Phase 3 clinical trial data showed Takeda Pharmaceuticals’ antiviral drug maribavir (Livtencity) was superior to conventional antiviral treatment for clearing cytomegalovirus infections in transplant recipients.
Transplant patients with cytomegalovirus (CMV) infections may benefit from treatment with maribavir, according to new research sponsored by Takeda that showed reductions in hospitalization rates and length of stays.
Takeda Pharmaceuticals recently presented new analysis of data from the phase 3 SOLSTICE trial of its drug maribavir (Livtencity) 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.
The analysis found that patients treated with Livtencity had 34.8% (p=0.021,) fewer hospitalizations and a 53.8%(p=0.029) reduction in length of stay compared with patients treated with conventional antiviral therapies.
“These findings demonstrate the value of Livtencity for patients requiring treatment for post-transplant CMV infections/disease that are refractory (with or without genotypic resistance),” Aimee Sundberg, PharmD, senior director, Clinical Sciences at Takeda Pharmaceuticals, told Contagion. “This value is seen both in terms of potential treatment benefits that meaningfully affect patients’ experience, as well as potential economic savings related to reduced burden of disease, which can be extremely beneficial for the transplantation community.”
The SOLSTICE trial, published in Clinical Infectious Diseases, included 352 recipients of hematopoietic stem cell transplants or solid organ transplants with CMV infections between December 2016 and August 2020. Among the participants, 235 received maribavir and 117 received conventional antiviral therapies valganciclovir/ganciclovir, foscarnet or cidofovir over an eight-week treatment period.
The study found that 55.7% (131/235) of patients in the Livtencity group achieved the primary endpoint of confirmed CMV DNA level below the lower limit of quantification of 137 IU/mL after eight weeks compared with 23.9% (28/117) of patients on conventional antiviral group. Through Week 16, 18.7% (44/235) of patients in the Livtencity group maintained those levels and symptom control, compared with 10.3% (12/117) in the control group.
Adverse events included taste disturbance, nausea, diarrhea, vomiting, and fatigue. More patients in the control group (32%) discontinued the study because of an adverse event than in the Livtencity group (13%). All-case mortality was 11% in both groups.
A total of 31.9% of patients in the Livtencity group had at least one hospitalization during treatment compared with 36.8% of patients in the conventional antiviral therapy group. Average length of hospital stay was 13.27 days in the Livtencity group compared with 28.73 in the control group.
Patients in the Livtencity group also reached the lower limit of quantification of CMV DNA faster than those in the conventional treatment group.
“These are important new findings, but they are consistent with the robust research represented by SOLSTICE and they confirm our understanding of LIVTENCITY’s value to the transplant community,” Sundberg said. “Ongoing Takeda-sponsored research like SOLSTICE will continue to employ rigorous scientific investigation to address unmet needs that are most meaningful for the transplant community.”
Further research is underway to compare safety and efficacy of Livtencity with valganciclovir for CMV infection in hematopoietic stem cell transplant recipients. A study of the treatment in pediatric transplant recipients also is planned.