Startseite Kongressberichte 2019 Annual Meeting of the American Society of Clinical Oncology 2019 Hematology Multiple Myeloma & Myelofibrosis

Choice of Oral & Poster Presentations

ORAL PRESENTATIONS

Sagar Lonial, Niels W.C.J. van de Donk, Rakesh Popat, Jeffrey A. Zonder, et al.

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).

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

Efficacy IBER dose 0.3–1.2 mg + DEX
(N = 51 evaluable)
Very good partial response 1
Partial response (PR) 15
Minimal response (MR) 10
Stable disease (SD) 19
Progressive disease 6
Overall response (≥ PR) 16 (31%)
Clinical benefit (≥ MR) 26 (51%)
Disease control (≥ SD) 45 (88%)

 

Francesca Gay, Chiara Cerrato, Maria Teresa Petrucci, Renato Zambello, et al.

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

Conclusions: KRd-ASCT-KRd and KRd12 were equally effective in inducing high-quality responses, with about 50% of high-risk pts achieving MRD negativity. In high-risk pts ASCT reduced the risk of early relapse. Clinical trial information: NCT02203643

  KRd_ASCT_KRd
N=158		 KRd12
N=157		 R-ISS 1
 R-ISS 2/3
KRd_ASCT_KRd
N=48		 KRd12
N=39		 KRd_ASCT_KRd
N=92		 KRd12
N=94
sCR 44% 43% 46% 49% 39% 38%
≥CR 60% 61% 60% 64% 56% 57%
≥VGPR 89% 87% 92% 79% 86% 86%
MRD negative 58% 54% 69% 62% 51% 47%

 

Sagar Lonial, Susanna J. Jacobus, Matthias Weiss, Shaji Kumar, et al.

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

Conclusions: Overall, this trial represents the largest randomized trial in SMM to date. In conjunction with the Spanish data, this trial may support a change in clinical practice. Clinical trial information: NCT01169337

Phase 2 PFS    
1 yr 0.98  
3 yr 0.87  
5 yr 0.78  
     
Phase 3 PFS Len Obs
1 yr 0.98 0.89
2 yr 0.93 0.76
3 yr 0.91 0.66

 

Paul G. Richardson, Michel Attal, S. Vincent Rajkumar, Jesus San Miguel, et al.

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).

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

 
POSTER PRESENTATIONS
 
Saad Zafar Usmani, Thierry Facon, Shaji Kumar, Torben Plesner, et al.
 

Conclusions: D-Rd pts received less R vs Rd group regardless of age. Efficacy of D-Rd in <75 and ≥75 y pts was consistent with the ITT population, and D-Rd demonstrated acceptable tolerability regardless of age. Together with the phase 3 ALCYONE study, these studies confirm clinical benefit of daratumumab plus standard-of-care in transplant-ineligible NDMM pts ≥75 y of age. Clinical trial information: NCT02252172

  <75 y
 ≥75 y
  D-Rd
(n=208)		 Rd
(n=208)		 D-Rd
(n=160)		 Rd
(n=161)
PFS        
Median, mo NR 33.7 NR 31.9
HR (95% CI) 0.50 (0.35-0.71) 0.63 (0.44-0.92)
30-mo PFS, % 75 58 66 52
ORR, % 95 82 90 81
≥CR, % 52 25 41 25
≥VGPR, % 81 53 77 53
MRD-negative rate, % (10-5) 28 7 19 8

 

Jonathan L. Kaufman, Meletios A. Dimopoulos, Merav Leiba, James Morton, et al.

Efficacy and safety of daratumumab, lenalidomide, and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): Updated subgroup analysis of POLLUX based on cytogenetic risk. 

Conclusions: D-Rd demonstrates significant efficacy in high-risk RRMM. Among high-risk pts, MRD negativity was only achieved with D-Rd. Clinical trial information: NCT02076009

  Std risk
 High risk
D-Rd
(n = 204)		 Rd
(n = 178)		 P value D-Rd
(n = 48)		 Rd
(n = 55)		 P value
ORR, % 93.6 79.2 <0.0001 87.5 69.1 0.0115
≥CR, % 59.3 27.0   43.8 9.1  
≥sCR, % 31.4 13.5   29.2 1.8  
≥≥VGPR, % 82.8 55.1 <0.0001 70.8 32.7 0.0003
MRD neg, %a 32.9 8.2 <0.0001 28.6 0 <0.0001
≥MRD neg (≥6 mo), %a 17.9 1.1 <0.0001 12.2 0 0.0082
≥MRD neg (≥12 mo), %a 14.0 0.5 <0.0001 10.2 0 0.0188

aIntent-to-treat population.

 

Myelofibrosis:

Claire N. Harrison, Nicolaas Schaap, Alessandro M Vannucchi, Jean-Jacques Kiladjian, et al.

Fedratinib (FEDR) in myelofibrosis (MF) patients previously treated with ruxolitinib (RUX): A reanalysis of the JAKARTA-2 study.

Conclusions: FEDR provided clinically meaningful reductions in splenomegaly and symptom burden in pts with MF who met more stringent criteria for R/R or intolerance to RUX. Clinical trial information: NCT01523171

RUX failure.
  Prior Analysis Current Analysis
Resistance RUX Tx ≥ 14 d with no response or stable disease per investigator, disease progression, or loss of response Relapsed: RUX Tx ≥ 3 mo with regrowth, defined as < 10% SVR or < 30% decrease in spleen size from BL, following an initial response
Refractory: RUX Tx ≥ 3 mo with < 10% SVR or < 30% decrease in spleen size from BL
Intolerance RUX Tx ≥ 14 d before discontinuing Tx due to unacceptable toxicity RUX Tx ≥ 28 d complicated by development of RBC transfusion requirement (≥ 2 units/mo for 2 mo); or grade ≥ 3 thrombocytopenia, anemia, hematoma/hemorrhage while on RUX