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enzolifesciences
enzolifesciencesThe treatment options for patients with metastatic urothelial carcinoma (mUC) who have progressed after combined treatment with platinum-based chemotherapy and immune checkpoint inhibitor (CPI) are limited
.
After progress, according to NCCN and ESMO guidelines, the only widely used drugs are taxane and vinflunine (approved by the European Union)
immunity
Recently, in the results of an international multi-center phase 2 clinical trial, a new treatment for advanced urothelial cancer is effective and the side effects are tolerable
.
The results prompted the US Food and Drug Administration Bureau ( the FDA ) on April 13 to approve the accelerated therapy offers a new treatment option for suffering from this very aggressive cancer patients
Manage FDA
In this study, published online on April 30 in the Journal of Clinical Oncology, researchers treated 113 patients with advanced urothelial cancer, the most common type of bladder cancer The research treatment drug is sacituzumab govitecan (SG), formerly known as IMMU-132, now the trade name is Trodelvy
.
TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors.
Journal of Clinical Oncology, 2021; 39 (22): 2474 DOI: 10.
1200/JCO .
20.
03489
Journal of Clinical Oncology, 2021; 39 (22): 2474 DOI: 10.
1200/JCO .
20.
03489
In general, they had received 3 treatments before, and despite receiving platinum-based chemotherapy and immune-boosting "checkpoint inhibitors", the trial population's condition is still progressing
.
After receiving SG treatment, the tumor size of 31 patients (27%) continued to shrink, including 6 patients whose tumors completely disappeared
Tumor response to sacituzumab govitecan
Tumor response to sacituzumab govitecanUrothelial cancer accounts for about 90% of bladder cancers, and there are approximately 70,000 new cases and 17,000 deaths in the United States each year
.
More than three-quarters of these cases are men, and smoking increases the risk of this cancer several times
Advanced urothelial cancer is usually inoperable or has metastasized.
It is usually treated with platinum-based chemotherapy drugs (such as cisplatin or carboplatin) and/or immune checkpoint inhibitor drugs designed to release the immune system's ability to fight cancer
.
But in most cases, these treatments are only effective for a limited time before the disease progresses again
SG represents a new choice for patients with this aggressive type and stage of cancer-compared with other drugs used in this indication, it has a different target and a good mechanism of action
.
Sacituzumab govitecan is an antibody drug conjugate
.
The drug component is a chemotherapeutic drug called SN-38, which is attached to an antibody that is located on a receptor called Trop-2, which is found in most urothelial cancer cells
The company that manufactures SG mainly tests it against other cancers.
In a pilot trial in 2015, 45 patients with refractory urothelial cancer (including many other advanced cancers) were recruited, and the results showed that 6 Among patients with advanced urothelial cancer who did not respond to platinum-based chemotherapy, 3 tumors shrank.
The results of this trial are encouraging
.
This time, in a new phase 2 trial called TROPHY-U-01 sponsored by Gilead Sciences, they tested SG in 113 patients with advanced urothelial cancer who received platinum and checkpoint inhibition.
The cancer still progressed after drug treatment
.
These patients are treated at 42 centers around the world and receive two SG infusions every three weeks
An independent, blinded analysis of tumor scans showed that 76% of patients had tumor shrinkage, and 27% of patients had an "objective response", that is, significant and sustained tumor shrinkage—including tumor disappearance in 6 patients
.
The median duration of response was 7.
In contrast, the objective response rate of standard cytotoxic chemotherapy for the treatment of drug-resistant advanced urothelial carcinoma in this category is about 10%, and the median overall survival is about 7 months
.
According to the TROPHY-U-01 study, another antibody drug conjugate called enfortumab vedotin (EV) has received accelerated approval from the FDA, and the recently announced phase 3 trial data may be fully approved
.
The number of patients who received EV therapy in the TROPHY-U-01 trial was small, but showed similar responses compared to other trial participants
.
The researchers said that this finding is not surprising given that each therapy has different targets and adaptors, and uses different toxins to destroy tumors
.
However, experts still emphasize that the TROPHY-U-01 trial is a preliminary trial and lacks a parallel control group-each patient has received the relevant treatment, so it is difficult to compare its results with the results of other drugs
.
However, he pointed out that the manufacturer of SG started a randomized, controlled, phase 3 trial at the end of last year to compare it with chemotherapy (TROPiCS-04)
.
The results of the study will expire in a few years and will determine whether the FDA will grant full regulatory approval
.
Original source:
Original source:TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors.
Journal of Clinical Oncology, 2021; 39 (22): 2474 DOI: 10.
1200/JCO .
20.
03489
Journal of Clinical Oncology, 2021; 39 (22): 2474 DOI: 10.
1200/JCO .
20.
03489 TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors.
Journal of Clinical Oncology, 2021; 39 (22): 2474 DOI: 10.
1200 /JCO.
20.
03489 Leave a message here
