Novartis Announces Pluvicto™ Demonstrates Strong rPFS Results In PSMA-Positive Metastatic Prostate Cancer

Novartis has announced positive topline results from a pre-specified interim analysis of the Phase III PSMAddition trial, evaluating its radioligand therapy Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The trial met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), with a positive trend also observed in overall survival (OS). These results highlight the potential of Pluvicto when combined with standard of care (SoC) in comparison to SoC alone.

In the PSMAddition trial, the standard of care included a combination of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). Since most patients with mHSPC eventually progress to metastatic castration-resistant prostate cancer (mCRPC), there is a critical need for innovative treatment options that offer improved disease control, delay disease progression, and extend survival, all while maintaining a manageable safety profile. Pluvicto, through its novel mechanism of action, aims to address these unmet medical needs.

Shreeram Aradhye, M.D., President, Development and Chief Medical Officer at Novartis, said in a statement, “The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy. Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients."

This marks the third successful Phase III readout for Pluvicto, following earlier positive outcomes from the VISION and PSMAfore trials. Notably, the results from PSMAfore recently led to the US FDA approving Pluvicto for earlier use in mCRPC. The new findings from the PSMAddition trial suggest that Pluvicto may also be effective in earlier stages of prostate cancer, potentially shifting treatment paradigms for patients with mHSPC.

Novartis continues to advance its precision medicine strategy, leveraging the expertise of its scientific teams, strategic collaborations, and a robust research pipeline to deliver targeted therapies. The company plans to present the full PSMAddition data at an upcoming medical congress and submit the findings for regulatory review in the second half of the year, based on guidance from the FDA.