CLINICAL NEWS
• 2-year OS : 58 % vs . 76 % ( p = 0.016 )
• 2-year PFS : 47 % vs . 67 % ( p =. 024 )
However , patients who received ATLG had a lower incidence of grade 2-4 acute GVHD at 6 months than patients who received placebo ( 23 % vs . 40 %; p = 0.003 ); this trend continued at the two-year follow-up time point ( 12 % vs . 33 %; p = 0.068 ).
“ This discrepancy was due in part to a higher incidence
of relapse among ATLG-treated patients ( 32 % vs . 19 %, p = 0.068 ),” the authors noted . “ Multivariable models confirmed that ATLG was associated with inferior OS ( hazard ratio [ HR ] = 1.85 ; 95 % CI 1.1-2.9 ; p = 0.0075 ) and PFS ( HR = 1.63 ; 95 % CI 1.1-2.41 ; p = 0.015 ).”
Given these varying results , “ further analyses are needed to understand the proper role for ATLG in alloHCT ,” the authors concluded .
The study ’ s findings were limited by the variation in myeloablative condition regimens . According to a posthoc analysis , there was “ a dramatic difference ” in survival
outcomes in patients who received Cy / TBI conditioning ( OS = 88 % vs . 48 % [ p = 0.006 ] and PFS = 75 % vs . 29 % [ p = 0.007 ] in placebo and ATLG arms , respectively ). This effect was not observed among patients treated with the other conditioning regimens .
REFERENCE
Soiffer RJ , Haesook TK , McGuirk J , et al . A prospective randomized double blind phase 3 clinical trial of anti-T lymphocyte globulin ( ATLG ) to assess impact on chronic graft-versus-host disease ( cGVHD ) free survival in patients undergoing HLA matched unrelated myeloablative hematopoietic cell transplantation ( HCT ). Abstract # 505 . Presented at the 2016 ASH Annual Meeting , December 4 , 2016 ; San Diego , California .
ABR for total bleeds
Primary endpoint : ABR measured within 48 hours 1
Secondary endpoint : ABR during the 6-month study 1 , 3
0
(
Median ABR
n = 51 ) ( IQR = 0.0 ; 4.0 )
2
Median ABR
( n = 51 ) ( IQR = 0.0 ; 6.0 )
2x / week prophylaxis
2
Median ABR
( n = 21 )* ( range : 0-14.1 )
3x / week or EOD prophylaxis
2Median ABR
( n = 30 )* ( range : 0-18.1 )
* During the LEOPOLD Kids study , one patient was moved from a 2x / week prophylaxis regimen to a 3x / week prophylaxis regimen .
†
In an ongoing extension study , a 13-year-old PTP had a titer of 0.6 BU after 550 EDs concurrent with an acute infection and positive lgG anticardiolipin antibodies . His ABR was zero and no change in therapy was required . 1
SELECTED IMPORTANT SAFETY INFORMATION
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Catheter-related infections may occur when KOVALTRY ® is administered via central venous access devices ( CVADs ). These infections have not been associated with the product itself .
The most frequently reported adverse reactions in clinical trials ( ≥3 %) were headache , pyrexia , and pruritus .
89.7 % of bleeding episodes resolved with ≤2 infusions of KOVALTRY ® 1
inhibitors
in the completed study of
51 previously treated patients 1
People with hemophilia A may develop inhibitors to rFVIII . People with a history of inhibitors and previously untreated children were excluded from LEOPOLD Kids — Part A 1 .