EMBRACA, a randomized 2:1 open-label Phase 3 trial (NCT01945775), showed a significant improvement in progression-free survival with talazoparib (TALA) vs physician’s choice of chemotherapy (PCT) (HR = 0.54; 95%CI: 0.41,0.71; P<.0001) in pts with HER2-negative ABC and a gBRCAm. This analysis evaluated the hospitalization and SCM utilisation while accounting for TALA/PCT–treatment-emergent period in EMBRACA.
From EMBRACA safety population (while pts were on TALA or PCT), serious adverse event (SAE)-associated hospitalization rates (per 100 patient-years), number of pts with ≥1 platelet/red blood cell (RBC) transfusion(s) and 7 types of SCM (opiate, antiemetic/anti-nauseant, antidiarrheal, appetite stimulant, bone disease treatment, antianemic, immunostimulant) utilisation ratios (total duration of each SCM type/treatment-emergent period) were compared between TALA vs PCT-treated pts.
EMBRACA safety population consisted of 286 TALA and 126 PCT-treated pts. Lower rates of SAE-associated hospitalization were observed with TALA vs PCT-treated pts (39.5 vs 64.0 per 100 patient-years). Nine TALA-treated pts (3.1%) had ≥1 platelet transfusion(s) vs 0 PCT-treated pts; 109 TALA-treated pts (38.1%) had ≥1 RBC transfusion(s) vs 7 (5.6%) PCT-treated pts. Across all 7 other types of SCM, the mean SCM utilisation ratios for TALA-treated pts were lower than PCT-treated pts (Table).
SCM Type Talazoparib Mean SCM Utilization Ratio (SD) n = 286 Overall PCT Mean SCM Utilization Ratio (SD) n = 126 Antianemic 8.0 (40.6) 14.3 (26.6) Antidiarrheal 1.3 (1.8) 5.0 (14.7) Antiemetic/Anti-nauseant 5.5 (11.2) 5.9 (8.8) Appetite Stimulant 1.2 (2.1) 9.9 (12.6) Bone Disease Treatment 4.5 (4.8) 6.6 (6.1) Immunostimulant 0.1 (0.2) 0.8 (1.5) Opiate 6.2 (10.9) 13.7 (17.4)
Pts with HER2-negative ABC and a gBRCAm treated with TALA had lower SAE-associated hospitalization rates and lower SCM utilization ratios vs PCT. More TALA-treated patients had ≥1 platelet/ RBC transfusion(s) vs PCT. These results may support the favorable clinical and patient reported outcomes observed with TALA vs PCT-treated pts in EMBRACA.
Pfizer.
Pfizer, Inc.
J. Ettl: Consulting fees: Lilly, Novartis, Pfizer, Roche, Tesaro, Eisai; Contracted research: Celgene; Honoraria: Pfizer, Roche, Teva, Lilly, AstraZeneca; Travel support: Celgene, Novartis, Pfizer. R.G.W. Quek: Employee: Pfizer Inc.; Stock ownership: Pfizer Inc., Amgen Inc. S.A. Hurvitz: Grants: Ambryx, Amgen, Bayer, BI Pharma, Biomarin, Cascadian, Daiichi Sankyo, Dignitana, Genentech, GSK, Lilly, Macrogenics, Medivation, Merrimack, Novartis, OBI Pharma, Pfizer, Pieris, Puma, Roche, Seattle Genetics; Travel: Lilly, Novartis, OBI Pharma. A. Goncalves: Travel/accommodation/meeting registration fees: Pfizer, AstraZeneca, Roche, Novartis, Amgen, Cellgene, MSD, Boehringer Ingelheim. H.S. Rugo: Research funding to the University of California: Eisai, Genentech, GlaxoSmithKline, Lilly, Macrogenics, Merck, Novartis, OBI Pharma, Pfizer, Plexxikon; Travel expenses: Lilly, Mylan, Puma. All other authors have declared no conflicts of interest.