Novartis has released encouraging results from the Phase III PSMAfore trial for prostate cancer, presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
The data was disclosed during the Presidential Symposium and indicated that Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) achieved its primary objective by providing a clinically meaningful and statistically significant improvement in radiographic progression-free survival (rPFS) among patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after prior treatment with androgen receptor pathway inhibitors (ARPI), in comparison to a change in ARPI.
The trial demonstrates an impressive rPFS outcome, potentially offering a treatment option for patients who need alternative and earlier therapy. The results are significant as they may alter the treatment paradigm for advanced prostate cancer patients by enabling them to potentially avoid or delay taxane-based chemotherapy, which often entails substantial side effects.
While the collection of overall survival (OS) data continues, the consistent improvements observed in other clinically relevant efficacy measures, coupled with the enhanced quality of life and favorable safety profile, suggest the potential of Pluvicto for taxane-naïve mCRPC patients.
The trial achieved its primary rPFS endpoint with a 59% reduction in the risk of radiographic disease progression in Pluvicto-treated patients compared to those experiencing a change in ARPI. An updated rPFS analysis confirmed this benefit, more than doubling the time to radiographic disease progression in Pluvicto-treated patients compared to those with a change in ARPI (12.0 months vs. 5.6 median months).
Patients on Pluvicto also reported improved quality of life. They had delayed worsening of pain compared to those with a change in ARPI, with other relevant efficacy endpoints showing favorability for Pluvicto. While the second interim OS analysis demonstrated a hazard ratio of 0.80, the unadjusted OS analysis was confounded by 84% of patients who discontinued ARPI due to radiographic progression crossing over to Pluvicto. The trial will continue to assess OS, with the next interim OS analysis expected in 2024.
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