Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma

Abstract

Key Points Mogamulizumab was well-tolerated in 41 patients with previously treated mycosis fungoides or Sézary syndrome. Durable responses observed with a global overall response rate of 36.8%; patients with Sézary syndrome had a response rate of 47.1%.

The “less-is-more” in therapeutic antibodies: Afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity

“…The antibody is produced in FUT8-knockout CHO cells (Biowa Potelligent Technology) to achieve afucosylation. Mogamulizumab has demonstrated effectiveness against CTCL in Phase 2 randomized controlled trials 122 . Currently, it is in several clinical trials in combination with other drugs to target several forms of solid tumors.…”

Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential

“…Twelve of 15 (80%) SS patients had a response in the blood, including seven (47%) CRs. SD was observed in 19 patients (50%); PD occurred in four patients (11%) [Duvic et al 2015].…”

“…Adverse events most frequently observed in the phase I/II study for CTCL [Duvic et al 2015] included nausea (31.0%), chills (23.8%), infusion-related reaction (21.4%), headache (21.4%), pyrexia (19.0%), fatigue (16.7%), and cutaneous drug eruption (16.7%). Thirteen patients (30.9%) had at least one skin infection, only one of which was considered related to treatment.…”

Htlv1 Associated Myelopathy, Its Diagnosis, Management and Complications

“…The HTLV1 associated myelopathy is even less frequent than hematologic complications with the incidence of 1-2%, respectively. The latency period for HTLV1 associated lymphoma has been reported to be as long as [20][21][22][23][24][25][26][27][28][29][30] months has been reported in rare cases [4,10]. Co-incidence of HTLV1 associated myelopathy and lymphoproliferative disorders has not been reported.…”

“…However, in spite of its successful role in reducing the pro-viral load, valproic acid alone didn't show clinical benefit for HAM/TSP. Combination of valproic acid and anti-retroviral nucleoside analogue zidovudine also tried in animal models infected with simian T cell Lymphotrophic Virus 1 (STLV1) with resultant reduction in proviral load, but its clinical benefit in human infected with HTLV1 needs to be determined [23][24][25][26][27][28].…”