FDA may approve new biological drug called IMMU-132 for treating patients with triple negative breast cancer
On a personal note
“My mother died of triple-negative breast cancer. Her name was Nili Eisenberg and she loved to play the piano more than anything else since she was in second grade until her day of death. She was amazing and incredibly talented. This article is dedicated to her.
This is the drug, IMMU-132, that I learned about 8 years ago and could help my mom. No one told us about it when she was still alive and the drug was available in clinical trials. I missed it. It was my responsibility to know about new investigational drugs that could help my mother live longer and meet her new granddaughter. This failure of mine led me to open my company TRIAL•IN Pharma.
I don’t want you to be in the same situation where you miss treatment options for your dear ones.”
From me, Nir Erez
About FDA Decision on IMMU-132 New BiologicalDrug for Triple Negative Breast Cancer
Published just two days ago, on April 6, 2020
The clinical trial, called ASCENT, is a phase III study examining IMMU-132 in patients with triple-negative metastatic breast cancer.
The study was discontinued due to significant evidence of drug efficacy in patients who received at least 2 prior chemotherapies for their metastatic disease.
The company, Immunomedics, discontinued the trial based on a recommendation from the Independent Data Safety Monitoring Commission.
In December 2019, the FDA accepted the company’s application for accelerated approval for IMMU-132 as a treatment for those patients who received at least 2 prior metastatic disease treatments.
The FDA plans to announce its final decision on drug approval by June 2, 2020.
About Triple Negative Breast Cancer
Triple Negative Breast Cancer is a disease with few options beyond the disappointing standard chemotherapies.
The remarkable results achieved at ASCENT justified the early study discontinuation. They indicated significant progress in treating this deadly disease.
Read more about breast cancer >>
The association between IMMU-132, sacituzumab govitecan and triple negative breast cancer
The IMMU-132 is a drug that consists of:
- Irinotecan Active Metabolite, SN-38
- The metabolite is attached to a manned antibody against TROP-2, a protein found on the cancer cell surface. TROP-2 is expressed in more than 90% of triple-negative cases.
TROP-2 expression is revealed by immunohistochemistry, a simple laboratory test.
Since more than 90% of Triple Negative Breast Cancer patients express this protein, there is no need to check the presence of this protein.
Therefore, IMMU-132 can be administered to all patients without any prior examination.
About ASCENT study and previous study
The ASCENT study is a phase III study, NCT02574455, which examines IMMU-132 therapy compared to standard physician-selected therapy for patients with metastatic triple-negative metastatic breast cancer.
The previous study was a phase I/II study involving 108 patients with triple negative breast cancer. They received IMMU-132 at 10 mg/kg on days 1 and 8 of each 28-day cycle.
Results of the previous study – almost half of patients responded to treatment
Results
The results of the previous Phase I/II study were published in the New England Journal of Medicine, NEJM, please note that these patients with metastatic disease have already received at least 2 previous chemotherapies for their metastatic disease:
- Nearly half of patients, 45.4%, responded to IMMU-132 and their disease stopped growing or shrunk for a median of 7.7 months
- From the start of treatment, the median overall survival was 13.0 months
- 78.5% of patients were alive at 6 months of starting treatment
- 51.3% of patients were alive at 12 months of starting treatment
Side Effects
The most common were neutropenia (41.7%), anemia (11%), decreased white-cell count (11%), hypophosphatemia (9%), diarrhea (8%) and fatigue and asthenia (8%). Ten patients (9.3%) developed febrile neutropenia during the course of the study.
Conclusion
The best treatment for a cancer patient is to get the most advanced cancer drugs in advanced stages of development. There, the hope and the chance to extend life go far beyond the standard protocols.
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