AstraZeneca has reported that its Phase III PACIFIC-2 clinical trial of Imfinzi (durvalumab) plus chemoradiotherapy (CRT) in unresectable, Stage III, non-small cell lung cancer (NSCLC) patients missed the primary endpoint.

The placebo-controlled, randomised, multi-centre, double-blind, global trial analysed Imfinzi dosed alongside platinum-based CRT. 

It enrolled 328 subjects at 88 trial sites spread across more than 20 countries. 

Progression-free survival (PFS) was the trial’s primary endpoint while secondary endpoints comprised objective response rate, overall survival, and duration of response.

According to the findings, the trial failed to attain statistically significant PFS following the Imfinzi combination regimen versus CRT alone.

Data from the preliminary analysis showed that the safety and tolerability profiles of Imfinzi and CRT in patients were in line with those that had already been reported.

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In addition, in the experimental arm, a higher infection rate was reported during concurrent treatment.

Sequential dosing of Imfinzi following platinum-based CRT is the established standard of care for unresectable Stage III NSCLC.

AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “Our goal with the PACIFIC-2 trial was to address a remaining unmet need for patients in this setting by introducing immunotherapy even earlier and concurrently administering Imfinzi with chemoradiotherapy. 

“While the results did not reach statistical significance, we will learn from this trial and we remain committed to improving patient outcomes by expanding the benefit of immunotherapy to lung cancer patients across treatment settings.”

In another development, China’s National Medical Products Administration (NMPA) granted approval for AstraZeneca’s Imfinzi plus chemotherapy regimen, comprising gemcitabine and cisplatin, as a first-line treatment for locally advanced or metastatic biliary tract cancer in adults.

The latest development comes after the company reported positive topline data from the Phase III EMERALD-1 trial of Imfinzi (durvalumab) for hepatocellular carcinoma.