Express significantly prolongs overall survival for patients with metastatic breast cancer! Gilead ADC is eligible for priority review by the U.S. FDA

Gilead Sciences today announced that the U.
S.
FDA has accepted a Supplemental Biologics License Application (sBLA) for its antibody-conjugate drug Trodelvy (sacituzumab govitecan) for the treatment of patients
with HR-positive/HER2-negative metastatic breast cancer who have received multiple upfront treatments.
In addition, FDA has granted priority review of this application, and is expected to respond
by February 2023.

HR-positive/HER2-negative breast cancer is the most common type of breast cancer, accounting for about 70%
of all new cases.
In patients with HR-positive/HER2-negative metastatic disease, the five-year survival rate is 30%.

As these patients develop resistance to endocrine-based therapies, their main treatment options are limited to single-agent chemotherapy and the prognosis remains poor
.

Trodelvy is a "first-in-class" antibody conjugate drug
that targets Trop-2.
Trop-2 is a cell surface antigen that is highly expressed in multiple tumor types, including more than 90% of breast and bladder cancers
.
Trodelvy's design links the topoisomerase inhibitor SN-38 to a monoclonal antibody via a hydrolyzable linker
.
This unique combination delivers potent activity to cells and microenvironments
expressing Trop-2.
It has been approved by the US FDA to treat patients
with triple-negative breast and bladder cancer.

The submission of sBLA is mainly based on the results of the Phase 3 clinical trial of
TROPiCS-02.
The trial achieved the primary endpoints of progression-free survival (PFS) and overall survival (OS)
for the key secondary endpoints.
TROPiCS-02 is a global, multicenter, open-label Phase 3 clinical trial in which 543 patients with HR-positive/HER2-negative metastatic breast cancer are randomized 1:1 to use Trodelvy or physician-selected regimens
.
These patients had previously received endocrine therapy, CDK4/6 inhibitors, and 2-4 line chemotherapy
.
Data analysis, published in March, showed a statistically significant improvement
in progression-free survival (PFS) in the Trodelvy treatment group, the primary endpoint of the trial.

Compared with the physician-selected chemotherapy group, patients in the Trodelvy group showed a 34% reduction in the risk of disease progression or death (median progression-free survival: Trodelvy vs.
control = 5.
5 vs.
4 months, HR: 0.
66, 95% CI: 0.
53-0.
83, p=0.
0003) and a 21% reduction in the risk of death compared to the control group (median overall survival: Trodelvy vs.
control = 14.
4).
vs.
11.
2 months, HR: 0.
789, 95% CI: 0.
646 to 0.
964, p=0.
02).

Trodelvy is consistent with previous trials in terms of safety, and no new safety issues
were identified in this trial.

"Trodelvy has changed the standard of care for patients with metastatic triple-negative breast cancer second-line therapy and treated for metastatic bladder cancer, and today's news is the third supplemental new drug application we have submitted in the past two years," said Dr.
Bill Grossman, Head and Senior Vice President, Oncology Therapies, Gilead.
We look forward to working with the FDA to make Trodelvy
as accessible to those in need as possible.
" ”

Resources:

[1] U.
S.
FDA Accepts For Priority Review The Supplemental Biologics License Application For Gilead’s Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer.
Retrieved October 11, 2022 from https://investors.
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S.
-FDA-Accepts-for-Priority-Review-the-Supplemental-Biologics-License-Application-for-Gileads-Trodelvy-for-Pre-Treated-HRHER2--Metastatic-Breast-Cancer/default.
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.
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