Tuesday, July 16, 2024

Imfinzi Shows Promise in Bladder Cancer Survival

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Positive high-level results from the NIAGARA Phase III trial show AstraZeneca’s Imfinzi (durvalumab) combined with chemotherapy significantly improves event-free survival (EFS) and overall survival (OS) for patients with muscle-invasive bladder cancer (MIBC). Patients received Imfinzi with neoadjuvant chemotherapy before cystectomy (bladder removal surgery) followed by Imfinzi as adjuvant monotherapy.

Approximately one in four bladder cancer patients have tumors invading the muscle wall without distant metastases, known as MIBC. Around 117,000 patients are treated with the current standard of care, which includes neoadjuvant chemotherapy and radical cystectomy. Despite cystectomy, recurrence rates are high, and the prognosis is poor. Professor Thomas Powles of Barts Cancer Centre, London, noted that nearly half of MIBC patients who receive standard care still experience disease recurrence or progression. The NIAGARA data indicate that adding durvalumab to chemotherapy before surgery, followed by durvalumab, extends patients’ lives.

Significance of NIAGARA Results

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, highlighted that the NIAGARA results support the strategy of moving immunotherapy to early cancer treatment stages. This perioperative regimen with Imfinzi improved survival and reduced recurrence or progression rates. AstraZeneca aims to bring this transformative regimen to patients swiftly. Imfinzi was generally well-tolerated, and no new safety concerns were observed. The safety profile was consistent with the known profile of the individual medicines. The addition of Imfinzi did not increase the discontinuation rate due to adverse events and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone.

Bladder cancer is the ninth most common cancer globally, with over 614,000 new cases annually. The most common type, urothelial carcinoma, begins in the urinary tract’s urothelial cells. MIBC, named for its growth into the bladder’s muscle wall, accounts for about a quarter of all bladder cancer cases. Approximately 50% of patients who undergo bladder removal surgery experience disease recurrence, highlighting the critical need for post-surgery treatments to prevent recurrence.

NIAGARA Trial Details

NIAGARA is a randomized, open-label, multi-center global Phase III trial evaluating Imfinzi for MIBC treatment before and after radical cystectomy. Involving 1063 patients across 192 centers in 22 countries, the trial compared Imfinzi plus chemotherapy with chemotherapy alone before cystectomy, followed by Imfinzi or no further treatment post-surgery. The dual primary endpoints are EFS and pathologic complete response, with key secondary endpoints including OS and safety.

Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein, blocking its interaction with PD-1 and CD80 proteins. This counteracts the tumor’s immune-evading tactics, releasing the inhibition of immune responses. Imfinzi is approved globally for various cancers, including unresectable Stage III non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (SCLC), and metastatic NSCLC in combination with Imjudo (tremelimumab) and chemotherapy. Additionally, Imfinzi is approved for locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma (HCC), and advanced or recurrent endometrial cancer. More than 220,000 patients have been treated with Imfinzi since its first approval in May 2017.

AstraZeneca’s Commitment to Oncology

AstraZeneca is a pioneer in introducing immunotherapy into clinical areas with high unmet medical needs. The company’s diverse immuno-oncology (IO) portfolio aims to overcome tumor immune evasion and stimulate the immune system to attack tumors. AstraZeneca’s innovative clinical strategy focuses on delivering long-term survival through IO-based therapies across various cancer types. The company is also investigating novel combinations to prevent treatment resistance and drive longer immune responses, championing the use of IO treatments in earlier disease stages for potential cures.

AstraZeneca’s commitment to redefining cancer care through persistent innovation has built one of the industry’s most diverse portfolios and pipelines. The company aims to provide life-changing medicines to patients and ultimately eliminate cancer as a cause of death.

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Resource: AstraZeneca, June 25, 2024

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