TALZENNA Safety and Therapy Management

Adverse Events

Manageable safety and tolerability with TALZENNA vs chemotherapy1,2
Adverse Events* (in ≥20% of Patients Receiving TALZENNA) in EMBRACA2,3
 
talzenna-safety-and-therapy-management

Adapted from Litton et al. Suppl Appendix 2018.2

*Graded according to NCI CTCAE 5.
Includes anemia, hematocrit decreased, and hemoglobin decreased.
Includes neutropenia and neutrophil count decreased.
§Includes thrombocytopenia and platelet count decreased.
||For talazoparib, Grade 1 is 21% and Grade 2 is 2%. For chemotherapy, Grade 1 is 20% and Grade 2 is 8%. Grade 1 defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss, but it does not require a wig or hair piece to camouflage. Grade 2 defined as hair loss of ≥50% of normal for that individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact. 
Includes fatigue and asthenia.

 

 

Safety

Manageable safety profile vs chemotherapy4

talzenna-safety-and-therapy-management

Special Warnings and Precautions for TALZENNA1

talzenna-safety-and-therapy-management

#Graded according to NCI CTCAE 5.

 

 

Tolerability

Most adverse events in the EMBRACA study were managed with standard supportive medical therapy or dose interruption/reduction4,5

tolerability

The median time to first dose reduction due to an adverse event was 19.3 weeks with TALZENNA vs 9.3 weeks with oral chemotherapy6**

  • Dose interruptions due to an adverse event of any grade occurred in 60% of patients receiving TALZENNA and 33% of those receiving oral chemotherapy
  • Dose reductions due to any cause occurred in 52% of TALZENNA patients and 49% of patients on oral chemotherapy

safety3

**Capecitabine was the only oral chemotherapy included in the comparator arm.

safety4

 

 

Therapy Management

Dose modifications due to adverse events

  • Adverse events resulting in dose modification (reduction or interruption) occurred in 66% of patients on TALZENNA vs 60% of patients on chemotherapy4

Incidence of Dose Modifications Due to Adverse Events With TALZENNA in EMBRACA2

therapy_management_0

††Percentages were calculated based on total number of patients in the safety population with a hematologic adverse event who were treated with TALZENNA during the month interval.

Detecting and managing anemia5,6

therapy_management2

Incidence of Grade ≥3 Anemia Over Time6 

therapy_management3_0

 

Detecting and managing neutropenia5,6

therapy_management2_1

‡‡In post hoc exploratory analysis. The analysis data cutoff date was September 15, 2017, and was conducted in the safety population.
§§Anemia includes preferred terms: anemia, decreased hemoglobin, decreased hematocrit.
|| ||Neutropenia includes preferred terms: neutropenia, decreased neutrophil count.

 

 

BRCA=breast cancer susceptibility gene; CI=confidence interval; CTCAE=Common Terminology Criteria for Adverse Events; gBRCA=germline breast cancer susceptibility gene; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; LABC=locally advanced breast cancer; mBC=metastatic breast cancer; NCl=National Cancer Institute; PARP=poly (ADP-ribose) polymerase.

 

 
REFERENCES
  1. TALZENNA Summary of Product Characteristics.
  2. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. doi:10.1056/NEJMoa1802905; supplementary appendix:1-22.
  3. National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: National Institutes of Health. Version 5.0. Published November 27, 2017.
  4. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.
  5. 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.
  6. Data on file. Pfizer Inc., New York, NY.
  7. Turner NC, Teli ML, Rugo HS, et al; on behalf of the ABRAZO Study Group. A phase II study of talazoparib after platinum or cytotoxic nonplatinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO). Clin Cancer Res. 2019;25(9):2717:2724. doi10.1158/1078-0432.CCR-18-1891.
  8. 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.
 

▼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.