LONG TERM OUTCOMES OF TABELECLEUCEL (ALLOGENEIC THIRD-PARTY EBV-TARGETED CYTOTOXIC T LYMPHOCYTES) FOR RITUXIMAB-REFRACTORY POST-TRANSPLANT EBV+ LYMPHOMAS: A SINGLE CENTER EXPERIENCE
Author(s): ,
Susan Prockop
Affiliations:
Pediatric BMT,Memorial Sloan Kettering Cancer Center,New York,United States
,
Ekaterina Doubrovina
Affiliations:
Pediatric BMT,Memorial Sloan Kettering Cancer Center,New York,United States
,
Amy Feng
Affiliations:
Clinical Development,Atara Biotherapeutics,Westlake Village,United States
,
Guenther Koehne
Affiliations:
BMT and Hematologic Oncology,Miami Cancer Institute,Miami,United States
,
Parastoo Dahi
Affiliations:
Adult BMT,Memorial Sloan Kettering Cancer Center,New York,United States
,
Esperanza Papadopoulos
Affiliations:
Adult BMT,Memorial Sloan Kettering Cancer Center,New York,United States
,
Craig Sauter
Affiliations:
Adult BMT,Memorial Sloan Kettering Cancer Center,New York,United States
,
Stephanie Suser
Affiliations:
Pediatric BMT,Memorial Sloan Kettering Cancer Center,New York,United States
,
Willis Navarro
Affiliations:
Clinical Development,Atara Biotherapeutics,Westlake Village,United States
,
Akshay Sudhindra
Affiliations:
Clinical Development,Atara Biotherapeutics,Westlake Village ,United States
Richard O'Reilly
Affiliations:
Pediatric BMT,Memorial Sloan Kettering Cancer Center,New York,United States
EHA Library. Prockop S. Jun 15, 2018; 214869; PF401
Susan Prockop
Susan Prockop
Contributions
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Abstract

Abstract: PF401

Type: Poster Presentation

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

Location: Poster area

Background
Monoclonal EBV+ post-transplant lymphoma disorders (PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) are life-threatening. Patients (pts) who fail rituximab(R)-based therapy have limited treatment options. R failure in EBV+ PTLD following HCT portends a dismal prognosis with a median overall survival (OS) in the range of 16-56 days (d). Pts with EBV+ PTLD following SOT tolerate anthracycline-based chemotherapy more poorly than non-immunocompromised lymphoma pts. Effective therapy with lower toxicity is needed. We have previously shown that treatment with tabelecleucel (tab-celTM) results in durable responses and a 1-year OS rate of 50-67% in R-refractory EBV+ PTLD pts after HCT (Prockop AACR 2015). Here we report longer-term study results of tabelecleucel for pts with EBV+ PTLD following HCT or SOT.

Aims
Report updated long-term survival results of tabelecleucel in pts with EBV+ PTLD following HCT or SOT

Methods
Protocols 11-130 and 95-024 were single-center, open-label studies enrolling pts with EBV+ PTLD following HCT or SOT and other EBV-driven malignancies with measurable disease and adequate organ function and performance status. Pts providing signed informed consent were treated with tabelecleucel sharing ≥2/10 HLA alleles with the disease, including ≥1 HLA allele through which tabelecleucel exerts cytotoxicity (HLA restriction). Tabelecleucel was given at 2 x 106 cells/kg/dose (Protocol 11-130) or 1-2 x 106 cells/kg/dose (Protocol 95-024) on d1, 8, and 15 of every 4-6 week cycle with imaging at ~d35 of each cycle. Pts could receive multiple cycles of tabelecleucel.

Results
Across both studies from 1995-2017, 50 (35 HCT; 14 SOT) pts with PTLD after R-based failure received tabelecleucel.

Median (range)

HCT-Associated PTLD (N=35)

SOT-Associated PTLD (N=14)

Age: yrs

28 (5-74)

18 (6-77)

Karnofsky Score—adults (Protocol 11-130 only)

70 (30-100, n=23)

60 (40-90, n=7)

Time from Diagnosis to Start of Tab-cel: months (mos)

1.2 (0.2-14.6)

13.3 (1.2-139)

Cell Dose: cells/kg/dose

2 x 106 (0.9-2.4)

1.9 x 106 (1.6-2.4)

Number of Cycles

2 (1-5)

2 (1-6)

Duration of Treatment: mos

1.4 (0.4-25.5)

1.4 (0.05-14.5)

Duration of Follow-Up: mos

23.3 (0.5-88.9)

21.3 (0.3-115)

The 1-yr Kaplan-Meier (KM) estimated OS for pts with PTLD following HCT and SOT is 68 and 64%, respectively. Median OS for HCT PTLD pts has not been reached after a median follow-up of 23.3 mos; median follow-up for SOT pts was 21.3 mos and median OS is 21.3 mos. Treatment-related serious adverse events (SAEs) were reported in 1 and 1 pts with PTLD following HCT and SOT, respectively.

Conclusion
Long term follow-up of pts with R-refractory PTLD following HCT or SOT treated with tabelecleucel shows durable responses and low incidence of related SAEs. Median OS for HCT pts with PTLD was not reached with a median follow-up time of 23.3 mos; recognizing limitations of cross-study comparisons, this represents a marked improvement compared to reports for this pt population prior to tabelecleucel. Phase 3 studies of tabelecleucel in pts with R relapsed/refractory PTLD after HCT or SOT are underway.

Session topic: 26. Gene therapy, cellular immunotherapy and vaccination - Clinical

Keyword(s): Cellular therapy, Cytotoxic T lymphocyte, EBV, Post-transplant lymphoproliferative disorder

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