Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

1443 - A Standardized Comparison of Outcomes in Patients (Pts) With Refractory, Aggressive Non-Hodgkin Lymphoma (rNHL) from the SCHOLAR-1 Analysis and the ZUMA-1 Study of Axicabtagene Ciloleucel (axi-cel)

Date

10 Sep 2017

Session

Poster display session

Presenters

Sattva Neelapu

Citation

Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376

Authors

S.S. Neelapu1, F.L. Locke2, N.L. Bartlett3, L.J. Lekakis4, P.M. Reagan5, D. Miklos6, C.A. Jacobson7, I. Braunschweig8, O. Oluwole9, T. Siddiqi10, Y. Lin11, M. Crump12, J. Kuruvilla12, E. Van den Neste13, B.K. Link14, U. Farooq15, L. Navale16, W.Y. Go16, J. Wiezorek17, C. Gisselbrecht18

Author affiliations

  • 1 Dept. Of Lymphoma And Myeloma, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 2 Blood And Marrow Transplant And Cellular Immunotherapy, H. Lee Moffitt Cancer Center University of South Florida, 33612 - Tampa/US
  • 3 Division Of Hematology And Oncology, Washington University, Saint Louis/US
  • 4 Hematology/oncology, University of Miami Health System, Sylvester Comprehensive Cancer Center, 33136 - Miami/US
  • 5 Department Of Medicine, Hematology/oncology, University of Rochester Medical Center, Wilmot Cancer Center, 14642 - Rochester/US
  • 6 Blood And Marrow Transplantation, Stanford University School of Medicine, 94305 - Stanford/US
  • 7 Hematologic Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 8 Department Of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx/US
  • 9 Department Of Medicine, Vanderbilt University Medical Center, Nashville/US
  • 10 Department Of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte/US
  • 11 Department Of Hematology, Mayo Clinic, Rochester/US
  • 12 Cancer Clinical Research Unit, Princess Margaret Cancer Center, Canadian Cancer Trials Group at Queen's University, Kingston/CA
  • 13 Pierre-bénite, LYSARC, Paris/FR
  • 14 Medicine, University of Iowa, Iowa City/US
  • 15 Department Of Hematology And Oncology, University of Iowa, Iowa City/US
  • 16 Biostatistics, Kite Pharma, Santa Monica/US
  • 17 Clinical Development, Kite Pharma, Santa Monica/US
  • 18 Haemato-oncology Department, LYSARC-CORAL, Centre Hospitalier Lyon Sude, 69495 - Pierre-Benite Cedex/FR
More

Resources

Abstract 1443

Background

SCHOLAR-1 (Crump, ASCO 2016) is a large, pooled analysis of rNHL and demonstrated poor outcomes: objective response rate (ORR)= 26%; complete response (CR)=8%. ZUMA-1 is the first, multicenter trial of anti-CD19 CAR T cells (axi-cel) in rNHL and reported positive results: ORR= 82%; CR = 54%. This is a comparative analysis of outcomes from ZUMA-1 and SCHOLAR-1 after adjusting for imbalances in key covariates of patients enrolled.

Methods

Eligible pts for both studies had rNHL (stable disease ≤6 mos with ≥4 cycles frontline or ≥ 2 cycles later-line therapy, progressive disease as best response, or relapse ≤12 mos post autologous stem cell transplant). Standardized analyses were performed to account for other baseline covariates that were imbalanced between the studies despite similar inclusion criteria. These analyses equally weighted the proportions of patients with select prognostic covariates between the two studies. The pre-specified covariates selected for weighting were refractory subgroup and occurrence of SCT after refractory status. Sensitivity analyses included additional covariates.

Results

101 ZUMA-1 pts received axi-cel; SCHOLAR-1 included data from 508 pts. Baseline characteristics for each study are listed in the Table. ZUMA-1 median follow-up was 8.7 mos. Using the standardized analysis, the estimated ORR and CR rates in SCHOLAR-1 were 20% and 6%, respectively. Standardized 6-mo survival rate for SCHOLAR-1 was 35%. Risk of death in ZUMA-1 was reduced by 77% relative to SCHOLAR-1 (P < .0001).Table:

1161P

ZUMA-1 mITTSCHOLAR-1 Response
N = 101N = 508
Age, ≥65 y, n (%)24 (24)74 (15)
Refractory subgroup, n (%)
Primary refractory2 (2)101 (20)
Refractory to ≥ 2L78 (77)316 (62)
Relapse

Conclusions

Despite the imbalances between the ZUMA-1 and SCHOLAR-1 studies, axi-cel appears to represent a significantly improved treatment option for pts with rNHL compared with currently available therapies as used in the SCHOLAR-1 study.

Clinical trial identification

NCT02348216

Legal entity responsible for the study

Kite Pharma

Funding

Kite Pharma

Disclosure

S.S. Neelapu: Kite research funding, consultant and advisory board member for Kite. F.L. Locke: Scientific advisory board and Moffitt receives research funding from Kite Pharma; Consultant for Cellular Biomedicine Group, Inc. P.M. Reagan: Research Funding: Seattle Genetics. D. Miklos, C.A. Jacobson: Consulting or Advisory Role: PCYC, Sanofi, Adaptive Biotechnologies, Kite, Genentech, Velos; Research Funding: PCYC; Patents: PCYC; Travel Accommodations: PCYC, Sanofi I. Braunschweig: Stock/Equity Ownership: Kite Pharma. T. Siddiqi: Speaker\'s bureau for Pharmacyclics/Jannsen (ibrutinib) and Seattle Genetics (brentuximab vedotin). Y. Lin: Employment: Mayo Clinic; Research funding: Janssen. J. Kuruvilla: Research funding: Celgene, Roche, Karyopharm; consultant: Bristol-Myers Squib, Gilead, Janssen, Hoffman LaRoche, Seattle Genetics; honoraria: Amgen, Bristol-Myers Squibb, Celgene, Gilead, Roche, Janssen, Lundbeck, Merck, Seattle Genetics, B.K. Link, U. Farooq: Research Funding: Kite Pharma. L. Navale, W.Y. Go: Employment: Kite Pharma. J. Wiezorek: Leadership: Kite Pharma. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.