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

Concomitant RT and systemic therapy in breast cancer: Focus on ADCs and CDK4/6i (ESTRO 2025) - "Currently, ADC include trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan...CDK4/6i include abemaciclib, ribociclib and palbociclib, where the evidence is in favor of using these drugs for first line metastatic therapy of selected patients with hormone positive BC...Few trials have investigated the adverse effects from this combination, whilst most trials have had the combined treatment as an exclusion criterium. When combining drugs with concomitant RT the recommendation is always to be cautious, even in patients where the combination is considered feasible, thus the patient and staff should be aware of the risk of serious adverse effects, e.g. pneumonitis."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Pain • Oncology • Pain • Palliative care • Pneumonia • Solid Tumor • CDK4 • HER-2

InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Laura Huppert, MD, BA | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Tumor mutational burden • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

Suppression of triple-negative breast cancer metastasis by a new glyco-humanized polyclonal antibody (AACR 2025) - "Here, we assess the efficacy of XON7, a first-in-class glyco-humanized polyclonal antibody (GH-pAb), in preclinical models of TNBC. The anti-tumor efficacy of XON7 was assessed in TNBC cell lines for its capacity to induce complement-dependent cytotoxicity (CDC) and apoptosis, compared to paclitaxel and the ADC Sacituzumab Govitecan. XON7 is a multi-target antibody currently under clinical evaluation, it represents a promising candidate for advancing treatment paradigms in TNBC."

Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CASP8 • CASP9

Humanistic Burden in Metastatic Triple-Negative Breast Cancer (mTNBC): A Systematic Literature Review (SLR) (ISPOR 2025) - "Four studies examined patients eligible for anti-PD-(L)1 therapy, and the remaining 9 studies examined all-comers (PD-(L)1 status unclear/mixed).Studies in anti-PD-(L)1 therapy eligible patients: These 4 studies compared atezolizumab+nab-paclitaxel versus placebo+nab-paclitaxel, pembrolizumab+chemotherapy versus placebo+chemotherapy, pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab+olaparib versus pembrolizumab+chemotherapy...One study showed HRQOL improvement and utility gains in later-line mTNBC for sacituzumab govitecan versus placebo/TPC... Newer therapies for mTNBC, including immunotherapy, showed no detriment or modest HRQOL benefit over comparators via exploratory analyses. More data are needed to better understand the humanistic burden of mTNBC on patient HRQOL, especially in the advanced/metastatic setting."

IO biomarker • Metastases • Review • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA

Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1 positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT05382286 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Real world evidence for patients with advanced and metastatic pancreatic cancer treated with sacituzumab govitecan: A retrospective trial in China. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

HEOR • Metastases • Real-world • Real-world evidence • Retrospective data • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Real-world clinical outcome of sacituzumab govitecan (SG) in HER2-negative metastatic breast cancer. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Effectiveness and safety of sacituzumab govitecan in heavily pretreated metastatic HER2-negative breast cancer: A real-world multicenter analysis in China. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Trodelvy use in advanced triple negative breast cancer in Australia (TRACIE): Study design and interim analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

A retrospective analysis of metaplastic triple negative breast cancer response to sacituzumab govitecan and candidacy for targeted therapy. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Retrospective data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Sacituzumab govitecan initial dose reduction in Polish patients with metastatic triple-negative breast cancer: Impact on efficacy and safety. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Assessment of weight change and BMI as prognostic markers of survival outcomes in sacituzumab govitecan therapy for mTNBC in a Polish female cohort. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Biomarker • Triple Negative Breast Cancer

Hemoglobin level and neutrophil-to-lymphocyte ratio as prognostic peripheral blood markers of survival outcomes in sacituzumab govitecan therapy for mTNBC in Polish female cohort. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Triple Negative Breast Cancer

Real-world effectiveness and safety with sacituzumab govitecan (SG)–based therapy in metastatic breast cancer (MBC) in China: A multicenter retrospective study. (ASCO 2025) - P | "Clinical Trial Registration Number: NCT06356519 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Pattern of granulocyte colony stimulating growth factors (G-CSGF) usage in patients treated with sacituzumab govitecan: A real world multicenter study using the TriNetX database. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Real-world • Real-world evidence • Breast Cancer • Oncology • Solid Tumor

Multimodal cancer therapy consisting of antibody-drug conjugates and radiotherapy in cancer treatment (AACR 2025) - "Accordingly, combination of RT with ADCs targeting HER2: trastuzumab emtansine/deruxtecan/duocarmazine (T-DM1/T-DXd/T-Duo) and disitamab vedotin, TROP2: datopotamab deruxtecan and sacituzumab govitecan, EGFR: depatuxizumab MMAE, HER3: patritumab deruxtecan, Nectin4: enfortumab vedotin and CEACAM5: tusamitamab ravtansine were evaluated. Together, this study demonstrates that inherent sensitivity of tumor cells to different payload classes, DAR and TAA dynamic are of relevance for the efficacy of ADC. Informed selection of ADC exhibited synergistic effects with RT providing a novel multimodal and promising strategy for efficient cancer eradication."

Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • CEACAM5 • EGFR • ERBB3 • HER-2 • NECTIN4

Genomic alterations (GAs) associated with durability of benefit from trastuzumab deruxtecan (T-DXd), trastuzumab emtansine (T-DM1) and sacituzumab govitecan (SG) in metastatic breast cancer (MBC). (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Metastases • Breast Cancer • Oncology • Solid Tumor

Trial in progress: Sacituzumab govitecan for the treatment of patients with diffuse pleural mesothelioma. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06477419 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Solid Tumor

Phase IB/II study to evaluate safety and preliminary efficacy of the WEE1 inhibitor Debio 0123 in combination with sacituzumab govitecan (SG) in triple-negative or hormone receptor–positive (HR+)/HER2-negative (HER2–) advanced breast cancer (ABC): The WIN-B study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06612203 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P1/2 data • 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

Identification of predictive biomarkers of response to ADCs by HTS of highly molecularly characterized panels of patient-derived organoids (PDOs) (AACR 2025) - "Background: Antibody-drug conjugates (ADCs) such as the HER2-targeting agent trastuzumab deruxtecan, the TROP-2 targeting agent sacituzumab govitecan, and the NECTIN4 targeting agent enfortumab vedotin-ejfv, have resulted in increased clinical response rates in previously difficult to treat solid tumor indications, but only a minority of patients exhibit such responses. The results shown here demonstrate that screening pan indication panels of PDOs can reveal ADC specific differences in efficacy which are rooted in molecular factors that include, but are not limited to target expression. Further analysis is ongoing, including establishing the prevalence of non-ADC target biomarkers in real-world patient populations via the projection of our screen-derived data onto Tempus RWD."

Biomarker • Clinical • Oncology • Solid Tumor • HER-2 • HNF1A • NECTIN4 • VIL1

Gilead Sciences Announces First Quarter 2025 Financial Results (Businesswire) - "Trodelvy (sacituzumab govitecan-hziy) sales decreased 5% to $293 million in the first quarter 2025 compared to the same period in 2024, primarily driven by inventory dynamics and lower average realized price, partially offset by higher demand."

Sales • Triple Negative Breast Cancer • Urothelial Cancer

Sacituzumab govitecan screening in a large organoid panel reveals the importance of functional assays for predicting ADC tumor response (AACR 2025) - "The OrganoidXplore screening platform provides insights into ADC efficacy, and responses and target engagement were validated with HCI. Combined, this demonstrates a lack of correlation between target expression (mRNA and protein) and drug efficacy, and the importance of functional testing for efficacy across a diverse patient population. The unique application of the 3D HCI platform for additional characterization, including ADC binding and uptake assays, will be an essential step to gain insight into the mode of action requirements for ADCs to be effective."

Oncology • TACSTD2

European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2025 Guidelines. (PubMed, Eur Urol) - "This overview of the 2025 EAU guidelines offers valuable insights into risk factors, diagnosis, classification, treatment, and follow-up of MIBC patients and is designed for effective integration into clinical practice."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology • Urothelial Cancer • FGFR3 • HER-2

Assessment of response and overall survival (OS) for various systemic therapies in ERBB2-altered advanced urothelial carcinoma (aUC) (AACR 2025) - "Based on available data, we hypothesized that ERBB2-altered aUC would respond less favorably to immune checkpoint inhibitor (ICI), enfortumab vedotin (EV), and sacituzumab govitecan (SG) than ERBB2-wildtype aUC. This single-center retrospective study included patients (pts) diagnosed with aUC between 5/6/2016 and 9/23/2022 who underwent panel-based somatic tumor sequencing (120 tissue-based, 9 ctDNA) and received ICI, EV, or SG in first line (1L) or as salvage (2L+). In pts receiving 2L+ ICI, significantly higher ORR and longer OS were noted in pts with ERBB2alt vs ERBB2wt aUC, contrary to our hypothesis; ERBB2alt was also associated with higher ORR to 2L+ EV. Limitations include retrospective design, limited sample size and power for subsets, lack of randomization, selection/confounding biases, and lack of HER2 protein IHC assessment. Results are hypothesis-generating and need external validation.Table 1."

Clinical • IO biomarker • Metastases • Oncology • Solid Tumor • Urothelial Cancer • HER-2

A 3D bioprinted vascularized human tumor-on-a-Chip model for simultaneous evaluation of immunotherapeutic efficacy and safety (AACR 2025) - "We also modeled T cell responses to immune checkpoint inhibition with pembrolizumab, showing increased tumor killing, evidenced by elevated markers such as IFN-γ, Granzyme B, and cleaved-caspase 3...In a TROP-2-expressing lung cancer model, we recapitulated the efficacy of the TROP-2 antibody-drug conjugate Sacituzumab govitecan, shown by increased cleaved-caspase 3 and reduced tumoroid viability...In conclusion, our 3D vascularized tumor-on-a-chip model outperforms traditional models by accurately replicating the TME and enabling the simultaneous assessment of drug-induced toxicities. This customizable platform facilitates mechanism-of-action studies and holds significant potential for personalized medicine, offering a powerful tool for advancing immuno-oncology research and improving therapeutic outcomes."

Clinical • IO biomarker • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor • CASP3 • GZMB • ICAM1 • IFNG • IL6 • TACSTD2 • TNFA