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2021 American Society of Clinical Oncology (ASCO) Annual Meeting

‘PACIFIC regimen’ shows long-term survival benefit with durvalumab in advanced NSCLC

2021-09-10


Improvements in overall survival (OS) and progression-free survival (PFS) were maintained with durvalumab in patients with unresectable stage III metastatic non-small cell lung cancer (NSCLC), according to updated results of the PACIFIC* trial presented at ASCO 2021.

This phase III, international, double-blind trial analysed 713 patients with unresectable stage III NSCLC who did not have disease progression after ≥2 cycles of platinum-based concurrent chemotherapy. Participants were randomly assigned to receive either durvalumab 100 mg/kg (n=476) or placebo (n=235) every 2 weeks for up to 12 months. [ASCO 2021, abstract 8511]

As of data cut-off on January 11, 2021, almost 60 percent of the participants had died, with 55.5 percent and 65.4 percent of the patients reported in the durvalumab and placebo arms, respectively.

In this updated analysis, a consistent improvement in OS and PFS was observed among patients treated with durvalumab compared with placebo at 5 years (median 47.5 vs 29.1 months; stratified hazard ratio [HR], 0.72 [OS] and median 16.9 vs 5.6 months; stratified HR, 0.55 [PFS]).

The updated 5-year OS and PFS rates were consistently higher in the durvalumab arm vs the placebo arm (42.9 percent vs 33.4 percent [OS] and 33.1 percent vs 19.0 percent [PFS]), indicating that more durvalumab- than placebo-treated patients remain alive and free of disease progression at 5 years.

“This establishes a new benchmark for the standard of care in the unresectable stage III NSCLC setting,” said lead author Dr David Spigel from the Sarah Cannon Research Institute/Tennessee Oncology in Nashville, Tennessee, US.

“The OS and PFS benefits with durvalumab vs placebo at this 5-year analysis were consistent with the findings of the primary analyses [in the overall population and across all subgroups],” Spigel noted.

“These updated results, based on 5-year data from the PACIFIC trial, demonstrated robust and sustained OS plus durable PFS benefit with the PACIFIC regimen,” Spigel concluded.

“The PACIFIC regimen is being investigated with different chemotherapy regimens, and with durvalumab in combination with other agents after chemotherapy, to extend clinical benefit to more patients in this setting,” he added.

 

*PACIFIC: A global study to assess the effects of MEDI4736 following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer

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