Articles related to CLINICAL TRIALS

Four-hundred seventy-three of 713 patients were randomly assigned to receive durvalumab; 236 received a placebo. The 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%. The median progression-free survival from randomization was 16.8 months with durvalumab versus 5.6 months with placebo. Durvalumab had a response rate that was higher than placebo (28.4% vs. 16.0%), and the median response time was also longer (72.8% vs. 46.8% of the patients continued to have a response at 18 months). Durvalumab extended the median time to death or distant metastasis compared to placebo (23.2 months vs. 14.6 months). 29.9% of patients who received durvalumab and 26.1% of patients who received a placebo experienced adverse events of grade 3 or 4.

This trial including more than 6,500 patients randomized to empagliflozin or placebo and followed for a median of 2 years. Progression of kidney disease or death from cardiovascular causes was monitored over the course of the trial. Those outcomes occurred in approximately 13% of patients in the empagliflozin group versus approximately 17% of patients in the placebo group.

Gantenerumab treatment generated a slowing of clinical decline from baseline score on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), but at levels that did not reach statistical significance. The relative reduction in clinical decline was 8% in GRADUATE I and 6% in GRADUATE II compared with placebo.

This approval was based on findings from the open-label, randomized, multicenter POSEIDON trial, which compared data from two of the study’s three treatment arms. When compared to patients in the other treatment arm, patients in this group had a significantly improved OS, with a median OS of 14 months as opposed to 11.7 months.

In this phase 3 nonrandomized controlled trial of 331 patients, patients with newly diagnosed glioblastoma (nGBM) receiving autologous tumor lysate-loaded dendritic cell vaccination (DCVax-L) had a median OS of 19.3 months from randomization (22.4 months from surgery), while contemporaneous, matched external control patients receiving SOC had a median OS of 16.5 months from randomization; for patients with recurrent glioblastoma (rGBM), the median OS was 13.2 months from relapse in the DCVax-L group vs. 7.8 months in the external control cohort. Both in nGBM and rGBM, significant increases in the long-term tails of the survival curves were seen.

The final results of this randomized clinical trial of 493 patients with pancreatic ductal adenocarcinoma (PDAC) showed that treatment with modified FOLFIRINOX as opposed to gemcitabine significantly increased overall survival (median survival, 53.5 vs. 35.5 months). Younger age, well-differentiated tumors, lower-stage tumors, larger-volume centers, and finishing the prescribed course of therapy all predicted better survival; early disease relapse was an adverse prognostic factor for overall survival from relapse.