Mogamulizumab versus investigator's choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma

0761-009 Study Group

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Mogamulizumab, a humanized defucosylated anti-C-C chemokine receptor 4 monoclonal antibody, has been approved in Japan for the treatment of C-C chemokine receptor 4-positive adult T-cell leukemia/lymphoma (ATL). This phase II study evaluated efficacy and safety of mogamulizumab in ATL patients with acute, lymphoma, and chronic subtypes with relapsed/refractory, aggressive disease in the US, Europe, and Latin America. With stratification by subtype, patients were randomized 2:1 to intravenous mogamulizumab 1.0 mg/kg once weekly for 4 weeks and biweekly thereafter (n=47) or investigator's choice of chemotherapy (n=24). The primary end point was confirmed overall response rate (cORR) confirmed on a subsequent assessment at 8 weeks by blinded independent review. ORR was 11% (95%CI: 4-23%) and 0% (95%CI: 0-14%) in the mogamulizumab and chemotherapy arms, respectively. Best response was 28% and 8% in the respective arms. The observed hazard ratio for progression-free survival was 0.71 (95%CI: 0.41-1.21) and, after post hoc adjustment for performance status imbalance, 0.57 (95%CI: 0.337-0.983). The most frequent treatment-related adverse (grade ≥3) events with mogamulizumab were infusion-related reaction and thrombocytopenia (each 9%). Relapsed/refractory ATL is an aggressive, poor prognosis disease with a high unmet need. Investigator's choice chemotherapy did not result in tumor response in this trial; however, mogamulizumab treatment resulted in 11% cORR, with a tolerable safety profile.

Original languageEnglish (US)
Pages (from-to)993-1003
Number of pages11
JournalHaematologica
Volume104
Issue number5
DOIs
StatePublished - May 1 2019

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Adult T Cell Leukemia Lymphoma
Research Personnel
Drug Therapy
CC Chemokines
Chemokine Receptors
Safety
Latin America
Thrombocytopenia
Disease-Free Survival
mogamulizumab
Lymphoma
Japan
Therapeutics
Monoclonal Antibodies
Neoplasms

ASJC Scopus subject areas

  • Hematology

Cite this

Mogamulizumab versus investigator's choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma. / 0761-009 Study Group.

In: Haematologica, Vol. 104, No. 5, 01.05.2019, p. 993-1003.

Research output: Contribution to journalArticle

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abstract = "Mogamulizumab, a humanized defucosylated anti-C-C chemokine receptor 4 monoclonal antibody, has been approved in Japan for the treatment of C-C chemokine receptor 4-positive adult T-cell leukemia/lymphoma (ATL). This phase II study evaluated efficacy and safety of mogamulizumab in ATL patients with acute, lymphoma, and chronic subtypes with relapsed/refractory, aggressive disease in the US, Europe, and Latin America. With stratification by subtype, patients were randomized 2:1 to intravenous mogamulizumab 1.0 mg/kg once weekly for 4 weeks and biweekly thereafter (n=47) or investigator's choice of chemotherapy (n=24). The primary end point was confirmed overall response rate (cORR) confirmed on a subsequent assessment at 8 weeks by blinded independent review. ORR was 11{\%} (95{\%}CI: 4-23{\%}) and 0{\%} (95{\%}CI: 0-14{\%}) in the mogamulizumab and chemotherapy arms, respectively. Best response was 28{\%} and 8{\%} in the respective arms. The observed hazard ratio for progression-free survival was 0.71 (95{\%}CI: 0.41-1.21) and, after post hoc adjustment for performance status imbalance, 0.57 (95{\%}CI: 0.337-0.983). The most frequent treatment-related adverse (grade ≥3) events with mogamulizumab were infusion-related reaction and thrombocytopenia (each 9{\%}). Relapsed/refractory ATL is an aggressive, poor prognosis disease with a high unmet need. Investigator's choice chemotherapy did not result in tumor response in this trial; however, mogamulizumab treatment resulted in 11{\%} cORR, with a tolerable safety profile.",
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T1 - Mogamulizumab versus investigator's choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma

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AU - Phillips, Adrienne A.

AU - Fields, Paul A.

AU - Hermine, Olivier

AU - Carlos Ramos, Juan

AU - Beltran, Brady E.

AU - Pereira, Juliana

AU - Wandroo, Farooq

AU - Feldman, Tatyana

AU - Taylor, Graham P.

AU - Sawas, Ahmed

AU - Humphrey, Jeffrey

AU - Kurman, Michael

AU - Moriya, Junji

AU - Dwyer, Karen

AU - Leoni, Mollie

AU - Conlon, Kevin

AU - Cook, Lucy

AU - Gonsky, Jason

AU - Horwitz, Steven M.

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