Results from a European multicenter phase-II mogamulizumab trial
Pier Luigi Zinzani from the University of Bologna, Italy, and colleagues recently published data from a phase-II study of mogamulizumab in R/R PTCL in a Letter to the Editor of Haematologica in October 2016. Mogamulizumab is approved in Japan for the treatment of CCR4-positive PTCL patients. The authors’ study aimed to primarily assess the ORR of R/R PTCL patients treated with the anti-CCR4 monoclonal antibody, mogamulizumab, in a 15 center, European, phase-II trial. Their secondary outcomes were duration of response, PFS, OS, and safety, and their study enrolled 38 patients of which 35 were included in their analysis.
- Mogamulizumab dose = 1 mg/kg weekly for 4 weeks, then every two weeks until PD, toxicity, death, or withdrawal
- Evaluated every 8 weeks from first treatment by investigators
- ORR = 11.5% (95% CI: 3.2–26.7%), mPFS = 2.1 months (95% CI: 1.3–3.9 months)
- 1pt CR, 3pts PR at 8 weeks (after two cycles)
- Median duration of SD = 2.8 months
- Treatment related AE ≥ grade 3 = 36.8%. AEs included thrombocytopenia, (13.2%) and anemia (7.9%)
Zinzani et al. noted that their reported ORR was much lower than a previous study of 29 patients with relapsed CCR4-positive PTCL by Ogura et al. within a Japanese population (11.5% vs 34%). There were many potential reasons given for this difference including that Zinzani et al. included refractory PTCL patients, which are known to have a poorer outcome than relapsed patients. Additionally, the dose in the Ogura et al. study was higher, with 68% of patients receiving the maximum eight doses in eight weeks.
In conclusion, despite a low ORR of 11.4%, there was an SD or better rate of 45.7%. For the future, the authors suggested exploring combination therapies with mogamulizumab in the treatment of R/R PTCL.
- Zinzani P. L. et al. European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma. Haematologica. Oct 2016; 101(10):e407-e410. doi:10.3324/haematol.2016.146977.
- Ogura M. et al. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr; 10;32(11):1157–63. doi:10.1200/JCO.2013.52.0924.