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

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 | "Clinical Trial Registration Number: NCT05351788 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell 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 | "Clinical Trial Registration Number: NCT05294172 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

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

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

Characterizing the impact of sarcopenia on treatment response and survival in previously treated recurrent or metastatic nasopharyngeal carcinoma: Insights from a secondary analysis of the KL-A167 randomized trial. (ASCO 2024) - "Sarcopenia significantly correlates with poor treatment response and survival outcomes in patients with R/M NPC receiving immunotherapy. Targeting fibrinogen may offer a novel strategy to mitigate the negative impact of sarcopenia on patient survival."

Clinical • IO biomarker • Metastases • Hematological Disorders • Nasopharyngeal Carcinoma • Oncology • Sarcopenia • Solid Tumor

A random forest model to predict the efficacy of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma based on the data from the KL167-II-05-CTP study. (ASCO 2024) - "In this study, a random forest model based on 10 clinical, laboratory and imaging indexes was constructed and showed a potential value in predicting the PFS of KL-A167 therapy in Chinese patients with previously treated R/M NPC, which could help to guide clinical trials and practices."

Clinical • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Merck to Present New Data at 2024 ASCO Annual Meeting Demonstrating Advancements in Novel Oncology Treatment Approaches Across Broad Portfolio and Diverse Pipeline (Businesswire) - "Key data from Merck’s pipeline to be presented at ASCO 2024: First-time data from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT in combination with KL-A167 (a PD-L1 antibody) as first-line treatment for advanced NSCLC....Data from cohort B1 of the Phase 2 KeyVibe-005 study evaluating vibostolimab/pembrolizumab in patients with previously treated advanced mismatch repair-deficient (dMMR) endometrial cancer."

P2 data • Endometrial Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Combination therapy • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - P2 | N=175 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | N=95 ➔ 175 | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Enrollment change • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma (clinicaltrials.gov) - P2 | N=109 | Completed | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Unknown status ➔ Completed

Trial completion • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

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. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Kelun-Biotech announces that a Phase III clinical trial of core product SKB264 (MK-2870, TROP2-ADC) in patients with unresectable locally advanced, recurrent or metastatic TNBC who have failed second-line or above prior standard of care has met its primary endpoint (PRNewswire) - "In addition, Kelun-Biotech is also advancing a Phase II trial of SKB264 with or without KL-A167 (Kelun's anti-PD-L1 monoclonal antibody) as a first-line treatment for advanced TNBC, and another randomized, open-label, multicenter Phase III clinical study of SKB264 versus investigator's choice regimens in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who had failed at least one line of chemotherapy is expect to be launched in the second half of 2023."

New P3 trial • Trial status • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Efficacy and safety of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma: a multicenter, single-arm, phase 2 study. (PubMed, Lancet Reg Health West Pac) - P2 | "Baseline plasma EBV DNA copy number might be a potentially useful prognostic biomarker for KL-A167 treatment, and post-treatment EBV DNA decrease might be correlated with better response to KL-A167. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., China National Major Project for New Drug Innovation (2017ZX09304015)."

Journal • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Efficacy and safety of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm, phase 2 study (Lancet Reg Health West Pac) - P2 | N=153 | NCT03848286 | "As of data cutoff date on Jul 13th, 2021, the median follow-up time was 21.7 months (95%CI 19.8–22.5). For FAS population, the IRC-assessed ORR was 26.5% (95%CI 19.2–34.9%), and disease control rate (DCR) was 56.8% (95%CI 47.9–65.4%). Median progression-free survival (PFS) was 2.8 months (95%CI 1.5–4.1) . Median duration of response was 12.4 months (95%CI 6.8–16.5), and median overall survival (OS) was 16.2 months (95%CI 13.4–21.3). When using the cutoff of 1000 copies/ml, 5000 copies/ml and 10,000 copies/ml for plasma EBV DNA titer, baseline low plasma EBV DNA was consistently related with better DCR, PFS and OS. Dynamic change of plasma EBV DNA was significantly associated with ORR and PFS. Among 153 patients, treatment related-adverse events (TRAEs) occurred in 73.2% of patients, and grade ≥3 TRAEs were in 15.0% of patients. No TRAE leading to death was reported."

P2 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

SKB264 +/- KL-A167 in Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P2 | N=95 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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

A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov) - P2 | N=110 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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

KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting ➔ Completed | N=112 ➔ 153 | Trial completion date: Aug 2020 ➔ Jan 2022 | Trial primary completion date: Aug 2020 ➔ Jul 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • 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: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial (clinicaltrials.gov) - P3 | N=291 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

New P3 trial • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

[VIRTUAL] Efficacy and safety of KL-A167 for relapsed or refractory classical Hodgkin Lymphoma: a multicenter, single arm, phase II study (ESMO 2021) - No abstract available

Clinical • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Harbour BioMed receives U.S. FDA IND approval for phase 2 clinical trial and Orphan Drug Designation for anti-PD-L1 monoclonal antibody, HBM9167 (Businesswire) - "Harbour BioMed (HBM) today announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC). Separately, the Agency’s Office of Orphan Products Development granted HBM9167 Orphan Drug Designation (ODD) for the use in treating NPC."

IND • Orphan drug