Jiataile (sacituzumab tirumotecan) / Sichuan Kelun Pharma, Merck (MSD) - LARVOL DELTA

Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Kidney Medullary Carcinoma • Oncology • Renal Cell Carcinoma • SMARCB1

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1 • ROS1

Efficacy and safety of sacituzumab tirumotecan (sac-TMT) plus pembrolizumab in patients with recurrent or metastatic cervical cancer (ESMO 2024) - P2 | "Sac-TMT (also known as MK-2870/ SKB264) is a TROP2 ADC developed with novel linker to conjugate a belotecan-derivative topoisomerase I inhibitor...47.4% had received two prior lines of therapy, 52.6% had received bevacizumab, and 42.1% had received anti-PD-1 based therapy... Sac-TMT plus pembrolizumab demonstrated promising and durable antitumor activity with manageable safety profile. No new safety signal was observed. Considering the activity of this combination among pts who were pre-treated with anti-PD-1 based therapy, further investigation is warranted."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Sac-TMT in Pts With Previously Treated Advanced NSCLC With Actionable Genomic Alterations Other Than Classic EGFR Mutations (IASLC-WCLC 2026) - P2 | "Introduction : Sacituzumab tirumotecan (sac-TMT) is a TROP2 ADC developed with a unique bifunctional linker to conjugate a belotecan-derivative topoisomerase I inhibitor. Conclusions : Sac-TMT monotherapy demonstrated promising clinical activity with a manageable safety profile in previously treated advanced NSCLC pts with advanced NSCLC harboring AGAs other than classic EGFR mutations. These findings warrant further investigation of sac-TMT as a potential therapy for this population."

Clinical • Metastases • Dental Disorders • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Stomatitis • ALK • EGFR • KRAS • ROS1

Sacituzumab Tirumotecan +/- Pembrolizumab in I/O Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Tufts Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2032 ➔ Sep 2036 | Initiation date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Mar 2032 ➔ Sep 2036

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Clear Cell Carcinoma • Oncology • Ovarian Cancer • Ovarian Clear Cell Cancer • Solid Tumor

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

Sacituzumab Tirumotecan (Sac-TMT) + Pembrolizumab (Pembro) in Post-Platinum Advanced Mismatch Repair Proficient (pMMR) Endometrial Cancer (EC): Results From a Phase 2 Study (2870-002/SKB264-II-06) (ESMO 2026) - No abstract available

Metastases • Mismatch repair • P2 data • pMMR • Endometrial Cancer • Oncology • Solid Tumor

Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase III OptiTROP-Lung04 study (ESMO 2025) - P3 | "Background Sac-TMT is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. Sac-TMT demonstrated significant survival benefits over docetaxel in EGFRm NSCLC after failure of EGFR-TKI and platinum-based chemotherapy ( Fang et al., BMJ 2025 )...Methods Patients (pts) were randomized (1:1) to receive sac-TMT monotherapy (5 mg/kg Q2W) or chemotherapy (pemetrexed 500 mg/m 2 + carboplatin AUC 5 or cisplatin 75 mg/m 2 Q3W for 4 cycles followed by maintenance of pemetrexed)...*censored at the date of initiation of subsequent anti-tumor ADC drug therapy. Conclusions Sac-TMT is the first TROP2 ADC to significantly improve PFS and OS over platinum-based chemotherapy, with manageable safety in EGFR-TKI resistant NSCLC, positioning it as a potential new standard of care for this population."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lorlatinib plus Sacituzumab Tirumotecan with Peripheral ctDNA Guidance as First‑Line Therapy for ALK Fusion‑Positive NSCLC (ChiCTR) - P2 | N=153 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

Circulating tumor DNA • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • 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

TROFUSE-022/ENGOT-OV84/GOG-3103 PART 2: PHASE 3 STUDY OF MAINTENANCE SACITUZUMAB TIRUMOTECAN±BEVACIZUMAB VS STANDARD OF CARE FOLLOWING SECOND-LINE PLATINUM-BASED DOUBLET CHEMOTHERAPY FOR PLATINUM-SENSITIVE RECURRENT OVARIAN CANCER (IGCS 2026) - P3 | "All participants must have received 6 cycles of 2L carboplatin-based doublet chemotherapy±bevacizumab and achieved NED/CR/PR/SD per investigator; participants with SD require prior bevacizumab with 2L chemotherapy and must be eligible to continue bevacizumab. Participants in arm 2 may not cross over to arm 1. Current Status & Future Directions: Enrollment began in January 2026 and is planned across 213 sites in 30 countries."

Clinical • P3 data • Platinum sensitive • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • HRD • TACSTD2

TROFUSE-036/GOG-3123/ENGOT-CX22: A 2-PART, PHASE 3, RANDOMIZED STUDY OF FIRST-LINE MAINTENANCE SACITUZUMAB TIRUMOTECAN + PEMBROLIZUMAB ± BEVACIZUMAB VS STANDARD OF CARE FOR PD-L1–POSITIVE CERVICAL CANCER (IGCS 2026) - P3 | "After part 1 safety data review is complete, ~802 eligible participants will be randomized 1:1 to receive sac - TMT+pembrolizumab±bevaciz umab or SoC with pembrolizumab±bevacizumab (Table). Current Status & Future Directions: Enrollment in part 1 began in November 2025 and is expected to include 113 sites in 17 countries."

Clinical • IO biomarker • P3 data • Cervical Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1 • TACSTD2

Prospective, Multicenter, Single-Arm Phase II Clinical Study of Sacituzumab Tirumotecan (SKB264) in Patients with Previously Treated Advanced Biliary Tract Malignancies (ChiCTR) - P=N/A | N=37 | Not yet recruiting | Sponsor: The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

New trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus pembrolizumab (P) as first-line treatment for PD-L1–positive advanced non-small cell lung cancer (NSCLC): Results from the randomized phase 3 OptiTROP-Lung05 study. (ASCO 2026) - P3 | "To our knowledge, this is the first phase 3 study to demonstrate the significant PFS benefit of an antibody-drug conjugate plus pembrolizumab in the first-line treatment of PD-L1 positive advanced NSCLC compared to pembrolizumab. The safety profile of sac-TMT + P was generally manageable and consistent with the safety profile of the components. No new safety signals were seen."

Clinical • IO biomarker • Metastases • P3 data • Dental Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • ALK • EGFR • PD-L1

Sacituzumab tirumotecan (Sac-TMT) plus pembrolizumab (Pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from phase 2 2870-002/SKB264-II-06 study. (ASCO-GU 2026) - P2 | "Sac-TMT (MK-2870/SKB264) is a TROP2-directed ADC with a unique bifunctional linker that maximizes delivery of a novel belotecan-derived topo I inhibitor payload to tumor cells, that has shown promising antitumor activity in several tumor types, including as monotherapy in UC (Ye, D, et al...Pts with prior adjuvant or neoadjuvant platinum-based therapy or nivolumab were eligible if they had disease recurrence >12 mo after completing therapy... Sac-TMT + pembro showed promising antitumor activity at both 4 and 5 mg/kg in previously untreated, cisplatin-ineligible pts with la/mUC, with a manageable safety profile consistent with that of the individual treatment components. Further studies are warranted. NE, not estimable; NR, not reached."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

First-line sacituzumab tirumotecan with tagitanlimab in advanced non-small-cell lung cancer: a phase 2 trial. (PubMed, Nat Med) - P2 | "sac-TMT plus tagitanlimab showed promising efficacy as a first-line treatment for advanced or metastatic non-small-cell lung cancer, with a manageable safety profile. ClinicalTrials.gov registration: NCT05351788 ."

Journal • P2 data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Antibody-Drug Conjugates in the Treatment of Esophageal Cancer. (PubMed, Curr Treat Options Oncol) - "For HER2-negative gastroesophageal adenocarcinoma, trophoblast cell-surface antigen 2 represents a promising target given its high prevalence of moderate to strong expression in nearly 80% of cases, and sacituzumab tirumotecan is currently under phase III investigation in this setting...For Nectin-4-expressing tumors, enfortumab vedotin may be considered as a later-line alternative despite modest activity. Notably, the bispecific ADC targeting both epidermal growth factor receptor and human epidermal growth factor receptor 3, BL-B01D1, has demonstrated compelling efficacy in immunotherapy-refractory esophageal squamous cell carcinoma, and I consider it a breakthrough option in this subtype. For claudin-18.2-positive gastroesophageal junction adenocarcinoma, several ADCs including CMG901, IBI343, and tecotabart vedotin represent promising later-line choices. I emphasize that patient selection should be guided by validated predictive biomarkers, and treatment decisions..."

Biomarker • IO biomarker • Journal • Review • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • CLDN18 • ERBB3 • HER-2 • NECTIN4

ARCANA: Sac-TMT in Vaginal and Vulvar Cancers (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Latin American Cooperative Oncology Group

New P2 trial • Gynecologic Cancers • Oncology • Solid Tumor • Squamous Cell Carcinoma • Vaginal Cancer • Vulvar Cancer • CD4

Safety and efficacy of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a phase II study (ESMO 2024) - P1/2 | "Sac-TMT (also known as MK-2870/SKB264) is a TROP2 ADC developed with a hydrolytically cleavable linker to conjugate a belotecan-derivative topoisomerase I inhibitor. Sac-TMT monotherapy has shown promising anti-tumor activity with a manageable safety profile in pts with heavily pre-treated advanced EC and OC."

Clinical • Metastases • P2 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • TACSTD2

Sacituzumab Tirumotecan Plus Anlotinib in Advanced Second-Line Wild-Type NSCLC: A Single-Arm, Phase II Study (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Anhui Chest Hospital; Anhui Chest Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10. (PubMed, Future Oncol) - P3 | "The TroFuse-011 study evaluates sac-TMT with/without pembrolizumab versus treatment of physician's choice (TPC; paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) in previously untreated, centrally confirmed, locally recurrent unresectable or metastatic TNBC with PD-L1 CPS <10. Secondary endpoints include PFS (arm B vs A), OS (arm B vs C and arm B vs A), objective response rate (arm A vs C and arm B vs C), duration of response, patient-reported outcomes, and safety. Enrollment is ongoing.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06841354."

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

Phase II Clinical Study of Sacituzumab Tirumotecan in Combination with Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIA NSCLC (ChiCTR) - P2 | N=28 | Not yet recruiting | Sponsor: Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute); Shandong First Medical University an

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Sacituzumab Tirumotecan in EGFR-Mutated NSCLC Patients With =3 Metastatic Sites: Subgroup Analysis of OptiTROP-Lung04 (IASLC-WCLC 2026) - P3 | "Introduction : Sacituzumab tirumotecan (sac-TMT) is a novel antibody-drug conjugate targeting trophoblast cell surface antigen 2 (Trop-2) with a unique bifunctional linker that maximizes delivery of a belotecan-derivative topo I inhibitor payload to tumor cells...Eligible pts with locally advanced or metastatic nonsquamous EGFRm NSCLC who progressed after EGFR-TKI therapy were randomized 1:1 to receive sac-TMT 5 mg/kg Q2W or pemetrexed plus platinum-based chemotherapy...Conclusions : In this subgroup analysis for patients with high tumor burden, sac-TMT provided substantial and clinical meaningful improvements in OS, PFS, and ORR compared with platinum-based chemotherapy. These result support sac-TMT as an effective treatment option following EGFR-TKI failure in patients with extensive metastatic disease."

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

Neoadjuvant Sacituzumab Tirumotecan Plus Aumolertinib in Resectable EGFR-Mutant NSCLC: A Phase II Trial (IASLC-WCLC 2026) - "The sample size calculation is based on a one-sided α of 0.05 and 80% power, assuming a historical control MPR rate of 25% (NeoADAURA) and an expected MPR rate of 40% in the experimental group. Accounting for a 10% dropout rate, a total of 64 patients will be enrolled."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. (ASCO 2024) - P2, P3 | "Background: Sacituzumab Tirumotecan (SKB264/MK-2870)is a TROP2 ADC developed with novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. SKB264 in combination with KL-A167 demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. SKB264 Q2W was recommended for further investigation. A Phase 3 study of SKB264 Q2W plus pembrolizumab vs pembrolizumab in 1L metastatic NSCLC with PD-L1 TPS ≥ 50% (NCT06170788) is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Anemia • Hematological Disorders • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor