AstraZeneca's Imfinzi: Mixed Results in Bladder and Lung Cancer Trials

AstraZeneca announced favorable results from a Phase III trial of Imfinzi (durvalumab) plus chemotherapy, demonstrating improved survival rates over standard neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC). However, another study in early-stage non-small-cell lung cancer (NSCLC) revealed that Imfinzi did not achieve the primary survival endpoint.

Survival Advantage in MIBC

The Phase III NIAGARA trial included 1063 patients with MIBC, who were randomly assigned to receive either Imfinzi combined with chemotherapy or chemotherapy alone before undergoing cystectomy. Post-surgery, patients continued with either Imfinzi or no further treatment. The trial data indicated that those treated with the combination of Imfinzi and chemotherapy exhibited significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) compared to those who received only neoadjuvant chemotherapy.

AstraZeneca reported that adding Imfinzi did not lead to higher discontinuation rates due to adverse events, nor did it compromise the patients' ability to complete surgery when compared to the use of neoadjuvant chemotherapy alone. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized that the NIAGARA results support the strategy to introduce immunotherapy in the early stages of cancer treatment. She stated that Imfinzi has the potential to transform the standard care for MIBC. The company plans to present these results at an upcoming medical meeting and submit them to regulatory authorities.

Imfinzi initially received accelerated approval from the FDA in 2017 for treating advanced bladder cancer. However, this indication was voluntarily withdrawn in 2021 after a confirmatory trial failed. Currently, AstraZeneca is investigating Imfinzi for both early and late-stage bladder cancer across various treatment settings and combinations.

Endpoint Missed in NSCLC

On a less positive note, the Phase III ADJUVANT BR.31 study did not meet its primary endpoint in early-stage NSCLC. The study enrolled 1415 patients with Stage IB, II, or IIIA NSCLC with at least 25% PD-L1 expression on tumor cells. Participants were randomized to receive either Imfinzi or a placebo following resection, administered every four weeks for up to 48 weeks. The results showed that Imfinzi did not achieve the primary goal of disease-free survival compared to the placebo.

Despite the disappointing outcome in this study, Galbraith highlighted that Imfinzi has significantly impacted the treatment landscape for earlier stages of lung cancer, with multiple positive Phase III trials. Currently, Imfinzi is approved for patients with unresectable Stage III NSCLC, who have not experienced disease progression following chemoradiation in a curative-intent setting. It is also approved for treating metastatic NSCLC in combination with AstraZeneca’s anti-CTLA-4 antibody Imjudo (tremelimumab) and chemotherapy. Last year, Imfinzi generated $4.2 billion in sales.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!