David R. Spigel, MD, presents data from the 2021 American Society of Clinical Oncology annual meeting on the updated results from the phase 3 PACIFIC trial of durvalumab treatment after chemotherapy in patients with unresectable stage III non-small cell lung cancer
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David R. Spigel, MD, discusses data from the following presentation:
5-year survival outcomes with durvalumab after chemotherapy in unresectable stage III non-small cell lung cancer – an update from the PACIFIC trial (Spigel, ASCO 2021, Abstract 8511)
The objective of this study is to report the updated and 5-year overall survival (OS) and progression free survival (PFS) outcomes from the PACIFIC trial (NCT02125461).
Phase 3 trial:
Comparator arm: durvalumab (10 mg/kg q2w) up to 12 months (N = 476)
Control arm: placebo (q2w) up to 12 months (N = 237)
Patients were randomized 2:1 and treatment effects were examined in the intent-to-treat population.
Primary end points: PFS by RECIST v1.1 and OS
Conclusions: efficacy
Durvalumab is a programmed death-ligand 1 (PD-L1) antibody thatdemonstrated meaningful clinical benefits in:
OS with 42.9% vs 33.4% of patients surviving at 5-years for durvalumab and placebo treated patients, respectively (HR = 0.72; 95% CI 0.59-0.89).
PFS with 33.1% and 19.0% of patients surviving and without disease progression at 5-years for durvalumab and placebo treated patients, respectively (HR = 0.55; 95% CI 0.45-0.68).
Conclusions: safety
No new safety signals were noted in the 5-year analysis.
In the updated and 5-year analysis of the PACIFIC trial, a sustained OS and PFS was noted in durvalumab treated patients with unresectable stage III non-small cell lung cancer.
Nearly 1/3 of patients treated with durvalumab remained alive and without disease progression at 5-years, leading to a new benchmark for the standard of care.
Investigations using the PACIFIC regimen are underway with other chemotherapy treatments to examine further potential clinical benefits.