ASH Clinical News May 2017 NEW | Page 36

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( alloHCT ). The median number of prior therapies ( including alloHCT ) was two ( range = 1-5 therapies ), and no patient had responded to SMILE or SMILE-like regimens .
After a median of seven cycles ( range = 2-13 cycles ) and a median follow-up of six months ( range = 2-10 months ), five patients remained in complete response ( CR ) and two patients achieved a partial response ( PR ).
Three patients achieved clinical and radiologic CR , including two cases of molecular remission ( undetectable EBV DNA ) but with minimal EBV-encoded-RNApositive cells in lesions comprising predominantly
CD3 + CD4 + and CD3 + CD8 + T cells , “ which ultimately disappeared , suggesting pseudo-progression ,” the authors wrote .
“ Responses after pembrolizumab treatment require clinical , radiologic , pathologic , and molecular assessment ,” the authors wrote , and these responses were often “ discordant .”
The authors outlined two cases in which patients had advanced disease and responded to pembrolizumab treatment . One patient had biopsy-proven esophageal involvement and radiologic pulmonary infiltration , and
Dr . Kwong and co-authors reported that “ pembrolizumab treatment led to immediate improvement , and a positron emission tomography / computed tomography ( PET / CT ) scan after six cycles showed metabolic CR .” The patient then continued to receive six more cycles of pembrolizumab .
Another patient who presented with marrow involvement , cytopenia , and HPS relapsed following alloHCT . Following two cycles of pembrolizumab , laboratory monitoring found that EBV DNA levels fell to undetectable levels ; after three cycles , marrow
REVLIMID ® [ lenalidomide ] capsules , for oral use
Table 5 : All Adverse Reactions in ≥5.0 % and Grade 3 / 4 Adverse Reactions in ≥ 1.0 % of Patients in the REVLIMID Vs Placebo Arms *
Maintenance Study 1
Maintenance Study 2
Body System
All Adverse Reactions [ a ]
Grade 3 / 4 Adverse
Reactions [ b ]
All Adverse Reactions [ a ]
Grade 3 / 4 Adverse
Reactions [ b ]
Adverse Reaction
REVLIMID
Placebo
REVLIMID
Placebo
REVLIMID
Placebo
REVLIMID
Placebo
( N = 224 )
( N = 221 )
( N = 224 )
( N = 221 )
( N = 293 )
( N = 280 )
( N = 293 )
( N = 280 )
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
Nervous system disorders
Paresthesia e
2 ( 0.9 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
39 ( 13.3 )
30 ( 10.7 )
1 ( 0.3 )
0 ( 0.0 )
Peripheral neuropathy * e
34 ( 15.2 )
30 ( 13.6 )
8 ( 3.6 )
8 ( 3.6 )
29 ( 9.9 )
15 ( 5.4 )
4 ( 1.4 )
2 ( 0.7 )
Headache d
11 ( 4.9 )
8 ( 3.6 )
5 ( 2.2 )
1 ( 0.5 )
25 ( 8.5 )
21 ( 7.5 )
0 ( 0.0 )
0 ( 0.0 )
Investigations Alanine aminotransferase
16 ( 7.1 )
3 ( 1.4 )
8 ( 3.6 )
0 ( 0.0 )
5 ( 1.7 )
5 ( 1.8 )
0 ( 0.0 )
1 ( 0.4 )
increased Aspartate aminotransferase
13 ( 5.8 )
5 ( 2.3 )
6 ( 2.7 )
0 ( 0.0 )
2 ( 0.7 )
5 ( 1.8 )
0 ( 0.0 )
0 ( 0.0 )
increased d
Metabolism and nutrition disorders Hypokalemia
24 ( 10.7 )
13 ( 5.9 )
16 ( 7.1 )
12 ( 5.4 )
12 ( 4.1 )
1 ( 0.4 )
2 ( 0.7 )
0 ( 0.0 )
Dehydration
9 ( 4.0 )
5 ( 2.3 )
7 ( 3.1 )
3 ( 1.4 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
Hypophosphatemia d
16 ( 7.1 )
15 ( 6.8 )
13 ( 5.8 )
14 ( 6.3 )
0 ( 0.0 )
1 ( 0.4 )
0 ( 0.0 )
0 ( 0.0 )
Musculoskeletal and connective tissue disorders
Muscle spasms e
0 ( 0.0 )
1 ( 0.5 )
0 ( 0.0 )
0 ( 0.0 )
98 ( 33.4 )
43 ( 15.4 )
1 ( 0.3 )
0 ( 0.0 )
Myalgia e
7 ( 3.1 )
8 ( 3.6 )
3 ( 1.3 )
5 ( 2.3 )
19 ( 6.5 )
12 ( 4.3 )
2 ( 0.7 )
1 ( 0.4 )
Musculoskeletal pain e
1 ( 0.4 )
1 ( 0.5 )
0 ( 0.0 )
0 ( 0.0 )
19 ( 6.5 )
11 ( 3.9 )
0 ( 0.0 )
0 ( 0.0 )
Hepatobiliary disorders
Hyperbilirubinemia e
34 ( 15.2 )
19 ( 8.6 )
4 ( 1.8 )
2 ( 0.9 )
4 ( 1.4 )
1 ( 0.4 )
2 ( 0.7 )
0 ( 0.0 )
Respiratory , thoracic and mediastinal disorders
Cough e
23 ( 10.3 )
12 ( 5.4 )
3 ( 1.3 )
1 ( 0.5 )
80 ( 27.3 )
56 ( 20.0 )
0 ( 0.0 )
0 ( 0.0 )
Dyspnea c e
15 ( 6.7 )
9 ( 4.1 )
8 ( 3.6 )
4 ( 1.8 )
17 ( 5.8 )
9 ( 3.2 )
2 ( 0.7 )
0 ( 0.0 )
Rhinorrhea e
0 ( 0.0 )
3 ( 1.4 )
0 ( 0.0 )
0 ( 0.0 )
15 ( 5.1 )
6 ( 2.1 )
0 ( 0.0 )
0 ( 0.0 )
Pulmonary embolism c d e
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
3 ( 1.0 )
0 ( 0.0 )
2 ( 0.7 )
0 ( 0.0 )
Vascular disorders Deep vein thrombosis * c d %
8 ( 3.6 )
2 ( 0.9 )
5 ( 2.2 )
2 ( 0.9 )
7 ( 2.4 )
1 ( 0.4 )
4 ( 1.4 )
1 ( 0.4 )
Neoplasms benign , malignant and unspecified ( incl cysts and polyps )
Myelodysplastic syndrome c d e
5 ( 2.2 )
0 ( 0.0 )
2 ( 0.9 )
0 ( 0.0 )
3 ( 1.0 )
0 ( 0.0 )
1 ( 0.3 )
0 ( 0.0 )
Note : AEs are coded to body system / adverse reaction using MedDRA v15.1 . A subject with multiple occurrences of an AE is counted only once in each AE
category .
a
All treatment-emergent AEs in at least 5 % of patients in the Lenalidomide Maintenance group and at least 2 % higher frequency (%) than the Placebo
Maintenance group .
b
All grade 3 or 4 treatment-emergent AEs in at least 1 % of patients in the Lenalidomide Maintenance group and at least 1 % higher frequency (%) than the
Placebo Maintenance group .
c
All serious treatment-emergent AEs in at least 1 % of patients in the Lenalidomide Maintenance group and at least 1 % higher frequency (%) than the
Placebo Maintenance group .
d
Footnote “ a ” not applicable for either study
e
Footnote “ b ” not applicable for either study
@
-ADRs where at least one resulted in a fatal outcome
%
- ADRs where at least one was considered to be Life Threatening ( if the outcome of the event was death , it is included with death cases )
#
- All adverse reactions under Body System of Infections and Infestation except for rare infections of Public Health interest will be considered listed
* Adverse Reactions for combined ADR terms ( based on relevant TEAE PTs included in Maintenance Studies 1 and 2 [ per MedDRA v 15.1 ]):
Pneumonias Bronchopneumonia ,. Lobar pneumonia , Pneumocystis jiroveci pneumonia , Pneumonia , Pneumonia klebsiella , Pneumonia legionella ,
Pneumonia mycoplasmal , Pneumonia pneumococcal , Pneumonia streptococcal , Pneumonia viral , Lung disorder , Pneumonitis
Sepsis : Bacterial sepsis , Pneumococcal sepsis , Sepsis , Septic shock , Staphylococcal sepsis
Peripheral neuropathy : Neuropathy peripheral , Peripheral motor neuropathy , Peripheral sensory neuropathy , Polyneuropathy
Deep vein thrombosis : Deep vein thrombosis , Thrombosis , Venous thrombosis