In subgroup analyses of the pivotal Phase 3 trial, viraemia clearance was observed in SOT recipients^2-5 In subgroup analyses of the pivotal Phase 3 trial, viraemia clearance was observed in HSCT recipients^2,6 SOLSTICE trial: rescue arm²

LIVTENCITY▼® (maribavir) efficacy data
 

LIVTENCITY (maribavir) is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).¹
Consideration should be given to official guidance on the appropriate use of antiviral agents.¹
 

In the pivotal Phase 3 trial, LIVTENCITY delivered viraemia clearance in twice the proportion of patients (55.7%) compared to investigator-assigned therapy (IAT) (23.9%) - primary endpoint²

In the pivotal Phase 3 trial, LIVTENCITY delivered viraemia clearance of 18.7% at Study Week 8 maintained through Week 16 - almost double the proportion of patients compared with IAT (10.3%) - key secondary endpoint²
 

Confirmed viraemia clearance^* of refractory CMV in all transplants (HSCT and SOT) at Study Week 8²  
 

Confirmed CMV viraemia clearance and symptom control* in all transplants (HSCT and SOT) at the end of Study Week 8, maintained through Study Week 16²

*Plasma CMV DNA <137 IU/mL in 2 consecutive tests ≥5 days apart.²
†CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline.²
 

LIVTENCITY - safety profile in post-transplant refractory CMV (with or without resistance)
 

• In the SOLSTICE trial, the most reported treatment-related adverse event was dysgeusia that typically resolved during or after treatment (35.9% [84/234] receiving LIVTENCITY vs 0.9% [1/116] receiving investigator-initiated therapy)³
• Transplant recipients treated with LIVTENCITY experienced less treatment-related neutropenia vs those receiving valganciclovir/ganciclovir (1.7% receiving LIVTENCITY vs 25% receiving valganciclovir/ganciclovir)²
• Transplant patients treated with LIVTENCITY experienced less treatment-related acute kidney injury vs those receiving foscarnet (1.7% receiving LIVTENCITY vs 19.1% receiving foscarnet)²

In subgroup analyses of the pivotal Phase 3 trial, viraemia clearance was observed in SOT recipients^2-5
 

Confirmed viraemia clearance in a subgroup analysis of SOT recipients with refractory CMV at Study Week 8*^2,4
 

Confirmed CMV viraemia clearance and symptom control at the end of Study Week 8, maintained through Study Week 16 in a subgroup analysis of SOT recipients with refractory CMV³

*Limitations: This study was not powered to detect differences between treatments in this patient subgroup.²
 
 

SOLSTICE primary endpoint: subgroup analysis of efficacy by organ type
 

In a subgroup analysis of heart transplant recipients with refractory CMV receiving LIVTENCITY (6/14; vs 11.1% [1/9] on IAT)⁴

95% Cl: 30.7% (-1.72–63.2)

In a subgroup analysis of lung transplant recipients with refractory CMV receiving LIVTENCITY (19/40; vs 13.6% [3/22] on IAT)⁴

95% Cl: 38.2% (16.9–59.5)

In a subgroup analysis of kidney transplant recipients with refractory CMV receiving LIVTENCITY (44/74; vs 34.4% [11/32] on IAT)⁴

95% Cl: 26.7% (7.5–45.9)

In a subgroup analysis of liver transplant recipients with refractory CMV receiving LIVTENCITY vs 0/1 on IAT⁵

Note: this subgroup analysis has been calculated from low patient numbers and the two treatment groups are not equally matched; therefore, it is insufficient to show a difference in treatment effect.
 

In subgroup analyses of the pivotal Phase 3 trial, viraemia clearance was observed in HSCT recipients^2,6

Confirmed viraemia clearance in a subgroup analysis (randomised population) of HSCT recipients with refractory CMV at Study Week 8^*2
 

Confirmed CMV viraemia clearance and symptom control† at the end of Study Week 8, maintained through Study Week 16 in a subgroup analysis (randomised population) of HSCT recipients with refractory CMV⁶
 

*Limitations: This study was not powered to detect differences between treatments in this patient subgroup.²
†CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline.²
 

SOLSTICE trial: rescue arm²
 

Summary of HSCT and SOT recipients randomised to IAT meeting criteria for entry into LIVTENCITY rescue arm^*7
 
 

HSCT and SOT recipients in rescue arm achieving confirmed CMV viraemia clearance^**7

 

*All patients who entered the LIVTENCITY rescue arm had demonstrated persistence of CMV viraemia despite treatment with IAT for at least 3 weeks. All patients entered the rescue arm between study Weeks 3–7, except for 1 patient who entered between Weeks 7–8.⁷
†Whole blood or plasma CMV DNA levels were measured by local or central specialty laboratory qPCR assay.⁷
‡Patient had to meet 2 criteria: (i) whole blood or plasma CMV DNA had decreased <1 log₁₀ from baseline as measured by local or speciality laboratory qPCR assay, and (ii) the presenting tissue-invasive CMV disease for symptomatic patients had not improved/worsened, or patient was asymptomatic at baseline and developed tissue-invasive disease.⁷
§At least 50% increase from baseline value, attributed to treatment toxicity (e.g. cidofovir, foscarnet).⁷ 
#When on treatment with cidofovir or foscarnet.⁷ 
¶Absolute neutrophil count <500/mm³ when on treatment with valganciclovir/ganciclovir.⁷
**Included all patients who entered the rescue arm and received any dose of LIVTENCITY as rescue therapy.⁷
 
 

Confirmed viraemia clearance = plasma CMV DNA < lower limit of quantification (i.e. <137 IU/mL) in 2 consecutive tests ≥5 days apart.²
IAT = one or a combination of ganciclovir, valganciclovir, foscarnet, or cidofovir.²
Refractory CMV = failure to achieve >1 log10 decrease in CMV DNA level in whole blood or plasma after a 14-day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir; IV foscarnet, or IV cidofovir.²
Cl = confidence interval; CMV = cytomegalovirus; HSCT = haematopoietic stem cell transplant; IAT = investigator-assigned therapy; qPCR = quantitative polymerase chain reaction; SOT = solid organ transplant.
 
 

References:

1. LIVTENCITY UK Summaries of Product Characteristics.
2. Avery RK, et al. Clin Infect Dis. 2022;75(4):690–701.
3. Data on File for Maribavir for SOT recipients. EXA/GB/MARI/0029.
4. Avery RK, et al. Am J Transplant. 2021;21(suppl. 3).
5. Data on File for Maribavir for 100% CMV clearance in LT patients. EXA/GB/MARI/0030.
6. Data on File for Maribavir for HCT recipients. EXA/GB/MARI/0028.
7. Pereira M, et al. Efficacy and safety of Maribavir as a rescue treatment for investigator assigned therapy in transplant recipients with refractory or resistant cytomegalovirus infections in the SOLSTICE study: phase 3 trial results. In: The 2021 IDWeek Virtual Conference; 2021. Oral Abstract 21.