AstraZeneca Ends Volrustomig Trial for First-Line Metastatic NSCLC

Rákkutatás · NSCLC

Durvalumab consolidation improves progression‑free survival compared with placebo in patients with stage III NSCLC who have not progressed after platinum‑based chemoradiotherapy.

Background: Locally advanced, unresectable stage III NSCLC often progresses after definitive chemoradiotherapy. This phase‑3, randomized 2:1 study compared durvalumab, a PD‑L1 inhibitor, as consolidation therapy versus placebo in patients who had not progressed after two or more cycles of platinum‑based chemoradiotherapy. Methods: Patients received durvalumab (10 mg/kg IV every 2 weeks, up to 12 months) or placebo, starting 1–42 days post‑chemoradiotherapy. Primary endpoints were progression‑free survival (PFS) and overall survival. Secondary endpoints included 12‑month and 18‑month PFS rates, objective response rate (ORR), duration of response, time to death or distant metastasis, and safety. Results: Of 713 randomized, 709 received study treatment (473 durvalumab, 236 placebo). Median PFS was 16.8 months with durvalumab versus 5.6 months with placebo (HR 0.52, 95% CI 0.42‑0.65, P < 0.001). 12‑month PFS rates were 55.9% vs 35.3%; 18‑month rates 44.2% vs 27.0%. ORR was 28.4% vs 16.0%. Median time to death or distant metastasis was 23.2 months vs 14.6 months. Grade 3/4 adverse events occurred in 29.9% (durvalumab) vs 26.1% (placebo). Conclusions: Durvalumab consolidation provides a clinically meaningful PFS benefit with a manageable safety profile in stage III NSCLC after chemoradiotherapy.

The study demonstrates that adding durvalumab after standard chemoradiotherapy prolongs disease control in stage III NSCLC, offering a new standard of care that may improve long‑term outcomes for patients who would otherwise experience rapid relapse.

Bizonyítékszint: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.

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