Novartis seeks to expand use of prostate therapy Pluvicto, citing positive trial results
Novartis recently shared promising trial results for its prostate cancer treatment Pluvicto (lutetium 177 vipivotide tetraxetan).
The radioligand therapy is currently approved by the U.S. Food and Drug Administration for treatment of men with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. That approval came in March of 2022.
This latest research is testing the treatment’s potential in a slightly different group—men with metastatic hormone-sensitive prostate cancer. The latter is still believed to respond to hormone therapy, whereas men with metastatic castration-resistant prostate cancer do not.
According to evidence shared Sunday, Oct. 19, at the European Society for Medical Oncology’s (ESMO) annual conference, Pluvicto reduces progression of prostate cancer by nearly 30% in men with hormone-sensitive cancer when combined with standard hormonal therapy. Compared to standard therapy alone, the addition of Pluvicto significantly prolonged radiographic, progression-free survival in this group.
What’s more, findings relative to safety aligned with those from previous trials that were used to earn the drug’s initial FDA approval. Data showed a slight increase in grade 3 adverse events in patients receiving both hormone therapy and Pluvicto compared to hormone therapy alone.
"With significant benefit now shown across multiple disease stages, Pluvicto is redefining the standard of care," Shreeram Aradhye, MD, Novartis' president of development and chief medical officer, said of the results.
With these latest results showing an “early positive trend,” Novartis has now set its sights on additional regulatory approval that would pave the way for patients to receive Pluvicto earlier in their treatment. This has the potential to double the number of patients eligible for treatment with the therapy.
Expert panelists at the conference, however, were hesitant to lend their support to the change. They contend that expanding the treatment’s use would require judicious patient selection, as there are yet enough data to back Pluvicto’s overall survival benefit in this cohort.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.