Pluvicto™ Update

30th October 2023

Pluvicto Summary 

Novartis’ new radiotherapy, Pluvicto™ has shown some promising and beneficial effects in their phase 3 clinical trials.  

What is Pluvicto™? 

Pluvicto™ is a medicine that treats prostate cancer. It is a targeted therapy that delivers radiation treatment directly to prostate cancer cells intravenously (via the bloodstream). It does this by binding to Prostate Specific Membrane Antigen (PSMA) which is a biomarker that is positive on prostate cancer cells. Pluvicto™ is used to treat adults with a type of advanced prostate cancer called PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). This type of advanced prostate cancer is defined as having spread from the prostate, to potentially the lymph nodes and/or bones and hormone therapy no longer stops the growth of the prostate cancer. 

About the Clinical Trial 

This clinical trial consisted of 469 patients with PSMA-positive mCRPC who had not been exposed to a taxane-containing regimen (a type of chemotherapy, such as docetaxel for prostate cancer). These patients must have progressed only once after receiving a second-generation Androgen Receptor Pathway Inhibitor, or ARPI (abiraterone, enzalutamide, darolutamide or apalutamide). The purpose of this trial was to compare the efficacy and safety of Pluvicto™ to a change in ARPI (abiraterone or enzalutamide) in these patients. 

Trial Results 

Key findings: 

  • Results from the trial indicate that Pluvicto™ shows clinically meaningful and highly statistically significant radiographic progression-free survival (rPFS) benefit in these patients.  
  • It more than doubled the average patient’s survival without prostate cancer progressing to 12 months. 
  • It also showed improved quality of life compared to daily oral ARPI. 
  • Pluvicto ™ also showed a delay in worsening pain. 
  • Furthermore, a PSA decline of at least 50% was more than 2.5 times more frequent with Pluvicto ™ than with a change in ARPI. 
  • The trial also demonstrated a favourable safety profile with 6 cycles of Pluvicto, with adverse events being lower in Pluvicto compared to change in ARPI. 

Dr. Oliver Sartor, PSMAfore Co-Principal Investigator, Chairman of the Trial Steering Committee commented, “We look forward to a future where Pluvicto may be a viable therapy for patients in need of alternative, earlier options”.


Men with metastatic prostate cancer need more options and these results seem to be really promising. The side effects of chemotherapy are well-known and if Pluvicto can provide an alternative, that is easier to live with and helps people live longer, it will be a great triumph of science over illness. The increase in time to live reported by this trial is incredibly important, and we also take heart at the results that show this treatment delays pain getting worse and improves quality of life overall. This and other developments show that we have good reason to be optimistic for the future.

Dr Naomi Elster
Director of Research and Communications

We extend our congratulations to Swiss company Novartis, who made the drug, all the scientists who have worked on it, and the patients who have been involved in the research which helped us reach the point where men facing a very difficult situation now have another option.


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