Locally advanced NSCLC OS benefit shown for durvalumab
medwireNews: Patients with stage III non-small-cell lung cancer (NSCLC) that has not progressed after concurrent chemoradiotherapy derive a significant overall survival (OS) benefit from treatment with durvalumab, indicate PACIFIC trial findings.
In a comment to medwireNews, study author Davey Daniel (Tennessee Oncology, Chattanooga, USA) said that he was “very excited” by the survival data, which confirm the previously reported improvement in progression-free survival (PFS) versus placebo and now also show prolonged OS.
“For so many years, we have failed to make significant headway in treating locally advanced lung cancer,” he commented. “Now we see a significant improvement [with] a very well-tolerated treatment.”
Daniel continued: “I believe this is now a standard of care for those with locally advanced lung cancer.”
Over a median follow-up of 25.2 months, median OS was unreached for the 473 participants who were randomly assigned to receive consolidation therapy with durvalumab 10 mg/kg every 2 weeks for up to a year and was 28.7 months for the 237 patients who instead received placebo. This translated into a significant 32% reduced risk for death with the anti-PD-L1 agent.
At the 12-month mark, 83.1% of durvalumab-treated patients and 75.3% of those given placebo were still alive, while the OS rates at 24 months were 66.3% and 55.6%, respectively.
The updated analysis gave a median PFS duration of 17.2 months in the durvalumab group and 5.6 months in the placebo group, equating to a significant hazard ratio (HR) for progression or death of 0.51.
And time to death or distant metastasis was also significantly longer with durvalumab than placebo, at a median of 28.3 versus 16.2 months, and an HR of 0.53.
Daniel also noted the improvement in the time to second progression and time to second therapy with durvalumab, describing the findings as “striking.”
“I believe this reflects a slowing of the disease pace (even in the setting of progression) in those treated with immunotherapy,” he said.
Reporting on safety, the researchers say that the adverse event (AE) profile of durvalumab was consistent with previous reports and “[n]o new safety signals were identified.”
AEs of grade 3 or 4 occurred in 30.5% of patients given durvalumab and 26.1% of those given placebo, and led to treatment discontinuation in a corresponding 15.4% and 9.8%.
The rate of serious AEs was 29.1% and 26.1% in the durvalumab and placebo study arms, respectively, and AE-related death occurred in 4.4% and 6.4% of patients, respectively.
The results were presented at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer in Toronto, Ontario, Canada, and simultaneously published in The New England Journal of Medicine.
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