Phase III study of @entity22798 long-acting release in @entity1 with metastatic @entity5 and @entity1109 refractory to available XXXX analogues.

@entity1671 @entity1 @entity390 @entity5 @entity1109 @entity22798 @entity1295 @entity2390 @entity1943 @entity4854
In a randomized, double-blind, Phase III study, we compared @entity22798 long-acting release ( @entity22798 LAR) with @entity2390 long-acting repeatable ( @entity2390 LAR) in managing @entity1109 refractory to first-generation @entity1943 analogues. Adults with @entity5 of the digestive tract were randomly assigned (1:1) to receive @entity22798 LAR (60 mg) or @entity2390 LAR (40 mg) every 28 days. Primary outcome was symptom control based on frequency of bowel movements and @entity1671 episodes. Objective @entity5 response was a secondary outcome. Progression-free survival (PFS) was calculated in a post hoc analysis. Adverse events were recorded. At the time of a planned interim analysis, the data monitoring committee recommended halting the study because of a low predictive probability of showing superiority of @entity22798 over @entity2390 for symptom control (n=43 @entity22798 LAR, 20.9%; n=45 @entity2390 LAR, 26.7%; odds ratio, 0.73; 95% confidence interval [CI], 0.27-1.97; P=0.53). Tumor control rate at month 6 was 62.7% with @entity22798 and 46.2% with @entity2390 (odds ratio, 1.96; 95% CI, 0.89-4.32; P=0.09). Median (95% CI) PFS was 11.8 months (11.0 - not reached) with @entity22798 versus 6.8 months (5.6 - not reached) with @entity2390 (hazard ratio, 0.46; 95% CI, 0.20-0.98; P=0.045). The most frequent drug-related adverse events ( @entity22798 vs @entity2390 ) included @entity4854 (28.3% vs 5.3%), @entity1295 (11.3% vs 3.5%), and @entity390 (9.4% vs 0%). We conclude that, among @entity1 with @entity1109 refractory to available @entity1943 analogues, similar proportions of @entity1 receiving @entity22798 LAR or @entity2390 LAR achieved symptom control at month 6. @entity22798 LAR showed a trend toward higher @entity5 control rate at month 6, although it was statistically not significant, and was associated with a longer PFS than @entity2390 LAR.
