A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Oral Brincidofovir for Cytomegalovirus Prophylaxis in Allogeneic Hematopoietic Cell Transplantation

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Presentation transcript:

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Oral Brincidofovir for Cytomegalovirus Prophylaxis in Allogeneic Hematopoietic Cell Transplantation Francisco M. Marty, Drew J. Winston, Roy F. Chemaly, Kathleen M. Mullane, Tsiporah B. Shore, Genovefa A. Papanicolaou, Greg Chittick, Thomas M. Brundage, Chad Wilson, Marion E. Morrison, Scott A. Foster, W. Garrett Nichols, Michael J. Boeckh Biology of Blood and Marrow Transplantation Volume 25, Issue 2, Pages 369-381 (February 2019) DOI: 10.1016/j.bbmt.2018.09.038 Copyright © 2018 Terms and Conditions

Figure 1 Consent, screening, enrollment, randomization, and follow-up. Biology of Blood and Marrow Transplantation 2019 25, 369-381DOI: (10.1016/j.bbmt.2018.09.038) Copyright © 2018 Terms and Conditions

Figure 2 Time to clinically significant CMV infection (A) and time to all-cause mortality (B) from day of transplantation through week 24 post-transplantation, intention-to-treat population. Patients without a clinically significant CMV infection were censored at the end-of-study visit or at 24 weeks (+2-week window) after transplantation, whichever was earlier. For mortality through week 24, patients who died after week 24 post-transplantation were censored at the end-of-study visit or week 24, whichever was earlier. Biology of Blood and Marrow Transplantation 2019 25, 369-381DOI: (10.1016/j.bbmt.2018.09.038) Copyright © 2018 Terms and Conditions

Figure 3 Time to clinically significant CMV infection according to several subgroups. (A and B) Results by randomization strata groups of higher and lower risk of CMV disease progression. (C and D) Post hoc results according to use of T cell depletion strategies (ATG, alemtuzumab, or ex vivo T cell depletion) (C) and all other patients (D). (E and F) Post hoc results according to conditioning regimen, either reduced-intensity (E) or myeloablative (F) conditioning. Biology of Blood and Marrow Transplantation 2019 25, 369-381DOI: (10.1016/j.bbmt.2018.09.038) Copyright © 2018 Terms and Conditions

Figure 4 (A) Brincidofovir exposure and risk of diarrhea, Common Terminology Criteria for Adverse Events grade ≥2 or gastrointestinal GVHD stage ≥1. The solid line indicates calculated risk; dotted lines, 95% CIs of calculated risk; X, individual patients who experienced the adverse event if on 1.0 on the y-axis, who did not experience the adverse event if on 0 on the y-axis. (B) Impact of SMMP patient management on clinically significant CMV infection and all-cause mortality from week 8 through week 24 among brincidofovir-treated patients. BCV, brincidofovir; primary endpoint event, clinically significant CMV infection. Biology of Blood and Marrow Transplantation 2019 25, 369-381DOI: (10.1016/j.bbmt.2018.09.038) Copyright © 2018 Terms and Conditions