AstraZeneca presents positive phase 3 results for Imfinzi regimen in lung cancer

AstraZeneca

AstraZeneca’s (AZ) Imfinzi has shown promising results when used before and after surgery in resectable early-stage non-small cell lung cancer (NSCLC), according to new phase 3 data presented at the American Association for Cancer Research Annual Meeting.

Interim results from the AEGEAN study, which is assessing the PD-1/L1 inhibitor in combination with neoadjuvant chemotherapy before surgery and as a monotherapy after surgery, showed the regimen reduced the risk of disease recurrence, progression or death by 32%.

The combination also demonstrated a significant improvement in pathologic complete response, a dual primary endpoint, compared to chemotherapy alone, at a previously reported interim analysis.

The trial will continue as planned to assess key secondary endpoints including disease-free survival and overall survival, the company said.

Susan Galbraith, executive vice president, oncology R&D, AZ, said: “The AEGEAN trial shows this novel Imfinzi-based regimen meaningfully improved outcomes in resectable lung cancer, further validating the importance of moving lung cancer diagnosis and treatment to earlier stages of disease where patients have the highest potential for cure.

“We look forward to discussing this data with global regulatory authorities with the goal of providing this important new treatment option to patients.”

Around 2.2 million people are diagnosed with lung cancer globally each year, with NSCLC accounting for up to 85% of cases.

While around 25-30% of patients are diagnosed early enough to have surgery with curative intent, the majority will eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.

Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks its interaction with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

“Too many patients with resectable NSCLC experience disease recurrence and poor clinical outcomes today,” said John Heymach, professor and chair thoracic/head and neck medical oncology, the University of Texas MD Anderson Cancer Center.

“Adding durvalumab both before and after surgery has the potential to become a backbone combination approach that may alter the course of a patient’s cancer, significantly increasing the potential for cure,” he added.

Imfinzi is already approved in the curative setting for certain patients with unresectable NSCLC, as well as for the treatment of extensive-stage small cell lung cancer.

In addition to its indications in lung cancer, Imfinzi also holds approvals in locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma and previously treated advanced bladder cancer.

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