Takeda Highlights LIVTENCITY (Maribavir) Data Demonstrating Reduced Hospitalization Rates and Shorter Length of Stay in Post-Transplant CMV Patients

Compiled by Tom Li

Latest news shows that Takeda will present multiple positive exploratory datasets for Livtencity (maribavir) at the Tandem Transplantation and Cell Therapy Meeting and the 32nd European Congress of Clinical Microbiology and Infectious Diseases.

The trial research announced this time focuses on the use of Livtencity for the first-line treatment of hematopoietic stem cell transplant (HSCT) recipients with cytomegalovirus (CMV) infection or disease. CMV infection is one of the most common and serious post-transplant infections. It is estimated that the incidence rate in solid organ transplant (SOT) recipients is about 16%-56% globally, and 30%-70% in HSCT recipients. Moreover, it may lead to severe consequences and even the loss of the transplanted organ.

Data Summary: Additional analysis results mainly related to the multicenter, randomized, open-label Phase 3 SOLSTICE trial data, which will also support the U.S. FDA's approval of Livtencity in November last year as the preferred treatment for patients aged 12 years and older, weighing at least 35 kg, who develop CMV infection or disease after transplantation and are refractory to conventional antiviral therapies (one or a combination of ganciclovir, valganciclovir, foscarnet, or cidofovir, with or without genotypic resistance). Livtencity can block viral replication by inhibiting the pUL97 protein kinase of the CMV virus and offers higher safety compared to existing therapies.

Exploratory analyses from the Phase 3 SOLSTICE trial evaluated the impact of Livtencity on healthcare resource utilization compared to conventional antiviral therapies, with measures including the number of hospitalized patients and average length of hospital stay. Results showed that during the treatment period, 31.9% (n=75/235) of patients receiving Livtencity were hospitalized at least once, compared to 36.8% (n=43/117) of those on conventional therapy. In terms of hospital stay duration, patients treated with Livtencity had 13.27 days/patient/year, versus 28.73 days/patient/year for those on conventional therapy.

In addition, based on the population pharmacokinetic and pharmacodynamic (PK/PD) model data results from the Phase 1, 2, and 3 (SOLSTICE) studies, no additional dose adjustment of Livtencity is required for patients regardless of age, weight, gender, race, type of transplantation, baseline plasma CMV-DNA level, or the presence of CMV mutations.

Subgroup analysis data from the Phase 3 SOLSTICE trial also evaluated the median time to the first confirmed CMV-DNA level <LLOQ. The post-hoc analysis of subgroups, including baseline resistance status and transplant type, were consistent with previously reported results. This indicates that compared with conventional antiviral therapy, patients in the Livtencity group had a shorter confirmation time for CMV-DNA levels <LLOQ. In patients with low baseline viral load, the median time to the first occurrence of CMV-DNA levels <LLOQ was 15 days in the Livtencity group, compared with 22 days, 43 days, and 44 days in the conventional antiviral treatment group.

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