British drug major AstraZeneca Plc. (AZN.L,AZN) Thursday announced positive high-level results from a planned interim analysis of the AEGEAN Phase III trial that evaluated Imfinzi (durvalumab) plus chemotherapy in resectable non-small cell lung cancer.
The company noted that Imfinzi in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response or pCR compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer or NSCLC.
A statistically significant improvement in major pathologic response or MPR was also observed.
The trial will continue to assess the additional primary endpoint of event-free survival or EFS to which the company, investigators and participants remain blinded.
The company said the safety and tolerability of adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination.
AstraZeneca will share the pCR data with global health authorities and present at a forthcoming medical meeting when EFS results are available.
Imfinzi is approved in the curative-intent setting of unresectable Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy in the US, Japan, China, across the EU and many other countries.
Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial.
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