प्राथमिक स्रोत रिकॉर्ड
निर्णायकटॉपलाइन परिणाम
AstraZeneca VOLGA Phase 3: perioperative durvalumab + neoadjuvant EV improves EFS/OS in MIBC
VOLGA Phase 3 trial reported positive topline results for perioperative IMFINZI plus neoadjuvant enfortumab vedotin versus radical cystectomy in cisplatin-ineligible/refusing MIBC patients. Primary endpoint EFS and key secondary OS both met with statistically significant and clinically meaningful improvements (HR 0.51 and 0.58). Data presented at ESMO 2026 and published in NEJM; already granted FDA Priority Review.
मुख्य तथ्य
- फाइल किया गया
- 24 अक्टू॰ 2026, 02:30 pm
- घटना
- टॉपलाइन परिणाम
- दिशा
- सकारात्मक
- कंपनी
AZNएस्ट्राजेनेका- संपत्ति
- durvalumab
- विश्वसनीयता
- स्रोत सहित
- समग्र उत्तरजीविता का खतरा अनुपात
- 0.58 (95% विश्वास अंतराल 0.40-0.83)
- घटना मुक्त उत्तरजीविता का खतरा अनुपात
- 0.51 (95% विश्वास अंतराल 0.38-0.67)
- 2-वर्षीय समग्र उत्तरजीविता दर
- 78% बनाम 69%
- 2-वर्षीय घटना मुक्त उत्तरजीविता दर
- 64% बनाम 45%
स्रोत का अंश
Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer More than three quarters of patients were still alive two years after treatment with perioperative IMFINZI plus three cycles of EV given before surgery Data demonstrated statistically significant and clinically meaningful survival benefit and manageable safety profile Positive results from the VOLG