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

Molecular pathology of bladder cancer. (PubMed, Histopathology) - "Alterations in FGFR3, commonly found in the luminal-papillary molecular subtype associated with low response to immunotherapy, are the target of erdafitinib. Enfortumab vedotin, which targets Nectin-4 (expressed in >95% of urothelial carcinomas), is approved for patients who progress after chemotherapy and/or immunotherapy...Sacituzumab govitecan, an antibody-drug conjugate directed against Trop-2, is effective in basal, luminal and stroma-rich subtypes but not in neuroendocrine carcinomas. In addition, therapies developed for HER2-positive breast cancer have shown efficacy in urothelial carcinoma, with recent data from the DESTINY pan-tumour phase II trial leading to FDA approval of trastuzumab deruxtecan for HER2-overexpressing metastatic urothelial carcinoma. This paper is a comprehensive review of the molecular pathology of bladder cancer, highlighting advances in molecular classification, biomarkers and personalized therapies. The transition from morphology-based..."

Biomarker • IO biomarker • Journal • Review • Bladder Cancer • Breast Cancer • Endocrine Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • Urothelial Cancer • FGFR3 • HER-2 • KDM6A • KMT2D • PIK3CA • RB1 • TP53

…Safety analysis of the phase 3 ASCENT-04 study (NCT05382286) presented as a poster at the 2025 San Antonio Breast Cancer Symposium (Targeted Oncology) - "Key findings indicated that, while the incidence of any treatment-emergent adverse events (TEAEs) was higher in the combination arm vs the control chemotherapy and pembrolizumab arm, the rate of TEAEs leading to dose reduction or discontinuation was lower compared with chemotherapy. Grade ≥3 TEAEs were reported in 71% of the experimental arm with an exposure-adjusted incidence rate (EAIR) of 2.19 (95% CI, 1.86–2.56) vs 70% in the chemotherapy arm with an EAIR of 2.13 (95% CI, 1.81–2.49)."

Adverse events • P3 data • Triple Negative Breast Cancer

Integrated Biomimetic Platform for Enhancing the Efficient Capture and Visual Identification of Circulating Tumor Cells. (PubMed, Anal Chem) - "Triple-negative breast cancer (TNBC) patients undergoing sacituzumab govitecan (SG) therapy suggests CTCs can be successfully detected...With the unique advantages of cell viability preservation, 100% diagnostic specificity, modular design adaptability, and cost-effectiveness, the PM-PAM platform establishes a new paradigm for liquid biopsy applications. This technology also shows the particular promise for monitoring antibody-drug conjugate (ADC) treatment efficacy through dynamic Trop-2 expression analysis in breast cancer management."

Circulating tumor cells • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTCs • TACSTD2

Integrating molecular targeting and immune modulation in triple-negative breast cancer: from mechanistic insights to therapeutic innovation. (PubMed, Front Immunol) - "Therapies targeting DNA repair pathways, angiogenesis, and androgen receptor signaling-particularly via PARP inhibitors and antibody-drug conjugates like sacituzumab govitecan-have demonstrated clinical benefit...This review delineates recent developments in targeted and immunotherapeutic strategies, emphasizing the role of TILs in shaping treatment response and highlighting combinatorial approaches that synergize molecular targeting with immunomodulation. Through a comprehensive understanding of TNBC's molecular and immune landscape, we propose new therapeutic trajectories to improve clinical outcomes in this challenging malignancy."

IO biomarker • Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • ER • HER-2 • mTOR • PGR • PI3K

A patient with metastatic upper tract urothelial carcinoma with EGFR exon 20 insertion and MTAP loss responding to amivantamab and pemetrexed-based chemotherapy (ESMO Asia 2025) - P2 | "Gemcitabine and carboplatin were started but lung metastasis worsened. He was switched to pembrolizumab without significant response. He was then given sacituzumab govitecan, with initial improvement but progressed later. He later had enfortumab vedotin and rechallenged carboplatin with nab-paclitaxel, and had further enlargement of lung metastasis...Our case offers insights into a patient with refractory urothelial carcinoma with EGFR exon 20 insertion and MTAP loss, having early and durable response to amivantimab and pemetrexed-carboplatin despite the failure of multiple prior therapies. This supports further investigation of broad molecular profiling and biomarker-guided trials in urothelial carcinoma to understand tissue-specific effects of genetic alterations."

Clinical • EGFR exon 20 • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CDKN2A • CDKN2B • EGFR • FGFR • HER-2 • MTAP • PD-L1 • PIK3CA • TP53

Triple-negative breast cancer with somatic BRCA1 mutation and metaplastic progression in a young woman: A case report (ESMO Asia 2025) - "She underwent modified radical mastectomy with sentinel lymph node biopsy, followed by adjuvant doxorubicin–cyclophosphamide (AC) for 4 cycles, which was complicated by pneumonitis and heart failure. Weekly paclitaxel for 11 cycles was discontinued due to fatigue and elevated troponin, despite a normal ECG...She received gemcitabine–cisplatin for 2 cycles with stable disease, followed by cytoreductive palliative surgery with reconstruction, and then 2 additional cycles of gemcitabine–cisplatin...She was treated with docetaxel–capecitabine for 1 cycle with poor response, followed by sacituzumab govitecan for 3 cycles, which resulted in disease progression. Currently, the patient is on eribulin plus durvalumab, having completed 1 cycle...This case illustrates an unusual histological evolution from medullary carcinoma to metaplastic carcinoma, and subsequently to mucoepidermoid carcinoma. It raises important questions about the optimal timing of genomic testing and the..."

Case report • Clinical • IO biomarker • Tumor mutational burden • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • BRCA • BRCA1 • HER-2 • PD-L1 • PGR • PTEN • RB1 • SF3B1 • STK11 • TMB • TP53

Frequent TROP2 expression and preclinical efficacy of Sacituzumab Govitecan in PatientDerived organoids of small bowel adenocarcinoma: Toward a novel TROP2ADC therapeutic strategy (ESMO Asia 2025) - "Our findings highlight that TROP2 is frequently expressed in SBA and that sacituzumab govitecan demonstrates meaningful efficacy against PDOs from SBA patients. These results suggest that TROP2-targeted ADC could represent a promising treatment option, and we are currently preparing an investigator-initiated clinical trial to further evaluate its potential."

Preclinical • Colorectal Cancer • Oncology • Small Intestinal Carcinoma • TACSTD2

Sacituzumab govitecan combined with toripalimab as first-line treatment for advanced triple-negative breast cancer: A prospective, single-arm, multicenter phase II clinical trial (ESMO Asia 2025) - P | "The primary endpoint is PFS per RECIST v1.1 and secondary endpoints including ORR, OS per RECIST v1.1, safety and exploration of efficacy-related biomarkers (Trop-2, PD-L1 expression, ctDNA mutations, etc.) . Imaging evaluations for efficacy assessment conducted every 2 treatment cycles up to 56 weeks."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

HER2 and TROP2 antibody–drug conjugates in metastatic breast cancer: A systematic review of clinical outcomes (ESMO Asia 2025) - "Background: Antibody-drug conjugates (ADCs) targeting HER2 (trastuzumab emtansine [T-DM1], trastuzumab deruxtecan [T-DXd]) and TROP2 (sacituzumab govitecan [SG]) offer novel treatment opportunities for patients with metastatic breast cancer (mBC). HER2- and TROP2-targeting ADCs demonstrate meaningful survival benefits across different metastatic breast cancer subtypes with manageable toxicity profiles. T-DXd shows improved efficacy over T-DM1 in HER2-positive mBC patients, while SG demonstrates clinical benefit in triple-negative and HR+/HER2-negative populations."

Clinical • Clinical data • Metastases • Review • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Real-world outcomes with sacituzumab govitecan in treating Asian patients with advanced triple-negative breast cancer (ESMO Asia 2025) - "In Taiwanese patients with mTNBC, SG demonstrated clinical efficacy and safety profile comparable to those observed in pivotal prospective trials. High Ki-67 is associated with significant longer PFS. Earlier SG use and prior taxane responsiveness may be associated with better efficacy."

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

Trop-2 high, stronger response: A meta-analysis of ADC efficacy in metastatic triple-negative breast cancer (ESMO Asia 2025) - "Background: Antibody–drug conjugates (ADCs) such as sacituzumab govitecan and datopotamab deruxtecan have emerged as promising therapies for metastatic triple-negative breast cancer (mTNBC). This is the first meta-analysis to quantitatively demonstrate that Trop-2 high expression confers a significantly greater likelihood of response to ADC therapy in mTNBC, with a pooled odds ratio exceeding seven. These findings establish Trop-2 as a clinically actionable predictive biomarker, underscoring its potential to guide patient selection in ADC-based treatment. The exploratory PD-L1 subgroup analysis revealed a numerical benefit with SG+pembrolizumab in CPS ≥10 patients, though statistical significance was not reached, highlighting the need for further validation."

IO biomarker • Metastases • Retrospective data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1 • TACSTD2

Sacituzumab govitecan in combination with capecitabine for the treatment of advanced gastrointestinal cancers after progression on standard therapy. (ASCO-GI 2026) - P1 | "Clinical Trial Registration Number: NCT06065371 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Combination therapy • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Single institution retrospective analysis of antibody-drug conjugate (ADC) sequencing in HR+/HER2-low and HR-/HER2-low metastatic breast cancer. (SABCS 2025) - "Patients with HR+/HER2-low and HR-/HER2-low metastatic breast cancer who received sequential ADC therapy with Enhertu and Trodelvy (ET or TE) had comparable PFS 1 + PFS2 and OS results. There were significant increases in PFS and RR with each ADC when used first compared to second in the treatment sequence. There were similar rates of cumulative hg-AE between the ET and TE groups with less hg-AE events in patients who received Enhertu with ET vs TE."

Metastases • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR • TOP1

Risk Signals of Antibody-Drug Conjugates in Bladder Cancer: A Real-World FAERS Study. (PubMed, Clin Epidemiol) - "Disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN), were used to detect significant adverse drug event (ADE) signals for four ADCs in bladder cancer treatment: enfortumab vedotin (EV), sacituzumab govitecan (SG), trastuzumab deruxtecan (DS-8201), and trastuzumab emtansine (T-DM1). This study delineates the safety profiles of ADC therapies for bladder cancer, confirming known risks and identifying potential new signals. The findings highlight the need for ADC-specific monitoring strategies and proactive management protocols to mitigate toxicities, thereby providing essential evidence for clinical decision-making."

Journal • Real-world evidence • Bladder Cancer • Candidiasis • Dermatology • Genito-urinary Cancer • Metabolic Disorders • Oncology • Solid Tumor

Dual-payload TROP2 targeted antibody drug conjugate: Multi-Payload Conjugates™ deliver orthogonal mechanisms of cell killing (SABCS 2025) - "Sacituzumab govitecan (SG), a TROP2 targeted ADC, is approved as a 3rd line therapy in locally advanced or metastatic HER2 negative breast cancer, and in combination with pembrolizumab, is likely to see approval in 1st line therapy for PD-L1 positive tumors...Our selective conjugation platform allows the attachment of distinct payloads targeting different mechanisms of action at three unique sites on antibody scaffolds. Catena's lead TROP2 targeting MPC, CATB-101, features an optimized combination and ratio of tubulin and Topo1 inhibitors...In head-to-head comparisons with T-DXd, SG and Dato-DXd, MPCs out-perform the current approved ADCs in breast cancer and demonstrate full tumor elimination at low mg/kg doses... While advances have been made in the design of ADCs to expand to previously unaddressed populations, high patient relapse and the failure of recent mono-payload ADCs in late-stage trials indicate a need for novel multi-payload conjugates. Catena's..."

IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer • HER-2 • TACSTD2

Utilization and safety of concurrent antibody drug conjugates alongside extracranial radiation therapy in the real-world setting (SABCS 2025) - "This study aims to assess real-world data on the safety of combining ADCs with extracranial RT.Method A retrospective chart review of patients who received concurrent ADC therapy (trastuzumab emtansine (T-DM1), sacituzumab govitecan (SG), and trastuzumab deruxtecan (T-DXd)) and extracranial RT at a single academic institution was conducted. Importantly, no radiation courses were discontinued due to adverse effects.Conclusion In our study of concurrent use of ADCs with RT to breast and/or chest wall +/- RNI, no unexpected toxicities occurred. This study adds to real-world evidence that extracranial radiation therapy can be safely administered alongside ADCs."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • HER-2

Development and Validation of TROP2/HER2-low/Ki67/HR multiplex-immunofluorescence panel with membrane identification: enabling improved Antibody Drug Conjugate therapy selection (SABCS 2025) - "Currently, two ADC drugs targeting HER2: Trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan-nxki (T-DXd), and two targeting Trop2: Sacituzumab govitecan (SG) and datopotomab deruxtecan-dlnk (Dato-DXd) have gained approval by the FDA in treating metastatic BC, with additional ADCs in development. Results also suggested that the custom membrane cocktail can enhance the subcellular evaluation of biomarkers. The study will be supplemented by an independent patient verification cohort to support forthcoming clinical-utility studies."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • HER-2 • TACSTD2

Reframing Breast Cancer Therapies in a Rare Context - A Case of Metastatic Mammary-Like Vulvar Carcinoma Treated with Breast Cancer Regimens (SABCS 2025) - "She received adjuvant radiation with concurrent cisplatin. Given HER2 positivity, she was treated with six cycles of docetaxel, trastuzumab, and pertuzumab, followed by maintenance trastuzumab and pertuzumab...She was treated with olaparib from February to November 2023. Following disease progression, she transitioned to trastuzumab deruxtecan for HER2-low disease, which resulted in temporary disease control between December 2022 to May 2024. Upon further progression, she received carboplatin, paclitaxel, and bevacizumab, completing six cycles in May 2024, followed by maintenance bevacizumab and pembrolizumab... MLVA is an extremely rare malignancy with no established standards of care. Its histologic resemblance to breast cancer suggests it may respond to breast cancer-based therapies. In the absence of defined treatment pathways, applying breast cancer therapeutic strategies—particularly in the metastatic setting—may offer a rational and effective approach for managing..."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • BRCA2 • ER • GATA3 • HER-2 • PAX8 • PGR • SOX10

Efficacy of systemic therapy in HER2-low breast cancer with CNS metastases: a "real-world" experience (SABCS 2025) - "Systemic therapies for the CNS disease included cytotoxic chemotherapy in seven patients (44%), trastuzumab deruxtecan (T-DXd) in four (25%), abemaciclib in two (13%), other CDK4/6 inhibitors in two (13%), and sacituzumab govitecan in one (6%). Commonly utilized chemotherapy included taxanes (paclitaxel or nab-paclitaxel) in 4 of 7 patients... This "real-world" experience highlights modest intracranial activity of systemic therapy in HER2-low breast cancer with CNS metastases. Although response rates were lower than in HER2-positive counterparts, HER2 2+ tumors and patients treated with T-DXd showed encouraging outcomes. These findings support the need for prospective studies focusing on HER2-low CNS disease and suggest T-DXd as a promising therapeutic option, even in the absence of concurrent local treatment."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Analysis of Efficacy, Safety and Cost of Datopotamab Deruxtecan and Sacituzumab Govitecan for Advanced Hormone Positive Breast Cancer Patients (SABCS 2025) - "DD should be used with caution in patients with preexisting eye disorders. Real-world comparative analysis and biomarker-driven studies are needed to guide optimal sequencing.Abbreviations: PFS, progression free survival; OS, overall survival; DCR, disease control rate; ORR, overall response rate; G3AER, grade 3 adverse events rate; DDR, drug discontinuation rate; HR, hazard ratio."

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

Sacituzumab Govitecan Combined with Anti-angiogenic Therapy and Radiotherapy in a BRCA1-Mutated Triple-Negative Breast Cancer Patient with Multiple Recurrences: A Case Report (SABCS 2025) - P2 | "She underwent left modified radical mastectomy, followed by 8 cycles of adjuvant chemotherapy (epirubicin + cyclophosphamide, followed by paclitaxel)...In December 2020, right chest wall recurrence was found, treated with local extended resection in January 2021, and followed by one-year oral capecitabine.In June 2023, she developed lung metastases (germline BRCA1 mutation),then enrolled in an IIT trial (NCT05085626) where she received Fluzoparib + Chidamide, achieving partial response (PR) with a progression-free survival (PFS) of 14 months...She declined brain surgery and received Bevacizumab + Trastuzumab Deruxtecan...Treatment with SG in combination with Anlotinib was initiated, accompanied by concurrent WBRT during the first cycle... This case report highlights the potential efficacy of SG in combination with anti-angiogenic therapy and radiotherapy in treating BRCA1-mutated TNBC patients with multiple recurrences and brain metastases. However, further studies..."

Case report • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • HER-2 • HRD • PGR

A case report of veno-occlusive disease (VOD) in a patient with metastatic triple-negative breast cancer receiving trastuzumab deruxtecan. (SABCS 2025) - "We present a rare case of VOD that occurred in a patient with breast cancer receiving T-DXd.Case Presentation: A 45-year-old female with triple-negative breast cancer developed a rapid metastatic recurrence following neoadjuvant chemo-immunotherapy, then rapid progression while on first-line sacituzumab govitecan...The two most implicated ADCs are gemtuzumab ozogamicin and inotuzumab ozogamicin, utilized in hematologic malignancies. Management of VOD includes defibrotide, a thrombolytic agent that stabilizes the endothelium. On review of the literature, there are reports of VOD occurring after treatment with trastuzumab emtansine, another ADC used in breast cancer... We present a rare case of VOD after receipt of T-DXd in a heavily pretreated patient with metastatic breast cancer."

Case report • Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Efficacy of antibody drug conjugates in patients with advanced metaplastic breast cancer: a multi-institutional retrospective cohort study (SABCS 2025) - "Most pts received ADC in the first (n=19, 40%) or second line (n=18, 38%) with Sacituzumab govitecan being the most common (n=38, 79%) ADC, followed by Trastuzumab deruxtecan (n=9, 19%). In this multi-institutional cohort of pts with metastatic MpBC, ADC treatment yielded a 38% ORR, including four complete responses. However, rwPFS was poor overall & similar between ADC & non-ADC therapy. These findings highlight the need to develop new treatment strategies for MpBC, though a subset of pts may experience meaningful response to ADC."

Metastases • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Basal-like residual disease after neoadjuvant chemotherapy is immunologically cold and associated with poor prognosis in triple negative breast cancer CALGB 40603 (Alliance) (SABCS 2025) - "In this study, we performed transcriptomic profiling on 340 pre-treatment and 70 matched post-treatment RD samples from the CALGB 40603 Phase II trial, which evaluated the effects of adding carboplatin or bevacizumab to a neoadjuvant chemotherapy (NACT) regimen of weekly paclitaxel, followed by dose-dense doxorubicin and cyclophosphamide, in patients with stage II/III TNBC...We therefore tested the antibody-drug conjugates (ADCs) sacituzumab govitecan and trastuzumab deruxtecan on a basal-like patient-derived xenograft model established from a pre-treatment biopsy of a "basal-basal" TNBC patient who ultimately had RD following conventional NACT...We show that in early-stage TNBC, prognostic features measured in RD specimens following NACT may be different from those in the pre-treatment setting, providing a rationale for prognostic biomarker development in the RD setting. Substantial immune depletion in basal-like RD may have implications for treatments with..."

Clinical • IO biomarker • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCND1 • CDK6 • HER-2 • TACSTD2

Molecular characterization of resistance to antibody drug conjugates in metastatic breast cancer: a prospective analysis from the AURORA US Network (SABCS 2025) - "As ADC1, 42 pts received HER2 ADC (35 trastuzumab deruxtecan, T-DXd; 7 trastuzumab emtansine), 29 TROP2 ADC (28 sacituzumab govitecan, SG; 1 datopotamab deruxtecan) and 1 NECTIN4 ADC. Multiplatform molecular characterization of mBC treated with ADC revealed potential mechanisms of resistance related to downregulation of target expression, payload (e.g., microtubule formation, DNA damage repair) and lysosomal processing. Additional analyses integrating these multimodal data are ongoing. Strategies to overcome resistance, e.g. modifying ADC target, are being evaluated in clinical trials."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • HER-2 • MED12 • NECTIN4 • TACSTD2