The most common grade 3 nonhematologic AEs with talazoparib included vomiting, back pain, and dyspnea, at 2.4% each. There were no grade 4 nonhematologic AEs in either arm. Grade 3/4 serious AEs occurred in approximately 25% of patients in each arm.
The investigators also examined QoL using the EORTC QLQ-C30 questionnaire, which was completed by 262 patients receiving the PARP inhibitor and 114 patients receiving chemotherapy.
The results showed that in patients receiving talazoparib, there was a statistically significant improvement from baseline in estimated overall mean change in global health status (GHS)/QoL: 3.0 (95% CI, 1.2-4.8) versus -5.4 (95% CI, -8.8 to -2.0) in patients receiving physician’s choice of therapy (P
The results also found a significant delay in the median time to clinically meaningful deterioration in GHS/QoL with talazoparib versus chemotherapy: 24.3 months (95% CI, 13.8 to not reached) versus 6.3 months (95% CI, 4.9-12.2; HR, 0.38; 95% CI, 0.26-0.55; P
“Overall, once-daily oral talazoparib was well tolerated in comparison to chemotherapy, with improvements in progression-free survival and clinical responses, providing a significant option for patients with BRCA
mutations and metastatic breast cancer. We look forward to following the OS results as those data mature,” said Litton.
Several PARP inhibitor are approved by the FDA for the treatment of patients with ovarian cancer. In October, the FDA granted a priority review to the PARP inhibitor olaparib (Lynparza) for the treatment of patients with germline BRCA
-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.
Litton JK, Rugo HS, Ettl J, et al. A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced breast cancer and a germline BRCA-mutation. Presented at: 2017 San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX. Abstract GS6-07.