Novartis (NVS) announced new data from the Phase III PSMAddition trial demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto combined with standard of care (SoC) in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).
Data were presented as a rapid oral presentation at the American Urological Association Annual Meeting 2026.
Company Details
Novartis focuses on developing radioligand therapy (RLT) for cancer treatment. By harnessing the power of targeted radiation, RLT is designed to deliver treatment directly to target cells throughout the body.
Novartis is investigating a broad portfolio of RLTs, exploring new isotopes, ligands, and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumours (GEP-NETs) and prostate cancer, and into breast, colon, lung, and pancreatic cancer. Trial Details
PSMAddition trial is a Phase III, open-label, prospective, 1:1 randomised study comparing the efficacy and safety of Pluvicto in combination with SoC (ARPI + ADT) vs SoC alone in adult patients with PSMA+ mHSPC.
The primary endpoint is rPFS, defined as the time to radiographic progression or death. The key secondary endpoint for OS is time to death from any cause.
The study remains ongoing, and a total of 1,144 patients with mHSPC across 20 countries have been randomised in the trial.
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Pluvicto is an intravenous radioligand therapy or RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, Lutetium-177).
Pluvicto is currently approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), and it is under investigation for mHSPC.
Notably, Novartis is also investigating Pluvicto in oligometastatic prostate cancer, an earlier stage of disease, in the PSMA-DC trial.
Key Findings
PSA progression can be an early indicator of emerging disease resistance, and approximately one-third of patients do not achieve undetectable PSA levels with SOC alone, according to the firm.
Results demonstrated that patients treated with Pluvicto experienced a higher frequency and greater depth of PSA response when combined with SoC (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) than with SoC alone.
The risk of PSA progression was 58% lower in patients treated with Pluvicto plus SoC compared with SoC alone.
Deep PSA reduction was higher in patients receiving Pluvicto combination vs. SoC at 12, 24 and 48 weeks.
According to the firm, the safety profile and tolerability of Pluvicto were consistent with those observed in the Phase 3 trials PSMAfore and VISION.
Meanwhile, Grade 3 or higher adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared with 43% in the SoC-alone arm.
What's Ahead?
Novartis has filed regulatory submissions in the United States, China and Japan, and decisions are expected in the second half of 2026.
Novartis estimates that approximately 186,000 men are diagnosed annually with metastatic hormone-sensitive prostate cancer across the United States, China, Japan, France, Germany, Italy, Spain and the United Kingdom. NVS has traded between $109.29 and $170.46 over the last year. NVS closed Friday's trade at $148.08, down 1.13%. In the overnight market, NVS is down 0.41% at $147.47.
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