The trial, evaluating the programmed death ligand-1 inhibitor durvalumab, alone or in combination with tremelimumab, versus platinum-based chemotherapy, has refined its endpoints to include overall survival (OS) along with progression-free survival.
A phase III trial evaluating the effect of the programmed death ligand-1 (PD-L1) inhibitor durvalumab, alone or in combination with tremelimumab, versus platinum-based chemotherapy, has refined its endpoints to include overall survival (OS) along with progression-free survival (PFS).
The randomized, multi-center, open-label trial, called MYSTIC, was designed to test whether durvalumab can be used as front-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who express wild-type epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) and PD-L1. The original primary outcome measure was PFS at 3 years, while secondary outcome measures include health-related quality of life, pharmacokinetics of the drugs, and immunogenicity of the biologicals durvalumab and tremelimumab.
In a press release, AstraZeneca, which is developing the drug, said that the decision to include OS as an endpoint “is based on recent internal and external data, including durvalumab’s strong efficacy in monotherapy presented at recent medical meetings, as well as significant opportunities in the competitive landscape.” This update will extend OS data collection to 2018, while PFS data are expected in mid-2017, in addition to several interim analyses for OS.
The company is simultaneously testing durvalumab as monotherapy (PEARL trial) or in combination with tremelimumab (NEPTUNE trial) against standard-of-care platinum-based chemotherapy, in patients with EGFR and ALK wild-type advanced or metastatic NSCLC.
“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,” Sean Bohen, executive vice president, Global Medicines Development and CMO at AstraZeneca, said in the press release.
Durvalumab is a PD-L1 inhibitor that received breakthrough designation for use in bladder cancer early last year. By interacting with both, the programmed death-1 receptor and CD80 on T cells, it boosts the immune system’s tumor-detecting capacity. AstraZeneca is also evaluating this antibody in head and neck cancer, liver cancer, and blood cancer.
Frameworks for Advancing Health Equity: Urban Health Outreach
May 9th 2024In the series debut episode of "Frameworks for Advancing Health Equity," Mary Sligh, CRNP, and Chelsea Chappars, of Allegheny Health Network, explain how the Urban Health Outreach program aims to improve health equity for individuals experiencing homelessness.
Listen
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
Study Highlights Significant Increases in Utilization, Spending on DMD Drugs in Medicaid
May 17th 2024The findings add to recent research on the growing utilization, expenditure, and prices of Duchenne muscular dystrophy (DMD) therapies in the current landscape, an area health care policy could potentially address.
Read More