Phase III TAK-620-303 (SOLSTICE) trial of TAK 620 meets primary endpoint in cytomegalovirus infection.- Takeda

Takeda announced new, late-breaking Phase III data from the TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK 620 (maribavir) which met its primary endpoint of superiority compared to conventional antiviral therapies (investigator assigned treatment, [IAT], one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) in transplant recipients with refractory, with or without resistance (R/R), cytomegalovirus (CMV) infection/disease. Overall, more than twice as many (55.7%; n=131/235) transplant recipients with R/R CMV infection/disease treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8 (end of treatment phase), the study’s primary endpoint, as compared to 23.9% (n=28/117) of those on conventional antiviral therapies (95% CI: 32.8%, 22.8–42.7; p<0.001). the study’s key secondary endpoint was met by demonstrating maribavir's improvement over conventional therapies in clearance of cmv viremia and associated symptom control maintained through study week 16. transplant recipients receiving maribavir exhibited lower incidence of treatment-related toxicities common with conventional antiviral therapies. those receiving maribavir experienced lower rates of treatment-related neutropenia vs. valganciclovir ganciclovir (1.7% [4 234] vs. 25% [14 56]) and acute kidney injury vs. foscarnet (1.7% [4 234] vs. 19.1% [9 47]). any treatment-emergent adverse events (teaes) were 97.4% (228 234) for maribavir and 91.4% (106 116) for the conventional therapy group. teaes leading to study drug discontinuation were 13.2% (31 234) in the maribavir group and 31.9% (37 116) in the conventional therapy group. two treatment-related serious teaes led to death (1 patient per treatment group).>