Durvalumab stage III NSCLC benefits extends to overall survival
medwireNews: Updated findings from the PACIFIC trial demonstrate a significant improvement in overall survival (OS) with the immune checkpoint inhibitor durvalumab for patients with stage III unresectable non-small-cell lung cancer (NSCLC) that has not progressed after concurrent chemoradiotherapy.
The phase III trial investigators previously demonstrated improved progression-free survival (PFS) for the 473 patients who received the PD-L1 inhibitor at a dose of 10 mg/kg every 2 weeks for up to 1 year compared with the 236 patients given placebo.
Scott Antonia, from the H Lee Moffitt Cancer Center in Tampa, Florida, USA, and team now report the OS findings for the study after a median of 25.2 months of follow-up. At this time, the 24-month OS rate was 66.3% with durvalumab versus 55.6% with placebo, giving a significant stratified hazard ratio (HR) for death of 0.68.
“[T]he results of the analysis of overall survival indicate that the progression-free survival benefit has translated to a significant prolongation in overall survival”, the researchers write, noting that the OS benefit was present in all prespecified subgroups.
The co-primary endpoint of PFS was updated to a median of 17.2 months with durvalumab versus 5.6 months with placebo, with a significant stratified HR for disease progression or death of 0.51. And the secondary endpoint of time to death or distant metastases was a median of 28.3 versus 16.2 months and a significant stratified HR of 0.53.
Grade 3 or 4 adverse events of any cause occurred in 30.5% of durvalumab-treated patients versus 26.1% of controls. Treatment was discontinued because of side effects by 15.4% of the durvalumab arm and 9.8% of controls, most commonly because of pneumonitis (4.8 vs 2.6%), radiation pneumonitis (1.3 vs 1.3%) and pneumonia (1.1 vs 1.3%).
“These findings help to define the safety profile of durvalumab use after chemoradiotherapy, despite the trial being limited in its ability to distinguish or assign causality for some adverse events or to identify risk factors for their occurrence, owing to incomplete data regarding previous treatment”, Antonia et al comment.
The current findings have been published in The New England Journal of Medicine and simultaneously presented at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer in Toronto, Ontario, Canada.
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