AstraZeneca PLC (LSE/STO/Nasdaq:LON:AZN) has announced positive results from the POTOMAC Phase III trial, which evaluated Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for high-risk non-muscle-invasive bladder cancer (NMIBC). The trial demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to BCG induction and maintenance therapy alone.
According to the press release dated Friday, the combination of Imfinzi plus BCG therapy showed patients lived significantly longer without high-risk disease recurrence or progression after one year of treatment versus BCG alone. The trial was not powered to formally test overall survival, but a descriptive analysis indicated no detriment.
Maria De Santis, MD, one of the principal investigators, emphasized the importance of the findings, highlighting that 80% of patients with NMIBC see their disease return, with nearly half requiring bladder removal surgery. The results signify a potential improvement in treatment, aiming to extend the time patients live without disease recurrence or progression.
Cristian Massacesi, AstraZeneca (NASDAQ:AZN)’s Chief Medical (TASE:BLWV) Officer, expressed that the positive outcome from the POTOMAC trial represents a significant advance, potentially allowing more patients with early-stage bladder cancer to benefit from immunotherapy.
The safety profile of Imfinzi in combination with BCG was consistent with the known safety profiles of the individual medicines, and no new safety concerns were identified. The trial’s second experimental arm, evaluating Imfinzi with BCG induction-only therapy, did not meet the endpoint of DFS.
AstraZeneca plans to present these data at an upcoming medical meeting and share the findings with global regulatory authorities. Imfinzi is already approved in the US and other countries for muscle-invasive bladder cancer (MIBC) based on results from the NIAGARA Phase III trial and is being investigated across early and late-stage bladder cancer in various treatment combinations.
The information is based on a press release statement from AstraZeneca and constitutes a summary of the key findings from the POTOMAC Phase III trial as reported to the Securities and Exchange Commission.
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