Drugs

Novartis Seeking Expanded Pluvicto Label

Novartis says it will seek FDA approval in the second half of this year for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — to slow disease progression in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibition (ARPI) and before taxane-based chemotherapy. The drug is currently approved for treating adults with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with ARPI and taxane-based chemotherapy.

The label expansion submission was delayed last year after the company reported that an interim analysis found that the pre-specified crossover-adjusted overall survival (OS) analysis demonstrated a hazard ratio of 0.80. “The unadjusted intent-to-treat OS analysis was confounded as 84% of patients who discontinued ARPI due to radiographic progression crossed over to receive Pluvicto,” the company said at the time.

The expanded indication will be based on Phase 3 data demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival, according to Novartis. It also says updated OS results from a “pre-planned analysis at approximately 75% information fraction demonstrates an OS hazard ratio less than 1.0 (HR<1.0) in the intent-to-treat population unadjusted for cross-over.”

Novartis says Pluvicto is the first PSMA-targeted radioligand therapy to demonstrate clinically meaningful benefits for patients with this type of prostate cancer who have not received taxane-based chemotherapy. “Despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, and there is an urgent need for new targeted treatment options to help improve long-term outcomes,” it says.

Pluvicto is described as an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). “After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein,” Novartis says. “Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and triggering cell death.”

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