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Adrienne A. Phillips et al.
vs. 17%) AEs were similar between mogamulizumab and investigator’s choice arms, respectively, while the overall incidence of treatment-related AEs leading to discontinua- tion (19% vs. 0%) was higher in the mogamulizumab arm and were most frequently due to infusion reactions and drug eruptions [2 patients (4.3%) each]. There were no treatment-related deaths during randomization or after crossover to mogamulizumab.
The most common treatment-related AEs during ran- domization and after crossover to mogamulizumab are summarized in Table 3. The most common treatment-relat- ed AEs (any grade) in the mogamulizumab arm were infu- sion-related reaction (47%), drug eruption (19%), thrombo- cytopenia (13%), and anemia (11%). The most common treatment-related AEs in the investigator’s choice arm were
neutropenia (25%), thrombocytopenia (21%), nausea (17%), diarrhea (17%), pyrexia (13%), headache (13%), constipation (13%), and vomiting (13%). The most com- mon treatment-related AEs grade ≥3 in the randomized mogamulizumab arm were infusion-related reaction (9%) and thrombocytopenia (9%). The most common treat- ment-related AE grade ≥3 in the investigator’s choice arm was thrombocytopenia (17%). Treatment-related AEs (any grade or grade ≥3) after crossover were generally similar to those seen in randomized patients. The only treatment- related serious AE occurring in more than one patient in the mogamulizumab arm was pneumonia (n=3).
None of the patients developed detectable anti-moga- mulizumab or neutralizing anti-mogamulizumab anti- body following treatment.
Table 2. Best overall response and by disease compartment response according to investigator assessment during randomization and after crossover to mogamulizumab (ITT population).
Best response overall and by disease compartment
Randomized
Investigator’s choice
After crossover Mogamulizumab
Mogamulizumab
Overall n=47 n=24
CR 1(2) 0 0
CRu 2(4) 0 1(6) PR 13(28) 0 2(11) SD 2(4) 6(25) 1(6)
PD 12 (26) 11 (46)
Not evaluable† 17 (36) 7 (29)
Blood n=39 n=18
6 (33) 8 (44) n=14 7 (50)
Lymphnodes n=44 n=22 n=17 CR 0 0 0 CRu 1(2) 0 0 PR 3(7) 0 0
n=18
CR 21 (54) 1 (6)
CRu 0 0 0 PR 0 0 0 SD 3(8) 10(56) 1(7) PD 0 4(22) 0 Not assessable* 15 (39) 3 (17) 6 (43)
SD
PD
Not assessable*
13 (30) 11 (25) 16 (36)
10 (46) 8 (36) 4 (18)
5 (29) 4 (24) 7 (41)
Skin n=18 n=9 n=9
CR 3(17) 0 2(22) CRu 0 0 0
PR 5 (28)
SD 2 (11)
PD 5(28)
Not assessable* 3(17) 0
1 (11) 4 (44) 0
2 (22)
5 (56) 3 (33) 1(11)
Data are given as n (%) unless otherwise stated. CR: complete response; CRu: uncertified CR; ITT: intent-to-treat; PD: progressive disease; PR: partial response; SD: stable disease. †All but one patient considered not evaluable for overall response received ≤1 cycle of treatment and did not have assessments for response. Of these, on the mogamulizumab arm, reasons for treament discontinuation from mogamulizumab were; adverse event (7), PD (6), death (2), withdrawal of consent (1), other (1); On the IC arm, PD (4), adverse event (2) withdrawal of consent (1). All were counted as non-responders for ORR in the ITT analysis.The patient on the IC arm who completed >1 treatment cycle,met eligibility criteria with disease in blood on local flow and not in lymph nodes according to the investigator but showed lymph node and no blood involvement on Independent Review and so was considered not evaluable for response by investigator assessment. One subject in crossover received 7 infusions of mogamulizumab and was discontinued from treatment due to an adverse event.Although this patient had a CR in blood and CR in skin,CT scan was not performed and so was not evaluable for overall response (See patient 19 in Figure 4).*If there was no post-baseline tumor assessment for response assessment,or there was no disease in that compartment,the response was designated not assess- able.
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haematologica | 2019; 104(5)