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2018 ASCO Annual Meeting!


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Oral Abstract Session

Time: Friday June 1, 2:45 PM to 5:45 PM

Location: E450

Pomalidomide (POM), bortezomib, and low‐dose dexamethasone (PVd) vs bortezomib and low-dose dexamethasone (Vd) in lenalidomide (LEN)-exposed patients (pts) with relapsed or refractory multiple myeloma (RRMM): Phase 3 OPTIMISMM trial.

Sub-category:
Multiple Myeloma

Category:
Hematologic Malignancies—Plasma Cell Dyscrasia

Meeting:
2018 ASCO Annual Meeting

Abstract No:
8001

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 8001)

Author(s): Paul G. Richardson, Albert Oriol Rocafiguera, Meral Beksac, Anna Marina Liberati, Monica Galli, Fredrik Schjesvold, Jindriska Lindsay, Katja Weisel, Darell White, Thierry Facon, Jesus San-Miguel, Kazutaka Sunami, Peter O'Gorman, Pieter Sonneveld, Xin Yu, Thomas Doerr, Amine Bensmaine, Mohamed H. Zaki, Kenneth Carl Anderson, Meletios A. Dimopoulos, on behalf of the OPTIMISMM trial investigators; Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain; Ankara University, Cebeci Yerleskesi, Dikimevi, Ankara, Turkey; University of Perugia, Terni, Perugia, Italy; A.O. Ospedale Papa Giovanni XXIII, U.O. di Ematologia, Ospedali Riuniti di Bergamo, Bergamo, Italy; Oslo Universitetssykehus Rikshospitalet Postboks, Oslo, Norway; East Kent Hospitals University NHS Foundation Trust, Canterbury, United Kingdom; University of Tuebingen, Department of Hematology, Tuebingen, Germany; Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada; Hôpital Claude Huriez, Lille, France; Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain; National Hospital Organization Okayama Medical Center, Kitaku, Japan; Mater Misericordiae University Hospital, University College Dublin, Dublin, Ireland; Erasmus MC Cancer Institute, Rotterdam, Netherlands; Celgene Corporation, Summit, NJ; National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

Abstract Disclosures

Abstract:

Background: POM, a standard-of-care treatment (Tx) in RRMM, has demonstrated synergistic anti-myeloma activity with dexamethasone (DEX) and proteasome inhibitors (PIs). POM + DEX is indicated for RRMM after ≥ 2 prior Txs including LEN and a PI, and is the only Tx to be investigated exclusively after LEN. As LEN becomes increasingly established in up-front Tx of MM, pts who have exhausted the benefit of LEN represent a clinically relevant unmet medical need. In preclinical studies, POM inhibited proliferation of LEN-resistant cells. Here we report final PFS and safety data from the first phase 3 POM triplet trial comparing PVd vs Vd in an entirely post-LEN treated population. Methods: Pts with RRMM, 1-3 prior Tx lines, and ≥ 2 cycles (c) of prior LEN were randomized 1:1 to receive PVd or Vd. In 21-d c, pts received POM 4 mg/d on d 1-14 (PVd arm only); BORT 1.3 mg/m² on d 1, 4, 8, and 11 of c 1-8 and on d 1 and 8 of c 9+; and DEX 20 mg/d (10 mg if aged > 75 yrs) on the days of and after BORT. The primary endpoint was PFS. Results: 559 pts were enrolled: 281 PVd and 278 Vd. Median age was 67 and 68 yrs, respectively. All pts had prior LEN (71% vs 69% LEN refractory), 72% vs 73% had prior BORT, and 70% vs 66% were refractory to last Tx. Median prior Tx lines was 2; 40% in PVd and 41% in Vd arm had 1 prior Tx line. After a median follow-up of 16 mos, PVd significantly reduced the risk of progression or death by 39% vs Vd (Table). OS data are not mature. Most common grade 3/4 treatment-emergent AEs were neutropenia (42% vs 9%), infections (31% vs 18%), and thrombocytopenia (27% vs 29%). Conclusions: To date, OPTIMISMM is the only phase 3 study in early RRMM to report a significant and clinically meaningful PFS improvement in pts who were entirely LEN exposed and 70% LEN refractory. Furthermore, the results showed improved benefit in pts with only 1 prior Tx line. POM safety remained manageable, consistent with its known profile. Clinical trial information: NCT01734928

Efficacy.

ITT
1 Prior Tx Line
PVd
n = 281
Vd
n = 278
PVd
n = 111
Vd
n = 115
PFS, mos
Median11.207.1020.7311.63
HR (95% CI)
P
0.61 (0.49-0.77)
< .0001
0.54 (0.36-0.82)
.0027
ORR (≥ PR), %82.250.090.154.8
≥ VGPR, %52.718.361.322.6

 
Other Abstracts in this Sub-Category:

 

1. Once-weekly vs twice-weekly carfilzomib (K) dosing plus dexamethasone (d) in patients with relapsed and refractory multiple myeloma (RRMM): Results of the randomized phase 3 study A.R.R.O.W.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8000 First Author: Maria-Victoria Mateos
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

2. Daratumumab (DARA) in combination with carfilzomib and dexamethasone (D-Kd) in lenalidomide (Len)-refractory patients (Pts) with relapsed multiple myeloma (MM): Subgroup analysis of MMY1001.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8002 First Author: Ajai Chari
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

3. Phase 2 study of venetoclax plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8004 First Author: Luciano J. Costa
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

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