On September 22, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported multiple Phase III clinical studies of the TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) have been selected as Late-Breaking Abstracts (LBAs) and the study results will be presented as oral reports at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress to be held in Madrid, Spain, from October 23 to 27. Abstract titles of these studies have been published on the official website of ESMO (Free ESMO Whitepaper). Among them, the Phase III studies of OptiTROP-Lung04 and OptiTROP-Lung06 have both been selected for the "Non-Small Cell Lung Cancer (NSCLC), Metastatic" session and will be presented in the same time slot as proffered paper presentations, as follows:
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Title: Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: randomized phase 3 OptiTROP-Lung06 study
Presentation Type: Proffered paper | NSCLC, metastatic
Presentation #: LBA66
Date and Time: October 25, 10:15 to 11:45 local time
Title: Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: phase III OptiTROP-Lung04 study
Presentation Type: Proffered paper | NSCLC, metastatic
Presentation #: LBA67
Date and Time: October 25, 10:15 to 11:45 local time
A Phase III study, TroFuse-005, evaluating sac-TMT in patients with previously treated advanced or recurrent endometrial cancer (EC), has also been selected as an LBA at this Congress and will be presented in an oral report in the Presidential Symposium.
Title: Sacituzumab Tirumotecan in Previously Treated Advanced or Recurrent Endometrial Cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 Study
Presentation Type: Presidential Symposium
Presentation #: LBA11
Date and Time: October 26, 16:30 to 18:15 local time
Other sac-TMT studies to be presented at this Congress are as follows:
Title
Presentation Type
Final OS analysis of sacituzumab tirumotecan versus
chemotherapy in previously treated locally recurrent or metastatic
triple-negative breast cancer: Phase 3 OptiTROP-Breast01
Rapid oral
Sacituzumab Tirumotecan (Sac-TMT) + Pembrolizumab (Pembro)
for Locally Advanced or Metastatic Urothelial Carcinoma (la/m
UC): Results from a Phase 2 Study (2870-002/SKB264-II-06)
Rapid oral
Sacituzumab Tirumotecan (Sac-TMT) + Pembrolizumab (Pembro)
in Post-Platinum Advanced Mismatch Repair Proficient (pMMR)
Endometrial Cancer (EC): Results from a Phase 2 Study (2870-
002/SKB264-II-06)
Poster
About sac-TMT(佳泰莱)
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from KL610023, a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023 induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations by the NMPA.
Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA and have been included in the priority review and approval process: 1) sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative; 2) sac‑TMT as first‑line treatment for patients with recurrent or metastatic TNBC who have a PD‑L1 combined positive score (CPS) <10 or have recurred after prior PD‑1/PD‑L1 inhibitor therapy in the early stage, two applications have been included in the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 18 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
(Press release, Kelun, SEP 22, 2026, View Source [SID1234671005])