Date: 2017-07-27
Type of
information: Results
phase: 3
Announcement: results
Company: AstraZeneca (UK)
Product: durvalumab (MEDI4736) and tremelimumab
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. This antibody is directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells.
Tremelimumab is a fully human monoclonal antibody which binds to the protein CTLA-4, expressed on the surface of activated T lymphocytes.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Republic of Korea, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Thailand, Vietnam, USA
Trial
details:
- The MYSTIC trial is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC.
- The trial is being conducted in 167 centres across 17 countries, including the US, Canada, Europe, parts of Asia including Japan, Korea, Thailand, Taiwan and Vietnam, and in Russia and Australia. Primary endpoints include progression free survival and overall survival.(NCT02453282)
Latest
news:
- • On July 27, 2017, AstraZeneca and MedImmune announced progression-free survival (PFS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi® (durvalumab) monotherapy or Imfinzi® in combination with tremelimumab versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer. The combination of Imfinzi® and tremelimumab did not meet the primary endpoint of improving progression free survival compared to standard of care in patients whose tumours express PD-L1 on 25% or more of their cancer cells (as determined by the VENTANA PD-L1 (SP263) assay).
- As a secondary endpoint, although not formally tested, Imfinzi® monotherapy would not have met a pre-specified threshold of PFS benefit over standard of care in this disease setting. The trial will continue to assess two additional primary endpoints of overall survival (OS) for Imfinzi® monotherapy and OS for the Imfinzi® plus tremelimumab combination. Final OS data from both primary endpoints are expected during the first half of 2018.
- Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “While the results from the MYSTIC trial for progression-free survival in first-line Stage IV non-small cell lung cancer compared with standard of care are disappointing, the trial was designed to assess overall survival and we look forward to evaluating the remaining primary endpoints of overall survival for both mono- and combination therapy.”
- • On May 20, 2015, a Phase 3 trial sponsored by AstraZeneca was published on the NIH website ClinicalTrials.gov for durvalumab (MEDI4736) and tremelimumab and is currently recruiting participants.
Is
general: Yes
