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AboutAboutUnmet needs in HRRm mCRPCMOATALAPRO-2 study designBaseline patient characteristicsTreatment guidelinesHRRm Testing

HRRm Testing

Why and when to test

How to test

EfficacyEfficacyrPFS: Primary and follow-uprPFS in patient subgroupsOSORRPSASafetySafetyWarnings and precautionsAdverse reactionsDosingDosingDosing and administrationDose modificationsSoft gelatin capsuleTherapy management strategiesSupportSupportCoverage and accessPatient supportResourcesContact a rep
Prescribing Information for Soft Gelatin CapsulesPrescribing Information for Hard CapsulesIndicationPatient SiteSee Information on a Different Indication
Median Overall Survival of 3.75 Years With TALZENNA + XTANDI in HRRm mCRPC1Median Overall Survival of 3.75 Years With TALZENNA + XTANDI 
in HRRm mCRPC1
Primary endpoint: TALZENNA + XTANDI demonstrated superior rPFS vs
XTANDI + placebo (HR = 0.45 [95% CI, 0.33–0.61]; P < 0.0001). See
details here. Overall survival was a key secondary endpoint.2,3
Primary endpoint: TALZENNA + XTANDI demonstrated superior rPFS vs
XTANDI + placebo (HR = 0.45 [95% CI, 0.33–0.61]; P < 0.0001). See
details here. Overall survival was a key secondary endpoint.2,3
 The information below is not included in the TALZENNA USPI. This analysis was prespecified and alpha protected per the statistical analysis plan.1
38% reduction in the risk of death with TALZENNA + XTANDI vs

XTANDI + placebo (HR = 0.62 [95% CI, 0.48–0.81); P = 0.0005)1
  • TALZENNA + XTANDI demonstrated a statistically significant improvement in overall survival vs XTANDI + placebo1
  • 14-month difference in median overall survival between TALZENNA + XTANDI and XTANDI + placebo1
  • Number of OS events: 93/200 (46.5%) with TALZENNA + XTANDI + ADT and 126/199 (63.3%) with XTANDI + placebo + ADT1,2
  • Median follow-up time was 44.2 months for the TALZENNA + XTANDI group and 44.4 months for the XTANDI + placebo group1

Non-BRCA HRRm mCRPC: 3.5-year median overall survival observed with TALZENNA + XTANDI1

 The information below is not included in the TALZENNA USPI. This descriptive analysis was prespecified but not alpha protected per the statistical analysis plan. Small sample size is a limitation of subgroup analyses.
  • 27% reduction in the risk of death with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.73 [95% CI, 0.52–1.02])1
  • Observed median OS was 42.4 months with TALZENNA + XTANDI + ADT and 32.6 months with XTANDI + placebo + ADT in the subgroup of patients with non-BRCAm mCRPC1,2
  • Number of OS events: 63/129 (48.8%) with TALZENNA + XTANDI + ADT and 70/115 (60.9%) with XTANDI + placebo + ADT1,2

BRCAm mCRPC: Observed median overall survival was not reached with TALZENNA + XTANDI at 44-month median follow-up1

 The information below is not included in the TALZENNA USPI. This descriptive analysis was prespecified but not alpha protected per the statistical analysis plan. Small sample size is a limitation of subgroup analyses.
  • 50% reduction in the risk of death with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.50 [95% CI, 0.32–0.78])1
  • Observed median OS was not reached with TALZENNA + XTANDI + ADT and was 28.5 months with XTANDI + placebo + ADT in the subgroup of patients with BRCAm mCRPC1,2
  • Number of OS events: 30/71 (42.3%) with TALZENNA + XTANDI + ADT and 56/84 (66.7%) with XTANDI + placebo + ADT1,2

The information below is not included in the TALZENNA USPI. This analysis was prespecified and alpha protected per the statistical analysis plan. Small sample size is a limitation of the subgroup analyses presented below the graph.

Secondary Endpoint: Time to PSA Progression‡1

38% reduction in the risk of death with TALZENNA + XTANDI
vs XTANDI + placebo (HR = 0.622 [95% CI, 0.475–0.814]; P = 0.0005)1,2
  • TALZENNA + XTANDI demonstrated a statistically significant improvement in overall survival vs XTANDI + placebo1
  • 14-month difference in median overall survival between TALZENNA + XTANDI and XTANDI + placebo1
  • Number of OS events: 93 (46.5%) with TALZENNA + XTANDI + ADT and 126 (63.3%) with XTANDI + placebo + ADT1,2
  • Median follow-up time was 44.2 months for the TALZENNA + XTANDI group and 44.4 months for the XTANDI + placebo group1
Prespecified subgroup analysis of OS in patients with HRRm based on BRCA1/2 status1BRCAm: 50% reduction in the risk of death in BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.497 [95% CI, 0.318–0.776])1
  • Observed median OS was not reached with TALZENNA + XTANDI + ADT and was 28.5 months with XTANDI + placebo + ADT1,2
  • Number of OS events: 30/71 (42.3%) with TALZENNA + XTANDI + ADT and 56/84 (66.7%) with XTANDI + placebo + ADT1,2
Non-BRCAm: 27% reduction in the risk of death in non-BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.727 [95% CI, 0.516–1.024])1
  • Observed median OS was 42.4 months with TALZENNA + XTANDI + ADT and 32.6 months with XTANDI + placebo + ADT1,2
  • Number of OS events: 63/129 (48.8%) with TALZENNA + XTANDI + ADT and 70/115 (60.9%) with XTANDI + placebo + ADT1,2
ReferencesADT, androgen deprivation therapy; CI, confidence interval; HR, hazard ratio; HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer; NR, not reached; ORR, objective response rate; OS, overall survival; PSA, prostate-specific antigen; rPFS, radiographic progression-free survival.References:Data on file. Pfizer Inc., New York, NY.TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.Fizazi K, Azad AA, Matsubara N, et al. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med 2024;30(1):257-64.Efficacy Review the study design for TALAPRO-2

Review key criteria including baseline HRR gene alteration status

 Learn more LoadingSee ORR results from TALAPRO-2See the dataLoading

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INDICATION

TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

WARNINGS and PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these five patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years, respectively. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.

Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA and enzalutamide. Overall, 39% of patients (199/511) required a red blood cell transfusion, including 22% (111/511) who required multiple transfusions. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 3%, and 0.4% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.

Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with TALZENNA and for 4 months after receiving the last dose. 

ADVERSE REACTIONS

Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).

The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA in combination with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%).

Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).

Based on animal studies, TALZENNA may impair fertility in males of reproductive potential.

DRUG INTERACTIONS

Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken in combination with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor.

Coadministration with BCRP inhibitors Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.

USE IN SPECIFIC POPULATIONS

Renal Impairment The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily in combination with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily in combination with enzalutamide. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

Please see the Full Prescribing Information for soft gelatin capsules and hard capsules for TALZENNA.

Please see the XTANDI Prescribing Information for safety information about XTANDI.

INDICATION
TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).