TALZENNA Efficacy

Primary Endpoint: Progression-free Survival (PFS)

TALZENNA significantly prolonged median PFS vs chemotherapy1*†

talzenna-efficacy
 

Adapted from TALZENNA Summary of Product Characteristics.1

  • Nearly twice as many patients remained on TALZENNA without disease progression at 1 year vs chemotherapy (37% vs 20%)2
  • Consistent PFS results were observed across prespecified subgroups defined by study stratification factors including: hormone receptor expression status, BRCA mutation type, visceral/nonvisceral metastases, and with/without a history of CNS metastasis1,2

*PFS was determined by blinded independent central review (BICR), according to RECIST, version 1.1.
Capecitabine, eribulin, gemcitabine, or vinorelbine.

 

PFS in Prespecified Subgroup Analysis

TALZENNA consistently improved PFS vs chemotherapy across multiple prespecified patient subgroups1-2

talzenna-efficacy

  • TALZENNA provided statistically significant improvement in mPFS vs chemotherapy in patients with TNBC, HR+ disease, and history of CNS metastases3,4

mPFS in patients with TNBC, HR+, and history of CNS metastases3,4

talzenna-efficacy

Adapted from Eiermann et al. 2018,3 and Rugo et al. 2018.4

 

 

Secondary Endpoints: Objective Response Rate (ORR); Unconfirmed

TALZENNA more than doubled ORR compared with chemotherapy1‡§

talzenna-efficacy

Adapted from TALZENNA Summary of Product Characteristics.1

  • 5.5% of patients on TALZENNA achieved a complete response vs 0% on chemotherapy2
  • 57.1% of patients on TALZENNA achieved a partial response vs 27.2% on chemotherapy2

Conducted in the intent-to-treat population with measurable disease at baseline. Per RECIST 1.1, confirmation of response was not required.1
§ ORR is the proportion of patients who have a partial or complete response to treatment.

Final Overall Survival in the Overall Population (OS)

  • Final OS analysis did not reach statistical significance2

Median OS: 19.3 months (95% CI: 16.6-22.5) with TALZENNA vs 19.5 months (95% CI: 17.4-22.4) with chemotherapy (HR=0.85 [95% CI: 0.67-1.07]; P=0.17)2

 

 

Exploratory Endpoint: Duration of Response (DoR); Unconfirmed

The median DoR (mDoR) was longer with TALZENNA vs chemotherapy1|| 

talzenna-efficacy

Adapted from TALZENNA Summary of Product Characteristics.1
| |Analyzed in the ITT patients who experienced an objective response as assessed by the investigator.1

 

 

 

ABC=advanced breast cancer; BRCA=breast cancer susceptibility gene; Cl=confidence interval; CNS=central nervous system; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; HR+=hormone receptor-positive; IQR=interquartile range; ITT=intent-to-treat; mPFS=median PFS; OR=odds ratio; PCT=physician's choice of therapy; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer.

 

 

REFERENCES
  1. TALZENNA Summary of Product Characteristics.
  2. Litton JK, Hurvitz SA, Mina LA, et al. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020. doi:10.1016/j.annonc.2020.08.2098.
  3. Eiermann W, Rugo HS, Diab S, et al. Analysis of germline BRCA1/2 mutated (gBRCAm) hormone receptor–positive (HR+) and triple-negative breast cancer (TNBC) treated with talazoparib (TALA). Poster presented at: Annual Meeting of the American Society of Clinical Oncology; June 1-6, 2018; Chicago, IL.
  4. Rugo HS, Ettl J, Woodward NE, et al. EMBRACA: efficacy outcomes in clinically relevant subgroups comparing talazoparib (TALA), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, to physician's choice of therapy (PCT) in patients with advanced breast cancer and a germline BRCA mutation. Poster presented at: Annual Meeting of the American Society of Clinical Oncology; June 1-6, 2018; Chicago, IL.
  5. Ettl J, Quek RGW, Lee KH, et al. Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018;29:1939-1947.
  6. Hurvitz SA, Gonçalvez A, Rugo HS, et al. Talazoparib, an oral poly(ADP-ribose) polymerase inhibitor for patients with locally advanced/metastatic breast cancer and a germline BRCA mutation: detailed safety analyses from the randomized, multinational, phase 3 EMBRACA trial. Poster presented at: 36th Annual Miami Breast Cancer Conference; March 7-10, 2019; Miami, FL. Poster 761.
 

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.