CONTEXT:  Report of findings from a RWE expanded access study in NSCLC patients presented at the European Lung Cancer Congress.  The initial findings showed a difference in outcomes for those receiving treatment in the real world setting compared to the study protocol.

IMPACT:  Medium

READ TIME:  5 mins

Quality Level Mean [1 – 10]:  8

1. “More patients with stage III non–small cell lung cancer (NSCLC) received sequential chemoradiation (CRT) and delayed the time to durvalumab (Imfinzi) treatment in a real-world setting compared with those enrolled on the phase 3 PACIFIC trial, according to preliminary findings of the PACIFIC-R study (NCT03798535) that was presented during the 2021 European Lung Cancer Congress.1. Results showed that the median time from completing radiation (RT) to starting durvalumab therapy was 52 days; 35% of patients began durvalumab within 42 days.” 

2. “The decision was based on interim results of the phase 3 PACIFIC trial, in which the addition of durvalumab led to a median progression-free survival (PFS) of 16.8 vs 5.6 months with placebo (HR, 0.52; 95% CI, 0.42-0.65; P <.0001) in this patient population.2 The 12-month PFS were 55.9% and 35.3% with durvalumab and placebo, respectively, and the 18-month PFS rates were 44.2% and 27.0%, respectively.” 

3. “In 4-year findings of the PACIFIC trial, the median overall survival (OS) was 47.5 months with durvalumab vs 29.1 months with placebo (HR, 0.71; 95% CI, 0.57-0.88).3 Additionally, the 4-year OS rates were 49.6% and 36.3% with durvalumab and placebo, respectively.” 

4. “For those who were treated longer than 14 days after RT, the median PFS was 14.0 months and 5.6 months for durvalumab and placebo, respectively (HR, 0.63; 95% CI, 0.49-0.80).4. Despite the advances with this clinical trial, McDonald noted that insights on treatment and clinical outcomes for patients receiving immunotherapy in a real-world setting are needed.” 

5. ““Following [European Medicines Agency] approval, the restriction in the last few months was to those who had a PD-L1 expression of at least 1%,” McDonald noted, adding that in France all patients had to have concurrent CRT.” 

Source URL: https://www.onclive.com/view/durvalumab-use-differs-in-real-world-pacific-stage-iii-nsclc-populations