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

A PHASE II EVALUATION OF THE EFFICACY AND SAFETY OF SACITUZUMAB GOVITECAN IN PATIENTS WITH RECURRENT UTERINE CANCER (IGCS 2025) - No abstract available

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

Outcomes of subsequent treatment regimens after trastuzumab deruxtecan in patients with metastatic breast cancer. (PubMed, J Natl Cancer Inst) - "Outcomes of post-T-DXd treatments differ significantly by MBC subtype and type of regimen administered. The use of SG immediately after T-DXd was associated with relatively short rwPFS across subtypes, highlighting some degree of cross-resistance with T-DXd."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A Phase 3 Study of Sacituzumab Govitecan in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (IASLC-WCLC 2025) - P3 | "EVOKE-SCLC-04 (NCT06801834) is a global, multicenter, randomized, open-label, phase 3 study evaluating the efficacy and safety of SG versus SOC (topotecan or amrubicin [Japan only]) in previously treated patients with ES-SCLC. Secondary endpoints include progression-free survival, duration of response, patient-reported outcomes (time to first deterioration in shortness of breath and physical functioning), and safety/tolerability. This study is open and actively recruiting as of February 2025 and is planning to enroll 695 patients from approximately 200 sites globally."

Clinical • P3 data • CNS Disorders • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

ARIAN, Adjuvant Treatment With Sacituzumab and ZimberelimAb in Resected Patients: A Phase III Study - Trial in Progress (IASLC-WCLC 2025) - "The emerging understanding of the therapeutic synergy between immune checkpoint inhibitors (ICIs) and antibody-drug conjugates (ADCs) - such as Sacituzumab Govitecan, a TROP-2-directed ADC - has opened a new chapter in adjuvant NSCLC therapy, offering promising survival benefits in clinical practice. Exploratory endpoints include assessing the prognostic value of ctDNA and the antitumor immune response. The study was approved by health authorities on 19 August 2024."

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • KEAP1 • PD-L1 • STK11

HER2- and TROP2-Directed Antibody Drug Conjugates Show Potent Antitumor Activities in Small Cell Lung Cancer (IASLC-WCLC 2025) - "Efficacy of trastuzumab deruxtecan (HER2-ADC), trastuzumab, sacituzumab govitecan (TROP2-ADC), sacituzumab and the TOP1 inhibitor payloads (deruxtecan and SN-38) were evaluated in SCLC preclinical models. TROP2-ADC similarly demonstrated significant antitumor activity. Conclusions : These findings demonstrate that targeting cell surface HER2 and TROP2 using ADCs is effective in SCLC, including the SCLC-P subtype, which typically is resistant to standard of care therapies and likely to tarlatamab, due to low DLL3 expression."

Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276 • DLL3 • HER-2 • SEZ6 • SLFN11 • TACSTD2 • TOP1

Single-Cell RNA Sequencing Reveals Subtype-Specific Resistance Mechanisms to TROP2-Targeted ADCs in Non-Small Cell Lung Cancer (IASLC-WCLC 2025) - "The currently available TROP2-targeted ADCs, sacituzumab govitecan and datopotamab deruxtecan, have shown limited benefit in NSCLC overall, with relatively greater efficacy in lung adenocarcinoma (LUAD) compared to lung squamous cell carcinoma (LUSC), as seen in the TROPION-1 trial. These findings highlight the need to optimize ADC payload selection for improved efficacy in NSCLC, especially in LUSC. Further translational studies are warranted to validate these findings."

Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ABCC2 • SLFN11 • TACSTD2 • TOP1

Antibody-Drug Conjugates Versus Docetaxel for Previously Treated Advanced NSCLC: Systematic Review and Meta-Analysis of RCTs (IASLC-WCLC 2025) - "Methods : Databases [PubMed (MEDLINE), EMBASE and Cochrane Library], clinical trial registries, and proceedings of global oncology conferences from January 2015 to November 2024 were screened for phase II/III RCTs comparing ADC (e.g., sacituzumab govitecan, datopotamab deruxtecan, and tusamitamab ravtansine) versus docetaxel. Conclusions : Our findings report a significant survival benefit in patients with non-squamous NSCLC treated with ADCs compared to docetaxel with a manageable safety profile. However, further research is needed to address heterogeneity, refine patient selection and obtain more mature survival data with predictive biomarkers."

IO biomarker • Metastases • Retrospective data • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor

Incidence and Severity of Interstitial Lung Disease Associated With Antibody-Drug Conjugates in NSCLC and SCLC: A Meta-Analysis (IASLC-WCLC 2025) - "In NSCLC, the highest pooled incidence of any-grade ILD was seen with patritumab deruxtecan (23%) and trastuzumab deruxtecan (22%), followed by datopotamab deruxtecan (9%), telisotuzumab vedotin (7%), and sacituzumab govitecan (1%)...Treatment discontinuation due to ILD in NSCLC was highest with telisotuzumab vedotin combined with erlotinib (36%), followed by trastuzumab deruxtecan (9%) and patritumab deruxtecan (7%)...In SCLC, any-grade ILD incidence was 8% with rovalpituzumab tesirine, with no reported grade ≥3 ILD events...HER2/HER3-targeted, deruxtecan-containing ADCs demonstrated the highest ILD rates, while other ADCs such as sacituzumab govitecan had minimal reported toxicity. These findings highlight the need for agent-specific ILD monitoring and support the consideration of ADC design, including target and payload, when evaluating pulmonary safety and guiding clinical decision-making."

Retrospective data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • ERBB3 • HER-2

Case Report: Personalized treatment in stage IV breast cancer using the patient-derived organoids. (PubMed, Front Oncol) - "In this study, we reported a case of stage IV breast cancer who responded well to sacituzumab govitecan that was highly sensitive by the PDO-based drug sensitivity testing, good pathological response was obtained postoperatively. This typical case suggests that PDO-based drug sensitivity testing is conductive to tailoring neoadjuvant chemotherapy options to enhance the feasibility of surgical resection in patients with stage IV breast cancer, thus improving the prognosis."

Journal • Breast Cancer • Oncology • Solid Tumor

EVER-132-003: Study of Sacituzumab Govitecan in Patients With Solid Tumor (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Tract Cancer • Cervical Cancer • Cholangiocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • ROS1

PBPK-PD Model for Predicting Pharmacokinetics, Tumor Growth Inhibition, and Toxicity Risks of Topoisomerase Inhibitor ADCs in Mice and Humans. (PubMed, Eur J Pharm Sci) - "All these results give a conclusion that the developed PBPK-PD model may be applied to predict the pharmacokinetics and therapeutical efficacy of T-DXd and SG as well as risk of ILD."

Journal • PK/PD data • Preclinical • Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

A Tale of Two TROP-2 ADCs: A Comparative Saga of Datopotamab Deruxtecan (Dato-DXd) and Sacituzumab Govitecan (SG). (PubMed, Oncologist) - No abstract available

Journal

Comparison of trastuzumab deruxtecan and sacituzumab govitecan in HER2-negative metastatic breast cancer: a large real-world data analysis. (PubMed, Breast Cancer Res) - No abstract available

Journal • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trodelvy: Regulatory filing in US for 1L mTNBC (based on ASCENT-03 trial) in H2 2025 (Gilead) - Q2 2025 Results: Regulatory filing in US for 1L mTNBC (based on ASCENT-04 trial) in H2 2025

FDA filing • Breast Cancer • Oncology • Triple Negative Breast Cancer

NCCN has published NEW NCCN Guidelines in the NCCN Guidelines Navigator. This interactive digital tool can be used to navigate the current version of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer, Version 1.2025. (NCCN)

NCCN guideline • Bladder Cancer • Urothelial Cancer

Penile carcinoma: the importance of histological classification and new treatment strategies (PubMed, Aktuelle Urol) - "Antibody-drug conjugates (ADCs), such as enfortumab vedotin (targeting Nectin-4) and sacituzumab govitecan (targeting Trop-2) have shown promising efficacy in other tumour types...HER2 is expressed in a relevant proportion of cases and may be an additional therapeutic target.Immune checkpoint inhibitors like atezolizumab have so far demonstrated limited efficacy in penile cancer, despite high rates of PD-L1 expression. This discrepancy may be attributed to the immunosuppressive tumour microenvironment. EGFR-targeted monoclonal antibody therapies are also a potential treatment option.Accurate histopathological and molecular characterisation is critical for personalised treatment approaches and should become an integral component of the clinical management of penile carcinoma."

IO biomarker • Journal • Dermatology • Genito-urinary Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Penile Cancer • Sarcoma • Solid Tumor • HER-2 • PD-L1 • TP53

Gilead plots Korea oncology push with Trodelvy, prepares Yescarta launch (Korea Biomedical Review) - "After dominating Korea’s virology market for more than a decade, Gilead Sciences is shifting gears, building out an oncology portfolio and preparing to file its first CAR-T therapy in the country. The pivot is anchored by Trodelvy (sacituzumab govitecan), the company’s only oncology drug currently on the Korean market....Next in line is Yescarta (axicabtagene ciloleucel), Gilead’s CAR-T therapy for relapsed or refractory large B-cell lymphoma, developed through Kite, its U.S.-based cell therapy subsidiary. Already designated an orphan drug in Korea, the company has completed its local regulatory filing and is aiming for a commercial launch in 2026."

Launch non-US • B Cell Lymphoma

Gilead Sciences Announces Second Quarter 2025 Financial Results (Businesswire) - "Trodelvy sales increased 14% to $364 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand and inventory dynamics."

Sales • Triple Negative Breast Cancer • Urothelial Cancer

Multicenter Retrospective Analysis of the Safety and Efficacy of Sacituzumab Govitecan Combined with Radiotherapy: The French ATTENTION Study (ASTRO 2025) - No abstract available

Retrospective data • Breast Cancer • Oncology • Solid Tumor

VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=593 | Recruiting | Sponsor: Gilead Sciences | Trial completion date: Jan 2027 ➔ Dec 2028

Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Sacituzumab govitecan (SG) + pembrolizumab vs chemotherapy + pembrolizumab in patients with previously untreated PD-L1+ advanced or metastatic triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. (BASCO-MN 2025) - No abstract available

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

TROPiCS-04: Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov) - P3 | N=712 | Completed | Sponsor: Gilead Sciences | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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) - No abstract available

Biomarker • Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

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) - No abstract available

Clinical • 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) - No abstract available

Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer