AstraZeneca trial of tremelimumab monotherapy for mesothelioma fails primary endpoint
AstraZeneca's DETERMINE study evaluating tremelimumab as a standalone treatment for mesothelioma did not meet its primary overall survival endpoint. The drug is being investigated in combination therapies.
AstraZeneca announced that its Phase IIb clinical trial, DETERMINE, evaluating tremelimumab monotherapy for unresectable malignant mesothelioma, did not meet its primary endpoint of overall survival. The trial tested the drug as a second or third-line treatment for patients who have no approved treatment options beyond first-line therapy.
The trial's outcome is a setback for patients with mesothelioma, a rare and challenging cancer with significant unmet medical needs. Median overall survival following diagnosis is typically between 9 and 12 months, and the disease accounts for approximately 43,000 deaths globally each year.
Despite the monotherapy trial's results, AstraZeneca maintains confidence in tremelimumab's potential when used in combination treatments. The drug is currently being studied alongside AstraZeneca's investigational anti-PD-L1 immunotherapy, durvalumab, across multiple cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, bladder, pancreatic, gastric, and liver cancers. Preclinical data suggest that targeting both PD-L1 and CTLA-4 may enhance the immune response against cancer cells.
AstraZeneca will conduct a full evaluation of the final DETERMINE trial data, which are slated for presentation at an upcoming medical meeting in 2016. Tremelimumab has previously received Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration for the treatment of malignant mesothelioma.