December 05, 2022
Pluvicto showed progression-free survival in patients with PSMA-positive mCRPC with ARPI pathway versus change in ARPI therapy.
Pluvicto is under evaluation in patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen-receptor pathway inhibitor (ARPI) therapy. Novartis announced that Pluvicto (lutetium (177Lu) vipivotide tetraxetan) showed a significant improvement in radiographic progression-free survival (rPFS).
Novartis announced a second positive read-out following the VISION study, which evaluated Pluvicto in patients with mCRPC previously treated with ARPI and taxane-based chemotherapy.
No new adverse events were reported compared to the existing safety profile.
Novartis is aiming for FDA regulatory approval in 2023.
October 4, 2022
Talzenna plus Xtandi showed improvement in PFS versus Xtandi.
Pfizer announced the positive Phase 3 TALAPRO-2 study results of Talzenna (talazoparib) plus Xtandi (enzalutamide) versus Xtandi plus placebo in patients with metastatic castration-resistant prostate cancer (mCRPC). Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, is under evaluation for mCRPC, with or without homologous recombination repair (HRR) gene mutations.
The study met the primary endpoint of demonstrating significant improvement in the radiographic progression-free survival (rPFS) versus Xtandi alone.
At the time of analysis, a progression towards the improvement in the overall survival was not met as the data was still immature. There was an improvement in the prostate-specific antigen (PSA) response, time to PSA progression, and overall response rate. The dose of Talzenna was 0.5mg/day, and Xtandi was 60mg/day.
Any regulatory agencies did not approve the combination for prostate cancer.