Clinical Data
Primary endpoint results
Learn about:
- Clinically significant CMV infection at week 24
- Rate of clinically significant infection vs placebo
- High- and low-risk strata
Clinically significant CMV infection at week 24
PREVYMIS demonstrated significant efficacy vs placebo in the primary endpoint: Clinically significant CMV infectiona at week 24 (NC=F approach)b
Parameter | PREVYMIS | Placebo |
---|---|---|
(n=325) | (n=170) | |
Proportion of subjects who failed prophylaxis | 38% | 61% |
Treatment difference for PREVYMIS vs placebo (95% CI) |
-23.5 (-32.5, -14.6) P<0.0001 | |
Reasons for failuresc | ||
Clinically significant CMV infection by week 24d | 18% | 42% |
Initiation of PET based on documented CMV viremia |
16% |
40% |
CMV end-organ disease |
2% |
2% |
Discontinued from study before week 24e | 17% | 16% |
Missing outcome in week 24 visit window | 3% | 3% |
(a) Clinically significant CMV infection was defined as either the occurrence of CMV end-organ disease or initiation of anti-CMV PET, based on documented CMV viremia and the clinical condition of the patient. Viremia was determined using the Roche COBAS® AmpliPrep/COBAS TaqMan® assay; lower limit of quantification was 137 IU/mL, which is approximately 150 copies/mL.
(b) The Noncompleter=Failure (NC=F) approach was used in which patients who discontinued from the study prior to week 24 post-transplant or had a missing outcome at week 24 post-transplant were counted as failures.
(c) The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
(d) Through week 14, 8% of subjects in the PREVYMIS group and 39% of subjects in the placebo group experienced clinically significant CMV infection.
(e) Reasons for discontinuation included adverse event (AE), death, lost to follow-up, physician decision, and withdrawal by subject.
Back to topRate of clinically significant CMV infection
Significantly lower rate of onset of clinically significant CMVf infection for PREVYMIS vs placebo1,g

Copyright © 2017 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.1
(f) Clinically significant CMV infection was defined as either the occurrence of CMV end-organ disease or initiation of anti-CMV PET, based on documented CMV viremia and the clinical condition of the patient. Viremia was determined using the Roche COBAS® AmpliPrep/COBAS TaqMan® assay; lower limit of quantification was 137 IU/mL, which is approximately 150 copies/mL.
(g) Included patients who received at least 1 dose of study drug and excluded patients with detectable CMV DNA at baseline.
Factors associated with clinically significant CMV infection between week 14 and week 24 post-transplant among PREVYMIS patients included:
- High-risk stratum for CMV reactivation at baseline
- Having GVHD
- Steroid use at any time after randomization
High- and low-risk strata
Efficacy results were consistent across high- and low-risk strata for CMV reactivation.
Treatment difference with clinically significant CMV infection at week 24 for PREVYMIS vs placebo2

PREVYMIS was studied in adult R+ patients who were at high risk for CMV reactivation. At baseline, 30% of all subjects had 1 or more of the following additional risk factors and were placed in the high-risk stratum:
- Related donor with HLA mismatch
- Haploidentical donor
- Unrelated donor with HLA mismatch
- Use of umbilical cord blood
- Use of ex vivo T-cell–depleted grafts
- GVHD requiring systemic corticosteroids
70% of subjects had no additional risk factors.