Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) approved Trodelvy® (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting....Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) approved Trodelvy® (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.

TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with...Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine based therapy and at least two additional systemic therapies in the metastatic setting.

Invasive Breast Cancer...HER2-Negative Regimens...Sacituzumab govitecan-hziy (for TNBC or HR+/HER2-)

SG showed benefit in PFS and OS vs TPC in pts with HR+/HER2‒ mBC across age subgroups, consistent with the intent to treat population.

Median PFS and OS were improved with SG vs TPC irrespective of prior LoT, with HR of 0.61 and 0.82 in pts with 2 prior LoT and 0.72 and 0.78 in pts with ≥ 3 prior LoT, respectively...CBR was improved with SG vs TPC in pts with 2 and ≥ 3 prior LoT, ORR was improved in pts with 2 prior LoT...Regardless of number of prior LoT, SG demonstrated improved efficacy vs TPC in pts with HR+/HER2- mBC, with manageable safety across subgroups.

Overall survival was significantly improved with sacituzumab govitecan versus chemotherapy (median 14·4 months [95% CI 13·0–15·7] vs 11·2 months [10·1–12·7]; hazard ratio [HR] 0·79, 95% CI 0·65–0·96; p=0·020); survival benefit was consistent across Trop-2 expression-level subgroups. ORR was significantly improved with sacituzumab govitecan compared with chemotherapy (57 [21%] patients vs 38 [14%]; odds ratio 1·63 [95% CI 1·03–2·56]; p=0·035), as was time to deterioration of global health status and quality of life (median 4·3 months vs 3·0 months; HR 0·75 [0·61–0·92]; p=0·0059) and fatigue (median 2·2 months vs 1·4 months; HR 0·73 [0·60–0·89]; p=0·0021)....Sacituzumab govitecan demonstrated statistically significant and clinically meaningful benefit over chemotherapy, with a 3·2-month median overall survival improvement and a manageable safety profile. These data support sacituzumab govitecan as a new treatment option for patients with pretreated, endocrine-resistant HR+ and HER2– metastatic breast cancer.

The OS rates (95% CI) for SG versus TPC were 60.9% (54.8-66.4) and 47.1% (41.0-53.0) at 12 months, 39.2% (33.4-45.0) and 31.7% (26.2-37.4) at 18 months, and 25.6% (20.4-31.1) and 21.1% (16.3-26.3) at 24 months….The final OS analysis of the TROPiCS-02 study confirms the clinically meaningful OS benefit of SG over single-agent CT in pts with pretreated, endocrine-resistant HR+/HER2–mBC.

Gilead Sciences...announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

The antibody-drug conjugate sacituzumab govitecan, or SG, may be a viable option for patients with metastatic HR-positive/HER2-negative breast cancer who have developed resistance to endocrine drugs. In the phase III TROPiCS-02 trial, compared with standard chemotherapy, SG extended both progression-free and overall survival, besides improving quality of life.

SG demonstrated statistically significant and clinically meaningful improvement in OS, and significant improvement in ORR and QoL vs TPC with manageable safety in pts with ET-resistant HR+/HER2- mBC, a population with limited treatment options. These data support the use of SG as a novel therapy for pts with pre-treated HR+/HER2- mBC.

The median PFS was 5.5 months (95% CI, 4.2 to 7.0) with SG and 4.0 months (95% CI, 3.1 to 4.4) with chemotherapy; the PFS at 6 and 12 months was 46% (95% CI, 39 to 53) v 30% (95% CI, 24 to 37) and 21% (95% CI, 15 to 28) v 7% (95% CI, 3 to 14), respectively....SG demonstrated statistically significant PFS benefit over chemotherapy, with a manageable safety profile in patients with heavily pretreated, endocrine-resistant HR+/HER2- advanced breast cancer and limited treatment options.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3 TROPiCS-02 study evaluating Trodelvy® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.

Gilead Sciences...announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS)...The first interim analysis of the key secondary endpoint of overall survival in the TROPiCS-02 study demonstrated a trend in improvement for overall survival.

..Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed...

SG shows encouraging activity in patients with pretreated HR+/HER2− mBC and a predictable, manageable safety profile.