Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer

Core Insights - Novartis announced positive topline results from the Phase III PSMAddition trial, demonstrating a significant benefit in radiographic progression-free survival (rPFS) for Pluvicto™ in combination with standard of care (SoC) compared to SoC alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) [2][4][7] Group 1: Trial Results - The PSMAddition trial met its primary endpoint with a statistically significant and clinically meaningful benefit in rPFS, along with a positive trend in overall survival (OS) [2][4] - The trial involved adult patients with PSMA-positive mHSPC, comparing the efficacy and safety of Pluvicto combined with SoC (androgen receptor pathway inhibitor therapy and androgen deprivation therapy) versus SoC alone [6][7] Group 2: Treatment Context - Most mHSPC patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC), highlighting the need for new treatment options that can delay progression and improve OS [3] - Pluvicto is already approved for mCRPC and shows potential for earlier use in mHSPC, addressing significant unmet needs in hormone-sensitive prostate cancer [4][8] Group 3: Future Plans - Novartis plans to present the trial results at an upcoming medical meeting and will submit data for regulatory review in the second half of the year based on FDA feedback [5][7] - The company is expanding its portfolio of radioligand therapies (RLTs) for various advanced cancers and enhancing manufacturing capabilities to meet growing demand [9]