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AstraZeneca refines endpoints in immuno-oncology trials for NSCLC

PBR Staff Writer Published 18 January 2017

AstraZeneca has refined the endpoints of its phase III clinical trial, Mystic, evaluating durvalumab and tremelimumab for first-line treatment of patients with non-small cell lung cancer (NSCLC).

The trial’s original objective was the effect on progression-free survival (PFS) but the company has now added overall survival (OS), both for the combination and durvalumab monotherapy.

The company expects PFS data to be available by middle of this year and final OS data no later than 2018.

Additionally, AstraZeneca is expanding the ongoing phase 3 Neptune study with local patients to support a regulatory submission in China for the combination in first-line NSCLC.

A new phase III trial has been started to assess durvalumab monotherapy versus standard-of-care chemo in first-line NSCLC patients whose tumors express programmed death ligand-1 (PD-L1).

It will focus on Asian countries, primarily China, because of the high prevalence of NSCLC in the region.

AstraZeneca executive vice president, global medicines development and chief medical officer Sean Bohen said: “The Mystic trial amendments, the Neptune trial expansion and initiation of the new PEARL trial are all designed to enhance our options in 1st-line NSCLC for IO-IO combination as well as for IO monotherapy.

“We continue to follow the science through both internal and external sources for the benefit of patients and look forward to sharing our first pivotal data in mid-2017.”

Durvalumab is an investigational human monoclonal antibody directed against PD-L1. It blocks PD-L1 interaction with both PD-1 and CD80 on T cells to counter the tumour's immune.

Tremelimumab is a fully human monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4.


Image: AstraZeneca’s laboratory testing. Photo: courtesy of AstraZeneca.