European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma

Zinzani, Pier Luigi; Karlin, Lionel; Radford, John; Caballero, Dolores; Fields, Paul; d’Amore, Francesco; Haı̈oun, Corinne; Thiéblemont, Catherine; González‐Barca, Eva; García, Carlos Grande; Johnson, Peter; Imhoff, Gustaaf W. van; Ng, Thomas; Dwyer, Karen M.; Morschhauser, Franck

doi:10.3324/haematol.2016.146977

Cited by 46 publications

(22 citation statements)

References 11 publications

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“…Another study also evaluated the efficacy of mogamulizumab in 41 pretreated patients with cutaneous T-cell lymphoma [57]. However, the same study conducted in European patients with relapsed or refractory cutaneous lymphoma showed an overall survival (ORR) only11.4 percentage, which did not reach the target ORR of 35% standard set by the protocol, and appeared lower when compared to the previous study of Japanese patients with ORR (34%) [58]. Thus, further more study will be needed to discovery the case.…”

Section: Monoclonal Antibody For Lymphoma Treatmentmentioning

confidence: 94%

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Development of Therapeutic Antibody Technology And Recent Perspectives For Leukemia-Lymphoma Treatment

Yirga¹,

Lin²,

Huang³

et al. 2019

J Leuk

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Advancement of monoclonal antibodies (Mabs) to be accepted as a therapy has long history. This article describes the dramatic developmental trend of therapeutic antibody technology and their significant role for treatment of leukemia-lymphoma at the current time. The therapeutic Mab technology development from murine (mouse origin) to fully human resulted in low immunogenicity and high quality Mabs. Chemotherapy is standard care for leukemialymphoma treatments. However, it is associated with high toxicities (side effects), painful and relatively ineffective against certain leukemia-lymphoma subtypes. The remarkable contribution of Von Behring, Paul Ehrlich and the discovery of hybridoma technology marked the beginning of antibodies for therapeutic applications. Rituximab is the first Mab approved by Food and Drug Administration against B-cell malignancies. Today, a number of effective Mabs targeting leukemia and lymphoma were approved and successfully developed. The Mab therapeutic phenomena in the body (also called war in the blood) has various mechanism of actions. In recent years, Mab against leukemialymphoma achieved significantly therapeutic outcomes, eventually this led to traditional chemotherapy treatment free era. We also reviewed that, the therapeutic efficacy of Mabs against leukemia-lymphoma as compared antibody alone and antibody conjugated with potent chemotherapy or cytotoxic drugs. This article extends our understanding of advancements in therapeutic Mabs technology and provides new insights of Mab leukemia-lymphomas therapy. We also encourage further more studies for Mab based diagnostics, treatments of leukemia and lymphomas.

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Section: Monoclonal Antibody For Lymphoma Treatmentmentioning

confidence: 94%

“…In Japan, mogamulizumab anti-CC chemokine receptor 4 (CCR4) humanized and defucosylated monoclonal antibody was approved for the treatment of relapsed/refractory peripheral T-cell lymphoma, its effectiveness of overall survival was 34% [56].…”

Section: Monoclonal Antibody For Lymphoma Treatmentmentioning

confidence: 99%

Development of Therapeutic Antibody Technology And Recent Perspectives For Leukemia-Lymphoma Treatment

Yirga¹,

Lin²,

Huang³

et al. 2019

J Leuk

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“…PFS, however, was short and some unusual grade 3/4 toxicities (polymyositis, cytomegalovirus retinitis) were reported (Ogura et al , ). A phase II study conducted in Europe found only 11% ORR in 35 PTCL patients with relapsed or refractory PTCL (Zinzani et al , ).…”

Section: New Targets‐new Drugsmentioning

confidence: 99%

How I manage peripheral T‐cell lymphoma, not otherwise specified and angioimmunoblastic T‐cell lymphoma: current practice and a glimpse into the future

Schmitz

Leval

2016

Br J Haematol

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Peripheral T-cell lymphoma (PTCL), not otherwise specified (NOS) and angioimmunoblastic T-cell lymphoma (AITL) are the most frequent of more than 20 mature PTCL entities featuring a broad spectrum of morphological, immunophenotypic, molecular and clinical characteristics. Unfortunately, recent progress in understanding the (epi)genetic background of PTCL has not been met with similar advances in treatment. Thus, CHO(E)P [cyclophosphamide, doxorubicin, vincristine, and prednisone (plus etoposide)] remains standard first-line therapy. Patients without comorbidities achieving complete or partial remission proceed to autologous stem cell transplantation. With this approach about 50% of patients survive long-term. Patients relapsing after or progressing during first-line therapy have a dismal prognosis. They receive salvage gemcitabine-therapy followed by allogeneic transplantation whenever possible. After allografting, approximately half of the patients survive long-term; any other treatment is palliative. New drugs investigated in phase II studies achieved response rates between 10% and 30%; long-term remissions are the exception to the rule. While most new drugs are not licensed and not readily available, a plethora of other innovative drugs targeting (epi-)genetic abnormalities are in early development. These, together with combinations of new and old drugs, will hopefully increase response to first-line therapy, bridge more patients to transplantation, and finally improve prognosis for all patients with PTCL.

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“…In Japan, a phase II study of mogamulizumab yielded an ORR of 35% among patients with relapsed CCR4‐positive PTCL and CTCL and has been approved for CCR4‐positive T‐cell NHL. In contrast, a European phase II study of mogamulizumab yielded an ORR of only 11% for relapsed or refractory CCR4‐positive PTCL patients . Accordingly, the lack of a clear optimal treatment regimen for T‐cell NHL has encouraged the search for new therapies.…”

Section: Introductionmentioning

confidence: 99%

“…In contrast, a European phase II study of mogamulizumab yielded an ORR of only 11% for relapsed or refractory CCR4-positive PTCL patients. 13 Accordingly, the lack of a clear optimal treatment regimen for T-cell NHL has encouraged the search for new therapies.…”

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confidence: 99%

E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T‐cell lymphoma: A phase I study

et al. 2018

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E7777, a recombinant cytotoxic fusion protein comprising diphtheria toxin fragments A and B and human interleukin‐2, shares an amino acid sequence with denileukin diftitox but has improved purity and an increased percentage of active protein monomer species. A phase I study was carried out to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T‐cell lymphoma. E7777 (6, 12, and expanded 9 μg/kg/day) was given to 13 patients by i.v. infusion on five consecutive days per 21‐day cycle. Dose‐limiting toxicities, including increased alanine aminotransferase, hyponatremia (n = 2), hypokalemia, lymphopenia, fatigue, hypoalbuminemia, rash, and increased lipase (n = 1), were observed in all three patients in the 12 μg/kg/day cohort, whereas two of six patients in the 9 μg/kg/day cohort showed decreased appetite or fatigue. The maximum tolerated and recommended dose of E7777 was 9 μg/kg/day for five consecutive days per 21‐day cycle. The objective response rate was 38% (5/13) and did not appear to depend on tumor expression of CD25. E7777 was well tolerated, assuming careful management of adverse events during treatment, and preliminary but clinically meaningful antitumor activity was observed. Subsequent studies of E7777 for T‐cell lymphomas are warranted. This study was registered with www.ClinicalTrials.gov (NCT1401530).

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European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma

Cited by 46 publications

References 11 publications

Development of Therapeutic Antibody Technology And Recent Perspectives For Leukemia-Lymphoma Treatment

Development of Therapeutic Antibody Technology And Recent Perspectives For Leukemia-Lymphoma Treatment

How I manage peripheral T‐cell lymphoma, not otherwise specified and angioimmunoblastic T‐cell lymphoma: current practice and a glimpse into the future

E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T‐cell lymphoma: A phase I study

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