Novartis’ Pluvicto Receives Highest Clinical Benefit Score from ESMO for Advanced Prostate Cancer

Novartis announced that its Pluvicto (lutetium (¹⁷⁷Lu) vipivotide tetraxetan) has received the highest possible score of 5 on the European Society for Medical Oncology – Magnitude of Clinical Benefit Scale (ESMO-MCBS) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This evaluation, based on the Phase 3 VISION trial, underscores Pluvicto’s significant clinical value in extending survival and improving quality of life for patients with this advanced disease.

What is the ESMO-MCBS?

The ESMO-MCBS is a rigorous evaluation tool designed to assess the clinical benefit of cancer treatments. It goes beyond statistical significance to consider factors like overall survival (OS), progression-free survival (PFS), quality of life and toxicity. A score of 4 or 5 indicates a high level of clinical benefit, with 5 representing the highest rating in an advanced cancer setting. ESMO-MCBS

Key Findings from the VISION Trial

The ESMO-MCBS score of 5 for Pluvicto is based on the results of the Phase 3 VISION trial, which involved patients with mCRPC who had previously received androgen receptor pathway blockade therapy (ARPI) and taxane-based chemotherapy. The trial demonstrated:

• A significant extension of median radiographic progression-free survival (rPFS) to 8.7 months, more than double the 3.4 months observed in the control group.
• A reduction in the risk of disease progression or death by approximately 60%.
• An improvement in overall survival (OS), with a 4-month extension compared to standard treatment and a 38% reduction in the risk of death.
• Improvements in patient-reported quality of life (FACT-P total score) and delayed worsening of pain intensity (BPI-SF), indicating enhanced health-related quality of life (HRQOL).

Expert Perspective

“In metastatic castration-resistant prostate cancer, which is an advanced stage of the disease with limited treatment options, it’s crucial to find therapies that not only prolong survival but likewise maintain quality of life,” said Professor Jeong Byeong-chang of the Department of Urology at Samsung Seoul Hospital. “The ESMO-MCBS score of 5 for Pluvicto reinforces its evidence-based clinical value in the treatment of mCRPC.”

Novartis’ Commitment to Innovation

“We are encouraged that Pluvicto, a new treatment option for metastatic castration-resistant prostate cancer, has reaffirmed its value as a standard of care, aligning with the latest global guidelines and receiving the highest rating from ESMO-MCBS,” stated Christie Gao, Executive Director of Novartis Korea’s Solid Tumor Business Division. “We remain dedicated to ensuring patients in Korea have access to innovative treatments supported by robust evidence.”

About Pluvicto

Pluvicto is an intravenous radioligand therapy (RLT) that combines a ligand with the therapeutic radionuclide lutetium-177. It targets and delivers radiation directly to prostate cancer cells expressing prostate-specific membrane antigen (PSMA). Novartis Pluvicto