PACIFIC-studien med IMFINZI (Durvalumab)

PACIFIC är den indikationsgrundande fas III-studien som undersökt effekt oh säkerhet för Imfinzi hos patienter med icke-resektabel, stadium III icke-småcellig lungcancer (NSCLC), efter kemoradioterapi (CRT).

En uppföljningsanalys av överlevnad (OS) och progressionsfri överlevnad (PFS) efter 5 år är publicerad.^1-3

PACIFIC study design²

PACIFIC Updated OS (PD-L1 ≥1% population)*

Imfinzi – Overall survival 50.1% after 5 years³

* Prespecified and exploratory post-hoc subgroup analysis. Unstratified HR, no statistical analyses performed for this comparison.

CI=confidence interval; HR=hazard ratio; NR=not reached; OS=overall survival; PD-L1=programmed cell death-ligand 1; TC=tumor cell.

† Treatment effect estimated using an unstratified Cox proportional hazards model.

PACIFIC updated PFS (PD-L1 ≥ 1% population by BICR)*

Imfinzi – 35.8% of patients had not progressed after 5 years³

* Prespecified and exploratory post-hoc subgroup analysis. Unstratified HR, no statistical analyses performed for this comparison.

BICR= Blinded Independent Central Review confidence interval; HR=hazard ratio; NR=not reached; PD-L1=programmed cell death-ligand 1; PFS=progression-free survival; TC=tumor cell.

† Treatment effect estimated using an unstratified Cox proportional hazards model.

PACIFIC updated PFS (ITT-population)

Imfinzi -33,1% had not progressed after 5 years.^3*

* Stratified HR. Statistical analysis not performed for this comparison. Stratified HR from the primary analysis of median PFS,  (95% CI): 0.52 (0.42 to 0.65), p<0.0001.

CI=confidence interval; HR=hazard ratio; ITT=intention-to-treat; NR=not reached; PFS=progression-free survival.

PACIFIC study
Progression-free survival (PFS) across prespecified subgroups (ITT population)³

CI=confidence interval; HR=hazard ratio; ITT=intention-to-treat; PFS=progression-free survival.

Safety

In the PACIFIC study
IMFINZI vs. placebo following CRT¹

Any-grade immune-mediated adverse events reported in ≥1% of patients²


* Grade 5 immune-mediated AEs occured in 4 patients (0.8%) recvieving durvalumab and 3 patients (1.3%) recieving placebo.

Overall the safety profile of durvalumab in PD‑L1 TC ≥ 1% subgroup was consistent with the intent to treat population, as was the PD‑L1 TC < 1% subgroup.