Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-6:05pm
*Purpose: Therapeutic options for refractory, with/without resistance (R/R), CMV infections are limited. We report organ type subgroup analyses from a large multi-center trial that studied the efficacy of maribavir (MBV) vs investigator-assigned therapy (IAT) in pts with R/R CMV infection.
*Methods: Transplant recipients aged ≥12 yrs, with CMV infection (viral load [VL] ≥2730 IU/mL/≥910 IU/mL CMV DNA [blood/plasma]) refractory to recent Tx (failure to achieve >1 log10 decrease in CMV DNA after ≥14 days) were eligible (NCT02931539). Pts were stratified (HCT/SOT + screening CMV VL) and randomized 2:1 to MBV 400 mg BID or IAT (val/ganciclovir, foscarnet, cidofovir, foscarnet+val/ganciclovir) for 8 wks + 12 wks follow-up. Primary endpoint: confirmed CMV clearance (plasma CMV DNA <137 IU/mL in 2 consecutive tests ≥5 days apart) at end of Wk 8. Key secondary endpoint: CMV clearance and symptom control at end of Wk 8 and maintained through Wk 16. Group differences, adjusted for baseline CMV DNA level <9100/≥9100 IU/mL, and SOT/HCT were compared (Cochran-Mantel-Haenszel tests). Subgroup analyses by SOT type were conducted.
*Results: 352 pts were randomized (235 MBV, 117 IAT; age range 19-79 years). Significantly more pts (MBV vs IAT) achieved the primary (55.7% vs 23.9%; difference, 95% CI: 32.8%, 22.8-42.7; p<0.001) and key secondary endpoint (18.7% vs 10.3%; difference, 95% CI: 9.5%, 2.0-16.9; p=0.013). 211 pts (59.9%) were SOT recipients (kidney, 50.2%; lung, 29.4%; heart, 10.9%; liver, 3.3%; pancreas, 0.9%; intestine, 0.5%; multiple, 4.7%). A benefit trend for MBV vs IAT in kidney, lung, and heart transplants was seen (Fig). No SOT pts lost grafts. Tx-emergent AEs (TEAEs) with MBV vs IAT (overall % pts): 97.4% and 91.4%. Acute kidney injury with MBV vs foscarnet was lower: 8.5% vs 21.3% (TEAE) and 1.7% vs 19.1% (Tx-related TEAE). Neutropenia with MBV vs val/ganciclovir was lower: 9.4% vs 33.9% (TEAE) and 1.7% vs 25.0% (Tx-related TEAE). Overall, 2 Tx-related serious TEAEs led to death (1 pt per arm).
*Conclusions: MBV showed superior efficacy vs IAT in clearing CMV in transplant recipients with R/R CMV infection, with consistent trends across organ types and lower rates of Tx limiting toxicities common with IAT.
To cite this abstract in AMA style:Avery RK, Blumberg EA, Florescu D, Kamar N, Kumar D, Wu J, Sundberg A. Randomized Phase 3 Open-label Study of Maribavir vs Investigator-assigned Therapy for Refractory/resistant Cytomegalovirus Infection in Transplant Recipients: Subgroup Analyses of Efficacy by Organ [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/randomized-phase-3-open-label-study-of-maribavir-vs-investigator-assigned-therapy-for-refractory-resistant-cytomegalovirus-infection-in-transplant-recipients-subgroup-analyses-of-efficacy-by-organ/. Accessed June 18, 2021.
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