Novartis: Phase 3 Trial Of Pluvicto Shows Positive Results In PSMA-positive MHSPC

(RTTNews) - Swiss drug major Novartis AG (NVS) announced Monday positive topline results from a pre-specified interim analysis of the Phase III PSMAddition trial for Pluvicto plus hormone therapy in patients with prostate-specific membrane antigen or PSMA-positive metastatic hormone-sensitive prostate cancer or mHSPC.

The company said it plans to present results at an upcoming medical meeting. Based on the feedback from the U.S. Food and Drug Administration, results will be submitted for regulatory review in the second half of the year.

Pluvicto is an intravenous radioligand therapy or RLT that combines a targeting compound with a therapeutic radionuclide. Pluvicto is already approved for metastatic castration-resistant prostate cancer or mCRPC and now shows potential in patients in an earlier disease setting, as almost all mHSPC patients ultimately progress to mCRPC.

The company noted that the Phase III PSMAddition trial met its primary endpoint for Pluvicto plus hormone therapy versus hormone therapy alone, with positive trend in overall survival.

The results showed a statistically significant and clinically meaningful benefit in radiographic progression-free survival or rPFS with a positive trend in overall survival in patients with PSMA-positive metastatic hormone-sensitive prostate cancer or mHSPC treated with radioligand therapy or RLT, Pluvicto (lutetium (177Lu) vipivotide tetraxetan), in combination with standard of care (SoC) versus SoC alone.

Shreeram Aradhye, President, Development and Chief Medical Officer at Novartis, said, "The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy. Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients."

This is the third positive read-out for Pluvicto in a Phase III trial, following the VISION and PSMAfore studies.

The company noted that Pluvicto is the only PSMA-targeted agent approved for PSMA-positive mCRPC and is the first targeted RLT to demonstrate a clinical benefit for patients with PSMA-positive mHSPC.

Novartis is investigating Pluvicto in earlier stages of disease, including oligometastatic prostate cancer.

Novartis is investigating a broad portfolio of RLTs in advanced cancers, including breast, colon, lung and pancreatic, with further investments in multiple manufacturing facilities.

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