tagitanlimab (HBM9167) / Sichuan Kelun Pharma, Harbour BioMed, Akesobio - LARVOL DELTA

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

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

NeoSaciA: SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: West China Hospital

New P2 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

A Single-center, Phase II Clinical Trial Evaluating the Efficacy of Sacituzumab Tirumotecan in Combination With Tagitanlimab as Neoadjuvant Therapy for PD-L1-positive, Resectable Stage II to IIIB Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Henan Cancer Hospital

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

Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC) (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Tianjin Medical University Second Hospital

New P2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Single-arm, Multicenter, Phase 2 Study of Sacituzumab tirumotecan (Sac-TMT) in Combination With KL-A167 as Maintenance Therapy in Extensive Stage Small Cell Lung Cancer (ES-SCLC) After First Line Immunochemotherapy Induction Therapy (ChiCTR) - P2 | N=39 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

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

Market access (PRNewswire) - "Preparations for the National Reimburesement Drug List access of marketed products are underway. Currently, sac-TMT, tagitanlimab and Cetuximab N01bhave all passed the preliminary formal examination of National Reimbursement Drug List."

Reimbursement • Colorectal Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Kelun-Biotech's Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical...announced that the Company has received a clinical trial notice approving the investigational new drug application for the its CLDN18.2-directed antibody-drug conjugate (ADC) SKB315 in combination of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab for the first-line treatment of gastric cancer / gastro-oesophageal junction cancer (GC/GEJC) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)."

New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical...announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan...in combination with the PD-L1 monoclonal antibody tagitanlimab...was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations....This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study."

Breakthrough therapy • Non Small Cell Lung Cancer

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

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

KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=295 | Active, not recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: May 2025 ➔ Dec 2027 | Trial primary completion date: May 2024 ➔ Dec 2027

Trial completion date • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Tagitanlimab versus placebo in combination with gemcitabine and cisplatin (GP) as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase Phase 3 study (The Manila Times) - P3 | N=295 | NCT05294172 | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | "The PFS per blinded independent central review (BICR) was met with a 53% reduction in risk of progression or death (HR=0.47, one-sided P <0.0001). The median PFS was not reached in tagitanlimab plus GP arm and 7.9 months in placebo plus GP arm. The ORR per BICR was 81.7% in tagitanlimab plus GP arm and 74.5% in placebo plus GP arm, with a median DoR of 11.7 months and 5.8 months (HR=0.48), respectively. The OS benefit was observed in tagitanlimab plus GP arm vs placebo plus GP arm (median OS not reached for either arm; HR=0.62). Tagitanlimab also showed a manageable safety profile."

P3 data • Nasopharyngeal Carcinoma

Kelun-Biotech to Present Results of Six Clinical Studies at 2025 ASCO Annual Meeting (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...announced that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30 to June 3. Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO's official website on May 22, 2025, local time."

Clinical data • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Thyroid Gland Carcinoma • Triple Negative Breast Cancer

Akeso Received Payment for the Development Collaboration on Tagitanlimab (PRNewswire) - "On January 22, 2025, Akeso Inc...announced that it had received payment from Sichuan Kelun Pharmaceutical Research Institute Co., Ltd...for their collaboration on the development of tagitanlimab, an innovative humanized monoclonal antibody targeting PD-L1, following its recent marketing approval by China's National Medical Products Administration. In 2014, Akeso signed a cooperation agreement with Sichuan Kelun for the development of tagitanlimab. Under the terms of the agreement, Akeso will receive royalties from the commercial sales of tagitanlimab in addition to the development payment."

Commercial • Nasopharyngeal Carcinoma

Anti-PD-L1 Tagitanlimab Approved For Marketing By The National Medical Products Administration (Firstwordpharma Press Release) - "The board (the 'Board') of directors ('Directors') of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the 'Company') is pleased to announce that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody ('mAb') tagitanlimab (formerly KL-A167)...for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. The approval is based on an open-label, multi-center, phase II clinical study in patients with recurrent or metastatic NPC who have failed after prior 2L+ systematic therapies, which evaluates the efficacy and safety profile of tagitanlimab monotherapy."

China approval • Nasopharyngeal Carcinoma

Kelun-Biotech's Product Tagitanlimab Approved for Marketing in Second Indication in Combination with Cisplatin and Gemcitabine For the First-line Treatment of Patients with recurrent or metastatic NPC (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody ('mAb') tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC)....The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator."

China approval • Nasopharyngeal Carcinoma

Findings from the OptiTROP-Lung01 Phase II study of recançant satuzumab (sac-TMT) in combination with KL-A167 (anti-PD-L1 monoclonal antibody) in patients with advanced non-small cell lung cancer: OptiTROP-Lung01 Phase II study (CSCO 2024) - "Study Group: [Organizing Committee]"

Clinical • Combination therapy • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kelun Biotech-B (06990), a leading biotech in the ADC field, joins hands with Merck to expand its global presence [Google translation] (Sina Corp) - "Kelun Biotech is a world-leading ADC Biotech, and joins hands with Merck to expand its global presence...A167 (PD-L1 monoclonal antibody) is expected to be approved for nasopharyngeal carcinoma in the second half of 2024. A400 (RET inhibitor) is expected to submit a marketing application in 2024."

Approval • Filing • Licensing / partnership • Nasopharyngeal Carcinoma • Oncology • Solid Tumor