Updated results presented Tuesday at the World Conference on Lung Cancer (WCLC) showed that AstraZeneca's Imfinzi (durvalumab) reduced the risk of death by almost one third regardless of PD-L1 status when used as monotherapy for the treatment of locally-advanced, unresectable non-small-cell lung cancer (NSCLC). Data from the Phase III PACIFIC study indicated that median overall survival (OS) was 28.7 months for patients on placebo, while it has not yet been reached for those receiving Imfinzi.
Chief medical officer Sean Bohen said "these data establish Imfinzi as the first immunotherapy to demonstrate an overall survival benefit for patients with unresectable, Stage III non-small cell lung cancer following chemoradiation therapy."
The trial randomised 713 patients with locally-advanced, unresectable NSCLC, regardless of PD-L1 status, whose disease has not progressed following platinum-based chemotherapy and radiation therapy to receive either Imfinzi or placebo. The study's primary endpoints were progression-free survival (PFS) and OS.
Last year, AstraZeneca reported that in the trial, Imfinzi significantly prolonged PFS by more than 11 months versus placebo, with PFS in the two groups of 16.8 months and 5.6 months, respectively. The company later announced that the OS goal had also been met. On Tuesday, the company noted that updated PFS remained similar, with a median of 17.2 months for Imfinzi and 5.6 months for placebo.
Earlier this week, the European Commission approved Imfinzi as monotherapy for the treatment of locally-advanced, unresectable NSCLC in adults whose tumours express PD-L1 on at least 1 percent of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. The clearance was based on results from the PACIFIC trial, while the FDA approved Imfinzi in this indication in February, although the US regulator did not restrict use of the PD-L1 inhibitor to patients whose tumours express PD-L1.
For further analysis, read ViewPoints: WCLC - A potential devil in the details for AstraZeneca’s PACIFIC study.
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