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AstraZeneca announces tremelimumab setback in mesothelioma test

pharmafile | March 1, 2016 | News story | Manufacturing and Production, Research and Development AstraZeneca, Cancer, MedImmune, tremelimumab 

AstraZeneca and its global biologics research and development arm, MedImmune, have announced a setback in the result of their Phase IIb clinical trial of tremelimumab as a monotherapy treatment for the cancer mesothelioma.

DETERMINE, the trial of 10 mg/kg tremelimumab in second or third-line treatment of unresectablable malignant mesothelioma, failed to meet its primary endpoint of overall survival, the companies revealed.

However, the British-based company said the drug remains a key component of its immuno-oncology strategy, in combination with other drugs, across multiple tumour types, including non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck, bladder, pancreatic, gastric and liver cancers. The preclinical data in AstraZeneca’s studies of tremelimumab has suggested that targeting both PD-L1 and CTLA-4 may have additive or synergistic effects.

Robert Iannone, senior vice president, head of immuno-oncology, Global Medicines Development at AstraZeneca, comments: “We are disappointed that tremelimumab monotherapy did not demonstrate a survival benefit in this patient population with no approved medicines beyond first-line treatment. However, we remain confident in tremelimumab’s clinical activity in combination, as shown in our recently published Study 006 trial of tremelimumab and durvalumab in non-small cell lung cancer.”

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AstraZeneca said it will complete a full evaluation of the DETERMINE data, before submitting it for presentation at an upcoming medical meeting later this year.

Mesothelioma is a rare and deadly form of cancer that affects the lining of the lungs or abdomen. Treatment options, particularly for patients with advanced disease, are limited, with the average patient surviving just nine to 12 months after they are first diagnosed. Tremelimumab was granted Orphan Drug Designation by the US FDA in April 2015.

Sean Murray

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