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

HRRm Testing

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EfficacyEfficacyrPFSrPFS in patient subgroupsORRPSASafetySafetyAdverse reactionsWarnings and precautionsDosingDosingDose 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
TALAPRO-2 Efficacy: rPFSTALAPRO-2 Efficacy: rPFSTALZENNA + XTANDI demonstrated superior rPFS vs XTANDI + placebo as first-line treatment of BRCAm and non-BRCA HRRm mCRPC*1,2TALZENNA + XTANDI demonstrated superior rPFS vs XTANDI + placebo as first-line treatment of BRCAm and non-BRCA HRRm mCRPC*1,2

Primary Endpoint: Radiographic Progression-Free Survival1,2

  • Number of rPFS events by BICR: 66 (33%) with TALZENNA + XTANDI + ADT vs 104 (52%) with XTANDI + placebo + ADT1
  • In TALAPRO-2, median rPFS was not reached and was at least 21.9 months within a 95% confidence interval (95% CI, 21.9-NR) for TALZENNA + XTANDI + ADT vs 13.8 months (95% CI, 11.0-16.7) for XTANDI + placebo + ADT1
  • Consistent rPFS results were observed in patients who received or did not receive a prior CYP17 inhibitor (including abiraterone) or docetaxel1
Exploratory subgroup analysis of rPFS in HRRm patients based on BRCA1/2 status1,2

Data from an exploratory rPFS subgroup analysis by BRCA status

  • In patients with BRCA alterations (N = 155), the rPFS hazard ratio was 0.20 (95% CI, 0.11-0.36). The median rPFS was NR and 11 months for TALZENNA + XTANDI + ADT and placebo + XTANDI + ADT, respectively. rPFS events were 15 (21%) and 54 (64%) for TALZENNA + XTANDI + ADT (n = 71) and placebo + XTANDI + ADT (n = 84), respectively1
  • In patients with non-BRCA alterations (N = 244), the rPFS hazard ratio was 0.72 (95% CI, 0.49-1.07). The median rPFS was 24.7 and 16.7 months for TALZENNA + XTANDI + ADT and placebo + XTANDI + ADT, respectively. rPFS events were 51 (40%) and 50 (43%) for TALZENNA + XTANDI + ADT (n = 129) and placebo + XTANDI + ADT (n = 115), respectively1


in the risk of disease progression or death for TALZENNA + XTANDI + ADT BRCAm patients vs XTANDI + placebo + ADT (HR = 0.20 [95% 
CI, 0.11-0.36])

The number of rPFS events: 15/71 (21%) with TALZENNA + XTANDI +
ADT vs 54/84 (64%) with XTANDI + placebo + ADT. Median rPFS was not reached for TALZENNA + XTANDI + ADT vs 11 months for XTANDI + placebo + ADT.


in the risk of disease progression or death for TALZENNA + XTANDI + ADT non-BRCAm patients vs XTANDI + placebo + ADT (HR = 0.72 [95% 
CI, 0.49-1.07])

The number of rPFS events: 51/129 (40%) with TALZENNA + XTANDI + ADT vs 50/115 (43%) with XTANDI + placebo + ADT. Median rPFS was 24.7 months for TALZENNA + XTANDI + ADT vs 16.7 months for XTANDI + placebo + ADT.

in the risk of disease progression or death for TALZENNA + XTANDI + 
ADT BRCAm patients vs XTANDI + placebo + ADT (HR = 0.20 [95% 
CI, 0.11-0.36])

The number of rPFS events: 15/71 (21%) with TALZENNA + XTANDI + 
ADT vs 54/84 (64%) with XTANDI + placebo + ADT. Median rPFS was 
not reached for TALZENNA + XTANDI + ADT vs 11 months for XTANDI + placebo + ADT.



in the risk of disease progression or death for TALZENNA + XTANDI + 
ADT non-BRCAm patients vs XTANDI + placebo + ADT (HR = 0.72 [95% 
CI, 0.49-1.07])

The number of rPFS events: 51/129 (40%) with TALZENNA + XTANDI + 
ADT vs 50/115 (43%) with XTANDI + placebo + ADT. Median rPFS was 
24.7 months for TALZENNA + XTANDI + ADT vs 16.7 months for XTANDI + placebo + ADT. Title
 The overall survival (OS) data were not mature at the time of the final rPFS analysis (24% of patients had died).‡1
The overall survival (OS) data were not mature at the time of the final rPFS analysis (24% of patients had died).‡1ReferencesADT, androgen deprivation therapy; BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer; NR, not reached; rPFS, radiographic progression-free survival.rPFS was defined as time from the date of randomization to first objective evidence of radiographic progression by blinded independent review, or death (occurring within 168 days of treatment discontinuation),whichever occurs first.3,4Plus ADT.1Overall survival was a key secondary endpoint of the TALAPRO-2 study.1References:TALZENNA [package insert]. 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.Agarwal N, Azad A, Shore ND, et al. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. Future Oncol 2022;18(4):425-36.Pfizer Inc. Talazoparib + enzalutamide vs. enzalutamide monotherapy in mCRPC (TALAPRO-2). ClinicalTrials.gov identifier: NCT03395197. Updated April 23, 2024. Accessed June 21, 2024. https://clinicaltrials.gov/study/NCT03395197?tab=tableEfficacy Explore rPFS results in prespecified subgroups See the data Loading Review the study design for TALAPRO-2

Review key criteria including baseline HRR gene alteration status

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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 has 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 (Grade ≥10, all Grades), including laboratory abnormalities, for patients in the TALAPR0-2 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 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).