Novartis aims for broader Pluvicto use after prostate cancer study update

2024-04-04

临床结果临床3期上市批准

Novartis confirmed plans Thursday to file for a label expansion of its radioligand drug Pluvicto (lutetium 177 vipivotide tetraxetan) in the second half of 2024, aiming to secure approval for its use in advanced prostate cancer patients prior to treatment with taxane-based chemotherapy.

The regulatory submission will be based on updated results from the Phase III PSMAfore study, which evaluated Pluvicto in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitors (ARPI).

OS prompted previous delay

In findings from the second interim analysis of PSMAfore with 45% of events, unveiled last October at the European Society for Medical Oncology (ESMO) congress, Pluvicto demonstrated a 59% benefit on the primary endpoint of radiographic progression-free survival (rPFS) compared to daily oral androgen therapy.

However, the study's design allowed control patients to receive Pluvicto at disease progression – something that muddied up the interpretation of overall survival (OS) data given the exceptionally high 84% rate of treatment crossover. At the time, Novartis said Pluvicto was associated with a 16% higher risk of death before adjusting for crossover; but when crossover events were taken into account, the drug exhibited a 20% decrease in mortality risk.

Nevertheless, questions about the OS data prompted Novartis to postpone its projected timeline for seeking a broader US label from the third quarter of 2023 to sometime this year. For more, see – KOL Views Q&A: PSMAfore not a win for Pluvicto but Novartis still has path to growth in CRPC.

HR of less than 1.0

On Thursday, Novartis said that "at approximately 75% of the targeted information fraction for the trial's primary endpoint of rPFS, Pluvicto demonstrated a hazard ratio (HR) of less than 1.0 compared to an alternative ARPI in the intent-to-treat population, unadjusted for crossover to Pluvicto treatment."

Novartis stated that rPFS and other secondary efficacy endpoints were "consistent" with interim results presented in 2023, while an additional eight months of follow-up data revealed no new safety concerns. Full results will be shared at an upcoming medical meeting.

Pluvicto is already approved in the US for patients with PSMA-positive mCRPC who have been treated with ARPI and taxane-based chemotherapy. The radiopharmaceutical became Novartis' fastest-growing drug in 2023 with sales more than tripling to $980 million.

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