Gianni, A. M. (Alessandro M.)

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    A phase II multicenter study of the anti-CD19 antibody drug conjugate coltuximab ravtansine (SAR3419) in patients with relapsed or refractory diffuse large B-cell lymphoma previously treated with rituximab-based immunotherapy
    (2018) Hatteville, L. (Laurence); Verhoef, G. (Gregor); Montgomery, P. G. (Paul G.); Gianni, A. M. (Alessandro M.); Dyer, M.J.S. (Martin J. S.); Radford, J. (John); Janikova, A. (Andrea); Siraudin, L. (Laure); Guidetti, A. (Anna); Ben-Yehuda, D. (Dina); Oprea, C. (Corina); Terol, M.J. (María José); Trneny, M. (Marek); Kazimierz, S. (Sulek); Canales-Albendea, M. A. (Miguel Ángel); Barbui, A. M. (Anna Maria); López, A. (Andrés); Di-Nicola, M. (Massimo); Awan, F. T. (Farrukh T.); Schwab, S. (Sandrine); Patti, C. (Caterina)
    This phase II, single-arm, multicenter study examined the efficacy and safety of coltuximab ravtansine (an anti-CD19 antibody drug conjugate) in 61 patients with histologically documented ( de novo2clinicaltrials.gov identifier: 01472887) or transformed) relapsed or refractory diffuse large B-cell lymphoma who had previously received rituximab-containing immuno-chemotherapy. Patients had received a median of 2.0 (range 0-9) prior treatment regimens for diffuse large B-cell lymphoma and almost half (45.9%) had bulky disease (≥1 lesion >5 cm) at trial entry. Patients received coltuximab ravtansine (55 mg/m) in 4 weekly and 4 biweekly administrations until disease progression or unacceptable toxicity. Forty-one patients were eligible for inclusion in the per protocol population. Overall response rate (International Working Group criteria) in the per protocol population, the primary end point, was 18/41 [43.9%; 90% confidence interval (CI:) 30.6-57.9%]. Median duration of response, progression-free survival, and overall survival (all treated patients) were 4.7 (range 0.0-8.8) months, 4.4 (90%CI: 3.02-5.78) months, and 9.2 (90%CI: 6.57-12.09) months, respectively. Common non-hematologic adverse events included asthenia/fatigue (30%), nausea (23%), and diarrhea (20%). Grade 3-4 adverse events were reported in 23 patients (38%), the most frequent being hepatotoxicity (3%) and abdominal pain (3%). Eye disorders occurred in 15 patients (25%); all were grade 1-2 and none required a dose modification. Coltuximab ravtansine monotherapy was well tolerated and resulted in moderate clinical responses in pre-treated patients with relapsed/refractory diffuse large B-cell lymphoma.