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Gilead Sciences, Inc. today reported positive topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, showing that in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10), Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) significantly improved progression-free survival (PFS) when compared to Keytruda and chemotherapy. The trial achieved its main goal with a statistically significant and clinically relevant improvement in PFS. Trodelvy + Keytruda's safety profile in the ASCENT-04 research aligned with each agent's established safety profile. The combination was not associated with any new safety signals. These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer, For patients with this difficult to treat type of breast cancer, these results potentially offer a new pathway that may redefine their treatment options. Dietmar Berger These data suggest that the combination of sacituzumab govitecan-hziy and pembrolizumab may offer a new treatment approach—bringing together a potent antibody drug conjugate with immunotherapy to improve outcomes for patients. Dr. Sara Tolaney A crucial secondary objective, overall survival (OS), was immature at the time of the PFS primary study. Nonetheless, Trodelvy + Keytruda showed an early trend of OS improvement in the ASCENT-04 study. Gilead will keep an eye on OS results, and more analysis and patient follow-up are planned. The study's comprehensive findings will be examined with regulatory bodies and presented at a subsequent medical symposium. The safety and effectiveness of using Trodelvy plus Keytruda in patients with PD-L1+ metastatic TNBC who have not yet received treatment are still being investigated. The possibility of Trodelvy plus Keytruda as a much-needed new therapy option for patients with previously untreated inoperable (unresectable) PD-L1+ locally progressed or mTNBC is further supported by the notable and meaningful improvement in PFS shown in ASCENT-04. Trodelvy is the only Trop-2-directed antibody-drug conjugate (ADC) that has been approved and shown to provide significant survival benefits in two distinct forms of metastatic breast cancers: pre-treated HR+/HER2-mBC and 2L+ mTNBC. According to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelinesi), it is a Category 1 preferred treatment for all indications and the only ADC for mTNBC to have an ESMO Magnitude of Clinical Benefit Scale (MCBS) rating of 5. Trodelvy's MCBS rating for women with HR+/HER2-mBC is 4. Trodelvy has demonstrated consistent results in clinical trials and real-world investigations in over 50,000 patients across over 50 nations over the course of five years, demonstrating established healthcare professional experience. In an effort to increase survival across a range of tumor forms and disease stages, it is currently being investigated in multiple ongoing clinical trials and has already shown improved results in three Phase 3 breast cancer trials. Gilead is currently conducting three Phase 3 studies to investigate Trodelvy across HER2- (IHC 0, IHC 1+, or IHC 2+/ISH–) mBC. These include the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy, the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC), and the upcoming ASCENT-03 pivotal trial in 1L mTNBC patients who are not candidates for PD-L1 based therapy. Additional Phase 3 studies are being conducted to examine Trodelvy in different disease contexts, such as gynecological and lung malignancies. TrodelvyTrodelvy® (sacituzumab govitecan-hziy) is a novel antibody-drug combination that is guided by Trop-2. A cell surface antigen called Trop-2 is abundantly expressed in a variety of tumor forms, including over 90% of lung and breast malignancies. Trodelvy is purposefully made with a topoisomerase I inhibitor payload, SN-38, coupled to a novel hydrolyzable linker. Through a bystander effect, this special combination provides strong activity to the tumor microenvironment as well as Trop-2-expressing cells.More than 50 countries presently approve Trodelvy for patients with second-line or later metastatic triple-negative breast cancer (TNBC), and more than 40 countries approve it for some patients with HR+/HER2-metastasized breast cancer who have already received treatment.In addition to a variety of tumor types where Trop-2 is highly expressed, such as extensive-stage small cell lung cancer and first-line metastatic non-small cell lung cancer, where Trodelvy has demonstrated clinical activity through the TROPiCS-03 proof-of-concept study and the EVOKE-02 proof-of-concept study, respectively, Trodelvy is being studied for use in other TNBC and HR+/HER2- breast cancer populations. Source: Gilead Last Modified:

Tag: Gilead Sciences

Gliead Releases the Results of Phase 3 ASCENT-04/KEYNOTE-D19 Trials Shows Positive Effect for Combinational Use of Trodelvy® Plus Keytruda®

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