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Update On The Phase III NEPTUNE Trial Of Imfinzi Plus Tremelimumab In Stage IV Non-Small Cell Lung Cancer

(AstraZeneca) Aug 21, 2019 - AstraZeneca today announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients. The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumour mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumour, and tumours with high levels of TMB may be more visible to the immune system.1,2

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H. Jack West, MD (Posted: August 21, 2019)

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Disappointing but not surprising. Despite the recent press release about CheckMate 227 results showing nivo/ipi beating chemo alone in first line NSCLC, the combination doesn't come close to deserving to displace the chemo/pembro combinations or pembro monotherapy that have handily beaten chemo already and are the current standards of care. And nivo/ipi has at least had some positive traction, while durva/treme has failed in every lung cancer setting in which it has been studied.

The durva/treme regimen deserves to be relegated to "asked and answered" status in lung cancer research. It has failed every way it can. In the process, it has only dampened enthusiasm for the concept of IO combinations and the potential benefit of TMB in clinical decision making, concepts that are on the cusp of being integrated at least into the margins of practice but are more questionable with the release of these findings.

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