“IMMU-132, an anti-Trop-2 antibody-drug conjugate (ADC) was safe, tolerable, and yielded meaningful clinical activity in heavily pretreated patients with metastatic triple-negative breast cancer (TNBC), according to data from a phase II clinical trial presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Nov. 5–9.
” ‘TNBC comprises about 15 to 20 percent of all invasive breast cancers diagnosed in the United States and is more prevalent in young and African-American women. It has a high recurrence rate and is perhaps the most difficult type of breast cancer to treat successfully with current cytotoxic agents. Currently, there are no targeted treatments available for TNBC,’ said Aditya Bardia, MD, MPH, assistant professor of medicine at Harvard Medical School, and attending physician of medical oncology at the Massachusetts General Hospital Cancer Center in Boston.”
Cancers that arise in the lung are mostly of the type known as NSCLC (non-small cell lung carcinoma). A much smaller proportion of lung tumors arise from neuroendocrine cells in the lungs. These cells (which are also found in most other organs) secrete a variety of hormones that are necessary for normal organ function, as well as for healing after injury or infection. Like other lung cells, neuroendocrine cells may transform to become cancers. Lung cancers that arise from neuroendocrine cells are called pulmonary neuroendocrine tumors (NETs), or lung NETs. Continue reading…
“The FDA granted fast track designation to sacituzumab govitecan for the treatment of patients with metastatic non–small cell lung cancer, according to a press release from the drug’s manufacturer.
“Sacituzumab govitecan (IMMU-132, Immunomedics) — a next-generation antibody-drug conjugate of the moderately toxic drug SN-38, the active metabolite of irinotecan — is intended for patients with metastatic NSCLC who have failed two prior lines of therapy, such as ALK, EGFR and PD-1 inhibitors.
“Sacituzumab govitecan has shown promise in a mid-stage clinical study for patients with metastatic solid cancers — including breast, lung, esophageal, colorectal, and urinary bladder cancers — who failed multiple prior therapies. Patients experienced limited and tolerable side effects, according to the press release.
“Previously, the FDA granted fast track status to sacituzumab govitecan for the treatment of patients with triple-negative breast cancer and small-cell lung cancer. In addition, sacituzumab govitecan received FDA orphan drug designation for the treatment of small-cell lung cancer and pancreatic 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.
“Immunomedics, Inc., (Nasdaq:IMMU) today reported that 71% of patients (34 of 48) with diverse metastatic solid cancers had durable disease stabilization after receiving treatments with the Company’s novel investigational antibody-drug conjugate (ADC), IMMU-132. These include 7 patients (15%) with colorectal, small-cell and non-small-cell lung, esophageal, and triple-negative breast cancers showing partial responses with tumor shrinkage of 30% or more as measured by computed tomography (CT).”
Editor’s note: Scientists have developed a new cancer drug called IMMU-132, which may work in a variety of cancer types. IMMU-132 is an immunotherapy, meaning it boosts a patient’s own immune system to fight cancer. A clinical trial to test the drug in volunteer patients found promising results, including in non-small cell lung cancer (NSCLC) patients.