Sacituzumab Govitecan Demonstrates Durable Responses in Metastatic TNBC


“Sacituzumab govitecan (IMMU-132) was well tolerated and demonstrated early and durable responses in heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC), according to the results of a recent phase I/II study published in the Journal of Clinical Oncology.

“Sacituzumab govitecan is an antibody–drug conjugate that targets Trop-2, which is expressed in more than 90% of TNBCs, by selectively delivering SN-38, the active metabolite of irinotecan. It was granted a breakthrough therapy designation by the FDA in February 2016 for the treatment of patients with mTNBC, following at least 2 treatments for metastatic disease.”

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Sacituzumab Govitecan Shows Promise for Metastatic NSCLC


“Treatment with sacituzumab govitecan induced objective responses and appeared tolerable in patients with metastatic non–small cell lung cancer who had received first-line platinum-based therapy, according to the results from an expansion cohort of a phase 1/2 study presented at the ASCO Annual Meeting.

” ‘This therapy showed efficacy for squamous and non-squamous patients as well as for patients with prior PD-1/PD-L1 therapy,’ D. Ross Camidge, MD, PhD, professor in the division of medical oncology and Joyce Zeff chair in lung cancer research at University of Colorado Anschutz Medical Campus, said during a presentation.

Sacituzumab govitecan (IMMU-132, Immunomedics) is an antibody drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti–Trop-2 humanized monoclonal antibody.”

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Novel Chemotherapy Drug Demonstrates Activity in Advanced Breast Cancer

“The novel chemotherapy drug etirinotecan pegol demonstrated a trend toward improved survival compared with treatment of physician’s choice among patients with late-stage advanced breast cancer, according to findings from a phase 3 trial presented at the ASCO Annual Meeting.

“Although treatment with etirinotecan pegol (NKTR-102; Nektar Therapeutics) did not reach the pre-determined statistically significant benefit in all patients, subgroups of patients — particularly those with brain or liver metastases — experienced significantly improved OS with etirinotecan pegol.

“ ‘Chemotherapy remains the backbone of management of many patients with advanced breast cancer,’ Edith A. Perez, MD, Deputy Director at Large for the Mayo Clinic Cancer Center in Jacksonville, Florida, director of the Mayo Clinic Breast Cancer Translational Genomics program and a HemOnc Today Editorial Board member, said in an interview. ‘So we are looking for novel chemotherapy agents with better pharmacokinetics and no neuropathy to speak of and very little myelosuppression or cardiac toxicity.’ “

FDA Grants Fast Track Status to IMMU-132 for Triple-Negative Breast Cancer

The gist: The U.S. Food and Drug Administration (FDA) has granted a “Fast-Track” designation to a new treatment for people with metastatic, triple-negative breast cancer who haven’t had success with their previous treatments. The treatment is called sacituzumab govitecan (aka IMMU-132). The Fast-Track designation means that the FDA will facilitate a faster approval process so that the treatment can soon be prescribed by oncologists in the U.S.

“The FDA today granted fast track status to sacituzumab govitecan, an antibody–drug conjugate in development for treatment of patients with triple-negative breast cancer who failed prior therapies for metastatic disease, according to the drug’s manufacturer.

“Sacituzumab govitecan (IMMU-132, Immunomedics) is formed by using the moderately-toxic SN-38 — the active metabolite of irinotecan (Camptosar; Pfizer), used to treat certain solid tumors — conjugated to an anti–TROP-2 antibody.

“The FDA’s Fast Track program is intended to facilitate the development and expedite the review of new drugs intended to treat serious conditions, as well as agents that would fill unmet medical needs.

“The FDA based its decision on the efficacy sacituzumab govitecan has shown in patients with advanced triple-negative breast cancer.