Page 121 - Haematologica August 2018

Coltuximab ravtansine monotherapy in DLBCL
that low levels of CD22 or CD79B expression on target cells does not reduce the antitumor activities of pinatuzumab vedotin or polatuzumab vedotin, respective- ly.39 Similar findings have also been reported in a brentux- imab vedotin phase II study in DLBCL, in which respons- es were not dependent on CD30 expression.30
Overall, coltuximab ravtansine exhibited a favorable safety profile, with the majority of the most common AEs reported at grade 1-2. The most frequent grade 3-4 AEs were hematologic or gastrointestinal in nature. No study- onset occurrences of grade 3-4 PN or ocular toxicity were observed, and grade 1-2 toxicities were reversible and manageable. In addition, the majority of these events occurred during cycles 1-2 suggesting that they may result from the more intensive dosing of coltuximab ravtansine during the first cycle of the study, rather than drug accu-
mulation. Indeed Ribrag et al.19 demonstrated a reduced incidence of ocular toxicities and PN with the optimized schedule used here versus a weekly dosing schedule. Dose modifications were required in 28% of patients due to AEs, approximately half of which were grade 3-4. No dose reductions were required during the study. SAEs consid- ered related to study treatment were uncommon.
In conclusion, the results of this phase II study indicate that the optimized dosing regimen of coltuximab ravtan- sine may have some efficacy in patients with relapsed or refractory DLBCL, previously treated with rituximab.
Acknowledgments
The authors would like to thank Amy-Leigh Johnson, PhD, of Adelphi Communications Ltd. (Bollington, UK) for editorial sup- port. This study and the editorial support were funded by Sanofi.
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