AstraZeneca says ADJUVANT BR.31 Phase III trial did not achieve primary endpoint

High-level results from the ADJUVANT BR.31 Phase III trial, sponsored by the Canadian Cancer Trials Group, showed Imfinzi did not achieve statistical significance for the primary endpoint of disease-free survival, or DFS, versus placebo in early-stage non-small cell lung cancer, or NSCLC, after complete tumour resection in patients whose tumours express PD-L1 on 25% or more tumour cells, AstraZeneca announced. Imfinzi is also being investigated as monotherapy and in combinations in several other early-stage lung cancer settings, including in medically inoperable or unresected Stage I-II NSCLC and unresectable, Stage III NSCLC, the company noted. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, 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.”