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.
- 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”.