Novartis has reported topline outcomes from the Phase III PSMAddition trial’s pre-specified interim analysis, where Pluvicto (lutetium (¹⁷⁷Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).

The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population.

The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT).

This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials.

According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT.

PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone.

Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC).

Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year.

The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial.

Novartis Development president and chief medical officer Shreeram Aradhye said: “The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients.

“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 March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years.