Takeda Presents New Exploratory Analysis Showing Patients Treated With LIVTENCITY (Maribavir) Had Reductions in Hospitalization Rates and Length of Hospital Stay

By AIT News Desk On Apr 25, 2022

Data Include Exploratory Analysis Showing LIVTENCITY Treated Patients With Post-Transplant Cytomegalovirus (CMV) Infections/Disease Had Reductions in Hospitalizations (34.8%; p=0.021) and Length of Hospital Stay (53.8%; p=0.029) Compared to Those Treated With Conventional Antiviral Therapies^1*
Post-Hoc Analyses by Subgroup Showed Shorter Time to First Confirmed CMV DNA Level Less Than the Lower Limit of Quantification (<LLOQ) With LIVTENCITY Compared to Conventional Antiviral Therapies, Consistent With Previously Reported Findings²
Data Presented at the 2022 Tandem Meetings and European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) Builds Upon the Growing Body of Evidence Supporting LIVTENCITY’s Role in Redefining Treatment for Patients With Post-Transplant CMV Infections

Takeda (“Takeda”) announced that it will present four company-sponsored abstracts at the Tandem Transplantation & Cellular Therapy Meetings in Salt Lake City, Utah, and the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Lisbon, Portugal between April 23 and 26, 2022. The exploratory data presented at both meetings provide an opportunity to share important new analyses of LIVTENCITY (maribavir) with the transplant and infectious disease communities. These data announcements follow completion of patient enrollment in Takeda’s AURORA (TAK-620-302) study, focusing on LIVTENCITY for first-line use in hematopoietic stem cell transplant (HSCT) recipients with cytomegalovirus (CMV) infection/disease.

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“When managing post-transplant CMV infections, we’re always looking for additional treatment options for patients that are refractory with or without resistance”

The abstracts include additional analyses that underscore the relevance of the multicenter, randomized, open-label Phase 3 SOLSTICE trial data, which supported the U.S. Food and Drug Administration (FDA) approval of LIVTENCITY as the first and only treatment for people ages 12 and older and weighing at least 35kg with post-transplant CMV infection/disease, refractory^† (with or without genotypic resistance^‡) to conventional antiviral therapies (one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir).^5,6

CMV is one of the most common and serious post-transplant infections with an estimated global incidence rate of around 16-56% in solid organ transplant (SOT) recipients and 30-70% in HSCT recipients,^7–12 and can lead to serious consequences, including loss of the transplanted organ and failure of the graft.^13,14

“When managing post-transplant CMV infections, we’re always looking for additional treatment options for patients that are refractory with or without resistance,” said Barbara Alexander, MD, Professor of Medicine and Professor of Pathology at Duke University School of Medicine. “The additional LIVTENCITY data being presented at the Tandem Meetings and ECCMID, including time to confirmed CMV DNA level <LLOQ, patient safety data, and potential impact to hospitalization and length of stay is encouraging towards outcomes for transplant patients.”

Highlights of data being presented at the 2022 Tandem Meetings include:

Healthcare Resource Utilization in Transplant Recipients With Cytomegalovirus Infection Refractory/Resistant to Treatment Receiving LIVTENCITY Versus Investigator Assigned Therapy: Exploratory Analysis of a Phase 3 Trial

Data from an exploratory analysis of the Phase 3 SOLSTICE trial evaluating the impact of treatment with LIVTENCITY compared to conventional antiviral therapies on healthcare utilization, including number of patients with ≥1 hospitalization and length of hospital stay will be presented [Poster #52].¹
This analysis aimed to quantify the healthcare resource utilization experience of patients requiring treatment for post-transplant CMV. During the treatment phase, 31.9% of patients treated with LIVTENCITY (n=75/235) had at least one hospitalization compared to 36.8% of patients treated with conventional therapies (n=43/117). Adjusting for time on treatment, the LIVTENCITY treatment group had a 34.8% reduction compared to the conventional therapy group (p=0.021). The length of hospital stay during the treatment phase (adjusting for time on treatment) was 13.27 days/person/year in LIVTENCITY-treated patients compared to 28.73 for those conventionally treated, a 53.8% decrease (p=0.029). Reducing hospitalizations is a critical part of reducing disease burden to healthcare systems.¹

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Population Pharmacokinetics and Exposure-Response Relationships of LIVTENCITY in Transplant Recipients With Cytomegalovirus Infections

Data from population pharmacokinetic and pharmacodynamic (PK/PD) models based on Phase 1, 2 and 3 (SOLSTICE) studies, which were developed to characterize LIVTENCITY plasma concentrations and exposure-response relationships, which support dosage recommendations, will be presented [Poster #470].⁴
PK/PD modeling results suggest that dose adjustments of LIVTENCITY will not be required in adult transplant patients for the treatment of CMV infection regardless of age, body weight, s**, race, transplant type, baseline plasma CMV DNA, or presence of CMV mutations.⁴

Assessment of Discontinuations and Anti-Cytomegalovirus Treatment Switching in Post-Transplant Refractory/Resistant Cytomegalovirus Infections: Safety and Sensitivity Analyses From a Phase 3 Randomized Trial

Data from a safety and sensitivity analysis of the Phase 3 SOLSTICE trial, assessing the impact of discontinuations or treatment switching on achieving confirmed CMV DNA level <LLOQ (lower limit of quantification, i.e. <137 IU/mL), will be presented [Poster #467].³

Highlights of data being presented at ECCMID include:

Kaplan-Meier Estimates of Time to First Cytomegalovirus Viremia Clearance in Transplant Recipients With Refractory Cytomegalovirus Infection With or Without Resistance Receiving LIVTENCITY Versus Investigator-Assigned Therapy: Subgroup Analyses of a Phase 3 Trial

Data from a subgroup analysis of the Phase 3 SOLSTICE trial assessing median time to first confirmed CMV DNA level <LLOQ will be presented [Abstract #O0059].²
Post-hoc analyses by subgroups, including baseline resistance status and transplant type, were consistent with previously reported results, demonstrating a shorter time to confirmed CMV DNA level <LLOQ for LIVTENCITY compared to conventional antiviral therapies. In patients with low baseline viral load, median time to first CMV DNA level <LLOQ was 15 days (95% CI: 13-17) for LIVTENCITY and 22 days (95% CI: 20-29) for conventional antiviral therapies, and 43 (95% CI: 30-49) and 44 days (95% CI: 26-NA) respectively for patients with intermediate/high viral load

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