ASKP1240 in De Novo Kidney Transplant Recipients

R. Harland,¹ G. Klintmalm,² H. Yang,³ S. Jensik,⁴ T. Shah,⁵ P. West-Thielke,⁶ F. Shihab,⁷ W. Zhang,⁸ V. Santos,⁸ R. Tainaka,⁸ X. Wang,⁸ R. First,⁸ J. Holman.⁸

¹East Carolina University, Greenville, NC
²Baylor University Medical Center, Dallas, TX
³Pinnacle Health System, Harrisburg, PA
⁴Rush University, Chicago, IL
⁵Transplant Research Institute, Los Angeles, CA
⁶University of Illinois Chicago, Chicago, IL
⁷University of Utah Health Science Center, Salt Lake City, UT
⁸Astellas Pharma Global Development, Northbrook, IL.

Meeting: 2015 American Transplant Congress

Abstract number: 517

Keywords: Immunosuppression, Kidney transplantation

Session Information

Session Name: Concurrent Session: Late Breaking

Session Type: Concurrent Session

Date: Tuesday, May 5, 2015

Session Time: 2:15pm-3:45pm

Presentation Time: 2:27pm-2:39pm

Location: Terrace IV

Primary objective was to evaluate the efficacy and safety of ASKP1240, antagonistic anti-CD40 antibody, in either a CNI free regimen or a CNI minimization regimen compared to a standard of care (SOC) with CNI.

Randomized, open-label, non-inferiority study. Subjects were >18 years, receiving a first or repeat transplant from a living or deceased donor in the US. Primary efficacy variable was biopsy proven acute rejection (BPAR) at 6 months. All patients received basiliximab and steroids. Randomization (1:1:1) to:

· SOC: Tacrolimus (target trough 4-11 ng/mL for duration of study) and MMF (1g BID)

· ASKP1240+MMF: ASKP1240 and MMF (1g BID)

· ASKP1240+Tac minimization: ASKP1240, tacrolimus (target trough 4-11 ng/mL, Day 0-30; target trough 2-5 ng/mL, >Day 31)

Results: 138 subjects were transplanted and received at least one dose of study drug. Treatment groups were similar with regards to baseline donor and recipient characteristics. Key outcomes at Day 180 are shown below.


Parameter	SOC (n=48)	ASKP1240+MMF (n=46)	ASKP1240+Tac Minimization (n=44)
BPAR	3 (6.3%)	17 (37.0%)	4 (9.1%)
Serious AE	24 (49.0%)	38 (82.6%)	24 (54.5%)
BK Infection	6 (12.2%)	7 (15.2%)	12 (27.3%)
CMV Infection	2 (4.1%)	4 (8.7%)	3 (6.8%)
GFR MDRD (mean mL/min)	63.5	63.9	62.6
Patient Survival	48 (100%)	45 (97.8%)	43 (97.7%)
Death Censored Graft Survival	47 (97.9%)	46 (100%)	43 (97.7%)
NODAT*	13/33 (39.4%)	5/25 (20.0%)	8/23 (34.8%)
AST or ALT>3xULN	7 (14.6%)	10 (21.7%)	6 (13.6%)

No subjects experienced thromboembolic events. There were 3 malignancies in ASKP1240 groups (1 renal cell carcinoma and 2 squamous cell carcinoma). No PTLD reported. No graft loss from BK infection/nephropathy. Anti-ASKP1240 antibodies were infrequent (3.3%).

Conclusions:

ASKP1240+Tac minimization regimen demonstrated similar efficacy in the prevention of acute rejection compared to SOC while similar efficacy was not observed with ASKP1240/MMF. There were more viral infections in the ASKP1240 arms.

To cite this abstract in AMA style:

Harland R, Klintmalm G, Yang H, Jensik S, Shah T, West-Thielke P, Shihab F, Zhang W, Santos V, Tainaka R, Wang X, First R, Holman J. ASKP1240 in De Novo Kidney Transplant Recipients [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/askp1240-in-de-novo-kidney-transplant-recipients/. Accessed November 21, 2024.

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