1. 0761-009: Mogamulizumab in R/R Adult T-Cell Leukemia-Lymphoma
CCO Independent Conference Coverage* of the 2016 ASCO Annual Meeting, June 3-7, 2016
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
R/R, relapsed/refractory.
This activity is supported by educational grants from Amgen, Ariad, Bayer Healthcare Pharmaceuticals, Celgene Corporation, Genentech, Incyte, Merck, and Taiho Pharmaceuticals.

2. 0761-009: Mogamulizumab in R/R Adult T-Cell Leukemia-Lymphoma
ATL is a rare malignancy of T-cells infected with human T-cell lymphotropic virus type 1
No approved treatment outside of Japan
Poor prognosis with high incidence of relapse
Mogamulizumab monoclonal antibody
Approved in Japan for ATL and other T-cell malignancies
Enhances antibody-dependent cellular cytotoxicity through CCR4, expressed in ≈ 90% of pts with ATL
: randomized phase II trial of mogamulizumab vs investigator’s choice (largest prospective trial in R/R ATL)
ATL, adult T-cell leukemia-lymphoma; R/R, relapsed/refractory.
Slide credit: clinicaloptions.com
Phillips AA, et al. ASCO Abstract 7501.

3. Investigator’s Choice
: Study Design
Open-label, multinational phase II trial[1]
Primary endpoint: ORR
Secondary endpoints: PFS, OS, DoR, ORR for IC, ORR after crossover
Efficacy assessments by modified Tsukasaki criteria[2] in all affected compartments (skin, lymph nodes, liver/spleen, blood, bone marrow)
Randomized 2:1
Mogamulizumab
1 mg/kg/wk x 4
then Days 1, 15 Q4W
(n = 47)
Crossover allowed
after PD
(n = 18)
HTLV-1+ adults with relapsed/ refractory ATL; ECOG PS 0-2
(N = 71)
Investigator’s Choice
Pralatrexate, DHAP,
or GemOx
(n = 24)
ATL, adult T-cell leukemia-lymphoma; DHAP, rituximab/dexamethasone/cytarabine/cisplatin; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; GemOx, gemcitabine/oxaliplatin; HTLV-1, human T-cell lymphotropic virus type 1; IC, investigator’s choice; ORR, objective response rate; PD, progressive disease; PS, performance status.
1. Phillips AA, et al. ASCO Abstract 7501.
2. Tsukasaki K, et al. J Clin Oncol. 2009;27:
Slide credit: clinicaloptions.com

4. 0761-009: Patient Characteristics
Mogamulizumab
(n = 47)
Investigator’s Choice
(n = 24)
Median age, yrs
Older than 65 yrs, %
Younger than 40 yrs, %
55.0 23 13
50.5 4 29
ECOG PS 0/1/2, %
26/34/40
46/25/29
ATL clinical subtype, %
acute/lymphoma/chronic
32/55/13
25/58/17
Bone marrow involvement, % 57 33
CR or PR to most recent tx, % 26 46
CCR4+, % 92
Race/ethnicity, %
black/Hispanic or Latino
68/19
63/25
ATL, adult T-cell leukemia-lymphoma; ECOG, Eastern Cooperative Oncology Group; PS, performance status; tx, treatment.
Slide credit: clinicaloptions.com
Phillips AA, et al. ASCO Abstract 7501.

5. Investigator’s Choice
: Efficacy
Response, %
Mogamulizumab
(n = 47)
Investigator’s Choice
(n = 24)
Investigator Assessment
All responses 34
Confirmed responses 15
Independent Review 28 8 11
Confirmed response: maintained at evaluations over ~ 8 wks
Median duration of confirmed responses: 5.5 mos (IA), 5.0 mos (IR)
3 of 18 (17%) crossover pts had response (1 confirmed) to mogamulizumab
IA, investigator assessment; IR, independent review.
Slide credit: clinicaloptions.com
Phillips AA, et al. ASCO Abstract 7501.

6. 0761-009: Treatment Emergent AEs
Event, % (> 20% Pts)
Mogamulizumab
(n = 47)
Investigator’s Choice
(n = 24)
Gastrointestinal disorders
53.2
62.5
Metabolism/nutrition disorders
51.1
58.3
Infections
20.8
Injury, poisoning, procedural complications
Infusion-related reaction
46.8
Respiratory/thoracic/mediastinal disorders
44.7
29.2
Skin/subcutaneous disorders
42.6
8.3
Musculoskeletal/coactive tissue disorders
34.0
Blood/lymphatic disorders
31.9
45.8
Nervous system disorders
29.8
37.5
Psychiatric disorders
21.3
Renal/urinary disorders
AE, adverse event.
Slide credit: clinicaloptions.com
Phillips AA, et al. ASCO Abstract 7501.

7. : Conclusions
Investigator’s choice regimens resulted in limited or no response in R/R ATL pts
Mogamulizumab resulted in ORR of 34% by investigator assessment (28% by independent review)
Duration of response 5.5 mo by investigator assessment (5 mo by independent review)
Most common treatment-related AEs with mogamulizumab include infection, infusion-related reaction, rash
Investigators suggest mogamulizumab offers therapeutic potential in a setting with no current consensus treatment
AE, adverse event; ATL, adult T-cell leukemia-lymphoma; ORR, objective response rate; R/R, relapsed/refractory.
Slide credit: clinicaloptions.com
Phillips AA, et al. ASCO Abstract 7501.

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