We present the interim results of a postmarketing all-case surveillance study in patients with C-C chemokine receptor 4 (CCR4)-positive, relapsed or refractory adult T-cell leukemia-lymphoma (ATL) treated with the anti-CCR4 monoclonal antibody mogamulizumab since its 2012 launch in Japan. The safety and efficacy analysis populations comprised 484 and 442 patients, respectively. The ATL subtype was acute in 58.9% and lymphoma in 34.2% of patients. All patients were scheduled to receive intravenous infusions of mogamulizumab (1.0 mg/kg) once weekly for eight weeks, alone or in combination with other modalities. Adverse drug reactions (ADRs) were reported in 74.0% of patients, of which 35.7% were serious and 6.2% were fatal. The priority survey items of infusion-related reaction, skin disorder, infection, immune disorder, and tumor lysis syndrome were reported in 29.3, 34.3, 22.1, 3.5, and 2.5% of patients, respectively. Graft-versus-host disease was reported in 25/42 patients who received mogamulizumab before allogeneic hematopoietic stem cell transplantation. The best overall response rate was 57.7% overall, 57.5% in patients treated with mogamulizumab alone, and 58.2% in patients treated with combination therapy. This surveillance indicates that mogamulizumab shows acceptable tolerability in practice; however, because of the risk of serious/fatal ADRs, patients administered mogamulizumab should be carefully monitored.

ObjectiveThis prospective, observational, postmarketing surveillance was conducted to evaluate the safety and effectiveness of mogamulizumab, an anti‐CC chemokine receptor 4 (CCR4) monoclonal antibody, in patients with CCR4‐positive, relapsed or refractory (r/r) adult T‐cell leukemia‐lymphoma (ATL) in Japan.MethodAll patients were scheduled to receive intravenous infusions of mogamulizumab 1.0 mg/kg once weekly for 8 weeks, alone or in combination with other modalities.ResultsIn the safety analysis population comprising 572 patients, mogamulizumab therapy was started between May 29, 2012, and April 30, 2013, and adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion‐related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]). In the effectiveness analysis population comprising 523 patients, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months. Safety and effectiveness results were similar between patients aged ≥70 and <70 years.ConclusionThis postmarketing surveillance confirmed the safety and effectiveness of mogamulizumab for the treatment of patients with r/r ATL, including elderly patients, in clinical practice.

that is uniquely farnesylated. Tipifarnib has been shown to be well tolerated and to have a 41% response rate (7 responses out of 17 patients) in patients (pts) with T-cell non-Hodgkin Lymphoma, including 4 objective responses in 8 pts with peripheral T-cell lymphoma (PTCL) (Witzig et al., 2011). Building on this prior experience, we report herein the preliminary efficacy, safety, and biomarker data from our ongoing Phase 2 study in PTCL.Methods: This Phase 2 study is a multi-institutional, single-arm, openlabel, two-stage (11 + 7) study designed to determine the efficacy and safety of tipifarnib in pts with relapsed/refractory (R/R) PTCL. Pts with R/R PTCL after prior cytotoxic systemic therapy, aged ≥18 years old, and with a performance status of 0-2 were eligible. The primary endpoint of the study is overall response rate. Based on activity observed in the first 18 pts in the study, the protocol has been amended and enrollment is ongoing to an expansion cohort in AITL (N = 12). Enrolled pts are treated with tipifarnib 600 mg administered orally twice daily on days 1-7 and 15-21 of 28-day treatment cycles until progression of disease or unacceptable toxicity. Clinical trial information: NCT02464228. Conclusions: Although this study is ongoing, these preliminary data indicate that tipifarnib is generally well tolerated and has antitumor activity, particularly in pts with AITL histology, absence of 3'UTR CXCL12 SNV, and high levels of CXCL12 gene expression.