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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

M. Trnĕný, G. Verhoef, MJ. Dyer, D. Ben Yehuda, C. Patti, M. Canales, A. Lopez, FT. Awan, PG. Montgomery, A. Janikova, AM. Barbui, K. Sulek, MJ. Terol, J. Radford, A. Guidetti, M. Di Nicola, L. Siraudin, L. Hatteville, S. Schwab, C. Oprea, AM. Gianni,

. 2018 ; 103 (8) : 1351-1358. [pub] 20180510

Language English Country Italy

Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19045461

Grant support
P30 CA016058 NCI NIH HHS - United States

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 novo 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/m2) 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. (Registered at: clinicaltrials.gov identifier: 01472887).

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$a Verhoef, Gregor $u Department of Hematology, University Hospital, Leuven, Belgium.
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$a Montgomery, Paul G $u Boise VA Medical Center, Boise, ID, USA.
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$a Barbui, Anna M $u Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
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$a Sulek, Kazimierz $u Wojskowy Instytut Medyczny, Warsaw, Poland.
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$a Terol, Maria J $u Hospital Clínico Universitario de Valencia, Health Research Institute INCLIVA, Spain.
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$a Radford, John $u University of Manchester and The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, UK.
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$a Guidetti, Anna $u Fondazione Istituto Nazionale Tumori, Milan, Italy. University of Milan, Italy.
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