PSMAddition data show Novartis Pluvicto™ delays progression to end-stage prostate cancer

Core Insights - Novartis presented new data on Pluvicto™ at the ESMO Congress 2025, highlighting its efficacy in treating metastatic hormone-sensitive prostate cancer [1][5] Efficacy of Pluvicto - Pluvicto combined with standard of care (SoC) showed a 28% reduction in the risk of radiographic progression or death compared to SoC alone in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) [2][7] - An early positive trend in overall survival was observed with a hazard ratio (HR) of 0.84, indicating potential benefits in long-term outcomes [3][7] - The overall response rate (ORR) was higher in the Pluvicto plus SoC group (85.3%) compared to SoC alone (80.8%) [3][7] Safety Profile - The safety profile of Pluvicto was consistent with previous studies, with grade ≥3 adverse events reported in 50.7% of patients receiving Pluvicto plus SoC, compared to 43% in the SoC group [4][7] - Common adverse events included dry mouth, fatigue, nausea, hot flush, and anemia [4] Regulatory and Market Implications - PSMAddition marks the third positive Phase III trial for Pluvicto, reinforcing its potential to improve outcomes in earlier stages of metastatic prostate cancer [5][7] - Novartis plans to submit these findings to regulatory authorities by the end of the year, which could double the number of patients eligible for Pluvicto [7] Unmet Need in mHSPC - Approximately 172,000 men are diagnosed with mHSPC annually in major markets, with most progressing to metastatic castration-resistant prostate cancer (mCRPC) within 20 months [6] - The progression to mCRPC is associated with significantly worse outcomes, highlighting the urgent need for effective therapies [6][7] About Pluvicto - Pluvicto is a radioligand therapy that targets PSMA-expressing cells, delivering treatment directly to cancer cells [9][10] - It is the only PSMA-targeted agent approved for PSMA+ mCRPC and has shown clinical benefits in mHSPC [10] Novartis and RLT - Novartis is advancing cancer care through radioligand therapy (RLT), focusing on targeted radiation to treat advanced cancers [11] - The company is expanding its RLT manufacturing capabilities to meet growing demand [11]