Novartis(US:NVS) Globenewswire·2025-10-19 14:30Core Insights - Novartis presented new data on Pluvicto™ from the Phase III PSMAddition trial, showing significant improvements in treatment outcomes for patients with metastatic hormone-sensitive prostate cancer [1][5]. Efficacy of Pluvicto - Pluvicto combined with standard of care (SoC) reduced the risk of radiographic progression or death by 28% (HR 0.72; 95% CI: 0.58, 0.90) compared to SoC alone in patients with PSMA+ metastatic hormone-sensitive prostate cancer [2][6]. - An early positive trend in overall survival (OS) was observed with a hazard ratio of 0.84 (95% CI: 0.63, 1.13) for patients treated with Pluvicto plus SoC [3][6]. - The complete response rate was higher in the Pluvicto plus SoC group (57.1%) compared to SoC alone (42.3%), and the overall response rate was also numerically higher (85.3% vs. 80.8%) [3][6]. - Pluvicto delayed progression to metastatic castration-resistant prostate cancer (mCRPC) with a hazard ratio of 0.70 (95% CI: 0.58, 0.84) [3][6]. Safety Profile - The safety profile of Pluvicto was consistent with previous studies, with grade ≥3 adverse events reported in 50.7% of patients in the Pluvicto plus SoC arm compared to 43% in the SoC alone group [4][6]. - Common adverse events included dry mouth, fatigue, nausea, hot flush, and anemia [4][6]. Regulatory and Market Implications - PSMAddition is the third positive Phase III trial for Pluvicto, building on previous successes that led to FDA approval for mCRPC in March 2025 [5][6]. - Novartis plans to submit the new data to regulatory authorities by the end of the year, which could potentially double the number of patients eligible for Pluvicto [5][6]. Unmet Medical Need - Approximately 172,000 men are diagnosed with metastatic hormone-sensitive prostate cancer annually in major markets, highlighting the urgent need for effective therapies [6][7]. - Most patients with this condition progress to mCRPC, which is associated with significantly worse outcomes and a life expectancy of less than two years [7][6]. About Pluvicto - Pluvicto is a radioligand therapy that targets PSMA-expressing cells, delivering treatment directly to prostate cancer cells [9][10]. - It is the only PSMA-targeted agent approved for PSMA+ mCRPC and the first to show clinical benefit in mHSPC in a Phase III trial [10]. Novartis and Radioligand Therapy - Novartis is advancing cancer care through radioligand therapy, focusing on targeted radiation to treat advanced cancers [11]. - The company is expanding its RLT manufacturing capabilities to meet growing demand and is exploring new isotopes and combination therapies for various cancers [11].