Trodelvy Combined with Keytruda Significantly Improves Progression-Free Survival in Patients with PD-L1-Positive Metastatic Triple-Negative Breast Cancer

2025Year4Month21Gilead Sciences, Inc. announced that its conducted3PeriodASCENT-04/KEYNOTE-D19The study achieved positive topline results. The study showed that for tumor expression PD-L1（CPS≥10) Inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) Patient,TrodelvyUnitedKeytrudaTreatment ComparisonKeytrudaCombination chemotherapy can significantly improve patients' progression-free survival (PFS), and this improvement is statistically significant and clinically meaningful.

InASCENT-04In the study,TrodelvyUnitedKeytrudaThe safety profile is consistent with the known safety characteristics of these two drugs, and no new safety signals were identified. Although the overall survival (OS) as a key secondary endpoint, inPFSData at the primary analysis were still immature but already showed an early trend toward improvement. Gilead Sciences will continue to monitor.OSResults, and plans for further analysis and patient follow-up.

It is worth noting that, currentlyTrodelvyUnitedKeytrudaFor previously untreatedPD-L1Patients with positive metastatic triple-negative breast cancer are still in the research stage, and their safety and efficacy have not been determined. However,ASCENT-04Under StudyPFSThe significant improvement further confirmed thatTrodelvyUnitedKeytrudaIs expected to become a new treatment option urgently needed by these patients.

TrodelvyIs currently the only approved treatment forTrop-2Antibody-drug conjugates (ADC), has demonstrated significant survival benefits in two different types of metastatic breast cancer, namely second-line and above.mTNBCAnd preprocessedHR+/HER2- mBC. According to the National Comprehensive Cancer Network (NCCN) in the United States®（NCCN®) Clinical Practice Guidelines (NCCN Guidelines), which is indicated for these two conditions.1Class prioritization treatment plan, and it is also the only one to have received the European Society for Medical Oncology Clinical Benefit Scale (MCBS）5Grade RatingmTNBC ADC. In addition,TrodelvyInHR+/HER2- mBCAlso obtained in female patients4LevelMCBSRating.

With rich clinical application experience,TrodelvyIn the past approximately5Over the years, approximately50National50,000Multiple patients have shown stable results in clinical trials and real-world studies. It has been demonstrated in three major3In the breast cancer trial, it demonstrated the ability to improve outcomes and is currently being studied in multiple ongoing clinical trials, aiming to extend survival benefits to various tumor types and disease stages.

Currently, Gilead has three ongoing3Phase Research, Targeting HER2-（IHC 0、IHC 1 + Or IHC 2+/ISH–）mBC, including the upcoming campaign targeting those unsuitable forPD-L1 Therapeutic 1L mTNBC Patient'sASCENT-03Key Trials, Targeting Early StagesTNBC（eTNBC) Patient'sASCENT-05Key trials, as well as those targeting patients who have received endocrine therapyHR+/HER2- mBCPatient'sASCENT-07Key Trials.TrodelvyAlso in other disease areas3Exploration will be conducted in subsequent studies, including lung cancer and gynecological cancers.

Triple-negative breast cancer is an aggressive subtype of breast cancer with a poor prognosis, and traditional treatment options are relatively limited.TrodelvyUnitedKeytrudaDemonstrated in the researchPFSImprovement, bringing new hope to patients.

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