Zinger Key Points
- Imfinzi perioperative regimen reduced disease progression or death risk by 42% in pCR patients and 23% in those without pCR in MIBC.
- The regimen lowered the risk of distant metastases or death by 33% and disease-specific death by 31% versus the comparator arm.
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On Friday, AstraZeneca Plc AZN shared results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase 3 trial.
The study showed that Imfinzi (durvalumab), administered perioperatively in combination with neoadjuvant (before surgery) chemotherapy, demonstrated improvements in event-free survival (EFS) and overall survival (OS) versus neoadjuvant chemotherapy with radical cystectomy alone in patients with or without a pathologic complete response (pCR) in muscle-invasive bladder cancer (MIBC).
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Patients were treated with four cycles of Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder), followed by eight cycles of Imfinzi monotherapy.
In NIAGARA, treatment with the Imfinzi perioperative regimen improved EFS and OS versus the comparator arm in patients who achieved pCR and those who did not.
The regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 42% in patients who achieved pCR and by 23% in those who did not, and reduced the risk of death by 28% in patients who achieved pCR and by 16% in those who did not.
The Imfinzi perioperative regimen also improved metastasis-free survival (MFS) and disease-specific survival (DSS), two secondary endpoints, versus the comparator arm in the intent-to-treat (ITT) population.
This regimen reduced the risk of developing distant metastases or death by 33% and the risk of death specifically due to bladder cancer by 31% versus the comparator arm.
Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings.
In December, the FDA accepted and granted Priority Review to a supplemental application seeking approval for Imfinzi (durvalumab) for MIBC patients.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the second quarter of 2025.
Price Action: AZN stock is down 0.93% at $73.76 at the last check on Friday.
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