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

Sacituzumab govitecan: a new hope for patients with pretreated extensive small-cell lung cancer (SCLC)-insights from the TROPiCS-03 trial. (PubMed, Transl Lung Cancer Res) - No abstract available

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Outcomes with trastuzumab deruxtecan by biomarker status, line of treatment and prior receipt of sacituzumab govitecan in a large real-world database of patients with metastatic breast cancer. (PubMed, ESMO Open) - "In a large dataset, T-DXd showed favorable activity for treating MBC, although outcomes for HER2-positive disease appeared worse than those observed in clinical trials. Prior SG treatment was associated with inferior outcomes with T-DXd, suggesting cross-resistance between these antibody-drug conjugates."

Biomarker • Journal • Real-world evidence • 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 • BRCA • HER-2 • PD-L1

Synergistic strategies: ADC-PARP inhibitor combinations in triple-negative breast cancer therapy. (PubMed, Pathol Res Pract) - "ADCs like sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) target cytotoxic payloads with specificity, whereas PARPis like olaparib, rucaparib, niraparib, and talazoparib cause synthetic lethality in homologous recombination repair (HRR)-deficient tumors. Future directions include biomarker-driven patient selection, combination with immune checkpoint inhibitors, and advancement in next-generation ADCs. The synergistic potential of ADC-PARPi combinations provides a new avenue for overcoming TNBC resistance, enhancing treatment outcomes, and widening therapeutic strategies for this challenging disease."

IO biomarker • Journal • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HRD

Preclinical evaluation of 89Zr labeled anti-Trop2 antibody–drug conjugate (Trodelvy) for imaging in gastric cancer (SNMMI 2025) - "The radiochemical yield of 89Zr-DFO-Trodelvy exceeded 90%, with a radiochemical purity greater than 99%. Trop2 expression was high in NCI-N87 cells, while it was low in HGC-27 cells. The KD value of 89Zr-DFO-Trodelvy was 3.51 nM for NCI-N87 cells."

Preclinical • Gastric Cancer • Oncology • Solid Tumor • TACSTD2

Noninvasive evaluation of Trop2 expression using 64Cu-NOTA-Trodelvy-F(ab')2 in gastric cancer (SNMMI 2025) - "Trodelvy-F(ab')2 generated using the IdeS digestion system were validated through non-reducing SDS-PAGE and HPLC. The radiochemical yield of 64Cu-NOTA-Trodelvy-F(ab')2 exceeded 90%, with radiochemical purity surpassing 99%. Trop2 expression was found to be high in NCI-N87 cells but low in HGC-27 cells."

Non-invasive • Breast Cancer • Gastric Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

ASCENT-GYN-01 (GOG-3104/ENGOT-en26): A randomized, phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with endometrial cancer (EC) after platinum-based chemotherapy and immunotherapy (ESMO-GC 2025) - P3 | "Trial Design ASCENT-GYN-01 (NCT06486441) is a randomized, open-label, global phase III study assessing SG vs TPC (doxorubicin or paclitaxel) in pts with EC who have received prior platinum-based chemotherapy and PD-(L)1 inhibitor therapy. Editorial acknowledgement Medical writing and editorial assistance were provided by Priya Talluri, MSc, of Parexel, and funded by Gilead Sciences, Inc. Legal entity responsible for the study Gilead Sciences, Inc."

Clinical • P3 data • Endometrial Cancer • Oncology • Solid Tumor

Evolution of TROP2: Biological insights and clinical applications. (PubMed, Eur J Med Chem) - "We examine the efficacy of targeted therapies against TROP2, in particular the use of sacituzumab govitecan (SG), and evaluate their clinical impact on the treatment of various cancers. Through recent studies and clinical trials, we analyze the clinical effects of TROP2-ADCs and explored the prospects for their application in different cancers, including combination therapies with other therapeutic approaches, studies of resistance mechanisms, and further exploration of TROP2 as a biomarker. This review aims to provide a concise overview of TROP2 applications in cancer therapy, emphasizing emerging trends and therapeutic strategies to provide direction for future research and clinical practice."

Journal • Review • Oncology • TACSTD2

Advances in targeted therapy for triple-negative breast cancer: a review of key antigens and recent advances. (PubMed, J Drug Target) - "Antibodies known as Pembrolizumab, Atezolizumab, and Sacituzumab Govitecan-hziy have been approved by the FDA, and many are under investigation. The present review discusses the antigens with high expression in TNBC, their role in cancer development and progression, and the targeted therapies like antibodies, recombinant proteins, and antibody-drug conjugates (ADC)."

IO biomarker • Journal • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • MSLN • PD-1 • PD-L1

Trop-2 expression as a biomarker of response to sacituzumab govitecan in patients with HER2-negative metastatic breast cancer: A pilot study. (PubMed, Cancer Treat Res Commun) - "In this study, Trop-2 expression did not predict excellent response versus non-response to SG in patients with HER2-negative MBC. Low Trop-2 expression, as determined by percentage staining, was predictive of shorter PFS, although the same association was not observed using the H-score. A complete lack of Trop-2 expression may predict SG ineffective, which requires further investigation."

Biomarker • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2 • TACSTD2

A Meta-Analysis of Patient-Reported Outcomes of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Previously Treated HR+/HER- mBC Using Two Phase 3 (TROPiCS-02 and EVER-132-002) Trials. (PubMed, Cancers (Basel)) - "SG significantly improved PROs versus chemotherapy for several subdomains of EORTC QLQ-C30 and EQ-5D-5L-VAS. The consistency of these results in the overall population and subgroups supports the generalizability of the meta-analytic evidence and reinforces the PRO benefits associated with SG versus chemotherapy."

Journal • P3 data • Retrospective data • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Pain • Pulmonary Disease • Solid Tumor • CDK4 • HER-2

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

New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

The antibody-drug conjugate sacituzumab govitecan (IMMU-132) represents a potential novel therapeutic strategy in cholangiocarcinoma. (PubMed, Mol Cancer Ther) - "This study reveals that TROP2 is widely expressed in cholangiocarcinoma. Moreover, it provides preclinical evidence for the potential of use of sacituzumab govitecan as a novel therapeutic strategy in treating cholangiocarcinoma patients."

Journal • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • ERBB3 • FOLR1 • HER-2 • NECTIN4 • TACSTD2

Advancing Antibody-Drug Conjugates: Precision Oncology Approaches for Breast and Pancreatic Cancers. (PubMed, Cancers (Basel)) - " In TNBC, ADCs such as sacituzumab govitecan and trastuzumab deruxtecan have improved progression-free survival in advanced cases. While ADCs have significantly advanced treatment options in TNBC, PDAC remains a difficult target due to its stroma-rich microenvironment and lack of high-density, tumor-specific antigens. This article emphasizes the need for tailor-made ADC designs to enhance results in various types of cancers and provides valuable insight into future advancements in precision oncology."

Journal • Review • Breast Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • MSLN • MUC1

Efficacy and Safety of TROP-2-Targeting Antibody-Drug Conjugate Treatment in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer: A Systematic Review and Pooled Analysis of Reconstructed Patient Data. (PubMed, Cancers (Basel)) - "The anti-TROP-2 regimen showed a better safety profile but failed to demonstrate a relevant clinical improvement over docetaxel. Anti-TROP-2 ADCs could find a role in the management of patients with AGAs."

Journal • Retrospective data • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Comparative pharmacological analysis of fam-trastuzumab deruxtecan-nxki and sacituzumab govitecan-hziy: Two recently developed chemotherapies in the crucial battle against breast cancer. (PubMed, Toxicol Rep) - "While both therapies demonstrate therapeutic promise, continuous safety monitoring is essential. The FAERS dataset's demographic limitations highlight the need for more comprehensive post-marketing surveillance to assess long-term AE risks and optimize BC treatment safety."

Journal • Breast Cancer • Cardiovascular • Infectious Disease • Musculoskeletal Diseases • Oncology • Solid Tumor

Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - P=N/A | N=70 | Active, not recruiting | Sponsor: Peking University Cancer Hospital & Institute

Monotherapy • New trial • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Gilead’s Trodelvy wins Korean coverage for breast cancer -- too late for some and still off-limits up front (Korea Biomedical Review) - "Effective June 1, coverage applies to third-line treatment of locally advanced or metastatic TNBC, as well as second-line use if recurrence occurs within a year of prior chemotherapy. Reimbursement also extends to third-line treatment of hormone receptor-positive, HER2-negative breast cancer...Each cycle of Trodelvy now costs patients 1,052,300 won ($769), a sharp drop from nearly 10 million won ($7,307), with the Korea Alliance of Patient Organizations estimating that about 280 patients a year will gain access under the new listing."

Reimbursement • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

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

Real-world use of antibody drug conjugates (ADCs) in metastatic bladder cancer: Analysis of 10,204 patients treated in clinical practice. (ASCO 2025) - "Enfortumab vedotin (EV) and Sacituzumab Govitecan (SG) are approved by regulatory agencies worldwide, and several other compounds are being investigated in clinical trials...Of all patients, only 922 (9%) were treated with any ADCs as a current or prior line of treatment, including EV, SG, Disitamab Vedotin, Tisotumab Vedotin, and Trastuzumab Deruxtecan... ADCs represent a new therapeutic option for the treatment of mBC, but our data suggest limited access worldwide despite regulatory approvals and clinical guideline recommendations. There is a geographic variation in the percentage of patients treated with ADCs, suggesting higher access in the US. Potential reasons include drug cost limiting access and approval delays in different regions."

Clinical • Metastases • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • NECTIN4

Real-world clinical outcomes of sacituzumab govitecan after prior exposure to enfortumab vedotin in patients with metastatic urothelial carcinoma. (PubMed, ESMO Open) - "SG resulted in limited clinical efficacy in our large cohort of real-world advanced mUC patients with prior exposure to EV."

Clinical data • Journal • Real-world evidence • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Urothelial Cancer

Effectiveness of sacituzumab govitecan and management of neutropenia in patients with metastatic triple-negative breast cancer treated in real-world settings in the United States. (PubMed, ESMO Open) - "SG demonstrated real-world effectiveness and manageable safety, consistent with findings from ASCENT and other published real-world studies. Patients receiving any G-CSF prophylaxis had low rates of any-grade neutropenia, suggesting SG-related neutropenia can be effectively managed with G-CSF in patients with increased risk for febrile neutropenia."

Journal • Real-world evidence • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

The impact of ethnicity on benefit from novel drugs approved for breast cancer treatment: a systematic review and meta-analysis of randomized phase 3 trials of the last decade. (SABCS 2024) - "23 phase III RCTs were identified in the aBC setting, with 1547 (11.1%) patients of Asian ethnicity. Experimental drugs tested included CDK4/6i (palbociclib, ribociclib, abemaciclib), SERD (elacestrant), PI3Ki (alpelisib), PARPi (olaparib, talazoparib), broad variety of anti-HER2 drugs (tucatinib, trastuzumab deruxtecan, pertuzumab, T-DM1, neratinib, margetuximab), anti-PD-1 and anti-PD-L1 drugs (pembrolizumab, atezolizumab) and anti-TROP2 drug (sacituzumab govitecan). 16 RCTs provided HR (95%CI) for PFS in the subgroup of Asians and 17 RCTs for Non-Asians."

IO biomarker • P3 data • Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Results of a phase I study of alpelisib and sacituzumab govitecan (SG) in patients with HER2-negative metastatic breast cancer (MBC). (ASCO 2025) - P1 | "Combination of SG + alpelisib was feasible, with manageable side effects. The toxicity profile of the combination was consistent with the known safety profiles of the two agents. This combination demonstrated encouraging efficacy in HER2-negative MBC, with prolonged duration of responses, and warrants further evaluation in larger studies."

Clinical • Metastases • P1 data • Breast Cancer • Diabetes • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

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 | " Patients were randomized 1:1 to SG (10 mg/kg IV, day 1 & 8) + pembro (200 mg, day 1, max 35 cycles) in 21-day cycles or chemo (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + pembro until disease progression or unacceptable toxicity. SG + pembro led to a statistically significant and clinically meaningful improvement in PFS vs chemo + pembro with durable responses, no new safety concerns for SG or pembro, and a lower rate of treatment discontinuation due to TEAEs in patients with previously untreated, PD-L1–positive advanced TNBC. These data support the use of SG + pembro as a potential new standard of care treatment in this patient population."

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

Real-world clinical outcome of trastuzumab derutexcan (T-DXd) in metastatic breast cancer. (ASCO 2025) - "13 pts (14.3%) received sacituzumab govitecan (SG) prior to T-DXd. Among 53 pts (58.2%) who received post-T-DXd therapies, the most common immediate therapies were: SG (n = 14), eribulin (n = 6) and capecitabine (n = 5)... This study highlights the differential efficacy of T-DXd across breast cancer subtypes and HER2 expression levels in a real-world cohort of MBC pts. A considerable amount of cross-resistance of SG use immediately after T-DXd was observed. Notably, the presence of brain metastases and TP53 mutations were associated with worse PFS in HER2-low cohort."

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • PIK3CA • TMB • TP53