Three Oral Presentations Highlight Multiple Clinical Advances of TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) at the 2025 CCHIO Congress

Nov 09, 2025 09:01 CST Updated 09:01

Kelun-Biotech

Innovative Drug Developer

MSD

Pharmaceutical R&D and Manufacturer

November 6 to 9,2025 China Conference on Integrated Oncology (CCHIO) to be held in Kunming, Yunnan. This conference is hosted by the Chinese Anti-Cancer Association (CACA) and the Tengchong Science Forum Organizing Committee Office, co-hosted by the World Association for Integrative Oncology (WAIO) and the China Academy of Integrative Medicine Development Strategy. Academicians, experts, and scholars from across China gathered to focus on innovations in cancer diagnosis and treatment, sharing breakthroughs in scientific research. At this conference,Sichuan Kelun-Biotech Biopharmaceutical Co.,LTD(hereinafter referred to as "Kelun-Biotech" or "the Company," 6990.HK)The multiple clinical research results of TROP2 ADC Luskantuzumab (sac-TMT) (Jiatailai®) were announced in the form of an oral presentation.

Endometrial Cancer (EC)

On November 7, fromProfessor Sheng Jindong from Tianjin Tumor HospitalOral Report at the ConferenceEfficacy and Safety Results of Phase II Study (KL264-01/MK-2870-001) of Sac-TMT (Lukansatuzumab) Monotherapy in Locally Advanced or Metastatic Endometrial Cancer (EC).

In this study, the endometrial cancer cohort enrolled a total of 158 patients, with 114 patients in the 4 mg/kg sac-TMT group and 44 patients in the 5 mg/kg sac-TMT group. As of May 21, 2025, the median follow-up times for the 4 mg/kg and 5 mg/kg groups were 11.7 months and 21.8 months, respectively. The confirmed ORR for the 4 mg/kg and 5 mg/kg groups were 30.7% and 34.1%, respectively. The confirmed + unconfirmed ORR for the two groups were 35.1% and 36.4%, respectively. The median DOR for the 4 mg/kg and 5 mg/kg groups were 9.3 months and 8.7 months, respectively, and the median PFS were 6.0 months and 7.3 months, respectively. In the 4 mg/kg and 5 mg/kg groups, ≥ Grade 3 treatment-related adverse events (TRAEs) occurred in 59 patients (51.8%) and 34 patients (77.3%), respectively, and TRAEs leading to permanent discontinuation occurred in 2 and 1 patients, respectively.

In patients with locally advanced or metastatic endometrial cancer, sac-TMT (Lukansatuzumab) monotherapy demonstrated promising antitumor activity and manageable safety in the second-line setting and beyond.Based on the aforementioned data, MSD has initiated two global Phase III clinical trials to further evaluate the efficacy and safety of Sac-TMT (Lukansatuzumab) 4 mg/kg in patients with endometrial cancer.

Professor Sheng Jindong stated: The incidence of endometrial cancer in China is increasing year by year. The treatment of advanced and recurrent patients still faces many challenges. Recent advancements have mainly focused on the field of immunotherapy. However, there remains an urgent need to expand new effective treatment options for patients with immunotherapy resistance and pMMR. Against this backdrop, sac-TMT (Lukansatuzumab), a TROP2 ADC independently developed in China, demonstrated promising therapeutic potential in the Phase II clinical study reported at this year’s CCHIO, offering a new treatment option for clinicians and patients. We look forward to sac-TMT (Lukansatuzumab) achieving more positive outcomes in subsequent Phase III clinical studies, further enriching the treatment landscape for advanced and recurrent endometrial cancer.

Professor Wang Ke from Tianjin Cancer Hospital stated: The results of this research report show that both 4mg/kg and 5mg/kg doses of Lukansatuzumab monotherapy demonstrated good anti-tumor activity, with ORR reaching 35.1% and 36.4%, respectively. Notably, the 4mg/kg dose exhibited a more controllable safety profile while maintaining similar efficacy. Therefore, we believe it is necessary to further validate the efficacy and safety of Lukansatuzumab in a larger patient population. We look forward to positive results from the Phase III study, which could potentially change the clinical treatment landscape for advanced endometrial cancer in the future, providing patients with a more effective and safer treatment option.

Non-Small Cell Lung Cancer (NSCLC)

On November 8, fromProfessor Wenfeng Fang from the Sun Yat-sen University Cancer CenterAt the conference sitePreliminary Results of a Phase II Clinical Study of Sac-TMT (Lukang Satuzumab) in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Rare EGFR MutationsAn oral report was presented.

As of December 1, 2024, the study enrolled a total of 42 patients with advanced NSCLC harboring rare EGFR mutations whose disease progressed during or after systemic therapy. This included 23 patients with EGFR exon 18 (exon18) G719X, exon 20 (exon20) S768I, or exon 21 (exon21) L861Q mutations, and 19 patients with EGFR exon 20 insertion mutations (ex20ins). Patients received monotherapy with Lukangsatumab (sac-TMT) at 5 mg/kg Q2W until disease progression or intolerable toxicity occurred. After a median follow-up of 9.9 months, the ORR was 35.7%, and the DCR was 85.7%. Responses were durable, with the median DoR not yet reached. The median PFS was 9.5 months. In the subgroup of patients with rare non-ex20ins mutations, the ORR was 34.8%, and the median PFS was 10.9 months; in the ex20ins subgroup, the ORR was 36.8%, and the median PFS was 9.0 months. The incidence of grade 3 or higher TRAEs was 52.4%. No treatment discontinuation or deaths due to TRAEs occurred, and no cases of ILD/pneumonia were reported.

Sac-TMT (Lukang Satuzumab) Monotherapy Shows Promising Clinical Efficacy in Previously Treated Advanced NSCLC Patients with Rare EGFR Mutations, with Manageable Safety.The research results indicate that sac-TMT (芦康沙妥珠单抗) has the potential to become a treatment option for such patients and is worth further investigation.

Professor Fang Wenfeng stated: Compared with classical EGFR mutations, treatment options for patients with rare EGFR mutations are more limited. Due to the complex and diverse types of these mutations and the relatively small number of patients, there has long been a lack of targeted standard treatments, making clinical management of these patients a major challenge. In this study, we are pleased to see that Lukansatuzumab (sac-TMT) has also shown encouraging efficacy in NSCLC patients with rare EGFR mutations. These data indicate that Lukansatuzumab can efficiently cover various subtypes of rare EGFR mutations, providing a new treatment option for patients with rare EGFR mutations who have long lacked standard treatment.

On the same afternoon, Professor Fang Wenfeng also participated in the oral presentation session of the conference, focusing onResults of the Non-Squamous Population in the Phase II Clinical Study (OptiTROP-Lung01) of Lucantuzumab (sac-TMT) Combined with Tagrilimab as First-Line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)Shared. (The OptiTROP-Lung01 study was led by Professor Zhang Li's team from the Sun Yat-sen University Cancer Center)

As of December 30, 2024, the study enrolled a total of 81 patients with non-squamous non-small cell lung cancer who had not previously received systemic treatment and had no driver gene mutations. Patients received sac-TMT (5 mg/kg Q3W or Q2W) in combination with tazagolumab (1200 mg Q3W or 900 mg Q2W) until disease progression or intolerable toxicity occurred. After a median follow-up of 17.1 months, the confirmed ORR was 59.3%; the median DoR was 16.5 months; and the median PFS was 15.0 months. In the patient population with PD-L1 tumor proportion score (TPS) ≥50%, the confirmed ORR was 77.8%; the median PFS was 17.8 months. In the patient population with PD-L1 TPS ≥1%, the confirmed ORR was 68.1%; the median PFS was 17.8 months. In the patient population with PD-L1 TPS <1%, the confirmed ORR was 47.1%; the median PFS was 12.4 months. No treatment-related adverse events leading to discontinuation or death were reported.

Sac-TMT (芦康沙妥珠单抗) Combined with Tagrilimab as First-Line Treatment for Advanced Non-Squamous NSCLC Demonstrates Promising Antitumor Activity. Durable Clinical Benefit Observed Regardless of PD-L1 Expression Levels.。The safety profile of the combination therapy was consistent with the known safety profiles of each monotherapy, was well-tolerated, and no new safety signals were observed.

Currently, a Phase III registrational study (OptiTROP-Lung06) of sac-TMT (Lukangsatumab) in combination with pembrolizumab versus chemotherapy plus pembrolizumab as first-line treatment for PD-L1-negative advanced non-squamous NSCLC patients, and a Phase III registrational study (OptiTROP-Lung05) of sac-TMT (Lukangsatumab) in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for PD-L1-positive advanced non-squamous NSCLC patients are both ongoing.

Professor Wenfeng Fang stated: This report presents the results of the non-squamous cell carcinoma population stratified by PD-L1 expression levels in the OptiTROP-Lung01 study, strongly confirming the significant synergistic potential of TROP2 ADC and immunotherapy. It provides a new paradigm for the treatment of non-squamous cell carcinoma patients with different PD-L1 expression levels. This highlights how China's original solutions offer new ideas for global lung cancer treatment and provide a new direction for the precise and efficient development of global lung cancer therapy.

Targeting the urgent clinical needs of patients, Kelun-Biotech has strategically advanced over 30 clinical studies across multiple disease areas including lung cancer, breast cancer, and gynecological tumors. These efforts are based on the company's proprietary ADC and novel DC technology platforms.OptiDC^TMKelun-Biotech will continue to develop innovative drugs with significant clinical value, further enhance clinical patient benefits, and contribute corporate strength to the advancement of Healthy China.

About Lucantusumab (sac-TMT, Jiatelai)^®)

As the core product of our company,Lukansatuzumab(sac-TMT)Is a new type of product with independent intellectual property rights owned by our company.TROP2 ADC, for non-small cell lung cancer (NSCLC), Breast Cancer (BC), Gastric Cancer (GC), gynecological tumors and other advanced solid tumors.Sac-TMTDeveloped using a novel linker, which is conjugated with a belotecan-derived topoisomerase.IInhibitors as payloads, drug-to-antibody ratio (DAR) Reach7.4. Lukansatuzumab (Sac-TMT) Through recombinant anti-TROP2Humanized monoclonal antibody specifically recognizes the surface of tumor cellsTROP2, which is then endocytosed by tumor cells and releases its payload intracellularly.KL610023。KL610023As a topoisomeraseIInhibitors, capable of inducing tumor cellsDNADamage, leading to cell cycle arrest and apoptosis. Moreover, it is also released in the tumor microenvironment.KL610023。In view ofKL610023It has cell membrane permeability, which enables the bystander effect, i.e., killing neighboring tumor cells.

In May 2022, our company granted MSD (the trade name of Merck & Co., Inc. in Rahway, New Jersey, USA) the exclusive rights to develop, use, manufacture, and commercialize Sac-TMT (Lukansatuzumab) in all regions outside of Greater China (including mainland China, Hong Kong, Macau, and Taiwan).

As of now, Lumoxiti (sac-TMT) of3The indication has been approved for marketing in China, respectively for the treatment of patients who have previously received at least 2 Systemic treatment (of which at least1This treatment targets unresectable locally advanced or metastatic triple-negative breast cancer (at an advanced or metastatic stage).TNBC), Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) and progressed after platinum-containing chemotherapyEGFRMutation-positive locally advanced or metastatic non-squamousNSCLCAnd viaEGFR-TKIProgression After TreatmentEGFRMutation locally advanced or metastatic non-small cell lung cancer. Lumoxiti (sac-TMT) is the world's first approved for marketing in lung cancer indicationsTROP2 ADCDrug. In addition, Lutikizumab (sac-TMT) For the treatment of unresectable locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor2Negative (HER2-)BCThe new indication marketing application has been accepted.CDEAccepted and included in the priority review and approval process.

Currently, Kelun-Biotech has launched 9 registrational clinical trials in China. MSD has initiated 15 ongoing clinical trials of Lurkonstatuzumab (sac-TMT) as a monotherapy or in combination with Pembrolizumab*.Or other anticancer drugs in global Phase 3 clinical trials for various types of cancer (these studies are sponsored and led by MSD).

*Pembrolizumab (Keytruda)^®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), an affiliate of Merck & Co., Inc. in Rahway, New Jersey, USA.

About Kelun-Biotech

Sichuan Kelun-Biotech Biopharmaceutical Co., LTD (referred to as "Kelun-Biotech", stock code: 6990.HK) is a holding subsidiary of Kelun Pharmaceutical, focusing on the research and development, production, commercialization, and international cooperation of innovative biotechnological drugs and small molecule drugs. Centering around unmet clinical needs globally and in China, the company prioritizes major disease areas such as oncology, autoimmune disorders, inflammation, and metabolism, building an international platform for drug research, development, and industrialization. It aims to become a globally leading enterprise in the field of innovative drugs. The company currently has over 30 key innovative drug projects., of which four projects haveApproved for marketing, one project is in the NDA stage, and more than 10 projects are currently in the clinical stage. The company has successfully built the internationally renowned proprietary ADC and novel conjugate drug platform OptiDC.^TM，There are already 2IndividualADCProject Approved for Marketing, MultipleADCOr novel conjugate drug products are in clinical or preclinical research stages. For more information, please visit the official website.https://kelun-biotech.com/。

Note: This article is only used to disclose the latest progress of Kelun-Biotech as of the date of publication, for communication among healthcare professionals only. It is not a product promotion advertisement and does not constitute investment advice.

Media Contact: klbio_pr@kelun.com