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

Therapeutic Applications and Target Strategies of Antibody-Drug Conjugates in Ovarian Cancer. (PubMed, Iran J Pharm Res) - "This review summarizes a range of ADCs targeting tumor-associated antigens in ovarian cancer, including mirvetuximab soravtansine (MIRV), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), sacituzumab tirumotecan (SKB-264), PF-06664178, anetumab ravtansine (BAY 94-9343), BMS-986148, DMOT4039A, RC88, lifastuzumab vedotin (DNIB0600A), upifitamab rilsodotin (ABBV-181), ZW220, DMUC4064A, and sofituzumab vedotin (DMUC5754A). The ADCs hold significant potential to reshape the treatment landscape for ovarian cancer by providing targeted therapeutic options. Further research is required to optimize patient selection, address resistance mechanisms, and improve safety profiles."

Journal • Review • Oncology • Ovarian Cancer • Solid Tumor • MUC4

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) (clinicaltrials.gov) - P1/2 | N=38 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor • Urothelial Cancer

OptiTROP-Breast01: SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P3 | N=254 | Active, not recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Mar 2025 ➔ Jun 2027

Trial completion date • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • HER-2 • PGR

MSD Pharma Gets Conditional SEC Approval to Begin Phase III Trial of Sacituzumab Tirumotecan (Medical Dialogues) - "The conditions include that the firm should submit safety data for the completed Induction phase, and the firm should increase the number of subjects in India. This came after the firm presented phase III clinical study protocol no.: MK-2870-036 Version No. 00 dated 22-JUL-2025."

Trial status • Cervical Cancer

Trofuse-032: a phase 3, randomized study of pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer or hormone receptor-low-positive (HR-low+)/ human epidermal growth factor receptor 2-negative (HER2−) breast cancer (SABCS 2025) - P3 | "Sacituzumab tirumotecan or sac-TMT (also known as MK-2870/SKB264), a novel antibody-drug conjugate composed of an anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker, has demonstrated significant PFS and OS benefits vs chemo in patients with metastatic TNBC...Participants are randomized 1:1 to neoadjuvant pembro plus sac-TMT followed by pembro plus paclitaxel plus carboplatin (arm 1) vs pembro plus paclitaxel plus carboplatin followed by pembro plus doxorubicin or epirubicin plus cyclophosphamide (arm 2; Table)...Secondary endpoints include OS, pCR-no DCIS (ypT0 ypN0), distant progression- or distant recurrence-free survival, patient-reported outcomes, and safety. Enrollment is ongoing."

Clinical • P3 data • 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 • HER-2 • TACSTD2

Trofuse-012: a phase 3, randomized study of adjuvant sacituzumab tirumotecan plus pembrolizumab vs treatment of physician's choice in participants with triple-negative breast cancer who received neoadjuvant therapy and did not achieve a pathological complete response at surgery (SABCS 2025) - P3 | "Sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264) is a novel antibody-drug conjugate composed of anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker (average drug/antibody ratio, 7.4)...This study (NCT06393374) evaluates adjuvant sac-TMT plus pembrolizumab vs treatment of physician's choice (TPC; pembrolizumab ± capecitabine) in participants with TNBC who received neoadjuvant therapy and did not achieve pCR at surgery. This phase 3, multicenter, open-label study is enrolling participants ≥18 years old with centrally confirmed TNBC per most recent American Society of Clinical Oncology/College of American Pathologists guidelines...Secondary endpoints are OS, distant recurrence-free survival, patient-reported outcomes, and safety. Enrollment began Q2 2024."

Clinical • P3 data • Surgery • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Trofuse-011: a phase 3, randomized, open-label study of sacituzumab tirumotecan with or without pembrolizumab vs treatment of physician's choice for previously untreated locally recurrent unresectable or metastatic triple-negative breast cancer (SABCS 2025) - P3 | "Sacituzumab tirumotecan (sac-TMT; MK-2870/SKB264) is a novel antibody-drug conjugate (ADC) composed of an anti-trophoblast cell surface antigen 2 (TROP2) monoclonal antibody coupled to a cytotoxic belotecan derivative, topoisomerase I inhibitor payload via a novel linker. Tumor imaging occurs at baseline, Q8W after randomization until week 48, and Q12W thereafter. Enrollment is ongoing."

Clinical • IO biomarker • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22) (clinicaltrials.gov) - P3 | N=1023 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Sac-TMT Plus Bevacizumab as Second-Line Treatment for Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=89 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC (clinicaltrials.gov) - P2 | N=41 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Kelun-Biotech Announces Phase III Trial of Sac-TMT in Combination with KEYTRUDA (pembrolizumab) as First-Line Treatment for PD-L1-Positive NSCLC Met Primary Endpoint (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...announced today that the Independent Data Monitoring Committee (IDMC) concluded that the Phase III clinical study (OptiTROP-Lung05) of the company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with MSD's anti-PD-1 therapy KEYTRUDA (pembrolizumab), as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC), has demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study's primary endpoint. A positive trend in overall survival was also observed...Based on the results from the interim analysis, the Company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China regarding the submission of a supplemental new drug application (sNDA) of sac-TMT."

DSMB • Non-US regulatory • P3 data • Non Small Cell Lung Cancer

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) (clinicaltrials.gov) - P1/2 | N=38 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=98 ➔ 38 | Trial completion date: Jul 2028 ➔ Mar 2028 | Trial primary completion date: Jul 2028 ➔ Mar 2028

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • Urothelial Cancer

The Annals of Oncology Publishes Results of Phase II Study of Sacituzumab Tirumotecan Monotherapy for Urothelial Carcinoma (PRNewswire) - "This publication is based on the efficacy and safety results of cohort 9 of a phase II MK-2870-001/KL264-01 study evaluating sac-TMT monotherapy in patients with advanced or metastatic UC and disease progression after chemotherapy and immune checkpoint inhibitors...Median follow-up was 18.8 months. The confirmed ORR was 31% (sac-TMT as second-line therapy demonstrated a confirmed ORR of 50%) and the disease control rate was 71%. Median DOR was not reached, and the 12-month probability of sustained response was 53%. Median PFS was 5.5 months, with 12-month PFS rate was 29%."

P2 data • Urothelial Cancer

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (clinicaltrials.gov) - P3 | N=686 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2028 ➔ Jun 2028 | Trial primary completion date: Oct 2028 ➔ Jun 2028

Monotherapy • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

MODULE 3: Selection and Sequencing of Therapy for Relapsed/Refractory (R/R) mTNBC (SABCS 2025) - "Supported by educational grants from Gilead Sciences Inc and Helsinn Therapeutics (US) Inc. Clinical and biological factors influencing the choice of treatment for patients with mTNBC progressing on first-line therapy Key efficacy and safety findings from the Phase III ASCENT trial comparing sacituzumab govitecan to physician's choice of chemotherapy for previously treated mTNBC Optimal integration of sacituzumab govitecan into mTNBC management algorithms Updated data with T-DXd in the subset of patients with previously treated HR-negative, HER2-low advanced breast cancer in the Phase III DESTINY-Breast04 study; current role with regard to other available treatment options Clinical trial findings with and ongoing investigation of other ADCs (eg, Dato-DXd, sacituzumab tirumotecan) for patients with R/R mTNBC"

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

Sacituzumab Tirumotecan in Participants With Advanced or Metastatic Urothelial Carcinoma and Disease Progression after Chemotherapy and Immune Checkpoint Inhibitors. (PubMed, Ann Oncol) - "Sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population."

Checkpoint inhibition • Journal • Dental Disorders • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Stomatitis • Urothelial Cancer • TACSTD2

Sacituzumab Tirumotecan in Participants With Advanced or Metastatic Urothelial Carcinoma and Disease Progression after Chemotherapy and Immune Checkpoint Inhibitors (Ann Oncol) - "By data cutoff (February 17, 2025), 49 participants were treated with sac-TMT; 37 (76%) had received ≥2 prior lines of therapy....Sac-TMT 5 mg/kg every 2 weeks demonstrated a confirmed ORR of 31%, and duration of response was not reached. 18-month PFS and OS rates were 26% and 33%, respectively, with sac-TMT 5 mg/kg every 2 weeks. Safety with sac-TMT was manageable, with no febrile neutropenia events or grade 5 treatment-related adverse events."

P1/2 data • Urothelial Cancer

Inhibiting TROP2 in advanced non-small-cell lung cancer with sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan: similarities and differences. (PubMed, Cancer Chemother Pharmacol) - "There are differences in pharmacological effects, efficacy, and incidence of adverse events among sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan. For patients with EGFR-mutated progression after targeted therapy or driver gene negative advanced non-small cell lung cancer, the individualized optimization of TROP2 ADCs treatment can obtain the greatest benefit."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

OptiTROP-Lung04: A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients (clinicaltrials.gov) - P3 | N=376 | Active, not recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

OptiTROP-Breast05: SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Sep 2027 | Trial primary completion date: Apr 2025 ➔ Sep 2027

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

OptiTROP-Lung01 (PRNewswire) - "Kelun-Biotech Presented TROP2 ADC Sacituzumab Tirumotecan Results...at the 2025 CCHIO Congress....As of Dec 30, 2024, 81 patients with non-squamous histology were enrolled....After median follow-up of 17.1 months, the confirmed ORR was 59.3%; The DCR was 91.4%; mDOR was 16.5 months (95% CI: 11.7, 22.1); mPFS was 15.0 months (95% CI: 10.8, 24.8). Among pts with PD-L1 TPS< 1%, the confirmed ORR was 47.1%; mPFS was 12.4 months (95%CI: 7.6, 15.4); while for patients with PD-L1 TPS≥ 1%, the confirmed ORR was 68.1%; mPFS was 17.8 months (95%CI: 14.5, NE). Among patients with PD-L1 TPS≥ 50%, the confirmed ORR was 77.8%; mPFS was 17.8 months (95% CI: 10.8, NE)."

P2 data • Lung Non-Squamous Non-Small Cell Cancer

OptiTROP-Lung03 (PRNewswire) - "Kelun-Biotech Presented TROP2 ADC Sacituzumab Tirumotecan Results...at the 2025 CCHIO Congress....As of Dec 01, 2024, 42 patients were enrolled....After a median follow-up of 9.9 months, the ORR was 35.7% (15/42, 3 pending confirmation). The disease control rate (DCR) was 85.7%. Responses were durable with the median duration of response (mDoR) not yet reached, and the 6-month DoR rate was 90.9%. The median progression-free survival (mPFS) was 9.5 months (95% CI: 5.6, 10.9). In the subset of patients with uncommon non-ex20ins, the ORR was 34.8% (8/23, 1 pending confirmation); the mPFS was 10.9 months (95% CI: 5.6, NE). In the subset of patients with ex20ins, the ORR was 36.8% (7/19, 2 pending confirmation); the mPFS was 9.0 months (95% CI: 2.4, NE)."

P2 data • Non Small Cell Lung Cancer

KL264-01/MK-2870-001 (PRNewswire) - "Kelun-Biotech Presented TROP2 ADC Sacituzumab Tirumotecan Results...at the 2025 CCHIO Congress....The endometrial carcinoma (EC) cohort in this study enrolled a total of 158 patients....At data cutoff (May 21, 2025), median (range) follow-up was 11.7 months in the 4 mg/kg group and 21.8 months in the 5 mg/kg group. Confirmed objective response rate (ORR) was 30.7% and 34.1% in the 4 mg/kg and 5 mg/kg groups; all responses were partial response (PR). Confirmed and unconfirmed ORR was 35.1% and 36.4% in the 4 mg/kg and 5 mg/kg groups. Median duration of response (DOR) was 9.3 months and 8.7 months in the 4 mg/kg and 5 mg/kg groups. Median progression free survival (PFS) was 6.0 months and 7.3 months in the 4 mg/kg and 5 mg/kg groups."

P2 data • Endometrial Cancer

SACITUZUMAB TIRUMOTECAN MONOTHERAPY IN ADVANCED/METASTATIC ENDOMETRIAL CARCINOMA: RESULTS FROM A PHASE 1/2 STUDY (2870-001/KL264-01) (IGCS 2025) - P1/2, P3 | "As of May 21, 2025, median (range) follow-up was 11.7 (7.9–15.9) months and 21.8 (19.1–28.1) months in the 4- and 5-mg/kg groups, respectively. 102 participants (64.6%) had received ≥2 prior lines of therapy. Treatment was ongoing for 31 participants (27.2%) and 2 participants (4.5%) in the 4- and 5-mg/kg groups, respectively, with PD the most common reason for treatment discontinuation."

Late-breaking abstract • Metastases • Monotherapy • P1/2 data • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI