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Mogamulizumab vs. investigator's choice in ATL
ine,28 irinotecan,29 or bortezomib.30 A study of 26 patients in Japan published subsequent to enrollment of our trial reported an ORR of 42% with lenalidomide,31 and a report on the use of alemtuzumab in relapsed/ refractory patients demonstrated an ORR of 50% in a lower-risk population.32 A recent phase I study examining the combination of romidepsin with pralatrexate included six relapsed/refrac- tory ATL patients and reported a preliminary response rate of 50%.33 Landmark therapeutic trials leading to US Food and Drug Administration approval in the US of beli- nostat, pralatrexate, romidepsin, and brentuximab vedotin
in relapsed/refractory PTCL included solitary or no patients with ATL,34-37 precluding extrapolation of results to ATL.
The safety profile for mogamulizumab was manageable and consistent with previous reports, with infusion-relat- ed reactions and drug eruptions as the most common AEs.22,38,39 The rate of discontinuation for drug eruption was similar to the recently reported phase III study of mogamulizumab in CTCL.39 As in that study, use of sys- temic steroids was not permitted by protocol and most rashes were successfully managed with topical steroids.
Figure 4. Duration on study for patients receiving ≥2 cycles of mogamulizumab. (Top) Initially randomized to mogamulizumab. (Bottom) Initially randomized to inves- tigator’s choice of chemotherapy and then crossed over to mogamulizumab. Response as assessed by investigator. *Indicates confirmed response. Patient 16 had salvage chemotherapy prior to transplant but no date was provided.
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