AstraZeneca and MedImmune, its global biologics research and development arm, have presented positive trial data for two of its key oncology drugs.
Two Phase I trials evaluating Imfinzi (durvalumab) in combination with tremelimumab in 2nd-line immunotherapy-naïve patients with either non-squamous advanced non-small cell lung cancer (NSCLC) or metastatic urothelial carcinoma (mUC) were conducted to assess the efficacy and safety of the combination treatment.
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Data from the trials was presented at the American Association for Cancer Research annual meeting.
The combination therapy demonstrated clinical activity in PD-L1 ≥25% and <25% groups in both trials. It also demonstrated a manageable safety profile.
AstraZeneca Chief medical officer and executive vice-president of global medicines development Sean Bohen said: “The mature data sets from these Phase I trials help further characterise the overall survival of durvalumab plus tremelimumab combination in 2nd-line non-squamous non-small cell lung cancer and 2nd-line metastatic urothelial carcinoma.
“We look forward to exploring whether OS [overall survival] is distinguished from durvalumab monotherapy in our Phase III Mystic and Danube trials, expected to read out later this year and next year, respectively.”
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By GlobalDataImfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. It is the cornerstone of AstraZeneca’s immune-oncology portfolio, which has been boosted by several regulatory approvals in recent years.
The drug was approved by the US Food and Drugs Administration (FDA) for the treatment of Stage III non-small cell lung cancer in February. In May 2017 the FDA also granted the drug accelerated approval for the treatment of urothelial cancer.
Tremelimumab works by blocking the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer.
Astra Zeneca and Merck also presented positive overall survival results for Lynparza in metastatic breast cancer at the meeting.
