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AstraZeneca: Phase III NEPTUNE Trial Of Imfinzi Fails To Meet Primary Goal

AstraZeneca plc (AZN.L,AZN) announced Wednesday final overall survival or OS results from the Phase III NEPTUNE trial of Imfinzi plus tremelimumab in Stage IV non-small cell lung cancer or NSCLC.

In the trial, the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving OS, while safety and tolerability profile for the combination was consistent with previous trials.

The Phase III NEPTUNE trial was a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care or SoC platinum-based chemotherapy in previously-untreated Stage IV (metastatic) NSCLC patients.

The trial is being conducted in more than 200 centres across 29 countries, including the US, Europe, South and Central America, the Middle East and Asia.

The company noted that the trial was performed in an all-comers population. The primary analysis population was patients with a high tumour mutational burden or TMB, which is a measurement of the number of mutations within the genome of a tumour.

According to the company, in the primary analysis population of patients whose blood TMB was 20 or more mutations per megabase or mut/Mb, the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving OS compared to SoC chemotherapy.

José Baselga, Executive Vice President, Oncology R&D said, "We are fully committed to a deep analysis of the vast clinical and biomarker data from this trial to gain further insights to improve Immuno-Oncology approaches for patients with metastatic non-small cell lung cancer."

AstraZeneca plans to submit the full results for presentation at a forthcoming medical meeting.

Imfinzi is also being tested as monotherapy in the Phase III PEARL trial, and in combination with chemotherapy with or without tremelimumab in the Phase III POSEIDON trial. These are part of an extensive late-stage Immuno-Oncology programme in Stage IV NSCLC.

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