Gemcitabine/Cisplatin
- Generic Name
- Gemcitabine/Cisplatin
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
Durvalumab Gains Priority Review for Muscle-Invasive Bladder Cancer Treatment
• The FDA has granted priority review to durvalumab (Imfinzi) for muscle-invasive bladder cancer (MIBC), potentially expediting its approval.
• Phase 3 NIAGARA trial data supports the application, showing a 32% reduction in disease progression or recurrence with perioperative durvalumab.
• The Imfinzi regimen also demonstrated a 25% reduction in the risk of death, offering a significant survival benefit.
• Regulatory decisions are anticipated in the second quarter of 2025, with potential implications for MIBC treatment standards.
Imfinzi Approved for Limited-Stage Small Cell Lung Cancer, Redefining Treatment
• The FDA has approved AstraZeneca's Imfinzi (durvalumab) for treating adults with limited-stage small cell lung cancer (LS-SCLC) after platinum-based chemotherapy and radiation therapy.
• The approval was based on the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death compared to placebo, marking a significant breakthrough.
• Median overall survival improved to 55.9 months with Imfinzi versus 33.4 months with placebo, establishing a new benchmark for LS-SCLC treatment.
• Imfinzi is now the only immunotherapy approved for both limited and extensive-stage small cell lung cancer, underscoring its potential to improve survival rates.
Perioperative Durvalumab Plus Chemotherapy Improves Survival in Muscle-Invasive Bladder Cancer
• Perioperative durvalumab combined with neoadjuvant chemotherapy significantly improved event-free survival (EFS) compared to chemotherapy alone in cisplatin-eligible MIBC patients.
• The durvalumab regimen also demonstrated a 25% reduction in the risk of death, showing a statistically significant overall survival (OS) benefit.
• A re-analysis of pathologic complete response (pCR) rates showed nominal statistical significance favoring the durvalumab arm, supporting the perioperative approach.
• The addition of perioperative durvalumab to neoadjuvant chemotherapy was tolerable, with no new safety signals observed in the NIAGARA trial.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath