A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Start Date16 Apr 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT06849492

/ Not yet recruitingPhase 2IIT

An Open, Multicenter Study on the Treatment of Recurrent and Metastatic Triple-negative Breast Cancer Guided by Cell Surface Protein Typing (HIM) in Triple-negative Breast Cancer

To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).

Start Date01 Apr 2025

Sponsor / Collaborator

Fudan University

NCT06706219

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Pembrolizumab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Multi-center Phase II Study

This study is a phase 2 open-label, multicenter clinical study to evaluate the efficacy and safety SKB264 in combination with pembrolizumab in patients with unresectable stage III non-small cell lung cancer.

Start Date31 Mar 2025

Sponsor / Collaborator

Hunan Cancer Hospital

100 Clinical Results associated with Sacituzumab tirumotecan

100 Translational Medicine associated with Sacituzumab tirumotecan

100 Patents (Medical) associated with Sacituzumab tirumotecan

Literatures (Medical) associated with Sacituzumab tirumotecan

15 Jul 1999·BloodQ1 · MEDICINE

Fibrinogen Receptor Antagonist-Induced Thrombocytopenia in Chimpanzee and Rhesus Monkey Associated With Preexisting Drug-Dependent Antibodies to Platelet Glycoprotein IIb/IIIa

Q1 · MEDICINE

Article

Author: Bednar, Bohumil ; Holahan, Marie A. ; Hartman, George D. ; Gould, Robert J. ; Cook, Jacquelynn J. ; Cunningham, Michael E. ; Bednar, Rodney A. ; Jumes, Patricia A.

Most clinical trials with fibrinogen receptor antagonists (FRAs) have been associated with thrombocytopenia. This report describes the occurrence of thrombocytopenia in one chimpanzee and one rhesus monkey upon administration of potent FRAs. Chimpanzee A-264 experienced profound thrombocytopenia on two occasions immediately upon intravenous administration of two different potent FRAs, L-738,167 and L-739,758. However, an equally efficacious antiaggregatory dose of another potent antagonist, L-734,217, caused no change in platelet count. These compounds did not affect platelet count in five other chimpanzees or numerous other nonhuman primates. Flow cytometric analysis showed drug-dependent antibodies (DDAbs) in the plasma of chimpanzee A-264 that bound to platelets of chimpanzees, humans, and all other primates tested only in the presence of the compounds that induced thrombocytopenia. Rhesus monkey 94-R021 experienced thrombocytopenia upon administration of a different antagonist, L-767,679, and several prodrugs that are converted into the active form, L-767,679, in the blood. More than 20 other FRAs, including those that induced thrombocytopenia in chimpanzee A-264, had no effect on platelet count in this monkey. Flow cytometric measurements again identified DDAbs that reacted with platelets of all primates tested and required the presence of L-767,679. Screening for DDAbs in the plasma of 1,032 human subjects with L-738,167 and L-739,758 demonstrated that the incidence of these preexisting antibodies in this population was 0.8% ± 0.6% and 1.1% ± 0.6%, respectively.

Experimental Hematology & Oncology

Antibody-drug conjugates in breast cancer: current evidence and future directions

Review

Author: Li, Na ; Du, Tian ; Zhao, Zixuan ; Liang, Gehao ; Li, Ning ; Tang, Jun ; Yang, Lu

Abstract:

Antibody-drug conjugates (ADCs) are a rapidly evolving class of antitumor drugs and have already revolutionized the treatment strategy of many hematologic and solid cancers. So far, trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) are the four ADCs that have been approved by US food and drug administration (FDA) in treatment of breast cancer, and SKB264 has been approved by Chinese national medical products administration (NMPA). Many ADCs for treatment of breast cancer are currently being tested in late-phase clinical trials, with several encouraging results achieved recently. However, major issues arise during the use of ADCs, including emergence of acquired resistance, occurrence of treated-related toxicities, and identification of biomarkers of response and resistance. ADCs are being increasingly tested in combination with other agents, and novel next-generation ADC development is progressing rapidly. A better understanding of the design and development of ADCs will promote ADC development for cancer treatment. In this review, we aim to provide a broad overview of the design and the recent advances of ADCs in breast cancer. We also propose several notable future directions of ADCs in treatment of breast cancer.

NATURE MEDICINE

Sacituzumab tirumotecan in advanced non-small-cell lung cancer with or without EGFR mutations: phase 1/2 and phase 2 trials

Article

Author: Xu, Huiting ; Yin, Yongmei ; Zhuang, Wu ; Wang, Qiming ; Sun, Longhua ; Li, Xingya ; Yi, Tienan ; Yang, Jiacheng ; Su, Cuiyun ; Wainberg, Zev A ; Wang, Wei ; Li, Jin ; Rodon, Jordi ; Ge, Junyou ; Li, Yongsheng ; Lai, Shuzhen ; Zhao, Shen ; Fan, Yun ; Wang, Xian ; Mi, Yanjun ; Luo, Yongzhong ; Yu, Qitao ; Meng, Xiangjiao ; Fang, Wenfeng ; Chen, Zhendong ; Zhang, Li ; Liao, Jun ; Wang, Xiang ; Li, Yaling ; Cheng, Ying ; Yu, Guohua

Trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) is a promising anticancer agent that has shown remarkable efficacy in several malignancies. However, in lung cancer, two phase 3 trials on TROP2-ADCs in unselected patients with advanced non-small-cell lung cancer (NSCLC) have both failed. Sacituzumab tirumotecan (sac-TMT) is a novel TROP2-directed ADC. Here we report the efficacy and safety of sac-TMT in previously treated, advanced NSCLC with or without activating EGFR mutations from the phase 1/2 KL264-01 and phase 2 SKB264-II-08 studies. Primary endpoint was objective response rate (ORR). KL264-01 enrolled EGFR-wild-type and EGFR-mutant NSCLC (n = 43). Confirmed ORR was 40% (17 of 43; 95% confidence interval (CI), 25-56). Median progression-free survival (PFS) was 6.2 months (95% CI, 5.3-11.3). Post-hoc subgroup analyses found better outcomes in the EGFR-mutant subset (22 of 43, 51%) with a confirmed ORR of 55% (12 of 22) and median PFS of 11.1 months. These findings were independently supported by results from SKB264-II-08, where sac-TMT led to confirmed ORR of 34% (22 of 64; 95% CI, 23-47) and median PFS of 9.3 months (95% CI, 7.6-11.4) in 64 patients with EGFR-mutant NSCLC. For a total of 107 patients receiving sac-TMT, the most common treatment-related adverse events were hematologic toxicities. Diarrhea (4%) and interstitial lung disease (1%) were uncommon. Exploration of potential mechanisms revealed that the presence of EGFR mutation substantially increased the internalization and activity of sac-TMT in vitro. Overall, sac-TMT showed encouraging single-agent activity and manageable tolerability in previously treated, advanced NSCLC with EGFR mutations. Randomized phase 3 trials in treatment-naive and previously treated patients with EGFR-mutant NSCLC are ongoing. ClinicalTrials.gov Identifiers: NCT04152499 , NCT05631262 .

News (Medical) associated with Sacituzumab tirumotecan

24 Apr 2025

·www.prnewswire.com

Kelun-Biotech to Present Results of Six Clinical Studies at 2025 ASCO Annual Meeting

CHENGDU, China, April 24, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) 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. Detailed information on the studies selected for ASCO 2025 are as follows: Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. Presentation Type: Oral Abstract Number: 8507 Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT Title: 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. Presentation Type: Oral Abstract Number: 6004 Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study. Presentation Type: Rapid oral Abstract Number: 1019 Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT Title: 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. Presentation Type: Poster Abstract Number: 8529 Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study. Presentation Type: Poster Abstract Number: 8615 Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer. Presentation Type: Poster Abstract Number: 6098 Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT About Sac-TMT 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 Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor 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 KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, 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 (includes Mainland China, Hong Kong, Macau, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About KL590586 ( A400/EP0031) A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031. In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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Phase 1Phase 2Clinical ResultPhase 3ASCO

21 Apr 2025

·www.fiercepharma.com

Gilead's Trodelvy-Keytruda proposal hits goal in first-line triple-negative breast cancer

Gilead argues that the Ascent-04 trial readout shows the potential of Trodelvy plus Keytruda as a “much-needed new treatment option” in first-line, PD-L1-positive metastatic triple-negative breast cancer. In the first phase 3 trial to show the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in first-line triple-negative breast cancer (TNBC), Gilead Sciences’ Trodelvy has notched a much-needed win.Trodelvy’s combination with Merck & Co.’s Keytruda was better than Keytruda and chemotherapy at prolonging the time before cancer returns or death in patients with previously untreated metastatic TNBC whose tumors express PD-L1, Gilead announced Monday.The readout came from the phase 3 Ascent-04, or Keynote-D19, trial, which sets PD-L1 positivity cutoff at a combined positive score of at least 10, the same population that got Keytruda-chemo its FDA nod in this setting in 2020.“These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer,” Gilead’s newly minted chief medical officer, Dietmar Berger, M.D., Ph.D., said in a statement Monday.Before the Trodelvy readout, a combination of Pfizer and Astellas’ Nectin-4 ADC Padcev and Keytruda won a full FDA approval in late 2023 as a first-line treatment for advanced bladder cancer. Also on Monday, AstraZeneca and Daiichi Sankyo said their HER2 ADC Enhertu and Roche’s monoclonal antibody Perjeta was successful in first-line HER2-positive breast cancer.The positive first-line TNBC readout is a much-needed win for Trodelvy. The first-in-class drug is dealing with the market entrant of two other TROP2 ADCs, AZ and Daiichi’s Datroway in the U.S., and Kelun-Biotech’s Merck-partnered sacituzumab tirumotecan (sac-TMT) in China. Trodelvy is also reeling from some clinical setbacks, including a high-profile flop in previously treated non-small cell lung cancer and another failed phase 3 that led to the withdrawal of an accelerated approval in bladder cancer.Now, Gilead argues that the “significant and meaningful” improvement in progression-free survival as shown in Ascent-04 “further reinforces the potential of Trodelvy plus Keytruda as a much-needed new treatment option” in first-line, PD-L1-positive metastatic TNBC.While data on the key secondary endpoint of overall survival was not mature, Gilead said there was an early sign of improvement with the Trodelvy-Keytruda combo.The company will discuss the results with regulatory authorities. Despite existing treatment options, more than 50% of PD-L1-positive TNBC patients do not get to second-line treatments, Gilead pointed out.Gilead has put Ascent-04’s addressable patient population at about 10,000 across the U.S. and EU5 countries in 2030, Citi analysts noted Monday. The Citi team has a more bullish view of Trodelvy’s potential, predicting the drug could reach peak sales of $3.2 billion by 2030, versus the consensus estimate of $2.9 billion. Besides Ascent-04, Gilead expects a readout by June from the phase 3 Ascent-03 trial pitting Trodelvy against chemo in first-line, PD-L1-negative metastatic TNBC. The Ascent-05 study is testing Trodelvy and chemo as an adjuvant treatment in TNBC patients who have residual invasive disease after surgery and neoadjuvant therapy.Trodelvy was once a main talking point for Gilead and its oncology ambition. But after several clinical flops, investors’ attention has lately turned back to the company’s bread-and-butter HIV business, especially the much-anticipated potential launch of the twice-yearly PrEP drug lenacapavir, as well as the Arcellx-partnered CD19 CAR-T candidate anito-cel.

Phase 3ImmunotherapyADCDrug ApprovalAccelerated Approval

12 Apr 2025

·www.prnewswire.com

Clinical research results for Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) published in Nature Medicine, a top international medical journal

CHENGDU, China, April 12, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that results from a Phase 3 registrational clinical study evaluating the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) for the treatment of adult patients with advanced triple-negative breast cancer (TNBC) and results from an early Phase I/II clinical study of sac-TMT for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) were published in the top international medical journal Nature Medicine (Impact Factor (IF)= 58.7). Results TNBC: Based on the results of the multicenter, randomized, controlled Phase III OptiTROP-Breast01 (NCT05347134) clinical study, the current publication reports on the efficacy and safety of sac-TMT versus investigator's choice chemotherapy for the treatment of patients with locally advanced, recurrent or metastatic TNBC. The results of the study showed that sac-TMT demonstrated statistically and clinically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to investigator's choice chemotherapy. Based on this study, sac-TMT was approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). The data from this study were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. NSCLC: Based on the results of two early clinical studies of sac-TMT, the article reports on the efficacy and safety of sac-TMT in previously treated advanced NSCLC with or without epidermal growth factor receptor (EGFR) mutations. The article also explored in vitro experiments on the potential mechanisms of sac-TMT treatment for NSCLC, suggesting that EGFR mutations can increase the endocytosis and anti-tumor activity of TROP2 ADCs. Dr. Michael Ge, CEO of Kelun-Biotech said, "These successful publications in Nature Medicine mark the international academic community's recognition of the clinical efficacy and application value of sac-TMT in the treatment of advanced TNBC and NSCLC. The Company's novel product, sac-TMT, has been marketed in China for two indications. Meanwhile, the Company is also actively promoting the registrational clinical studies of sac-TMT in multiple indications, including breast cancer and lung cancer. Kelun-Biotech has always been committed to promoting innovation and leadership, and we look forward to continuing our research in the field of ADCs in partnership with MSD." 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, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor 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 KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, 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 (includes Mainland China, Hong Kong, Macau, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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Phase 3Clinical ResultASCONDADrug Approval

100 Deals associated with Sacituzumab tirumotecan

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR positive Non-squamous non-small cell lung cancer	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	04 Mar 2025
Triple Negative Breast Cancer	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 Nov 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	20 Aug 2024
Fallopian Tube Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	16 Apr 2025
Fallopian Tube Carcinoma	Phase 3	Japan	Merck Sharp & Dohme LLC	16 Apr 2025
Fallopian Tube Carcinoma	Phase 3	Taiwan Province	Merck Sharp & Dohme LLC	16 Apr 2025
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	16 Apr 2025
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 3	Japan	Merck Sharp & Dohme LLC	16 Apr 2025
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 3	Taiwan Province	Merck Sharp & Dohme LLC	16 Apr 2025
Platinum-Sensitive Ovarian Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	16 Apr 2025
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Japan	Merck Sharp & Dohme LLC	16 Apr 2025
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Taiwan Province	Merck Sharp & Dohme LLC	16 Apr 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05347134 (OptiTROP-Breast01, Pubmed \| Nat Med) Manual	Phase 3	Metastatic Triple-Negative Breast Carcinoma Second line	263	Sacituzumab tirumotecan (sac-TMT)	trkqusmmgk(uggytifcmi) = ezfdfpqior ezfupdudpy (vcepvmgeeo, 5.5 - 8.0) Met View more	Positive	11 Apr 2025
				Chemotherapy	trkqusmmgk(uggytifcmi) = mhsrhtghos ezfupdudpy (vcepvmgeeo, 1.7 - 2.7) Met View more
NCT05631262 \| NCT04152499 (KL264-01, Pubmed \| Nat Med \| NEWS) Manual	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	107	Sacituzumab tirumotecan (KL264-01)	sjcakkdlbv(zregyesdgd) = clbmjrwsyc linljksrdg (rgxmafnoqp, 25 - 56) View more	Positive	10 Apr 2025
				Sacituzumab tirumotecan (EGFR-mutant + KL264-01)	sjcakkdlbv(zregyesdgd) = kizeuyhqud linljksrdg (rgxmafnoqp ) View more
NCT04152499 (MK-2870-001, ASCO_GU2025) Manual	Phase 1/2	Advanced Urothelial Carcinoma Last line \| Third line \| Second line	49	sac-TMT 5 mg/kg (UC 2L)	yigvwgsvst(bjxqibeyrn) = siktwpefsx usuxqowycv (rvvtxredbz, 16.7 - 76.6) View more	Positive	13 Feb 2025
				sac-TMT 5 mg/kg (UC 3L+)	yigvwgsvst(bjxqibeyrn) = viiwefvkdg usuxqowycv (rvvtxredbz, 13.4 - 43.1) View more
ptiTROP-Breast01 (NEWS 1 \| NEWS 2) Manual	Phase 3	Triple Negative Breast Cancer PR Negative \| ER Negative \| HER2 Negative	263	芦康沙妥珠单抗	cosgovxvvc(upqiowiqvd) = kqsvtfgixi dcxtlyjvlm (zqqstavnqv ) View more	Positive	29 Sep 2024
				化疗	cosgovxvvc(upqiowiqvd) = lodxbdearl dcxtlyjvlm (zqqstavnqv ) View more
NCT05351788 (OptiTROP-Lung01, NEWS) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma PD-L1	103	sac-TMT 5 mg/kg Q3W + KL-A167 KL-A167 1200 mg Q3W	oogdbxgmgu(puvviyueri) = rwlnjxpvzg vtsdhfrokl (cgnezxmvle ) View more	Positive	29 Sep 2024
				sac-TMT 5 mg/kg Q2W + KL-A167 KL-A167 900 mg Q2W	oogdbxgmgu(puvviyueri) = tiyzhihnmg vtsdhfrokl (cgnezxmvle ) View more
NCT05347134 (OptiTROP-Breast01, ESMO2024) Manual	Phase 3	Triple Negative Breast Cancer	-	Sacituzumab tirumotecan (sac-TMT)	vdgbbsypkg(xamyyenuqo) = wbmusensxn csmuqybzus (yqvdoffbae ) View more	Positive	16 Sep 2024
				Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine)	vdgbbsypkg(xamyyenuqo) = swtpvifieb csmuqybzus (yqvdoffbae ) View more
NCT04152499 (KL264-01, ESMO 12024 \| ESMO 22024) Manual	Phase 2	Ovarian Cancer \| Advanced Endometrial Carcinoma TROP2 Expression	84	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (advanced endometrial carcinoma (EC))	etvnebjdkr(rgjgdqajzu) = lwkfrxileg gfrtpdxnew (zyewbeizpq ) View more	Positive	15 Sep 2024
				sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (ovarian cancer (OC))	etvnebjdkr(rgjgdqajzu) = rrpsvqqebg gfrtpdxnew (zyewbeizpq ) View more
NCT05642780 (SKB264-Ⅱ-06, ESMO2024) Manual	Phase 2	Uterine Cervical Cancer	38	Sacituzumab tirumotecan 3 Pembrolizumabolizumab 400 mg	gcwjbugzrk(ozvpyzwaps) = hhfqtkaysb vvfqjxxvcp (zdoxyagvld ) View more	Positive	15 Sep 2024
				Sacituzumab tirumotecan + Pembrolizumab (pre-treated with anti-PD-1 based therapy)	fpyiqkngio(jlcecaqwez) = iyvvdaypkg mvnqxyioqo (jphstgtvhv )
CTR20222948 \| NCT05631262 (OptiTROP-Lung03, Corporate Publications) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	-	SKB264	bujnnhypbm(gexeujtfak) = demonstrated a statistically significant and clinically meaningful improvement fwokdetdto (bbwugzmqey ) View more	Positive	19 Aug 2024
				Docetaxel
NCT05347134 (OptiTROP-Breast01, ASCO2024) Manual	Phase 3	Triple Negative Breast Cancer Third line TROP2	263	Sacituzumab tirumotecan (SKB264/MK-2870)	graobhwksp(ovbugwaejx) = vrbbuuapbu uxtceipxoo (jnscbnwaaf, 4.3 - 7.2) Met View more	Positive	24 May 2024
				Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)	graobhwksp(ovbugwaejx) = jpdndzqybq uxtceipxoo (jnscbnwaaf, 1.6 - 2.7) Met View more

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