Novartis : Pluvicto Shows RPFS Benefit In Positive Metastatic Castration-resistant Prostate Cancer

(RTTNews) - Novartis (NVS) presents data from the Phase III PSMAfore trial at the 2023 European Society for Medical Oncology Congress. Data presented at the Presidential Symposium showed that Pluvicto (lutetium (177Lu) vipivotide tetraxetan) met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI.

The company noted that the trial met its primary endpoint of rPFS2 with a 59% reduction in the risk of radiographic disease progression in patients with Pluvicto versus a change of ARPI.

Using a data cut off with a median of 8.6 months longer study follow-up, an updated rPFS analysis demonstrated a consistent clinical benefit in patients with Pluvicto versus a change in ARPI, more than doubling time to radiographic disease progression (12.0 months vs. 5.6 median months).

Patients on Pluvicto also showed improved quality of life, maintaining their FACT-P total score for 3 months longer than a change in ARPI (7.5 vs. 4.3 months), with a delay in worsening pain (BPI-SF) of 5.0 versus 3.7 months. Other clinically meaningful efficacy endpoints also favored Pluvicto, with a PSA decline of at least 50% being >2.5X more frequent with Pluvicto than with a change in ARPI1.

At the second interim OS analysis with 45% of events, the pre-specified crossover-adjusted OS analysis demonstrated a hazard ratio of 0.80. The unadjusted intent-to-treat OS analysis was confounded as 84% of patients who discontinued ARPI due to radiographic progression crossed over to receive Pluvicto. The trial will continue to assess OS, with the next interim OS analysis expected in 2024.

The trial demonstrated a favorable safety profile with 6 cycles of Pluvicto.

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