AstraZeneca’s trial of Imfinzi for lung cancer did not meet primary endpoint

AstraZeneca, a UK-based pharmaceutical company, has reported outcomes from the ADJUVANT BR.31 Phase III trial of Imfinzi (durvalumab), indicating that the trial did not meet its primary endpoint. This study involved 1,415 patients with Stage IB (≥4cm), II, or IIIA non-small cell lung cancer (NSCLC) after complete tumour resection, with or without adjuvant chemotherapy.

Conducted by the Canadian Cancer Trials Group (CCTG) across 269 centres in 19 countries, the randomized, double-blind trial assigned patients at a 2:1 ratio to receive a 20mg/kg intravenous infusion of Imfinzi or a placebo every four weeks for up to 48 weeks. The primary endpoint was disease-free survival (DFS) in patients with PD-L1 expression on ≥25% of tumour cells and no EGFR mutations or ALK rearrangements.

Imfinzi’s safety profile in the trial was consistent with previous reports. Despite these results, AstraZeneca continues investigating Imfinzi in other early-stage lung cancer settings, including as monotherapy and combinations for Stage I-II and unresectable Stage III NSCLC (PACIFIC-4, 5, 8, and 9).