- In a phase 2b study, AstraZeneca's (AZ) tremelimumab did not improve overall survival in patients with advanced mesothelioma.
- The CEO Robert Iannone conceded that although tremelimumab is out of the running for a monotherapy indication, it will now be testing in combination with other oncologic immunotherapy drugs.
- This phase 2 failure is seen as a setback for AZ, which is pinning its hopes on developing a portfolio of new drugs, including immuno-oncologics, to offset lost revenues from patent expiries.
In April 2015, the FDA granted AZ Orphan Drug status for tremelimumab, an anti-CTLA-4 monoclonal antibody, for treatment of mesothelioma. Usually caused by exposure to asbestos, mesothelioma is currently treated surgically and associated with a poor prognosis. According to the American Cancer Society, patients diagnosed at stage 1 have a median survival of 21 months, while a stage 4 diagnosis yields a median life expectancy of just one year.
With roughly 20,000 people affected each year, mesothelioma is rare, but it is associated with a significant unmet medical need because there are no second-line treatments.
Currently, tremelimumab is being studied in combination with the anti-PD-L1 immunotherapy drug durvalumab for treatment of non-small cell lung cancer (NSCLC) and head and neck cancer. It is also being studied in combination with Iressa (gefitinib) in EGFR-mutated NSCLC and with MEDI6469, also an immunotherapy, in solid tumors.