Rapid Readouts: Updated Results and 5-Year Survival Outcomes From the PACIFIC Trial

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.