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

Primary Results from Phase 3 EVOKE-03/KEYNOTE D46: Sacituzumab Govitecan + Pembrolizumab in PD-L1 TPS ≥50% Metastatic NSCLC (IASLC-WCLC 2026) - P2, P3 | "Conclusions : Despite numerical improvement, SG + pembrolizumab did not meet statistical significance for PFS vs pembrolizumab monotherapy in participants with untreated PD-L1−high mNSCLC; at this interim analysis, OS did not meet statistical significance. The safety profile of SG + pembrolizumab was consistent with the known profiles of each agent, and no new or additional toxicities were observed with the combination."

Late-breaking abstract • Metastases • Alopecia • Hematological Disorders • Immunology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • ROS1

ARIAN, a Phase III, Randomized Study of Adjuvant Treatment With Sacituzumab and Zimberelimab in Resected Patients (IASLC-WCLC 2026) - "The combination of PD-1/PD-L1 agents and antibody-drug conjugates (ADCs), such as sacituzumab govitecan, (a TROP-2 directed ADC), has emerged as a promising therapeutic option in clinical practice. Survival outcomes will be analyzed using Cox proportional hazard models, log-rank tests, and Kaplan-Meier curves, while categorical and numerical variables will be analyzed using Pearson's chi-squared or Fisher's exact tests and Kruskal-Wallis tests, respectively.The study was approved by health authorities on 19 August 2024. As of the data cut off in February 2026, 39 patients have been screened and 26 enrolled in the study: 9 patients in arm 1, 9 patients in arm 2, and 8 patients in arm 3."

Clinical • IO biomarker • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sacituzumab Govitecan Combined With Tislelizumab for Locally Advanced/Metastatic Esophageal Cancer (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Shanghai Chest Hospital

Checkpoint inhibition • New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy (clinicaltrials.gov) - P2 | N=87 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2026 ➔ Jun 2027

Enrollment open • Platinum sensitive • Trial initiation date • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Sequential Antibody-Drug Conjugate Therapy with Enfortumab Vedotin and Sacituzumab Govitecan in Metastatic Urothelial Carcinoma: A Systematic Review and Meta-Analysis (ESMO 2026) - No abstract available

ADC • Metastases • Retrospective data • Review • Oncology • Solid Tumor • Urothelial Cancer

Phase 2 EVOKE-02 Study of Sacituzumab Govitecan and Pembrolizumab±Platinum in First-Line Metastatic NSCLC (IASLC-WCLC 2022) - P1/2, P2 | "We hypothesize that combining SG with pembrolizumab or with pembrolizumab + platinum chemotherapy will improve outcomes for patients with advanced NSCLC. EVOKE-02 (NCT05186974) is an open-label, multicenter, multicohort, global phase 2 study evaluating SG plus pembrolizumab with or without carboplatin (carbo) or cisplatin (cis) in advanced NSCLC. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting."

Clinical • IO biomarker • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Patient-reported outcomes (PROs) with sacituzumab govitecan (SG) vs chemotherapy in patients with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors in the phase 3 ASCENT-03 study (SABCS 2025) - P3 | " Patients were randomized to SG or chemotherapy (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel). The key secondary endpoints of LS mean changes from baseline to week 25 in physical functioning favored SG vs chemotherapy, while TTD in fatigue was similar in both treatment arms. These data, along with additional exploratory results reported here, suggest that SG was associated with more favorable and sustained benefits in QOL vs chemotherapy. The known gastrointestinal side effects of SG did not negatively impact global health status/QoL or functional domain scores in this analysis."

Clinical • Metastases • P3 data • Patient reported outcomes • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ASCENT-04: Analysis of efficacy by biomarker subgroups with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC). (ASCO 2026) - P3 | " 443 pts received (1:1 ratio) SG + pembro in 21-day cycles or chemo (gemcitabine + carboplatin; taxane) + pembro. SG + pembro demonstrated longer PFS vs chemo + pembro across all Trop-2, tBRCA, and HER2 subgroups. These analyses strengthen support for the significant, clinically meaningful benefit of SG + pembro as first-line treatment for mTNBC across subgroups."

Biomarker • Clinical • IO biomarker • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • HER-2 • PD-L1 • TACSTD2

Real-world granulocyte colony-stimulating factor strategies with sacituzumab govitecan inmetastatic triple-negative breast cancer: a national pilot study among Polish medicaloncologists (ESMO 2026) - No abstract available

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

Efficacy and safety of sacituzumab govitecan in patients with metastatic HR+/HER2- pleomorphic lobular breast cancer complicated by renal impairment. (PubMed, Recenti Prog Med) - "Following multidisciplinary evaluation, sacituzumab govitecan was initiated in December 2025 at full dose (10 mg/kg), with primary prophylaxis using filgrastim. The patient is currently continuing treatment with overall good tolerability. This case highlights the feasibility of a personalized approach with sacituzumab govitecan in frail patients with severe renal impairment and lobular breast cancer, populations underrepresented in clinical trials."

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

Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. (PubMed, N Engl J Med) - P3 | "Sacituzumab govitecan plus pembrolizumab led to significantly longer progression-free survival than chemotherapy plus pembrolizumab among patients with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. (Funded by Gilead Sciences; ASCENT-04/KEYNOTE-D19 ClinicalTrials.gov number, NCT05382286.)."

Clinical • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Sacituzumab Govitecan (SG) vs Treatment of Physician’s Choice (TPC): Efficacy by Trop-2 Expression in the TROPiCS-02 Study of Patients (Pts) With HR+/HER2– Metastatic Breast Cancer (mBC) (SABCS 2022) - "Pts were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (eribulin, gemcitabine, capecitabine, or vinorelbine) until disease progression or unacceptable toxicity. In this TROPiCS-02 post-hoc analysis, improved efficacy with SG vs TPC was observed regardless of Trop-2 expression, and there was no clear level of Trop-2 expression at which a better treatment effect for SG was observed. These results support SG as an effective novel treatment option for patients with pretreated, endocrine- resistant HR+/HER2- mBC, and reinforce that Trop-2 testing is not required for SG treatment."

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology • Triple Negative Breast Cancer • HER-2

Treatment-Related Toxicities of Antibody-Drug Conjugates in Breast Cancer: A Bayesian Network Meta-Analysis. (PubMed, Cancer Control) - "The protocol was registered in PROSPERO (CRD42024606194).ResultsSeventeen randomized trials including 8,946 patients and five ADCs-trastuzumab emtansine (T-DM1), sacituzumab govitecan (SG), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), and ARX788-were analyzed. For gastrointestinal toxicities, SG ranked worst for diarrhea (SUCRA 6.0%), whereas T-DXd was associated with higher risks of nausea (2.2%), vomiting (7.9%), and decreased appetite (8.6%). In analyses of SAEs, SG had the highest rates of anemia (11.7%) and neutropenia (8.5%), while gastrointestinal SAEs occurred more frequently with T-DXd.ConclusionsThis network meta-analysis highlights clinically meaningful differences in ADC safety profiles and may help guide individualized toxicity management in breast cancer."

Clinical • Journal • Retrospective data • Review • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Interim results of a phase II trial of sacituzumab govitecan (SG) in patients (Pts) with metastatic castration resistant prostate cancer (mCRPC) progressing on androgen receptor signaling inhibitors (ARSI) (ESMO 2022) - P2 | "Background Resistance to ARSIs (e.g. abiraterone, enzalutamide) is inevitable and there is critical need to develop new therapies for mCRPC...All pts had progressed on an ARSI with 30% of pts having received docetaxel chemotherapy in the castration sensitive setting...PSA stabilization was observed in pts meeting this endpoint. Analysis of tissue and liquid biopsies is ongoing to identify predictive biomarkers for SG in prostate cancer."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CSF3

Exploring trop-2-directed ADCs monotherapy and combination therapy in pretreated mTNBC: a real-world study. (PubMed, Breast Cancer Res Treat) - "To our knowledge, this study represents one of the earliest real-world evaluations of this triple-agent strategy in previously treated mTNBC, providing a basis for further prospective validation and biomarker-guided application."

IO biomarker • Journal • Monotherapy • Real-world evidence • Retrospective data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

First-Line Sacituzumab Govitecan Plus Pembrolizumab and Carboplatin in Metastatic Non-Small Cell Lung Cancer: Nonsquamous and Squamous Cohorts of the EVOKE-02 Study. (PubMed, Clin Cancer Res) - P2 | "SG plus pembrolizumab and carboplatin had activity in mNSCLC. When combined with pembrolizumab and carboplatin, SG was tolerated at a dose of 7.5 mg/kg."

Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Impact of Sacituzumab Govitecan Dose Reduction on Time to Treatment Discontinuation in Second-Line Metastatic Triple-Negative Breast Cancer (ESMO 2026) - No abstract available

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

A PHASE II EVALUATION OF SACITUZUMAB GOVITECAN IN PLATINUM-RESISTANT OVARIAN CANCER (NCT06028932) (IGCS 2026) - P2 | "Sacituzumab govitecan (SG) is an antibody-drug conjugate consisting of a Trop-2–specific antibody conjugated with SN-38, an active metabolite of irinotecan. Twenty patients enrolled. Median age was 67 years (range: 45-84). Most participants (85%, n=17) were White."

P2 data • Platinum resistant • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • TACSTD2

SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer. (ASCO 2024) - P2 | "Pts who received prior topoisomerase I inhibitor ADC, irinotecan or PD-1/L1 inhibitors were excluded. Addition of pembrolizumab to SG showed a non-significant trend toward improved PFS in unselected HR+/HER2- MBC at this preliminary time point. Final PFS and updated OS with further follow-up will be presented at the meeting. Exploratory outcome analyses by TROP2 and PD-L1 expression will be reported."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Alopecia • Anemia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • STING • TACSTD2

Sacituzumab govitecan (SG) + pembrolizumab (pembro) in first-line (1L) metastatic non-small cell lung cancer (mNSCLC): Efficacy results by histology from the EVOKE-02 study (ELCC 2024) - P2 | "Conclusions In EVOKE-02, SG + pembro showed promising activity regardless of histology (squamous and nonsquamous) in previously untreated mNSCLC. The safety profile was manageable and consistent with the known safety profile of each agent."

Clinical • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sacituzumab Govitecan (SG) Combined With Enfortumab Vedotin (EV) and Zimberelimab (ZIM) in Treatment-Naive Metastatic Urothelial Cancer (mUC): Interim Results From Phase 1b TROPHY-U-01 Cohort 7 (ESMO 2026) - No abstract available

Metastases • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

FINAL OS Analysis from the Phase 3 TROPICS-02 Study: Sacituzumab Govitecan in HR+/HER2-METASTATATIC BREAST CANCER (JSMO 2024) - No abstract available

P3 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i). (ASCO 2026) - P3 | " 588 pts randomized 1:1 to SG or chemo (taxane or gemcitabine + carboplatin). PFS was longer with SG vs chemo across all Trop-2 categories, tBRCA genotypes, and HER2 subgroups. These results reinforce the significant, clinically meaningful benefit of SG as first-line treatment for pts in this population across multiple biomarker subgroups."

Biomarker • Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • HER-2 • TACSTD2

Overall survival (OS) and mature safety results of SURE-02, a phase 2 study of neoadjuvant Sacituzumab govitecan (SG) plus pembrolizumab (Pembro), followed by response-adapted bladder sparing and adjuvant Pembro, in patients with muscle-invasive bladder cancer (MIBC) (ESMO 2026) - No abstract available

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy and safety of sacituzumab govitecan (SG) plus trastuzumab in patients with HER2+ metastatic breast cancer after prior trastuzumab deruxtecan (T-DXd): Results from the phase II SATEEN trial (ESMO-BC 2026) - P2 | "In heavily pretreated HER2+ MBC after prior T-DXd, SG plus trastuzumab did not show clinically relevant activity. These prospective findings inform the activity of sequential TOPO1 inhibitor–based ADCs in HER2+ MBC and highlight the need for alternative strategies to optimize patients' outcomes."

Clinical • Late-breaking abstract • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2