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At the 2019 meeting of the American Society of Clinical Oncology, Sagar Lonial, Winship Cancer Institute of Emory University, presented the phase Ib/IIa results (NCT02773030) of iberdomide (IBER, CC 220) for the treatment of relapsed/refractory multiple myeloma (RRMM).1
IBER, a novel cereblon E3 ligase modulator (CELMoD) has shown preclinical activity and an ability to overcome immunomodulatory drug (IMiD) resistance. It also has a synergistic mechanism of action with daratumumab, bortezomib and dexamethasone (dex).
This study aimed to identify the maximum tolerated dose (MTD), the recommended phase II dose (RP2D), and obtain preliminary safety data for IBER. The patient population were RRMM patients who had disease progression despite more than two prior anti-myeloma treatments, including lenalidomide and/or pomalidomide, and a proteasome inhibitor (PI).
Dosing schedule for cohort B (N= 66, as per April 2019 data cut);
Patient characteristics:
Treatment emergent AEs (TEAEs) that did occur at grade 3 and grade 4 in this cohort are shown in Table 1.
Table 1: Grade 3 and 4 TEAEs in, cycle 1, occurring in ≥1 patient
|
Grade 3 |
Grade 4 |
---|---|---|
Anemia |
10 (15.2%) |
0 |
Neutropenia |
6 (9.1%) |
6 (9.1%) |
Thrombocytopenia |
2 (3.0%) |
3 (4.5%) |
Infection |
7 (10.6%) |
1 (1.5%) |
Pneumonia |
2 (3.0%) |
0 |
Dose-limiting toxicities (DLTs):
The responses are shown in Table 2 with Professor Lonial stating that these deepened over time.
Table 2: responses to IBER in total cohort, and by refractory status
CBR, clinical benefit rate; DCR, disease control rate; IMiD, immunomodulatory drug; MR, minimal response; PD, progressive disease; PR, partial response; ORR, overall response rate; SD, stable disease; VGPR, very good partial response | |||
|
All evaluable (n = 59) |
IMiD refractory (n = 51) |
Daratumumab + pomalidomide refractory (n = 27) |
---|---|---|---|
ORR |
32.2% |
35.3% |
29.6% |
VGPR |
3.4% |
2.0% |
3.7% |
PR |
28.8% |
33.3% |
25.9% |
MR |
16.9% |
17.7% |
14.8% |
SD |
35.6% |
33.3% |
37.0% |
PD |
15.3% |
13.7% |
18.5% |
CBR |
49.2% |
- |
- |
DCR |
84.7% |
- |
- |
This study indicates that IBER has activity in heavily pretreated patients with RRMM and has a manageable safety profile. The ORR was similar across the cohort, irrespective of lenalidomide, pomalidomide and anti-CD38 antibody refractory status. Enrollment is ongoing for cohorts looking at IBER in combination with other agents such as bortezomib and daratumumab.
References