Mesothelioma Drug Fails to Meet Expectations in Clinical Trial
During the week mesothelioma advocates were raising awareness to the plight of mesothelioma patients through Rare Disease Day, held Feb. 29, the community received the devastating news that a once promising mesothelioma treatment failed to meet expectations in a trial. Unfortunately, the news heightens the sense of urgency that mesothelioma patients experience every day when looking for a lifeline.
Tremelimumab, an immunotherapy from AstraZeneca received Orphan Drug Designation from the U.S. Food and Drug Administration in April after early results from a mesothelioma clinical trial with the drug found that an intensive regimen increased survival and was safe. However, the company announced on Feb. 29 that results of the clinical trial “did not meet primary endpoint of improving overall survival in challenging to treat mesothelioma patients with no currently approved treatment options in the second-line setting.”
Mesothelioma is one of nearly 7,000 diseases that are considered rare, or orphan, by the US government. In the United States an orphan disease status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time. In the case of mesothelioma, 3,000 Americans are diagnosed with the incurable disease each year. Rare Disease Day is an international advocacy day designated to raise public awareness of rare diseases and to bring widespread recognition of rare diseases as a global concern.
Tremelimumab, an immunotherapy drug that targets the T Cell receptor protein cytotoxic T-lymphocyte-associated protein 4 (CTLA4), belongs to a class of drugs that are known as “immune checkpoint inhibitors.” Immunotherapy treatment has been leading the news as the latest breakthrough in effective treatments for mesothelioma patients who often have no other treatment options.
Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca, said in a Feb. 29 press release from AstraZeneca:
“We are disappointed that tremelimumab monotherapy did not demonstrate a survival benefit in this [meosthelioma] 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.”
MesotheliomaHelp brought our readers the promising results tremelimumab was showing in early results of the clinical trial, as well as the FDA’s Orphan Designation news.
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