (2–27+ cycles). Conclusions: IBER + DEX showed favorable efficacy and safety in heavily pretreated pts with RRMM who failed multiple prior therapies. This study is ongoing, including combinations of IBER with DARA or BORT. Clinical trial information: NCT02773030

EfficacyIBER dose 0.3–1.2 mg + DEX
(N = 51 evaluable)
Very good partial response1
Partial response (PR)15
Minimal response (MR)10
Stable disease (SD)19
Progressive disease6
Overall response (≥ PR)16 (31%)
Clinical benefit (≥ MR)26 (51%)
Disease control (≥ SD)45 (88%)

 
Other Abstracts in this Sub-Category:

 

1. Updated risk stratification model for smoldering multiple myeloma (SMM) incorporating the revised IMWG diagnostic criteria.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8000 First Author: Jesus San Miguel
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

2. E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8001 First Author: Sagar Lonial
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

3. Efficacy of carfilzomib lenalidomide dexamethasone (KRd) with or without transplantation in newly diagnosed myeloma according to risk status: Results from the FORTE trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8002 First Author: Francesca Gay
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

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