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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.
The FDA granted breakthrough therapy status, an expedited investigational drug development pathway, in February 2016. Fast track designation was received 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
Breast cancer
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.
Under a Special Protocol Assessment agreement, Immunomedics is conducting a phase III clinical trial in patients with triple-negative breast cancer.
In Dec 2017 Immunomedics said they expect to submit a Biological License Application to the FDA in the first quarter of 2018 for accelerated approval of sacituzumab govitecan as a third-line treatment for patients with mTNBC.
References
- FDA Fast Track for TNBC
- New Therapy Shows Early Promise, Continues to Progress in Triple-Negative Breast Cancer. Feb 2016
- http://adisinsight.springer.com/drugs/800037529
- Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. 2015
- ^ Novel Agents are Targeting Drivers of TNBC. 2016
- Immunomedics Reports Complete Responses in Patients With Metastatic Triple-Negative Breast Cancer After Sacituzumab Govitecan Treatment June 2015
- https://clinicaltrials.gov/ct2/show/NCT02574455
- Immunomedics Announces Updated Results With Sacituzumab Govitecan (IMMU-132) In Patients With Relapsed Or Refractory Metastatic Triple-Negative Breast Cancer (mTNBC) Dec 2017
External links
- IMMU-132 (Sacituzumab Govitecan) Mentions FDA Orphan drug status, mechanism of action, and clinical trials
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