Background: TALA significantly improved progression-free survival versus physician’s choice chemotherapy (PCT) in patients (pts) with HER2- advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) in the randomized Phase (Ph) 3 EMBRACA trial. An integrated analysis of 5 clinical trials (Phases 1-3) in multiple advanced tumor types was performed to evaluate the hospitalization and SCM utilization among pts initially administered with TALA 1 mg/day (d). Methods: SCM utilization (9 types) and serious adverse event (SAE)-associated hospitalization data from safety populations (while pts were on TALA or PCT [in EMBRACA]) were analyzed from the ongoing Ph 3 EMBRACA trial in HER2- gBRCA1/2m ABC (NCT01945775), the Ph 2 ABRAZO trial in gBRCA1/2m ABC (NCT02034916), the Ph 1 trial in advanced/recurrent solid tumors PRP-001 (NCT01286987), the Ph 1 cardiac repolarization (CR) trial in advanced solid tumors (NCT03042910), and an ongoing Ph 2 open-label extension (OLE) trial (NCT02921919). EMBRACA was the only trial with an active comparator (PCT). While accounting for TALA/PCT–treatment-emergent (TE) periods, hospitalization rates (per 100 patient-yrs) and mean SCM utilization ratios (total duration of each SCM type divided by TE period) were compared between TALA and PCT-treated pts across trials. Results: 494 pts who received TALA and 126 pts who received PCT were included (Table). Median age (range) for TALA-treated pts was 49.0 (18.0-93.0) yrs and for PCT-treated pts 51.0 (24.0-89.0) yrs. Hospitalization rate (per 100 patient-yrs) across all 494 TALA-treated pts was 50.2. In EMBRACA, lower hospitalization rates were observed with TALA vs PCT-treated pts (46.8 vs 71.9); across 8 types of SCM, the mean SCM utilization ratios for TALA-treated pts were lower than PCT-treated pts (Table). See Table for mean SCM utilization ratios in the other trials. Conclusions: In EMBRACA, while accounting for TALA/PCT–TE periods, TALA-treated pts had lower hospitalization rates vs PCT; across a wide range of SCM, except for platelet transfusion, TALA led to lower SCM utilization. These results support the favorable clinical and patient-reported outcomes observed with TALA vs PCT-treated pts in EMBRACA. Results from future additional larger comparative trials involving TALA are warranted to support these findings across advanced tumor types, assess the patient experience and potential impact of resource utilization on healthcare systems. Funding Pfizer Inc.
