Cotelet (tagitanlimab) / Sichuan Kelun Pharma, Harbour BioMed, Akesobio - LARVOL DELTA

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 (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

Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study. (ASCO 2025) - P3 | "The addition of tagitanlimab to GP demonstrated superior PFS efficacy compared to GP alone, supporting that tagitanlimab, as a PD-L1 inhibitor, could be the new standard of treatment for pts with R/M NPC in the first-line setting. The safety profile of tagitanlimab combined with GP was manageable and consistent with previous reports, with no new safety signals identified."

Clinical • Combination therapy • Metastases • P3 data • Anemia • Hematological Disorders • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study. (ASCO 2025) - P2, P3 | "Clinical Trial Registration Number: NCT05351788 Background: Sac-TMT (MK-2870/SKB264) is a TROP2 ADC developed with a novel linker to conjugate a belotecan-derivative topoisomerase I inhibitor. Sac-TMT in combination with tagitanlimab demonstrated promising antitumor activity in treatment-naive advanced non-squamous NSCLC. The durable clinical activities were observed regardless of PD-L1 expression. This combination therapy showed a tolerable safety profile based on known profiles of the individual agents, with no new safety signals observed."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Anemia • Dental Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis

OptiTROP-Breast05: SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - P2 | N=184 | Completed | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2027 ➔ Jul 2026 | Trial primary completion date: Sep 2027 ➔ Jul 2026

Trial completion • 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

SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

dMMR • MSI-H • New P2 trial • Endometrial Cancer • Gynecologic Cancers • Microsatellite Instability • Oncology • Ovarian Cancer • MLH1 • MSH2 • MSH6 • MSI

Sacituzumab Tirumotecan (Sac-TMT/SKB264) Plus Tagitanlimab (KL-A167) in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: Sun Yat-sen University

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

Baseline Nutritional Indices as Prognostic Indicators in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma Treated with the PD-L1 Inhibitor KL-A167: A Secondary Analysis of the KL-A167 Trial. (PubMed, Cancer Manag Res) - "Baseline nutritional indices, particularly PNI, were associated with OS and PFS in patients with R/M NPC treated with the PD-L1 inhibitor KL-A167. Routine baseline nutritional screening may help identify high-risk patients before immunotherapy, although the clinical benefits of early nutritional interventions remain to be confirmed."

Biomarker • IO biomarker • Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

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

Enrollment open • IO biomarker • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Recent highlights and breakthroughs in immunotherapy for head and neck cancers. (PubMed, Curr Opin Oncol) - "Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors."

IO biomarker • Journal • Head and Neck Cancer • Nasopharyngeal Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF

OptiTROP-Lung01: SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Apr 2026 ➔ Dec 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2026

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

Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Jul 2027

Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

A single-arm, multicenter, phase II study of sacituzumab tirumotecan combined with tagitanlimab for the treatment of advanced non-small cell lung cancer that has progressed after previous platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy (ChiCTR) - P2 | N=42 | 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 • EGFR • ROS1

Association of Basal Thyroid Function with Clinical Outcomes in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma Treated with PD-L1 Inhibitor KL-A167: A Multicenter Post-hoc Analysis. (PubMed, Endocr Connect) - "Elevated basal TSH levels are independently associated with improved survival in R/M NPC patients receiving KL-A167. Baseline TSH may serve as a simple, non-invasive biomarker for risk stratification and personalizing immunotherapy in this population."

Clinical data • IO biomarker • Journal • Retrospective data • Endocrine Disorders • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

SKB500-II-02: SKB500 Combinations in Patients With Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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

A prospective, single-arm, phase II clinical trial of sacituzumab tirumotecan (SKB264) in combination with tagitanlimab (KL-A167) as second-line therapy for immune-resistant extensive-stage small cell lung cancer (ES-SCLC) (ChiCTR) - P2 | N=40 | Not yet recruiting | Sponsor: Shandong First Medical University Affiliated Cancer Hospital (Shandong Provincial Institute of Cancer Prevention and Treatment, Shandong Provincial Ca

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

ST-A-TN: Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

New P2 trial • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

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

SKB315-I-01: A Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=246 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Feb 2026 ➔ Jun 2028 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Solid Tumor • CLDN18

SKB264 combined with KL-A167 neoadjuvant therapy for early-stage, high-risk ER+/HER2- breast cancer (ChiCTR) - P2 | N=55 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for treatment-naïve advanced PD-L1-positive NSCLC: Results from the phase II MK-2870-003/SKB264-II-04 study (ESMO 2025) - P2, P3 | "Background Sac-TMT (MK-2870/SKB264) is an anti‒TROP2 ADC with a hydrolytically cleavable linker and belotecan-derivative topoisomerase I inhibitor payload...Sac-TMT combined with tagitanlimab (anti-PD-L1, KL-A167) showed promising clinical activity in the first-line treatment of NSCLC (Fang et al., ASCO, 2025)...Conclusions Sac-TMT + pembro had manageable safety and promising antitumor activity in pts with treatment-naïve advanced or metastatic PD-L1-positive NSCLC. Ongoing phase III studies are evaluating sac-TMT + pembro vs pembro as first-line treatment for pts with advanced NSCLC (SKB264-III-12 [TPS ≥1%], NCT06448312; MK-2870-007 [TPS ≥50%], NCT06170788)."

IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Commercialization Accelerates: Sales & Market Access Expanding Footprint (PRNewswire) - "Sac- TMT, tagitanlimab and Cetuximab N01 have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin in the China market and file one NDA for A400 in the second half of 2025."

China filing • Launch non-US • Colorectal Cancer • HER2 Positive Breast Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=47 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC (PRNewswire) - "The publication highlighted initial findings from the Phase II OptiTROP-Lung01 study...In Cohort 1A and Cohort 1B, respectively, the confirmed objective response rates (ORRs) were 40.0% (95% CI: 24.9–56.7) and 66.7% (95% CI: 53.7–78.0), and the ORRs were: 44.4% and 64.7% among patients with non-squamous carcinoma, 36.4% and 69.0% with squamous carcinoma; 41.7% and 57.1% among patients with PD-L1 tumor proportion score (TPS) <1%; 38.5% and 63.2% for TPS 1–49%; 40.0% and 78.3% for TPS ≥50%....The median progression-free survival (mPFS) for Cohort 1A was 15.4 months (95% CI: 6.7–17.9) and not reached (95% CI: 9.6–NE) for Cohort 1B."

P2 data • Non Small Cell Lung Cancer