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

Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: West China Hospital

IO biomarker • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Expert consensus on the clinical application of TROP2-targeted antibody-drug conjugates in non-small cell lung cancer (2026 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "Trophoblast cell surface antigen 2 (TROP2) has emerged as a pivotal therapeutic target, and TROP2-directed ADCs, including Sacituzumab Tirumotecan, Datopotamab Deruxtecan, and Sacituzumab Govitecan have shown substantial antitumor activity and survival benefits in clinical studies. To further standardize the clinical use and safety management of TROP2 ADCs, this expert consensus systematically reviews current evidence regarding their efficacy and safety in NSCLC. Particular emphasis is placed on strategies for the prevention and management of treatment-related adverse events such as mucositis, myelosuppression, and gastrointestinal toxicities, aiming to provide guidance for the rational and safe application of TROP2 ADCs in NSCLC."

Journal • Review • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Oncology • Solid Tumor

How case based education elevated clinical performance in metastatic breast cancer management: A study for TROP2 directed antibody drug conjugates (AACR 2026) - "Background: The treatment landscape of metastatic breast cancer (mBC) has advanced with antibody-drug conjugates (ADCs), notably the TROP2-directed agents sacituzumab govitecan and datopotamab deruxtecan. This case-based CME activity effectively improved clinician K/C regarding TROP2-directed ADCs for HER2- mBC and supported sustained practice change. Personalized, digital education formats may accelerate integration of newly available and emerging therapies into oncology care."

ADC • Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety profile of post-CDK4/6 treatments in HR+/HER2− metastatic breast cancer (mBC): A network meta-analysis (AACR 2026) - "Among ET-based strategies, the lowest RRs were observed for: imlunestrant alone (0.98, 95% CI 0.92-1.05) for any G AEs; camizestrant 75 mg (0.81, 0.36-1.83) for G≥3 AEs; elacestrant (1.45, 0.66-3.16) for AEs leading to discontinuation. While among antibody-drug conjugates (ADCs) the lowest RRs were observed for: sacituzumab govitecan (SG) for any G AEs (1.00, 0.99-1.01); datopotamab deruxtecan (Dato-DXd) (0.47, 0.37-0.59) for G≥3 AEs; SG (0.83, 0.26-2.66) for AEs leading to discontinuation...Among ET-based options, novel mono-ETs (oral SERDs and PROTACs) showed the lowest risk of discontinuation and G≥3 AEs. Among ADCs, TROP2-directed agents had fewer discontinuations, while ADCs with DXd as a payload showed higher rates of any G AEs but (except for DESTINY-Breast06) lower G≥3 AEs risk than other tx strategies."

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

A novel synergistic dual-payload TROP2 ADC (CTPH-03) delivering enhanced safety by increased MTD (AACR 2026) - "Although there are two FDA-approved ADCs, Trodelvy and Datroway, anti-tumor efficacy from these TROP2 ADCs have been subpar due to dose-limiting toxicities. We have developed a novel TROP2-targeting dual-payload ADC (AD2C) by using MMAE-based dual-payload combination to address this unmet need. The presentation highlights advantages of the synergistic dual-payload TROP2 ADC over known single-payload ADCs or other dual-payload ADC formats by demonstrating, (1) in vitro cytotoxicity for cancer cells having different TROP2 expression levels (2) in vivo efficacy in various CDX(cancer-cell derived xenograft) models (3) in vivo ADC stability in rats and monkeys by PK(pharmacokinetics) studies, and (4) preliminary toxicity studies conducted in mice and monkeys.In due course, we are currently in preparation of PDX efficacy studies for further confirming its in vivo efficacy over various patient-derived tumor cells, and IND-enabling toxicology studies in order to quickly move..."

ADC • Clinical • Oncology • TACSTD2

Dual-payload antibody drug conjugate targeting TROP2: Multi-Payload Conjugates™ targeting orthogonal mechanisms of cell killing (AACR 2026) - "Sacituzumab govitecan (SG), is approved as a 3rd line therapy in metastatic HER2 negative breast cancer...In head-to-head comparisons, CATB-101 outperforms T-DXd, SG and Dato-DXd with full tumor elimination at low doses... 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 next generation multi-payload conjugates. Catena's MPCs™ offer a next step in ADC design and allow for targeted delivery of multiple mechanisms of action with a single MPC™ while reducing off-target toxicity."

ADC • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EGFR • HER-2 • TACSTD2 • TOP1

WEE1 inhibition as a therapeutic strategy in triple-negative breast cancer: Evaluating single agent and combination activity of azenosertib in preclinical models (AACR 2026) - "We demonstrated in vitro and in vivo evidence that TNBC models are susceptible to WEE1 inhibition. Our findings suggest that azenosertib as a single agent, or in combination with standard-of-care therapies, may be a potential treatment strategy for TNBC and warrants further exploration."

IO biomarker • Preclinical • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • CCNE1

TROP2 expression predicts sensitivity to datopotamab deruxtecan (Dato-DXd) in patient-derived breast cancer organoids (AACR 2026) - "Importantly, Dato-DXd showed potent antitumor activity in three treatment-refractory TNBC PDOs, including models derived from tumors progressing after pembrolizumab plus chemotherapy combination (IC₅₀: OSV-001, 0.82 nM; SBO-105, 0.27 nM) and sacituzumab govitecan (IC₅₀: OSV-011, 0.55nM), whereas T-DXd showed lower activity compared to Dato-DXd in these organoids (IC₅₀: OSV-001, 200 nM; SBO-105 = 160 nM; OSV-011, not reached). These findings demonstrate that TROP2 expression is a key determinant of Dato-DXd sensitivity and provide mechanistic insights into ADC resistance. These findings demonstrate that TROP2 expression is a key determinant of Dato-DXd sensitivity and provide mechanistic insights into ADC resistance. Our results support the potential of TROP2-guided patient stratification to enhance therapeutic outcomes with Dato-DXd in breast cancer. Dato-DXd showed significant antitumor activity in PDOs from tumors resistant to anti-PD-1 and ADC treatment."

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

In vitro and in vivo evaluation of the bystander-killing effect of ADCs (AACR 2026) - "In this study, we assessed the bystander-killing effect of two Trop-2-targeted ADCs—sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd). These results demonstrate that co-culture systems and in vivo imaging are valuable tools for ADC drug discovery. Both in vitro and in vivo assays are essential for understanding bystander-killing mechanisms and predicting clinical success."

ADC • Preclinical • Oncology • TACSTD2

Evolution of TOP1 variants under selective pressure from topoisomerase-based therapeutics (AACR 2026) - "Background: Antibody-drug conjugates (ADCs) that incorporate topoisomerase I inhibitor payloads, including sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd), have demonstrated activity across multiple solid tumors...Patients exposed to topoisomerase inhibitor-based ADCs (SG, T-DXd, or datopotamab deruxtecan [Dato-DXd]) or irinotecan/topotecan-containing chemotherapy were identified (n = 1,807)... TOP1 alterations can appear after exposure to topoisomerase-payload ADCs or irinotecan-containing regimens, suggesting a potential resistance mechanism in a subset of patients. The functional impact of these variants and their relevance to therapeutic response remain undefined, warranting further mechanistic and clinical investigation."

Breast Cancer • Colorectal 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 • TOP1

REAL-TIME AI-ASSISTED LIVING SYSTEMATIC LITERATURE REVIEW (REAL-SLR) CAPTURES A 2025 STANDARD-OF-CARE (SOC) SHIFT DRIVEN BY ANTIBODY-DRUG CONJUGATES (ADCS) IN UROTHELIAL CARCINOMA (UC): IMPLICATIONS FOR HEALTH TECHNOLOGY ASSESSMENTS (HTAS) (ISPOR 2026) - "Among 31 ADC studies identified, 14 were published in 2025, including pivotal evidence supporting enfortumab-vedotin+pembrolizumab in first-line metastatic UC, marking a clear SOC transition. The REAL-SLR also captured evolving guideline-recommended ADCs (e.g., trastuzumab-deruxtecan) and changing regulatory status (e.g., sacituzumab-govitecan), as well as emerging agents in development such as disitamab-vedotin and datopotamab-deruxtecan. REAL-SLR enables HTA stakeholders to detect and contextualize SOC changes as they occur, rather than retrospectively. In UC, where ADC-driven innovation altered first-line treatment in 2025, REAL-SLR provides HTA-ready evidence foundation that reduces rework, improves transparency, and supports timely reimbursement and access decisions in rapidly evolving oncology landscapes."

Review • Oncology • Solid Tumor • Urothelial Cancer

Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Paired PDX-PDXO models serve an integrated preclinical platform for high-throughput payload screening and ADC drug development (AACR 2026) - "In vitro response to different payload of organoids were tested using CellTiter-Glo (CTG) assay and assessed by IC50 values.Results Biomarker analysis showed the PDXO models faithfully recapitulated key features of the corresponding PDX tumors, including high TROP2 expression and reduced sensitivity to Trodelvy...The PDX models showed less sensitivity to Trodelv Dato-Dxd and SKB264 which carry TOP1 inhibitor payloads (TGIs rang 24%-57%) but were more sensitive to Dato-MMAE, which showed obvious tumor regression with a TGI of more than 90%, thereby showing correlation with the in vitro predictions.Conclusion This study validates an efficient and integrated preclinical platform for early-stage ADC development. The combined PDX/PDXO approach significantly streamlines the ADC discovery process by enabling high-throughput payload screening, helping prioritize the most promising ADC candidates before advancing to more resource-intensive in vivo studies. This streamlined..."

ADC • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2 • TOP1

Distinct response profiles of TROP2-targeting ADCs Dato-DXd and sac-TMT across a large panel of cancer cell lines (AACR 2026) - "Sacituzumab govitecan gained FDA approval in 2020 for triple-negative breast cancer (TNBC). When the IC50 "fingerprints" of the two ADCs were compared to a reference dataset of 248 anticancer agents, Dato-DXd clustered with EGFR inhibitors, whereas sac-TMT showed highest similarity to topoisomerase I inhibitors, indicating mechanistically distinct selectivity patterns. Moreover, correlation between drug sensitivity and TROP2 gene expression was stronger for Dato-DXd than for sac-TMT.This large-scale cell panel profiling study underscores the power of integrative bioinformatic analyses to uncover biomarkers of ADC response, and identifies cell models suitable for investigating mechanisms of action, such as receptor internalization, payload processing, and bystander effects."

ADC • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • TACSTD2

ENABLING HEALTH TECHNOLOGY ASSESSMENT (HTA) TA READINESS THROUGH REAL-TIME AI-ASSISTED LIVING SYSTEMATIC LITERATURE REVIEWS (REAL-SLR): A BREAST CANCER (BCA) CASE STUDY (ISPOR 2026) - "REAL-SLR enables a shift from episodic SLRs to a continuously maintained HTA evidence foundation. By supporting real-time incorporation of emerging data and rapid alignment to HTA requirements, REAL-SLR improves preparedness, reduces rework, and enhances transparency for oncology HTA decision making."

Case study • Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

First 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). (ASCO 2025) - P2 | "Perioperative SG+Pembro revealed a compelling cCR rate, with a manageable safety profile, allowing a bladder preservation in ~40% of pts. Pre-treatment molecular biomarker analyses suggest a unique tumor profile associated with cCR. Overall, SURE-02 interim results support the completion of study accrual and further investigation of SG+Pembro in pts with MIBC."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • TOP1

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

Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i) (ESMO 2025) - P3 | "Background Significant PFS benefit was observed with SG vs chemo in pretreated metastatic (m)TNBC (ASCENT) and with SG + pembrolizumab vs chemo + pembrolizumab in first-line (1L) PD-L1+ mTNBC (ASCENT-04)...Randomization (1:1) to SG (10 mg/kg IV, days 1 & 8 in 21-day cycles) or chemo (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) was stratified by disease status and geography...These data support SG as a potential new standard of care for pts with previously untreated mTNBC who are unable to receive a PD-(L)1i. Table: LBA20 Efficacy: Intent-to-treat SG (n = 279) Chemo (n = 279) Median PFS per BICR (95% CI), mo 9.7 (8.2-11.1) 6.9 (5.6-8.3) HR (95% CI); adjusted two-sided P -value 0.62 (0.50-0.78); P < .0001 ORR (95% CI), % 48.4 (42.4-54.4) 45.5 (39.6-51.6) Median DOR (95% CI), mo 12.2 (9.7-13.8) 7.2 (5.7-8.4) Safety: All treated n = 275 n = 276 TEAEs, n (%) Any grade Grade ≥ 3 Led to dose reduction Led to treatment discontinuation 273 (99) 181 (66)..."

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

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

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2027 ➔ Mar 2029 | Trial primary completion date: Mar 2026 ➔ Mar 2028

Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • BARD1 • BRCA • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK1 • CHEK2 • FANCL • HRD • PPP2R2A • RAD51B • RAD51C • RAD51D • RAD54L

A phase 2 study of response-guided neoadjuvant sacituzumab govitecan and pembrolizumab (SG/P) in patients with early-stage triple-negative breast cancer: Results from the NeoSTAR trial. (ASCO 2025) - P2 | "In the first trial to investigate the SG/P combination in early TNBC, 34% of pts had pCR. Additional research is needed to determine the optimal duration and sequence of neoadjuvant SG/P and chemotherapy for pts with TNBC."

Clinical • IO biomarker • P2 data • Alopecia • Breast Cancer • Fatigue • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA

Sacituzumab govitecan in combination with capecitabine for the treatment of advanced gastrointestinal cancers after progression on standard therapy. (ASCO-GI 2026) - P1 | "SG is covalently bound to the topoisomerase I inhibitor SN-38, which is the active metabolite of irinotecan. The trial will enroll up to 20 patients. The trial is funded by Gilead Sciences, Inc."

Combination therapy • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • TACSTD2

Avelumab (Ave) in combination with other anticancer agents as first-line maintenance (1LM) treatment for advanced urothelial carcinoma (aUC): Primary analysis from the JAVELIN Bladder Medley phase 2 trial. (ASCO-GU 2026) - P2, P3 | "In the interim analysis of the JAVELIN Bladder Medley trial (NCT05327530), 1LM with Ave + sacituzumab govitecan (SG; Trop-2–directed antibody-drug conjugate) improved progression-free survival (PFS) vs Ave monotherapy (mono), thereby meeting the study's primary endpoint. In the primary analysis of the JAVELIN Bladder Medley trial, Ave + SG as 1LM in pts with aUC without progression after 1L PBC showed improved PFS vs Ave mono. While OS data are still immature, OS trends favored Ave + SG, Ave + M6223, and Ave + NKTR-255 vs Ave mono. No new safety signals were identified."

Clinical • Combination therapy • Metastases • P2 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • IL15 • TIGIT

Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2− (IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07 (SABCS 2025) - P3 | " Participants were randomized 2:1 to receive SG 10 mg/kg IV or chemotherapy treatment of physician's choice (TPC; capecitabine, nab-paclitaxel, or paclitaxel). The study did not meet the primary endpoint of PFS by BICR in participants with HR+/HER2−, locally advanced unresectable or mBC who have received prior ET and are candidates for first chemotherapy. No new safety concerns were identified. An early trend in improvement of OS was observed, and the study will continue to further assess OS."

Metastases • 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 • HER-2

Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: Hoffmann-La Roche | N=410 ➔ 250

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1