ARSI plus ADT showed a trend toward improved survival in Asian patients with metastatic hormone-sensitive prostate cancer, but results were not statistically significant. Prospective studies are needed to validate these findings.
Bayer outlined its 2030 growth strategy at Pharma Media Day 2026, driven by AI partnerships, precision medicine, and a strengthened pipeline. The company aims for mid-single-digit growth from 2027 and 30% margins by 2030.
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Real-world analyses of Novartis' Pluvicto show a median PFS of 13.5 months in taxane-naive mCRPC patients, with better outcomes when used after one ARPI. Additional data indicate subsequent therapies remain effective after Pluvicto, while a separate analysis found gaps in guideline-adherent treatment for mHSPC.
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
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A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France |
RECRUITING | |
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PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. |
COMPLETED | |
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A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics |
RECRUITING | |
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A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice |
ACTIVE_NOT_RECRUITING | |
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Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial. |
RECRUITING | PHASE3 |
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Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer |
NOT_YET_RECRUITING | |
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ACTIVE_NOT_RECRUITING | PHASE2 |
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An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care |
ACTIVE_NOT_RECRUITING | |
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An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care |
COMPLETED | |
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Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients |
COMPLETED |
