Trodelvy (sacituzumab govitecan-hziy) / Gilead - LARVOL DELTA

TROPICS-03: Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Endometrial Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) (clinicaltrials.gov) - P1/2 | N=31 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

NeoSTAR: Sacituzumab Govitecan In TNBC (clinicaltrials.gov) - P2 | N=260 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Oct 2026 ➔ Oct 2029 | Trial primary completion date: Oct 2025 ➔ Oct 2028

Trial completion date • Trial primary completion date • Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Patient reported outcomes (PROs) from the phase 3 ASCENT-04/KEYNOTE-D19 study were presented at the 2025 ESMO Congress… (Cure Today) - "According to time to deterioration, emotional functioning (median, 9.3 months versus 4.9) and pain (median, 4.3 versus 3.2) were favored with Trodelvy plus Keytruda compared with Keytruda plus chemotherapy....Lastly, from baseline to EORTC QLQ-C30 scores, the Trodelvy regimen was more favorable compared with the chemotherapy regimen for physical (least squares mean change, 2.45), role (3.34), and emotional (4.07) functioning, as well as pain (-5.39) and insomnia (-4.59)."

P3 data • Patient reported outcomes • Triple Negative Breast Cancer

Antibody-drug conjugates in the treatment of advanced triple-negative breast cancer. (PubMed, Prz Menopauzalny) - "Sacituzumab govitecan (anti-TROP2 antibody conjugated with inhibitor of topoisomerase I) improve median progression-free survival and overall survival in patients with advanced, metastatic triple-negative breast cancer. Similarly, a beneficial effect from the use of ADCs (trastuzumab deruxtecan) was observed in patients with low HER2 expression. These therapeutic advances are reflected in clinical guidelines from leading organizations such as ASCO and ESMO, and have become the basis for ongoing clinical trials evaluating new ADCs with different molecular targets and cytotoxic mechanisms. This paper reviews the most important studies evaluating the clinical effect of ADCs in the treatment of triple-negative breast cancer."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • TOP1

A PHASE II EVALUATION OF THE EFFICACY AND SAFETY OF SACITUZUMAB GOVITECAN IN PATIENTS WITH RECURRENT UTERINE CANCER (IGCS 2025) - "Patients received a median of 2 prior therapies (range:1-4) and 50% had failed pembrolizumab/dostarlimab. Fifty patients were enrolled/evaluable, including 21 (50 screened) and 29 (34 screened) in stages 1/2, respectively. Eighty-four percent (n=42) harbored serous carcinoma, carcinosarcoma, or grade 3 endometrioid tumors (Table 1). Median follow-up was 10.3 months (range:2.4-59.5)."

Clinical • IO biomarker • P2 data • Carcinosarcoma • Endometrial Cancer • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • TACSTD2

Patient-reported outcomes (PROs) with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in patients (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) in the phase III ASCENT-04/KEYNOTE-D19 study (ESMO 2025) - P3 | "Methods Pts were randomized to SG + pembro or chemo (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + pembro. Worsening of nausea/vomiting and diarrhea are consistent with the known safety profile of SG. These data, along with the improvement in PFS, support SG + pembro as a potential new standard of care in pts with previously untreated PD-L1+ mTNBC."

Clinical • Late-breaking abstract • Metastases • P3 data • Patient reported outcomes • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Optimizing the integration of modern systemic therapies and advanced radiotherapy techniques in breast cancer management: An expert opinion from the Institut Curie Breast Radiotherapy Group. (PubMed, Int J Cancer) - "This expert consensus from the Institut Curie Breast Radiotherapy Group focuses exclusively on modern systemic agents, synthesizing current evidence on the concurrent administration of human epidermal growth factor receptor 2-targeted agents (trastuzumab, pertuzumab, trastuzumab emtansine, trastuzumab deruxtecan), cyclin-dependent kinase 4 and 6 inhibitors (palbociclib, ribociclib), immunotherapies (pembrolizumab), poly(ADP-ribose) polymerase inhibitors (olaparib), and new antibody-drug conjugates (sacituzumab govitecan). In addition to systemic therapy considerations, this review highlights the importance of advanced RT techniques, including proton therapy, isocentric lateral decubitus positioning, and volumetric modulated arc therapy with deep inspiration breath hold, which play a crucial role in minimizing cardiac and pulmonary toxicities, particularly in patients receiving cardiotoxic agents or those with predisposing risk factors. By integrating both systemic..."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • CDK4 • HER-2

Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i) (ESMO 2025) - P3 | "Background Significant PFS benefit was observed with SG vs chemo in pretreated metastatic (m)TNBC (ASCENT) and with SG + pembrolizumab vs chemo + pembrolizumab in first-line (1L) PD-L1+ mTNBC (ASCENT-04)...Randomization (1:1) to SG (10 mg/kg IV, days 1 & 8 in 21-day cycles) or chemo (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) was stratified by disease status and geography...These data support SG as a potential new standard of care for pts with previously untreated mTNBC who are unable to receive a PD-(L)1i. Table: LBA20 Efficacy: Intent-to-treat SG (n = 279) Chemo (n = 279) Median PFS per BICR (95% CI), mo 9.7 (8.2-11.1) 6.9 (5.6-8.3) HR (95% CI); adjusted two-sided P -value 0.62 (0.50-0.78); P < .0001 ORR (95% CI), % 48.4 (42.4-54.4) 45.5 (39.6-51.6) Median DOR (95% CI), mo 12.2 (9.7-13.8) 7.2 (5.7-8.4) Safety: All treated n = 275 n = 276 TEAEs, n (%) Any grade Grade ≥ 3 Led to dose reduction Led to treatment discontinuation 273 (99) 181 (66)..."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Circulating immune-biomarkers of response to neoadjuvant Sacituzumab Govitecan (SG) alone and with pembrolizumab (pembro) in muscle-invasive bladder cancer (MIBC): Secondary analyses from SURE-01 and SURE-02 trials (ESMO 2025) - P2 | "Background Antibody drug conjugates and immunotherapy are promising novel neoadjuvant therapies (NAT) in patients (pts) with MIBC who refuse or are ineligible for cisplatin-based chemotherapy. However, modulation of e-MDSCs and monocytes emerged to be a putative SG-induced effect. Updated findings with complete study cohorts will be presented."

Biomarker • Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD14 • CD33 • ITGAM

Long-term safety profile of sacituzumab govitecan (SG) vs docetaxel in patients (Pts) with metastatic non-small cell lung cancer (mNSCLC) from EVOKE-01 (ESMO 2025) - P3 | "Clinical trial identification NCT05089734. Table: 1952P Safety summary Any grade, % Grade ≥3, % Median exposure, mo Median time to onset, D Median time to resolution, D Dose reduction, % Drug discontinuation, % Recovered, % Required treatment, % Fatigue SG 58 13 4 12 17 7 <1 33 4 Doc 57 10 3 8 22 8 2 35 1 Diarrhea SG 53 10 5 11 8 6 <1 47 30 Doc 34 4 3 9 8 2 1 28 14 Alopecia SG 44 <2 5 20 29 <1 0 9 0 Doc 30 <2 4 18 84 <1 0 7 0 Nausea SG 42 <2 5 8 11 1 <1 31 25 Doc 26 <2 4 7 8 2 <1 19 15 Anemia SG 42 6 4 22 23 <1 0 28 15 Doc 31 6 3 29 27 2 <1 18 10 Neutropenia SG 38 25 6 11 10 6 <1 37 13 Doc 43 37 3 8 14 13 1 41 16 Constipation SG 30 <2 5 25 8 <1 0 18 14 Doc 17 <2 3 20 8 <1 0 11 10 Decreased appetite SG 27 2 5 19 14 1 0 17 6 Doc 24 2 3 14 20 1 <1 13 3 Vomiting SG 21 2 4 24 4 <1 0 19 10 Doc 15 2 4 23 5 <1 0 13 6 Cough SG 17 <2 7 61 15 <1 0 10 6 Doc 16 <2 5 38 21 <1 0 9 5 Conclusions SG had an..."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Neoadjuvant sacituzumab govitecan versus sacituzumab govitecan plus pembrolizumab in low-risk, triple-negative early breast cancer: WSG-ADAPT-TN-III (ESMO 2025) - P3 | "Current recruitment status is 62 randomized pts. Estimated trial duration is 6 years."

Clinical • IO biomarker • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Efficacy and Safety of Antibody Drug Conjugates in Previously Treated Hormone Receptor Positive HER2 Negative (or Low) Metastatic Breast Cancer-A Systematic Review and Meta-Analysis. (PubMed, Am J Clin Oncol) - "T-DXd demonstrated better efficacy in pretreated HR+/HER2-low metastatic breast cancer (MBC), especially in earlier lines. SG showed significant OS benefit primarily in later lines. Dato-DXd showed no OS benefit but had the most favorable safety profile."

Journal • Retrospective data • Breast Cancer • Dental Disorders • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Stomatitis • HER-2

Trodelvy Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast Cancer in ASCENT-03 Study (Gilead Press Release) - "ASCENT-03 successfully met its primary endpoint of PFS with a 38% reduced risk of disease progression or death for Trodelvy versus chemotherapy (HR: 0.62; p<0.0001). Median PFS with Trodelvy was 9.7 months versus 6.9 months for chemotherapy....The objective response rate (ORR) was 48% with Trodelvy and 46% with chemotherapy."

Late-breaking abstract • P3 data: top line • Triple Negative Breast Cancer

Optimizing nursing care for TROP2 ADC-related oral mucositis: Emphasizing patient education, early prevention, and dental integration (ESMO 2025) - "Background TROP2 antibody-drug conjugates (ADCs), including sacituzumab govitecan (SG), Sacituzumab Tirumotecan(sac-TMT), and Dato-DXd, have revolutionized cancer treatment but are associated with a high incidence of oral mucositis (OM), affecting 10%–72.7% of patients depending on the ADC type.This adverse event (AE) significantly impacts patients' nutritional intake, quality of life, and treatment adherence, necessitating evidence-based nursing interventions.This study aims to establish an evidence-based nursing pathway prioritizing patient empowerment, early intervention, and dental integration to mitigate OM severity and improve clinical outcomes. Standardized multidisciplinary pathways significantly reduce severe OM incidence. Legal entity responsible for the study The authors."

Clinical • Oncology

Prevalence and prognostic role of TROP2 expression in prostate cancer (ESMO 2025) - "Background Trophoblast cell surface antigen 2 (TROP2) is a membrane glycoprotein which is target of sacituzumab govitecan (SG), an antibody-drug conjugate that has been approved for breast and urothelial carcinomas...Conclusions It is concluded from our data, that TROP2 is regularly expressed at high levels in newly diagnosed adenocarcinomas of the prostate and that a reduced expression is a feature of tumor progression and increased tumor aggressiveness. Legal entity responsible for the study The authors."

Biomarker • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Urothelial Cancer • ERG • TACSTD2 • TMPRSS2

Translational study and first-in-human (FIH) study design of KH815, a novel dual-payload TROP-2 targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO 2025) - P1 | "Especially, in a Trodelvy-resistant Triple-Negative Breast Cancer (TNBC) PDX model, KH815 demonstrated significantly superior anti-tumor activity compared to Sacituzumab Govitecan and Datopotamab Deruxtecan. 30 to 60 participants are planned for each dose levels in phase Ib. One patient enrolled as of May 5th, 2025."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Clinical Outcomes and Safety of Sacituzumab Govetican in Chinese Metastatic HER2 Negative Breast Cancer Patients: A Real World Study [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

JAVELIN bladder medley phase II trial of avelumab + sacituzumab govitecan (Ave + SG) vs avelumab monotherapy (Ave mono) as first-line (1L) maintenance treatment for advanced urothelial carcinoma (aUC): Subgroup analyses based on metastatic sites (ESMO 2025) - P2 | "Table: 3083P Median PFS (95% CI), months Stratified HR for PFS (95% CI) Ave + SG Ave mono Visceral mets at start of 1L PBC Yes 9.30 (5.55-14.00) 2.20 (1.91-3.71) 0.43 (0.24-0.77) No 13.73 (5.55-NE) 7.46 (3.75-13.31) 0.59 (0.30-1.18) Liver lesions at randomization Yes 7.62 (4.17-NE) 1.94 (1.87-3.61) 0.38 (0.17-0.86) No 13.86 (9.23-NE) 5.65 (3.65-9.00) 0.50 (0.29-0.87) Lung lesions at randomization Yes 5.62 (1.87-13.86) 1.94 (1.87-3.68) 0.52 (0.23-1.15) No 13.73 (9.30-NE) 5.65 (3.58-9.23) 0.47 (0.27-0.82) NE, not estimable. Conclusions Ave + SG as 1L maintenance treatment improved PFS vs Ave mono in pts with aUC without progression after 1L PBC, irrespective of visceral mets at start of 1L PBC or liver/lung lesions at randomization."

Clinical • Metastases • Monotherapy • P2 data • Oncology • Solid Tumor • Urothelial Cancer

Objective response to sacituzumab-govitecan (SG) in patients with metastatic esophagogastric adenocarcinoma in second-line or beyond: Primary endpoint analysis of the SAGA phase Ib/II trial (AIO-STO-0123/ass, UCCL-IKF-SAGA/IKF065) (ESMO 2025) - P1/2 | "The SAGA trial did not meet its primary endpoint. TROP-2 tumor expression data will be presented at the meeting."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • TACSTD2

Phase II study of sacituzumab govitecan (SG), domvanalimab (dom), and zimberelimab (zim) in metastatic non-small cell lung cancer (mNSCLC): VELOCITY-Lung substudy-01 (ESMO 2025) - P2 | "Conclusions SG+dom+zim had a tolerable safety profile and activity in 1L mNSCLC irrespective of histology and notably in pts with tumors expressing PD-L1. Further study of this combination is warranted, especially in pts with mNSLC with PD-L1 expression ≥50%."

IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • P2 data • Oncology • Solid Tumor • Uterine Cancer

A multicenter, prospective, cohort study of trop-2 ADC combination therapy for advanced triple-negative breast cancer (ESMO 2025) - P2 | "This multicenter, prospective cohort study aims to assess the efficacy and safety of sacituzumab govitecan (SG)—a Trop-2 ADC—in combination with a PD-1 inhibitor or anti-angiogenic drugs in patients with mTNBC...Cohort 1 receives IV SG 10 mg/kg d1, d8 Q3W plus toripalimab 240 mg Q3W. Cohort 2 receives IV SG 10 mg/kg d1, d8 Q3W plus an anti-angiogenic targeted agent (either bevacizumab or anlotinib, selected at the investigator's discretion and administered according to the standard dosage), until PD, unacceptable toxicity, pt withdrawal, or discontinuation criteria are met...Secondary endpoints include ORR, OS, safety, DOR, DCR per RECIST v1.1, and biomarker research.Imaging assessments will be performed Q6W from randomization until week 56, followed by Q12W thereafter. Enrollment began in December 2024."

Clinical • Combination therapy • IO biomarker • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Outcomes of subsequent antibody drug conjugate (ADC) regimen in ADC-resistant HER2 low metastatic breast cancer (ESMO 2025) - "We evaluated the outcomes of ADC sequences, sacituzumab govitecan (SG) followed by fam-trastuzumab deruxtecan (T-DXd) versus T-DXd followed by SG in patients (pts) with HER2 low MBC. These findings warrant further prospective studies to optimize ADC sequencing and study biomarkers of resistant in this pts population. Legal entity responsible for the study The authors."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer: A real-world retrospective cohort study from central Europe (ESMO 2025) - "These findings reflect the heterogeneity of real-world populations and support SG as a valuable therapeutic option. Legal entity responsible for the study The authors."

Metastases • Real-world • Real-world evidence • Retrospective data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer