Novartis announces positive phase 3 results for prostate cancer drug Pluvicto

Novartis has announced positive results from its pivotal phase 3 PSMAfore study of Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan) in the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

The trial met its primary endpoint, with the PSMA-targeted radioligand therapy demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) after treatment with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI.

The results mark the second positive read-out for Pluvicto in a phase 3 trial following the VISION study, in which patients with PSMA–positive mCRPC who received Pluvicto plus standard of care after being treated with ARPI and taxane-based chemotherapy had a statistically significant reduction in risk of death.

No unexpected safety findings were observed in the latest study, the company said, with the results consistent with the established safety profile of Pluvicto.

“With the announcement of these positive topline phase 3 results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy,” said Shreeram Aradhye, president, global drug development and chief medical officer, Novartis.

The phase 3 data will be presented at an upcoming medical meeting, the company outlined in a statement, as well as discussed with the US Food and Drug Administration in 2023 for regulatory approval.

“We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis,” Aradhye added.

Prostate cancer is the most frequently diagnosed cancer in 112 countries, with more than 1.4 million new cases and 375,000 deaths in 2020 alone.

The majority of patients diagnosed with CRPC already present with metastases at time of diagnosis. However, despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, underscoring the need for new targeted treatment options to help improve long-term outcomes.

More than 80% of patients highly express a phenotypic biomarker called PSMA, making it a promising diagnostic and therapeutic target for radioligand therapy, Novartis said.

Pluvicto is already approved for treatment in adult patients with PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy in the US and several other countries.