RETREATMENT WITH BLINATUMOMAB AFTER CD19-POSITIVE RELAPSE: EXPERIENCE FROM 3 TRIALS IN PATIENTS WITH RELAPSED/REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (R/R ALL)
Author(s): ,
Max S. Topp
Affiliations:
Medizinische Klinik und Poliklinik II,Universitätsklinikum Würzburg,Würzburg,Germany
,
Matthias Stelljes
Affiliations:
Department of Medicine / Hematology and Oncology,University of Münster,Münster,Germany
,
Gerhard Zugmaier
Affiliations:
Amgen Research (Munich) GmbH,Munich,Germany
,
Phillip Barnette
Affiliations:
Pediatric Hematology/Oncology,Primary Children's Hospital,Salt Lake City, UT,United States
,
Leonard T. Heffner, Jr.
Affiliations:
Winship Cancer Institute,Emory University School of Medicine,Atlanta, GA,United States
,
Tanya Trippett
Affiliations:
Memorial Sloan-Kettering Cancer Center,New York, NY,United States
,
Ralf Bargou
Affiliations:
Comprehensive Cancer Center Mainfranken,Universitätsklinikum Würzburg,Würzburg,Germany
,
Catherine Jia
Affiliations:
Research and Development,Amgen Inc.,South San Francisco, CA,United States
,
Jonathan Benjamin
Affiliations:
Research and Development,Amgen Inc.,Thousand Oaks, CA,United States
Mark R. Litzow
Affiliations:
Division of Hematology,Mayo Clinic,Rochester, MN,United States
EHA Learning Center. Topp M. Jun 12, 2015; 100426
Dr. Max Topp
Dr. Max Topp

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Abstract
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Abstract: P165

Type: Poster Presentation

Presentation during EHA20: From 12.06.2015 17:15 to 12.06.2015 18:45

Location: Poster area (Hall C)

Background
Blinatumomab is a bispecific T-cell engager (BiTE®) antibody construct designed to link CD19-positive B cells to cytotoxic T cells and induce tumor cell lysis. Blinatumomab recently showed efficacy in Philadelphia-chromosome-negative (Ph–) R/R ALL in a large, multicenter, single-arm, phase 2 study (Topp et al. Lancet Oncol. 2015;16:57-66).

Aims
To determine the potential benefit of retreatment with blinatumomab among patients with R/R ALL who had previously responded to blinatumomab.

Methods
In this combined analysis, we evaluated outcomes among patients with R/R ALL enrolled in 3 open-label, phase 2 studies (NCT01471782: pediatric and adolescent R/R ALL, study 205; NCT01209286: adult R/R ALL, study 206; and NCT01466179: adult R/R ALL, study 211) who had a CD19-positive hematological relapse after initial response to blinatumomab and were retreated with blinatumomab. Patients were < 18 (study 205) or ≥ 18 (studies 206 and 211) years of age with Ph– R/R B-precursor ALL. All patients or their legal representatives provided informed consent. Blinatumomab was given by continuous IV infusion for up to 5 cycles. A cycle was 4 weeks on, 2 weeks off. The primary endpoint of the 3 studies was complete response or complete response with partial recovery of peripheral blood counts within the first 2 cycles. Patients who relapsed following a response that lasted ≥ 3 months could receive up to 3 cycles of retreatment; patients with GVHD or CNS involvement were ineligible.

Results
A total of 11 patients received retreatment with blinatumomab (study 205, n = 2; study 206, n = 5; study 211, n = 4). Seven patients (64%) were male; mean (range) age was 31 (4–77) years. At the time of initial treatment, 9 patients (82%) had ≥ 1 line of prior salvage chemotherapy; 7 (64%) had prior HSCT. Among the 10 patients who achieved hematological remission during the 2 cycles of initial treatment, the median (range) duration of response prior to relapse was 9 (3–11) months. Five patients (45%) had HSCT between the first blinatumomab response and relapse. Outcomes and adverse events (AEs) during retreatment are shown in the Table. Four of 11 patients (36%) with R/R ALL who relapsed following an initial response to blinatumomab responded to retreatment with blinatumomab. One patient was retreated a second time and achieved a complete response.

 

Retreated Patients (n = 11)

Median (range) duration of retreatment, days

28 (4–85)

Hematological remission (responders), n (%)

Minimal residual disease (MRD) responses among responders, n (%)

   MRD < 10-4

   Complete MRD responses

4 (36%)a

 

 

4 (100%)

1 (25%)

Patients with any AEs, n (%)

   Grade ≥ 3 AEs

   Grade ≥ 3 neurologic AEs

   Cytokine release syndrome

10 (91%)

8 (73%)

3 (27%)b

0 (0%)

a≤ 5% marrow blasts and full, partial, or incomplete recovery of peripheral blood counts. bThere were no grade 4 or grade 5 neurologic AEs.



Summary
Our results suggest that patients with R/R ALL who have responded to treatment with blinatumomab and have then relapsed may respond to retreatment. Overall, rates of AEs during retreatment were in line with recent clinical experience with blinatumomab.

Keyword(s): B cell acute lymphoblastic leukemia, Relapse, Retreatment

Session topic: Acute lymphoblastic leukemia - Clinical 1
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