Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study by Guillaume Cartron, Sophie de Guibert,

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Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study by Guillaume Cartron, Sophie de Guibert, Marie-Sarah Dilhuydy, Franck Morschhauser, Veronique Leblond, Jehan Dupuis, Beatrice Mahe, Reda Bouabdallah, Guiyuan Lei, Michael Wenger, Elisabeth Wassner-Fritsch, and Michael Hallek Blood Volume 124(14):2196-2202 October 2, 2014 ©2014 by American Society of Hematology

Study design and patient disposition in the GAUGUIN study. Study design and patient disposition in the GAUGUIN study. (A) Phase 1. (B) Phase 2. *One patient enrolled in phase 2 of GAUGUIN did not enter follow-up because of a new anti-leukemia therapy. Guillaume Cartron et al. Blood 2014;124:2196-2202 ©2014 by American Society of Hematology

Complement and cytokine levels over time among phase 1 and 2 study participants. Complement and cytokine levels over time among phase 1 and 2 study participants. (A) Complement C3 and C4 (mean ± standard deviation). (B) Cytokines (mean ± standard deviation). C, cycle; D, day. Guillaume Cartron et al. Blood 2014;124:2196-2202 ©2014 by American Society of Hematology

Kaplan-Meier plot of PFS in phase 2 of the GAUGUIN study. Guillaume Cartron et al. Blood 2014;124:2196-2202 ©2014 by American Society of Hematology

ETR by baseline tumor burden in phase 1 and 2 of the GAUGUIN study ETR by baseline tumor burden in phase 1 and 2 of the GAUGUIN study. *In phase 1 of GAUGUIN, 4 different doses of obinutuzumab were evaluated. ETR by baseline tumor burden in phase 1 and 2 of the GAUGUIN study. *In phase 1 of GAUGUIN, 4 different doses of obinutuzumab were evaluated. In phase 2, all patients received obinutuzumab 1000/1000 mg. The size of the bar below the x-axis reflects the dose received by the patient. Guillaume Cartron et al. Blood 2014;124:2196-2202 ©2014 by American Society of Hematology

Pharmacokinetic and pharmacodynamic properties of obinutuzumab. Pharmacokinetic and pharmacodynamic properties of obinutuzumab. (A) Mean serum concentrations of obinutuzumab over time. (B) B-lymphocyte count over time in all GAUGUIN study participants. Reported lymphocyte counts are preinfusion for each. FU, follow-up; SD, standard deviation; W, week. The 2 patients who were B-cell depleted at screening were included based on prior CLL diagnoses and lymph node progression. Guillaume Cartron et al. Blood 2014;124:2196-2202 ©2014 by American Society of Hematology