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

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

Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the phase II OptiTROP-Breast05 study. (ASCO 2025) - P2, P3 | "Sac-TMT (MK-2870/SKB264) is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. Sac-TMT demonstrated promising anti-tumor activity with a manageable safety profile as a first-line treatment for pts with a/mTNBC, independent of the PD-L1 status. A Phase 3 study comparing sac-TMT vs investigator's choice of chemotherapy in first-line PD-L1-negative (CPS < 10) a/mTNBC is currently underway (NCT06279364)."

Clinical • Metastases • P2 data • Anemia • Breast Cancer • Dental Disorders • Fatigue • Interstitial Lung Disease • Oncology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Triple Negative Breast Cancer

Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium (Businesswire) - "Late-breaking KEYNOTE-B15 data show KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for patients with certain types of bladder cancer; New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG (belzutifan) plus KEYTRUDA and progression-free survival benefit of WELIREG in combination with LENVIMA (lenvatinib), respectively; Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from the Phase 2 2870-002/SKB264-II-06 study; Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN)"

Clinical data • Bladder Cancer • Clear Cell Renal Cell Carcinoma • Genitourinary Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • 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

Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05631262 Background: Sac-TMT (MK-2870/SKB264), a novel TROP2 ADC developed to conjugate a belotecan-derivative topoisomerase I inhibitor, has shown encouraging antitumor activity in EGFRm NSCLC pts in phase Ⅰ trial (Fang et al. Sac-TMT demonstrated improved ORR, PFS and OS compared to docetaxel, with manageable safety profile in pts with previously treated advanced EGFRm NSCLC. These results highlight significant survival benefits and suggest that sac-TMT could emerge as a new standard of care for this population."

Clinical • Metastases • Anemia • Dental Disorders • Febrile Neutropenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • EGFR

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

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003) (clinicaltrials.gov) - P2 | N=356 | Active, not recruiting | Sponsor: Klus Pharma Inc. | Trial primary completion date: Dec 2025 ➔ Jun 2026

Monotherapy • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

A single-arm, multicenter, phase II clinical trial on sacituzumab tirumotecan with toripalimab in neoadjuvant therapy for triple-negative breast cancer (ChiCTR) - P2 | N=34 | Not yet recruiting | Sponsor: Jiangxi Cancer Hospital; Jiangxi Cancer Hospital

New P2 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A prospective single-arm phase II clinical trial on the sacituzumab tirumotecan treatment of targeted therapy pre-treated, advanced or metastatic non-small cell lung cancer patients with EGFR uncommon mutations (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

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

A Single-Arm, Single-Center, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) for Second-Line or Later Treatment of Advanced or Metastatic Biliary Tract Cancer (ChiCTR) - P2 | N=31 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Clinical Study of ctDNA Dynamic Monitoring in Sacituzumab tirumotecan for EGFR-Mutated Non-Squamous NSCLC After EGFR-TKI Failure (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Shaanxi Provincial Cancer Hospital; Shaanxi Provincial Cancer Hospital

New P4 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

An exploratory study of Sacituzumab Tirumotecan in the treatment of EGFR-mutated platinum-based chemotherapy-resistant transformed small cell lung cancer (ChiCTR) - P2 | N=39 | Not yet recruiting | Sponsor: Dongguan People's Hospital; Dongguan People's Hospital

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

A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib Monotherapy (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Guangdong Association of Clinical Trials

Circulating tumor DNA • Monotherapy • New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Phase II Clinical Trial of Sacituzumab tirumotecan Combined with Cadonilimab as Second-Line Therapy for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-Arm, Single-Center Study (ChiCTR) - P2 | N=33 | Not yet recruiting | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

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 | "Clinical Trial Registry Number: NCT05642780 . The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

A Phase II, Prospective, Single-Arm, Multicenter, Open-Label Study of Sacituzumab tirumotecan in Combination with Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Locally Advanced Cervical Cancer (ChiCTR) - P2 | N=25 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Cervical Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1 • TACSTD2

Sacituzumab tirumotecan plus Immune Checkpoint Inhibitor as Neoadjuvant Therapy for Resectable Stage IIIA–IIIB (N2) Non-small-cell Lung Cancer: A Single-arm, Single-center, Phase II Trial (ChiCTR) - P2 | N=34 | Not yet recruiting | Sponsor: The General Hospital of the Eastern Theater Command of the People's Liberation Army of China; The General Hospital of the Eastern Theater Command of t

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

A single-arm, phase II clinical study of Sacituzumab Tirumotecan combined with Bevacizumab for the treatment of platinum-resistant epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Sacituzumab tirumotecan (Sac-TMT) plus bevacizumab in 3rd generation EGFR-TKI treated advanced EGFR-mutant nonsquamous NSCLC with brain metastasis: a single-arm, phase II study（TOP BRAIN） (ChiCTR) - P2 | N=50 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Brain Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TroFuse-015: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (clinicaltrials.gov) - P3 | N=450 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

A Phase II Clinical Study of Sacituzumab tirumotecan in Combination with Anlotinib in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer without Driver Alterations (ChiCTR) - P2 | N=128 | Recruiting | Sponsor: Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College ,Huazhong University o

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • NTRK • ROS1

An Open-Label, Single-Center, Multi-Cohort, Phase II Study Evaluating the Safety and Efficacy of Vebreltinib-Based Combination Therapy in Previously Treated Patients with Locally Advanced or Metastatic MET-Overexpressing Non-Small Cell Lung Cancer (ChiCTR) - P2 | N=52 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • RET • ROS1

GOG-3119/ENGOT-en29/TROFUSE-033: A phase 3, randomised study of sacituzumab tirumotecan plus pembrolizumab vs pembrolizumab alone as first-line maintenance therapy for mismatch repair-proficient endometrial cancer (ESGO 2026) - P3 | "Sac-TMT (SKB264/MK-2870) is a TROP2-directed ADC with a unique, bifunctional linker that maximises delivery of a belotecan-derived topo I inhibitor payload to tumour cells...Participants will receive 6 cycles of induction treatment with pembrolizumab, carboplatin, and paclitaxel (≤2 additional cycles of pembrolizumab allowed)...Enrolment began in May 2025. Results N/AConclusion N/A"

Clinical • Mismatch repair • P3 data • pMMR • Endometrial Cancer • Oncology • Solid Tumor • TACSTD2

Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial. (PubMed, BMJ) - P2 | "Sac-TMT showed statistically significant and clinically meaningful improvements in objective response rate, progression-free survival, and overall survival compared with docetaxel, with a manageable safety profile in patients with EGFR-mutated locally advanced or metastatic NSCLC."

Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

The Pilot Study on Sacituzumab tirumotecan (SKB264) for the Treatment of Recurrent Adamantinomatous Craniopharyngioma (ACP) (ChiCTR) - P=N/A | N=12 | Not yet recruiting | Sponsor: Xuanwu Hospital, Capital Medical University; Xuanwu Hospital, Capital Medical University

New trial • Brain Cancer • CNS Tumor