logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Novacyt S.A. said it is seeing unprecedented demand for the novel coronavirus or COVID-19 diagnostic test kit developed by Primerdesign, the company's molecular diagnostics division based in the UK. As of March 27, Primerdesign has sold and received orders for more than 17.8 million pounds of its CE-Mark COVID-19 tests. Novacyt is currently selling its COVID-19 test to more than 80 countries. The U.S. Food and Drug Administration has issued an Emergency Use Authorization to allow anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile as possible treatments for coronavirus (COVID-19) patients. This is the first EUA for a drug related to the COVID-19 response. Gilead Sciences Inc. said it is transitioning to "expanded access programs" from "compassionate use" programs for its experimental anti-coronavirus drug, remdesivir. The company noted that the expanded access will allow hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at one time, as they struggle to deal with the COVID-19 or coronavirus pandemic.
Follow RTT
>