Gilead Sciences today announced the latest positive results

of a data analysis of its antibody-coupled drug Trodelvy (sacituzumab govitecan) for hr-positive/HER2-negative metastatic breast cancer patients who have undergone multiple pre-treatments.

In this TROPiCS-02 Clinical Phase 3 trial, patients in the Trodelvy treatment group achieved statistically significant and clinically significant improvements in overall survival (OS) compared with the chemotherapy regimen chosen by physicians

.

Detailed data will be published

at the European Society of Oncology (ESMO) Conference on 9 September 2022.

Based on the trial data, Gilead has submitted a Supplemental Biologics Licensing Application (sBLA) to the U.S.FDA.

 

 

 

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 relative survival rate is 30%.

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

.

 

Trodelvy is a "first-in-class" antibody-conjugated 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 U.S.
FDA for the treatment of patients with treated triple-negative breast and bladder cancer.

 

TROPiCS-02 is a global, multicenter, open-label phase 3 trial enrolling 543 HR-positive/HER2-negative metastatic breast cancer patients randomly assigned to use Trodelvy or physician-selected treatment regimens
in a 1:1 ratio.

These patients had previously received endocrine therapy, CDK4/6 inhibitors, and 2-4-line chemotherapy
.

Data analysis published in March showed that patients in the Trodelvy treatment group achieved statistically significant improvements
in the trial's primary endpoint progression-free survival (PFS).

 

The median overall survival of the key secondary endpoints published this time showed that the median overall survival of Trodelvy and the control group was 14.4 and 11.2 months, respectively, that is, the statistical and clinically significant 3.2-month improvement of patients in the Trodelvy group (HR: 0.79, 95% CI: 0.65-0.96, p=0.02).


Another key secondary endpoint, the objective response rate (ORR), also showed that Trodelvy outperformed the control group
.

In addition, patients in the Trodelvy group also showed a better quality of life when assessing patient health status/quality of life (QoL) by function and symptom to duration of deterioration (TTD) (QoL exacerbation time required by Trodelvy versus control group was 4.3 months versus 3.0 months, p=0.006),respectively).

Assessing the degree of fatigue according to the ENUMERAT-QLQ-C30 quality of life test also showed that Trodelvy performed better than the control group (the time required for fatigue deterioration in Trodelvy and control groups was 2.2 months and 1.4 months, p=0.002, respectively).


Trodelvy was consistent with the results of previous trials in terms of safety, in which no new safety issues were identified
.

 

"The data presented in the TROPiCS-02 trial indicate that Trodelvy has shown the survival benefits it can bring to HR-positive/HER2-negative metastatic breast cancer patients who have been treated, as well as second-line therapy in patients with triple-negative breast cancer," said Dr.Bill Grossman, Head of Oncology Treatment at Gilead and Senior Vice President, "Gilead's ambition is to make transformative changes in the treatment of cancer patients.
The improvement in patient survival seen in the TROPiCS-02 trial is a step towards this ambition.”

 

References:[1] Trodelvy® Significantly Improved Overall Survival In Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients In TROPiCS-02 Study.
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