ASH Clinical News May 2017 NEW | Page 35

CLINICAL NEWS

Pembrolizumab Induces Remission in Small Cohort of Patients With Natural Killer / T-Cell Lymphomas

For the 20 to 40 percent of patients with natural killer ( NK )/ T-cell lymphomas who do not respond to regimens such as SMILE ( dexamethasone , methotrexate , ifosfamide , etoposide ) that also contain L-asparaginase , outcomes remain poor . Because NK / T-cell lymphomas are infected by Epstein-Barr virus ( EBV ) and these cells upregulate programmed death ligand 1 ( PDL1 ), targeting the PDL1 axis could be a potential treatment option for patients with these lymphomas .
In a study published in Blood , Yok-Lam Kwong , MD , from the Department of Medicine at Queen Mary Hospital in Hong Kong , and co-authors retrospectively analyzed the use of pembrolizumab in a cohort of seven men ( median age = 49 years ; range = 31-68 years ) with relapsed / refractory NK / T-cell lymphomas who had not responded to L-asparaginase regimens . The study included patients from Hong Kong , Singapore , and Seoul . They received pembrolizumab 2 mg / kg every three weeks ( 1 patient received it every 2 weeks ). Most patients had advanced-stage disease with widespread organ involvement . Five patients had systemic hemophagocytic syndrome ( HPS ) prior to pembrolizumab treatment , and two patients had relapsed after allogeneic hematopoietic cell transplantation
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 (%)
Blood and lymphatic system disorders
Neutropenia c %
177 ( 79.0 )
94 ( 42.5 )
133 ( 59.4 )
73 ( 33.0 )
178 ( 60.8 )
33 ( 11.8 )
158 ( 53.9 )
21 ( 7.5 )
Thrombocytopenia c %
162 ( 72.3 )
101 ( 45.7 )
84 ( 37.5 )
67 ( 30.3 )
69 ( 23.5 )
29 ( 10.4 )
38 ( 13.0 )
8 ( 2.9 )
Leukopenia c
51 ( 22.8 )
25 ( 11.3 )
45 ( 20.1 )
22 ( 10.0 )
93 ( 31.7 )
21 ( 7.5 )
71 ( 24.2 )
5 ( 1.8 )
Anemia
47 ( 21.0 )
27 ( 12.2 )
23 ( 10.3 )
18 ( 8.1 )
26 ( 8.9 )
15 ( 5.4 )
11 ( 3.8 )
3 ( 1.1 )
Lymphopenia
40 ( 17.9 )
29 ( 13.1 )
37 ( 16.5 )
26 ( 11.8 )
13 ( 4.4 )
3 ( 1.1 )
11 ( 3.8 )
2 ( 0.7 )
Pancytopenia c d %
1 ( 0.4 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
12 ( 4.1 )
1 ( 0.4 )
7 ( 2.4 )
1 ( 0.4 )
Febrile neutropenia c
39 ( 17.4 )
34 ( 15.4 )
39 ( 17.4 )
34 ( 15.4 )
7 ( 2.4 )
1 ( 0.4 )
5 ( 1.7 )
1 ( 0.4 )
Infections and infestations # Upper respiratory tract
60 ( 26.8 )
35 ( 15.8 )
7 ( 3.1 )
9 ( 4.1 )
32 ( 10.9 )
18 ( 6.4 )
1 ( 0.3 )
0 ( 0.0 )
infection e
Neutropenic infection
40 ( 17.9 )
19 ( 8.6 )
27 ( 12.1 )
14 ( 6.3 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
Pneumonias * c %
31 ( 13.8 )
15 ( 6.8 )
23 ( 10.3 )
7 ( 3.2 )
50 ( 17.1 )
13 ( 4.6 )
27 ( 9.2 )
5 ( 1.8 )
Bronchitis c
10 (
4.5 )
9 ( 4.1 )
1 ( 0.4 )
5 ( 2.3 )
139 ( 47.4 )
104 ( 37.1 )
4 ( 1.4 )
1 ( 0.4 )
Nasopharyngitis e
5 (
2.2 )
2 ( 0.9 )
0 ( 0.0 )
0 ( 0.0 )
102 ( 34.8 )
84 ( 30.0 )
1 ( 0.3 )
0 ( 0.0 )
Gastroenteritis c
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
66 ( 22.5 )
55 ( 19.6 )
6 ( 2.0 )
0 ( 0.0 )
Rhinitis e
2 ( 0.9 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
44 ( 15.0 )
19 ( 6.8 )
0 ( 0.0 )
0 ( 0.0 )
Sinusitis e
8 ( 3.6 )
3 ( 1.4 )
0 ( 0.0 )
0 ( 0.0 )
41 ( 14.0 )
26 ( 9.3 )
0 ( 0.0 )
1 ( 0.4 )
Influenza c
8 ( 3.6 )
5 ( 2.3 )
2 ( 0.9 )
1 ( 0.5 )
39 ( 13.3 )
19 ( 6.8 )
3 ( 1.0 )
0 ( 0.0 )
Lung infection c
21 ( 9.4 )
2 ( 0.9 )
19 ( 8.5 )
2 ( 0.9 )
9 ( 3.1 )
4 ( 1.4 )
1 ( 0.3 )
0 ( 0.0 )
Lower respiratory tract
13 ( 5.8 )
5 ( 2.3 )
6 ( 2.7 )
4 ( 1.8 )
4 ( 1.4 )
4 ( 1.4 )
0 ( 0.0 )
2 ( 0.7 )
infection e
Infection c
12 ( 5.4 )
6 ( 2.7 )
9 ( 4.0 )
5 ( 2.3 )
17 ( 5.8 )
5 ( 1.8 )
0 ( 0.0 )
0 ( 0.0 )
Urinary tract infection c d e
9 ( 4.0 )
5 ( 2.3 )
4 ( 1.8 )
4 ( 1.8 )
22 ( 7.5 )
17 ( 6.1 )
1 ( 0.3 )
0 ( 0.0 )
Lower respiratory tract
6 ( 2.7 )
1 ( 0.5 )
4 ( 1.8 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
infection bacterial d
Bacteremia d
5 ( 2.2 )
0 ( 0.0 )
4 ( 1.8 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
Herpes zoster c d
11 ( 4.9 )
10 ( 4.5 )
3 ( 1.3 )
2 ( 0.9 )
29 ( 9.9 )
25 ( 8.9 )
6 ( 2.0 )
2 ( 0.7 )
Sepsis * c d @
2 ( 0.9 )
1 ( 0.5 )
0 ( 0.0 )
0 ( 0.0 )
6 ( 2.0 )
1 ( 0.4 )
4 ( 1.4 )
1 ( 0.4 )
Gastrointestinal disorders Diarrhea
122 ( 54.5 )
83 ( 37.6 )
22 ( 9.8 )
17 ( 7.7 )
114 ( 38.9 )
34 ( 12.1 )
7 ( 2.4 )
0 ( 0.0 )
Nausea e
33 ( 14.7 )
22 ( 10.0 )
16 ( 7.1 )
10 ( 4.5 )
31 ( 10.6 )
28 ( 10.0 )
0 ( 0.0 )
0 ( 0.0 )
Vomiting
17 ( 7.6 )
12 ( 5.4 )
8 ( 3.6 )
5 ( 2.3 )
16 ( 5.5 )
15 ( 5.4 )
1 ( 0.3 )
0 ( 0.0 )
Constipation e
12 ( 5.4 )
8 ( 3.6 )
0 ( 0.0 )
0 ( 0.0 )
37 ( 12.6 )
25 ( 8.9 )
2 ( 0.7 )
0 ( 0.0 )
Abdominal pain e
8 ( 3.6 )
7 ( 3.2 )
1 ( 0.4 )
4 ( 1.8 )
31 ( 10.6 )
15 ( 5.4 )
1 ( 0.3 )
1 ( 0.4 )
Abdominal pain upper e
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
0 ( 0.0 )
20 ( 6.8 )
12 ( 4.3 )
1 ( 0.3 )
0 ( 0.0 )
General disorders and administration site conditions
Asthenia
0 ( 0.0 )
1 ( 0.5 )
0 ( 0.0 )
0 ( 0.0 )
87 ( 29.7 )
53 ( 18.9 )
10 ( 3.4 )
2 ( 0.7 )
Fatigue
51 ( 22.8 )
30 ( 13.6 )
21 ( 9.4 )
9 ( 4.1 )
31 ( 10.6 )
15 ( 5.4 )
3 ( 1.0 )
0 ( 0.0 )
Pyrexia e
17 ( 7.6 )
10 ( 4.5 )
2 ( 0.9 )
2 ( 0.9 )
60 ( 20.5 )
26 ( 9.3 )
1 ( 0.3 )
0 ( 0.0 )
Skin and subcutaneous tissue disorders
Dry skin e
9 ( 4.0 )
4 ( 1.8 )
0 ( 0.0 )
0 ( 0.0 )
31 ( 10.6 )
21 ( 7.5 )
0 ( 0.0 )
0 ( 0.0 )
Rash
71 ( 31.7 )
48 ( 21.7 )
11 ( 4.9 )
5 ( 2.3 )
22 ( 7.5 )
17 ( 6.1 )
3 ( 1.0 )
0 ( 0.0 )
Pruritus
9 ( 4.0 )
4 ( 1.8 )
3 ( 1.3 )
0 ( 0.0 )
21 ( 7.2 )
25 ( 8.9 )
2 ( 0.7 )
0 ( 0.0 ) ( continued )