AZ’s Durvalumab/Tremelimumab combo flops in NSCLC

Durvalumab plus tremelimumab missed the primary endpoint as third-line treatment in a subpopulation of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who showed low PD-L1 expression in a pivotal Phase III trial (NCT02352948). Last summer AstraZeneca already missed the progression-free survival endpoint in another Phase III trial designed to show efficacy of the combo in stage IV NSCLC patients.

In about patients with high PD-1 expression, who had two or more prior treatments, durvalumab/tremelimumab treatment reduced the risk of death vs chemotherapy. Clinical activity with single-agent durvalumab or tremelimumab was similar to previously reported outcomes,  AstraZeneca (MedImmune), the developer of both agents, noted in a statement. However, in patients, in which less than a quarter of tumour cells carried the PD-L1 marker did not show statistical significant improvement of progression-free survival (PFS) and overall survival (OS) compared to chemotherapy.

“While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in this heavily pretreated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting,” said Sean Bohen, MD, Phd, executive vice president, Global Medicines Development and Chief Medical Officer, AstraZeneca.

Latest findings from competitors suggest that adding chemotherapy to immunotherapy, rather than giving two checkpoint blockers together, is the most promising approach, reports Reuters.