DARATUMUMAB, CARFILZOMIB, AND DEXAMETHASONE (D-KD) IN LENALIDOMIDE-REFRACTORY PATIENTS WITH RELAPSED MULTIPLE MYELOMA (MM): SUBGROUP ANALYSIS OF MMY1001
Author(s): ,
Philippe Moreau
Affiliations:
University Hospital Hôtel-Dieu,Nantes,France
,
Joaquín Martinez-Lopez
Affiliations:
Hospital-12-de-Octubre,Madrid,Spain
,
Maria-Victoria Mateos
Affiliations:
University Hospital of Salamanca/IBSAL,Salamanca,Spain
,
Joan Bladé
Affiliations:
Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona,Barcelona,Spain
,
Sagar Lonial
Affiliations:
Winship Cancer Institute, Emory University,Atlanta, GA,United States
,
Lotfi Benboubker
Affiliations:
Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU),Tours,France
,
Albert Oriol
Affiliations:
Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol,Barcelona,Spain
,
Bertrand Arnulf
Affiliations:
Hôpital Saint Louis, APHP,Paris,France
,
Paula Rodriguez-Otero
Affiliations:
Clínica Universidad de Navarra-CIMA, IDISNA,Pamplona,Spain
,
Luis Pineiro
Affiliations:
Texas Oncology-Baylor Charles A. Sammons Cancer Center,Dallas, TX,United States
,
Andrzej Jakubowiak
Affiliations:
University of Chicago Medical Center,Chicago, IL,United States
,
Carla de Boer
Affiliations:
Janssen Biologics,Leiden,Netherlands
,
Jianping Wang
Affiliations:
Janssen Research & Development, LLC,Raritan, NJ,United States
,
Jordan Schecter
Affiliations:
Janssen Research & Development, LLC,Raritan, NJ,United States
Ajai Chari
Affiliations:
Tisch Cancer Institute, Mount Sinai School of Medicine,New York, NY,United States
EHA Learning Center. Moreau P. Jun 15, 2018; 215029
Prof. Philippe Moreau
Prof. Philippe Moreau
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Abstract
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Abstract: PF579

Type: Poster Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 17:30 - 19:00

Location: Poster area

Background
Lenalidomide-refractory patients have poor outcomes, highlighting an unmet medical need. In the phase 1b MMY1001 study (NCT01998971), D-Kd induced deep responses and was well tolerated in patients with relapsed MM.

Aims
We examined the safety and efficacy of D-Kd in lenalidomide-refractory patients.

Methods
In total, 85 carfilzomib-naïve patients with 1-3 prior lines of therapy were enrolled. Patients received carfilzomib (20 mg/m2 on Cycle 1 Day 1 [C1D1] and 70 mg/m2 on C1D8+) on Days 1, 8, and 15 of 28-day cycles and dexamethasone 40 mg QW. Daratumumab was given QW C1-C2, Q2W C3-C6, and Q4W thereafter; 10 patients received a standard first dose of daratumumab (16 mg/kg) on C1D1, and 75 patients received a split first dose of daratumumab (8 mg/kg on C1D1 and C1D2). Median infusion times during Week 1 were 7.08 hours (range: 6.5-8.9 h) for patients who received a standard first daratumumab dose and 4.25 hours (range: 3.9-10.6 h) and 4.17 hours (range: 3.9-8.6 h) for Day 1 and Day 2, respectively, among patients who received a split first daratumumab dose. Refractory MM was defined as progression during or within 60 days of completion of the last line of therapy.

Results
Among lenalidomide-refractory patients (n = 51) in the MMY1001 D-Kd arm, median age was 66 years (range 38-85 years), and 92% had an Eastern Cooperative Oncology Group status ≤1. Patients had received a median of 2 (range 1-4) prior lines of therapy; 98% had received bortezomib, 18% had received pomalidomide, 43% were refractory to bortezomib, and 18% were refractory to pomalidomide. In total, 20 patients (39%) discontinued due to progressive disease (26%), adverse events (AEs; 6%), patient withdrawal (6%), or physician decision (2%). The most common hematologic grade 3/4 treatment-emergent AEs (TEAEs; ≥10%) were thrombocytopenia (37%), anemia (29%), neutropenia (28%), and lymphopenia (26%). Infusion-related reactions were observed in 37% of patients (43% for standard first daratumumab dose; 36% for split first daratumumab dose); none were grade 3/4. With 8.3 months of median follow up, median progression-free survival (PFS) was 14.1 months (95% CI 9.4-not estimable); the 12-month PFS rate was 69% (95% CI 49-82). Overall response rate (ORR) and minimal residual disease (MRD)-negative rates are summarized in the Table. Median time to MRD negativity (10–5) was 5.1 months.

 

%

Lenalidomide refractory

All

ORRa

81

86

   Stringent complete response

8

6

   Complete response

4

14

   Very good partial response

56

53

   Partial response

13

14

MRD-negative rate

 

 

   104

6

9

   105

2

5

   106

0

2

aAmong response-evaluable patients who received >2 cycles or discontinued treatment.

 

Conclusion
The combination of daratumumab and weekly Kd was well tolerated and demonstrated promising efficacy in lenalidomide-refractory patients. Updated data will be presented.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple Myeloma

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