AstraZeneca has big growth expectations for Imfinzi and is hoping to prove its medicine can treat cancer before the advanced stages. As part of that effort, the company is touting positive interim results for Imfinzi combined with chemotherapy in certain lung cancer patients before surgery.
In the phase 3 Aegean trial, Imfinzi plus chemo demonstrated meaningful improvements in helping early non-small cell lung cancer patients achieve no sign of cancer in resected tissue samples. The investigators looked at the drug's performance versus chemotherapy alone for this endpoint for a planned interim analysis, and the trial is continuing to assess whether the PD-L1 inhibitor can prevent disease recurrence or progression.
Compared with Imfinzi's current win on the pathologic complete response marker, event-free survival is a more approveable endpoint. Bristol Myers Squibb's Opdivo, used alongside chemo, in March became the first PD-1/L1 inhibitor approved by the FDA in the same neodjuvant non-small cell lung cancer setting based on data showing it could reduce the risk of recurrence, progression or death.
In a statement, Susan Galbraith, AstraZeneca's executive vice president of oncology R&D, noted the importance of treating lung cancer early. Engaging an immune response with Imfinzi both before and after surgery is an “exciting new strategy," she added.
Imfinzi is the global standard of care for stage 3 unresectable non-small cell lung cancer. Up to 30% of patients are diagnosed early enough for surgery, but only around 56% to 65% of patients with stage 2 disease progression will survive for five years. That number falls to 24% to 41% for patients with stage 3 disease.
AZ plans to share full data with regulators and at medical meetings when the event-free survival results become available. The company has several ongoing trials testing Imfinzi in the early stages of lung cancer.
Imfinzi is currently approved for stage 3 NSCLC in patients whose disease has not progressed after chemoradiotherapy in the U.S., Japan, China, and in many other countries across the EU. Lung cancer affects 2.2 million people worldwide as of 2020. It’s the leading cause of cancer mortality in both men and women, with 80% to 85% of lung cancer patients having NSCLC.
Since the drug’s first approval in 2017, Imfinzi has treated more than 100,000 patients.