UK-based pharmaceutical company AstraZeneca has reported high-level results from the ADJUVANT BR.31 Phase III trial of Imfinzi (durvalumab) showing that the trial did not meet its primary endpoint.
The trial evaluated Imfinzi’s ability to treat NSCLC, enrolling 1,415 patients with Stage IB (≥4cm), II or IIIA NSCLC following complete tumour resection with or without adjuvant chemotherapy.
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The randomised, double-blind, multi-centre study was sponsored by the Canadian Cancer Trials Group (CCTG) and was carried out at 269 centres across 19 countries and regions.
Subjects were randomised 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.
Disease-free survival (DFS) in patients whose tumours expressed PD-L1 on 25% or more tumour cells and did not have known common EGFR mutations or ALK rearrangements was the trial’s primary endpoint.
The trial did not achieve statistical significance for the primary endpoint.
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By GlobalDataImfinzi’s safety profile in the trial was consistent with its previously reported safety data, with no new safety concerns being identified.
The drug continues to be investigated in various other early-stage lung cancer settings, including as a monotherapy and in combinations for medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable Stage III NSCLC (PACIFIC-5, 8, and 9).
AstraZeneca Oncology research and development executive vice-president Susan Galbraith said: “We are disappointed in the ADJUVANT BR.31 results.
“Imfinzi has helped change the treatment landscape and achieved multiple positive Phase III trials for patients with earlier stages of lung cancer.
“We are committed to addressing the remaining unmet need in lung cancer through our broad development programme.”
Last week, AstraZeneca shared results from a Phase III trial in which its flagship breast cancer drug, Truqap (capivasertib), did not improve overall survival rates.
