Sacituzumab govitecan (IMMU-132 or hRS7-SN-38) is an antibody-drug conjugate being investigated as a treatment for cancers such as pancreatic cancers, small-cell lung cancer (SCLC) and triple-negative breast cancer. It is being developed by Immunomedics, and in 2017, was licensed to Seattle Genetics.
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The FDA awarded breakthrough therapy status, an expedited investigational drug development pathway, in February 2016. Fast track designation was awarded in 2013 for treatment of non-small cell lung cancer, small cell lung cancer, and metastatic triple-negative breast cancer. Orphan drug status was granted for small cell lung cancer and pancreatic cancer.
Mechanism
It is a conjugate of the humanized anti-Trop-2 monoclonal antibody linked with SN-38, the active metabolite of irinotecan. Each antibody having on average 6.7 molecules of SN-38 attached. SN-38 is too toxic to administer directly to patients, but linkage to an antibody allows the drug to specifically target cells containing Trop-2.
Development
Activity has been seen in a phase II trial for metastatic triple-negative breast cancer. It was included in the I-SPY2 adaptive clinical trial for breast cancer and has 'graduated' to the later stage trials.
Immunomedics announced in late 2016 that they plan to submit a Biological License Application to the FDA within the next year.
Under a Special Protocol Assessment agreement, Immunomedics is conducting a phase III clinical trial in patients with triple-negative breast cancer.