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The PARP-plus-hormone combination that eventually showed an overall survival benefit, in 2024-25.
TALAPRO-2, trial NCT03395197 sponsored by Pfizer and reported in 2023, is the PARP inhibitor plus hormone therapy combination that eventually showed an overall survival benefit, reported between 2024 and 2025. It randomised 805 unselected men with first-line metastatic castration-resistant prostate cancer to enzalutamide with talazoparib or placebo, met its primary radiographic progression-free survival endpoint with a larger effect in the homologous recombination repair-mutant cohort, and at the final analysis showed improved survival in both populations, though the 2023 FDA approval was limited to HRR-mutant disease. OnCo links it to BRCA1 and BRCA2 and PARP as targets, to talazoparib and enzalutamide. As the only such combination with a significant all-comer survival benefit, whether that finding widens the label is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
805 randomised.
Median not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival, all comersprimary | Talazoparib + enzalutamide | 402 | Median not reached | 0.63 (0.51 to 0.78) | <0.0001 | link |
| Placebo + enzalutamide | 403 | 21.9 months | ||||
| Overall survival, all comers (final) | Talazoparib + enzalutamide | - | 45.8 months | 0.8 (0.66 to 0.96) | 0.016 | link |
| Placebo + enzalutamide | - | 37 months |
A second publication from the TALAPRO-2 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT03395197 with the most citations, so it is the natural first reading for anyone following the TALAPRO-2 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares PROpel, TRITON3, Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, Prostate cancer drugs in England: what NICE recommends, and what it refuses.
Shares MAGNITUDE, PARP, PARP inhibitors, BRCA1 / BRCA2 (HRD).
Shares Neeraj Agarwal, Talazoparib, Enzalutamide, PARP inhibitors.
Shares Talazoparib, Enzalutamide, PARP inhibitors, Pfizer (incl. Seagen).
Shares Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Enzalutamide, Pfizer (incl. Seagen), Metastatic castration-resistant prostate cancer.
Shares Talazoparib, PARP, PARP inhibitors, BRCA1 / BRCA2 (HRD).
Shares TRITON3, Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, PARP, PARP inhibitors.
Shares Enzalutamide, Pfizer (incl. Seagen), Metastatic castration-resistant prostate cancer, Prostate cancer.