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Results From the ARCTIC Trial in Third-Line Treatment of NSCLC

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AstraZeneca and MedImmune have announced high-level results from the phase III ARCTIC trial in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who have received at least two prior treatments. This randomized, open-label, multicenter trial assessed the efficacy and safety of the combination of durvalumab (Imfinzi) plus tremelimumab, as well as durvalumab and tremelimumab monotherapies vs standard-of-care chemotherapy in patients with programmed cell death ligand 1 (PD-L1)-low or PD-L1–negative NSCLC (substudy B), and durvalumab monotherapy vs standard-of-care chemotherapy in patients with PD-L1–high NSCLC (substudy A). Tumor PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay, with PD-L1–high defined as ≥ 25% of tumor cells with membrane staining.

Study Results

In substudy B, the combination of durvalmab plus tremelimumab in patients with PD-L1–low or PD-L1–negative NSCLC did not meet the primary endpoints of a statistically significant and clinically meaningful improvement in progression-free survival and overall survival compared to standard-of-care chemotherapy. Activity and safety of monotherapy arms of substudy B were consistent with prior published data.

Substudy A was not powered for statistical significance; however, durvalumab monotherapy showed a clinically meaningful reduction in the risk of death compared to chemotherapy.

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

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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