Scientific Poster Session II - Encore

Encore Presentations
  Sunday, November 12, 2023
  12:45 PM–02:15 PM

Abstract

Background

In this Phase 3 study (NCT02931539), maribavir (MBV) was superior to investigator-assigned therapy (IAT) for CMV viremia clearance at Study Wk 8 in HCT/SOT recipients with refractory CMV infection with/without resistance (R/R).

Aim

To explore if time from transplant to randomization impacted treatment (tx) efficacy with MBV or IAT (val/ganciclovir, foscarnet or cidofovir) in SOLSTICE.

Methods

Pts were randomized 2:1 to MBV or IAT for 8 wks, with 12 wks follow-up. The primary endpoint was confirmed CMV clearance at the end of Wk 8. This post hoc analysis evaluated the impact of time from transplant to randomization with time as a categorical variable or a continuous covariate (by month).

Results

There was no statistical difference between MBV and IAT tx arms in median time from transplant. By time categories, 64 and 28 (=3 mo), 53 and 28 (3–6 mo), 62 and 39 (6–12 mo), and 55 and 21 (>12 mo) pts received MBV or IAT, respectively. More MBV-treated pts achieved confirmed CMV clearance at the end of Wk 8 than those treated with IAT in all time ranges explored (=3 mo 50% vs 21%, 3–6 mo 68% vs 46%, 6–12 mo 57% vs 15%, >12 mo 51% vs 14%). Time from transplant had no effect on either CMV clearance at end of Wk 8 or recurrences requiring tx between Wks 8 and 20 when time was used as a continuous covariate.

Conclusions

In this post hoc analysis, higher proportions of pts treated with MBV achieved CMV clearance at end of Wk 8 than with IAT, irrespective of time from transplant to randomization.

Funding

This study was funded by Takeda Development Center Americas, Inc.

Presenting Author

Jessica Auciello PharmD, MPH
Takeda Development Center Americas, Inc.

Authors

Robin K. Avery MD
Johns Hopkins Hospital

Nassim Kamar MD
Toulouse Rangueil University Hospital

Johan Maertens MD
University Hospitals Leuven

Joan Gu PhD
Takeda Development Center Americas, Inc.

Genovefa Papanicolaou MD
Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine

Roy Chemaly MD, MPH
University of Texas MD Anderson Cancer Center

Sanjeet Dadwal MD
City of Hope National Medical Center

Oliver Witzke Univ.-Prof. Dr. med.
West German Centre of Infectious Diseases, University Hospital Essen, University Duisburg-Essen