PACIFIC-2 Phase III Trial of Durvalumab Combined with Chemoradiotherapy Fails to Meet Primary Endpoint of Progression-Free Survival in Unresectable Stage III NSCLC

Nov 15, 2023 20:20 CST Updated 20:20

AstraZeneca

Biopharmaceutical Manufacturer

On November 14, AstraZeneca announced the latest results of the PACIFIC-2 Phase III clinical trial, which did not achieve statistically significant results for the primary endpoint of progression-free survival (PFS).

PACIFIC-2 is a randomized, double-blind, placebo-controlled multicenter Phase III clinical trial designed to compare the efficacy of durvalumab in combination with platinum-based chemoradiotherapy (CRT) versus CRT alone in the treatment of unresectable Stage III non-small cell lung cancer (NSCLC).

Figure 1: PACIFIC 2 Study Design

Based on the results of the PACIFIC trial, sequential administration of durvalumab after platinum-based chemoradiotherapy (CRT) for unresectable stage III NSCLC has become the global standard regimen. The PACIFIC-2 trial was conducted to evaluate the efficacy of concurrent administration of durvalumab with CRT, aiming to address disease progression or treatment discontinuation during CRT, which could prevent the implementation of the PACIFIC regimen.Progress.

Figure 2: PACIFIC Study Design

Despite an observed increase in infection rates in the experimental group during the trial, the initial analysis of safety and tolerability in patients treated with durvalumab in combination with CRT showed results broadly consistent with other current treatment regimens.

Jeffrey D. Bradley, MD, Vice Chair of Proton Therapy and Technology Development at the University of Pennsylvania School of Medicine in Philadelphia and principal investigator of this trial, stated: "Although the PACIFIC-2 trial did not yield the results we had hoped for, the PACIFIC regimen remains the standard of care for patients with unresectable stage III NSCLC. As a community, we will learn from these results to advance future research."

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated: "The goal of the PACIFIC-2 trial was to address the unmet clinical needs of some patients by introducing immunotherapy earlier and simultaneously administering durvalumab alongside chemoradiotherapy. Although today's results did not reach statistical significance, we will learn from this trial and continue our commitment to improving patient outcomes by expanding the benefits of immunotherapy across different treatment regimens for lung cancer patients."

Editor: lsh

Title image: Tuchong Creatives

Submission: luoshuhan@dxy.cn