AstraZeneca Presents Imfinzi (durvalumab) Plus tremelimumab Combination Data at AACR Annual Meeting

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CAMBRIDGE, United Kingdom, April 16, 2018 (GLOBE NEWSWIRE) -- AstraZeneca and MedImmune, its global biologics research and development arm, today presented efficacy and safety data from two Phase I trials evaluating (durvalumab) in combination with tremelimumab in 2nd-line immunotherapy-naïve patients with either non-squamous advanced non-small cell lung cancer (NSCLC) (Study 006) or metastatic urothelial carcinoma (mUC) (Study 10). The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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 is distinguished from durvalumab monotherapy in our Phase III MYSTIC and DANUBE trials, expected to read out later this year and next year, respectively.”

The combination of durvalumab and tremelimumab demonstrated a manageable safety profile in patients with advanced NSCLC. The most common treatment-related adverse events (AEs) were fatigue (19%), pruritus (17%), diarrhoea (15%), reduced appetite (14%) and rash (14%). 14 patients (7%) experienced a treatment-related AE that led to treatment discontinuation, and 23% experienced a Grade 3/4 treatment-related AE. There was one treatment-related death (multifactorial hypoxia).

The combination of durvalumab and tremelimumab demonstrated a manageable safety profile in patients with mUC. Treatment-related AEs occurred in 76% of patients and were Grade 3-4 in 29%. The most common treatment-related AEs were pruritus (26%), fatigue (24%), diarrhoea (20%), rash (14%) and increased lipase (12%). Treatment-related AEs led to discontinuation of therapy in 12% of patients. There was one treatment-related death (pulmonary haemorrhage).

For more information on AstraZeneca at AACR, please visit .

In February 2018, durvalumab received US FDA approval for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Durvalumab also received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

As part of a broad development programme, durvalumab is also being investigated as a monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, as a first line treatment for patients with NSCLC, small cell lung cancer, locally advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

We are pursuing a comprehensive clinical-trial programme that includes durvalumab (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

For more information, please visit and follow us on Twitter @AstraZeneca.

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Globe Newswire: 22:05 GMT Monday 16th April 2018

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