The Babak Lab shared on LinkedIn:
“Clinical Mondays
Radioligand therapy is moving earlier in prostate cancer treatment
The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S), previously referred to as metastatic hormone-sensitive prostate cancer.
Pluvicto is a PSMA-targeted radioligand therapy. It binds to PSMA-expressing prostate cancer cells and delivers radioactive lutetium-177 directly to them, allowing radiation to damage tumor cells while limiting exposure to surrounding tissue. Patients are selected using an approved PSMA PET imaging agent.
Key Insights
- The approval is based on the phase 3 PSMAddition trial, which included 1,144 patients with PSMA-positive mAPMN/S prostate cancer.
- Patients received Pluvicto + ARPI (n=572) or ARPI alone (n=572). ARPIs included abiraterone, apalutamide, enzalutamide, darolutamide, or another ARPI selected by the investigator.
- Adding Pluvicto significantly improved radiographic progression-free survival (rPFS), with a hazard ratio of 0.72 (95% CI: 0.58-0.90; p=0.002).
- Median rPFS was not reached in either treatment group at the time of analysis, and overall survival data were still immature.
- Pluvicto is administered at 7.4 GBq (200 mCi) every six weeks for six doses, or until disease progression or unacceptable toxicity.
- Important risks include radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility.
Conclusion
The important part of this approval is when Pluvicto can now be used. PSMA-targeted radioligand therapy is moving into an earlier stage of metastatic prostate cancer, before patients develop castration-resistant disease. Adding Pluvicto to ARPI therapy reduced the risk of radiographic progression or death by 28%, although longer follow-up is still needed to determine whether this translates into an overall survival benefit.
Image generated using Sora by OpenAI.
A link to the FDA announcement can be found in the comments section.
Maria (Masha) Babak, Head of the Lab at The Babak Lab, shared a post by The Babak Lab, adding:
“Selecting patients with PSMA PET makes this a great example of precision oncology in practice. The next question is which patients benefit most from adding radioligand therapy this early in their treatment.”
You can also read: Louis van Gaal’s Remarkable Prostate Cancer Journey: Diagnosis, Treatment, and Recovery
