TALAPRO-2 Study: Safety & Tolerability

The safety of TALZENNA^® in combination with enzalutamide was evaluated in mCRPC patients with or without HRR gene alterations enrolled in TALAPRO-2. Anaemia was the most common adverse reaction leading to dose interruptions, reductions and discontinuations.³

Figure includes treatment emergent adverse events (TEAEs) reported in ≥20% of patients in either arm.²
Figure adapted from Agarwal N et al. 2025.²
Data cut off 3 September 2024
* Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 4.03. No Grade 5 adverse reactions reported. †Includes anaemia, haematocrit decreased, haemoglobin decreased, and red blood cell count decreased. ‡neutropenia, and neutrophil count decreased. §Includes fatigue and asthaenia. ||Includes thrombocytopenia and platelet count decreased. ¶Includes leukopenia and white blood cell count decreased.²

In TALAPRO-2, TALZENNA^® dose modifications were permitted to help manage adverse reactions.³

Safety Profile

- The safety profile was consistent with the individual profiles for talazoparib and enzalutamide.¹ Upon extended follow-up, no new safety signals were observed with talazoparib + enzalutamide.²
- Most common adverse reactions (all grades in ≥ 10% of patients) were anaemia, neutropenia, fatigue, thrombocytopenia, back pain, leukopenia, decreased appetite, and nausea.¹
-The most common Grade 3/4 adverse reactions with talazoparib + enzalutamide were anaemia (49%) and neutropenia (19.3%).²
-Median time to onset of Grade 3/4 anaemia with talazoparib + enzalutamide was 3.3 months.^{1, 2}
- The 3 September 2024 data cutoff safety analysis corresponds to the following median duration of treatment: talazoparib (86 weeks) + enzalutamide (97 weeks) vs placebo (70 weeks) + enzalutamide (72 weeks).²

To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation. Please consult the SmPC for further details.

Summary of Treatment-Emergent Adverse Events

Figure adapted from Agarwal N, et al. 2025.²
The 3 September 2024 data cutoff safety analysis corresponds to the following median duration of treatment: talazoparib (86 weeks) + enzalutamide (97 weeks) vs placebo (70 weeks) + enzalutamide (72 weeks).²

- In the talazoparib arm (n=398), the most common TEAEs leading to dose reduction of talazoparib were: anaemia (46.2%), neutropenia (16.3%) and thrombocytopenia (6.2%).²

- 8.5% of patients discontinued talazoparib due to anaemia.²

- Only 19% of patients discontinued talazoparib due to adverse reactions in the primary analysis, the most common adverse reaction leading to discontinuation was anaemia (8%).¹..Upon extended follow up, only 22% of patients discontinued talazoparib due to adverse reactions.²

Special Warnings and Precautions for use

Abbreviations: 

AE - Adverse Event, AML - Acute Myeloid Leukemia, HRR - Homologous Recombination Repair, mCRPC - Metastatic Castration-Resistant Prostate Cancer, MDS - Myelodysplastic Syndrome, NCI CTCAE - National Cancer Institute Common Terminology Criteria for Adverse Events, PARPi - Poly ADP-ribose Polymerase Inhibitors, TEAEs - Treatment Emergent Adverse Events