Delving into the Latest Updates on Sacituzumab tirumotecan with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Sac-TMT, TROP-2-targeted antibody-drug conjugate, A-264

+ [7]

Target

Top I x Trop-2

Action

inhibitors

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesSkin and Musculoskeletal Diseases+ [6]

Active Indication

Hormone receptor positive HER2 negative breast cancerEGFR-mutated non-small Cell Lung CancerEGFR positive Non-squamous non-small cell lung cancer+ [71]

Inactive Indication-

Originator Organization

Sichuan Kelun Pharmaceutical Co., Ltd.

Active Organization

Merck Sharp & Dohme LLC

MSD R&D (China) Co. Ltd.

Sichuan Kelun Botai Biomedicine Co., Ltd.

+ [4]

Inactive Organization-

License Organization

Sichuan Kelun Botai Biomedicine Co., Ltd.

Merck Sharp & Dohme Corp.

Merck & Co., Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

China (22 Nov 2024),

Triple Negative Breast Cancer

RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

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Structure/Sequence

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Sequence Code 27958L

Source: *****

Sequence Code 319372635H

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Trophoblast cell-surface antigen 2 (TROP2) is overexpressed in advanced or metastatic urothelial cancer (UC), representing a promising therapeutic target. Sacituzumab tirumotecan (sac-TMT) is a TROP2-directed antibody-drug conjugate with a unique, bifunctional linker that maximizes payload delivery to tumor cells. We present preliminary results for sac-TMT monotherapy from cohort 9 of the phase 1/2 2870-001/KL264-01 study in participants with advanced or metastatic UC.

PARTICIPANTS AND METHODS:

Eligible participants with locally advanced or metastatic UC and disease progression on one or more prior line of platinum-based chemotherapy and anti-programmed cell death protein 1/programmed cell death-ligand 1 therapy received sac-TMT 5 mg/kg intravenously every 2 weeks until disease progression, unacceptable toxicity, or participant/physician decision. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST version 1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

By data cut-off (17 February 2025), 49 participants were treated with sac-TMT; 37 (76%) had received two or more prior lines of therapy. Median follow-up for this analysis was 18.8 months. The confirmed ORR was 31% [95% confidence interval (CI), 18% to 45%] and the disease control rate was 71% (95% CI 57% to 83%). Median DOR was not reached [range 2.1-22.2+ (+ indicates censored data for the longest DOR, suggesting that patients may have achieved longer remission duration) months], and the 12-month probability of sustained response was 53%. Median PFS and OS were 5.5 months (95% CI 3.6-7.2 months) and 12.1 months (95% CI, 9.9-15.3 months), with 18-month rates of 26% and 33%, respectively. Grade 3/4 treatment-related adverse events (AEs) occurred in 31 participants (63%), and the most common (≥5%) were anemia (41%), decreased neutrophil count (35%), decreased white blood cell count (20%), stomatitis (12%), and decreased platelet count (8%). There were no grade 5 treatment-related AEs or febrile neutropenia events.

CONCLUSIONS:

Sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.

15 Feb 2026·CANCER

Sacituzumab tirumotecan improved survival for patients with EGFR TKI–resistant, EGFR‐mutant advanced NSCLC

Author: Lawrence, Leah

15 Feb 2026·CANCER

TROP2‐targeted ADCs demonstrate survival benefit for patients with advanced triple‐negative breast cancer

Author: Lawrence, Leah

This news section offers Cancer readers timely information on events, public policy analysis, and topical issues. In this issue, TROP2‐targeted antibody–drug conjugates demonstrate a survival benefit for patients with advanced triple‐negative breast cancer. In addition, sacituzumab tirumotecan improved survival for patients with EGFR TKI–resistant, EGFR ‐mutant advanced non–small cell lung cancer, and an immunochemotherapy regimen demonstrates survival benefits for patients with platinum‐resistant ovarian cancer.

113

News (Medical) associated with Sacituzumab tirumotecan

03 Apr 2026

·www.prnewswire.com

Next Generation Drug Conjugates (NDCs) Market worth $42.55 billion by 2035 | MarketsandMarkets™

DELRAY BEACH, Fla., April 3, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Next Generation Drug Conjugates Market is projected to grow from about USD 15.75 billion in 2026 to USD 42.55 billion by 2035, at a CAGR of 11.7%. Browse 260 market data Tables and 60 Figures spread through 270 Pages and in-depth TOC on "Next Generation Drug Conjugates Market - Global Forecast to 2035" Next Generation Drug Conjugates Market Size & Forecast: Market Size Available for Years: 2026–2035 2026 Market Size: USD 15.75 billion 2035 Projected Market Size: USD 42.55 billion CAGR (2026–2035): 11.7% Next Generation Drug Conjugates Market Trends & Insights: By type, the peptide-radionuclide conjugate is projected to witness the highest CAGR of 14.6% between 2026 and 2035. By indication, breast cancer is expected to dominate the global next generation drug conjugates market in 2025 with a share of 45.9%. North America is projected to be the fastest-growing regional segment at a CAGR of 13.2% during the forecast period. Download PDF Brochure @ The growing prevalence of hematologic malignancies and solid tumors is a major driver for the next generation drug conjugates market. Additionally, continuous advancements in conjugation technologies, including improvements in targeting ligands, linker chemistry, payload design, and manufacturing processes, are enhancing the efficacy, safety, and scalability of these therapies. By product, The Enhertu segment accounted for the largest share of the global next generation drug conjugates market in 2025. the next generation drug conjugates market is segmented into Enhertu, Amvuttra, Pluvicto, Trodelvy, Sacituzumab Tirumotecan (SAC-TMT), Zilebesiran, 225Ac-PSMA-617, other commercialized products, and other pipeline products. The Enhertu dominated the market share in 2025, driven by its superior clinical efficacy, strong global adoption, and expanding approvals across multiple HER2-targeted indications, particularly in breast cancer. Its growing use in HER2-low populations and ongoing clinical trials in lung and gastric cancers further support its market leadership. Additionally, the increasing prevalence of breast cancer and the rising demand for targeted therapies continue to boost the uptake of Enhertu, reinforcing its dominant position in the global NGDC market. Request Sample Pages@ By Targeting ligand, Amino sugar is estimated to be the fastest-growing target ligand segment. The global next generation drug conjugates market is segmented by target ligand into antibodies, amino sugars, peptides, and other targeting ligands. In 2025, the amino sugar segment is projected to be the fastest growing during the forecast period, driven by its emerging role in targeted delivery and improved cellular uptake. Amino sugar-based ligands offer enhanced biocompatibility and potential for selective binding, supporting their increasing adoption in novel drug conjugate development and expanding research applications in precision oncology. North America accounted for the largest regional share in the global next generation drug conjugates market in 2025. North America accounted for the largest share of regional revenues in the next generation drug conjugates (NGDC) market and remains the primary growth engine. The region's dominance is driven by a high concentration of leading biopharmaceutical companies, advanced research institutions, and specialized cancer centers, along with strong regulatory support from the FDA and rapid adoption of innovative targeted therapies such as antibody-drug conjugates. Robust oncology pipelines, significant NIH and private funding, and an active clinical trials landscape position the US as the key innovation hub for NGDCs, while Canada contributes steadily through expanding healthcare infrastructure, increasing cancer research initiatives, and growing adoption of advanced oncology treatments. Inquire Before Buying@ Top Companies in Next Generation Drug Conjugates Market: The Top Companies in Next Generation Drug Conjugates Market include Alnylam Pharmaceuticals, Inc (US), Gilead Sciences, Inc (Immunomedics) (US), Novartis AG (Switzerland), AstraZeneca (UK), Daiichi Sankyo, Company Limited (Japan), Ionis Pharmaceuticals, Inc. (US), Rakuten Group, Inc. (US), Novo Nordisk (Dicerna Pharmaceuticals) (Denmark), ADC Therapeutics SA (Switzerland), Sanofi (France), Arrowhead Pharmaceuticals (US), and AbbVie, Inc (US). Browse Adjacent Markets: Medical Devices Market Research Reports & Consulting Related Reports: Antibody Discovery Market - Global Forecast to 2030 Antibody Therapeutics Market - Global Forecast to 2028 Oligonucleotide Synthesis Market - Global Forecast to 2030 Peptide Synthesis Market - Global Forecast to 2029 Drug Discovery Services Market - Global Forecast to 2030 About MarketsandMarkets™ MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem. The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. MarketsandMarkets™ SalesPlay is an AI-driven Revenue Intelligence Co-Pilot designed to help revenue teams prioritize the right accounts, identify critical changes early, and surface opportunities ahead of demand, so pipeline builds naturally and deals close with greater consistency. To find out more, visit ™.com or follow us on Twitter , LinkedIn and Facebook . Contact: Mr. Rohan Salgarkar MarketsandMarkets™ INC. 1615 South Congress Ave. Suite 103, Delray Beach, FL 33445 USA: +1-888-600-6441 Email: [email protected] Visit Our Website: Logo - SOURCE MarketsandMarkets 21% more press release views with Request a Demo

31 Mar 2026

·www.pharmaceutical-technology.com

Blackstone closes largest ever private funding investment round at $6.3bn

BXLS funds innovation within the life sciences sector. Credit: Vector mall / Shutterstock.com. Private investment platform Blackstone closed a funding raise that has brought in $6.3bn in capital to support its ongoing life sciences investment strategy – marking the largest life sciences private fund ever raised. The firm’s dedicated BXLS platform will absorb this oversubscribed funding round, providing companies with capital to develop and commercialise new drugs and medical technologies across the entire lifecycle. In the last 12 months, BXLS has handed over nearly $2bn to various companies within the life sciences sector to fund their development and commercialisation journeys. This includes MSD (Merck & Co), which recently bagged $700m to support the development of its antibody-drug conjugate (ADC), sacituzumab tirumotecan , across various solid tumour indications. BXLS also poured $400m into Teva Pharmaceutical’s duvakitug development programme back in early March 2026, which is currently in late-stage trials for inflammatory bowel diseases like Crohn’s and ulcerative colitis. In February 2026, the investment platform teamed up with Johnson & Johnson (J&J) to co-fund future clinical trials of its acute myeloid leukaemia (AML) drug, bleximenib. Blackstone Life Sciences has previously secured 34 approvals for innovative medicines and devices it has backed, including blockbuster therapies like Alnylam Pharmaceuticals’ transthyretin amyloidosis (ATTR) therapy, Amvuttra (vutrisiran) and AbbVie & J&J’s Bruton’s tyrosine kinase (BTK) inhibitor, Imbruvica (ibrutinib). Taking a look at the life sciences investment landscape According to Blackstone Life Sciences’ global head, Nicholas Galakatos, this round highlights the firm’s “enduring conviction in the life sciences”, which remains one of its core areas of focus. This will be welcome news for the sector, which has been contending with a challenging funding landscape triggered by burgeoning interest rates and economic uncertainty in recent years. Geopolitical factors like tariffs are also currently shaping pharmaceutical investment and launch strategies . Despite these hurdles, there have been some positive signals hinting to the recovery of pharma funding. As per a report from GlobalData , parent company of Pharmaceutical Technology , the total value of venture capital investments made in the sector in Q4 2025 climbed 70.6% compared with Q3. This upward trend was also observed in the volume of investments, which saw a 30.4% uptick to 206 deals. GlobalData has also highlighted the shift in investor activity – especially in the cell and gene therapy (CGT) space – which has seen an enhanced interest in candidates in the Series B-stage , as investors become more selective and strategy-driven. In a previous conversation with Pharmaceutical Technology , LanceBio Ventures partner, Ilya Yasny, noted that early planning, adaptability, trust building and strong data make up the backbone of any successful startup, and that companies should always look to fulfil an unmet patient need.

Drug ApprovalADC

30 Mar 2026

·www.fiercebiotech.com

Blackstone closes record $6.3B life sciences fund

The fund tops Blackstone\'s own BLXS V, which raised $4.6 billion in 2020.\n One of the world’s leading investment firms has broken its own record with the closing of its $6.3 billion Blackstone Life Sciences VI (BLXS VI) fund, which is 40% larger than its predecessor.According to a March 30 release, the oversubscribed fund closed at its hard cap and is the largest private fund ever dedicated to life sciences. Since its launch in 2018, Blackstone Life Sciences has grown to manage $15 billion in assets.Blackstone portfolio companies have produced 34 regulatory approvals for medicines and devices, the firm said. These include Novartis’ cholesterol treatment Leqvio, Alnylam’s transthyretin-mediated (ATTR) amyloidosis drug Amvuttra and Pharmacyclics’ chronic lymphocytic leukemia therapy Imbruvica.In a statement, Nicholas Galakatos, Ph.D., global head of Blackstone Life Sciences, said the fund’s record “highlights how we work successfully with industry trailblazers to help bring their most important products to patients around the world.” Blackstone reported that BLXS investments have achieved an 86% approval success rate for phase 3 assets. Over the past 12 months, the platform has made $2 billion in new investments, including $400 million to support Teva’s Sanofi-partnered IBD drug duvakitug and $700 million for Merck’s antibody-drug conjugate sacituzumab tirumotecan.In July 2020, Blackstone reached its fundraising target for BLXS V, raising $4.6 billion to support late-stage product development and growth investments in emerging companies.

ADCAcquisitionDrug Approval

100 Deals associated with Sacituzumab tirumotecan

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	02 Feb 2026
EGFR-mutated non-small Cell Lung Cancer	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	30 Sep 2025
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.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Urothelial Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	15 Apr 2026
Bladder Cancer	Phase 3	United States	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	China	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	Japan	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	Argentina	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	Australia	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	Belgium	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	Brazil	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	Canada	MSD R&D (China) Co. Ltd.	03 Apr 2026
Bladder Cancer	Phase 3	France	MSD R&D (China) Co. Ltd.	03 Apr 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05631262 (OptiTROP-Lung03, ESMO_ELCC2026 \| PRNewswire) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	137	Sacituzumab Tirumotecan	pdhyycgixv(ubpmhaehmk) = hukgvsfnrb vpftamkvke (vizllauxmf ) View more	Positive	27 Mar 2026
				Docetaxel	pdhyycgixv(ubpmhaehmk) = khamzxfljr vpftamkvke (vizllauxmf ) View more
NCT06952504 (GOG-3119, ESGO2026)	Phase 3	Endometrial Carcinoma First line \| Maintenance pMMR	529	Sacituzumab tirumotecan + Pembrolizumab	qxhwjfhwhk(kezzyhfiwd) = fgefvnbvdg tliqfvxtzd (tkrjnglplq ) View more	Positive	28 Feb 2026
				Pembrolizumab	ydomqounbk(bnvvfdwjpg) = irieqcnvne uemqppyqjy (bxklktmduo ) View more
NCT06448312 (OptiTROP-Lung05, PRNewswire) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 Positive	-	sacituzumab tirumotecan + pembrolizumab	ssnukpawzy(iusrophhrr) = Sac-TMT, in combination with pembrolizumab, as a first-line treatment for PD-L1-positive NSCLC, has demonstrated a statistically significant and clinically meaningful improvement in PFS, the study's primary endpoint. ixmplxijgd (xbfkxiqwav ) Met View more	Positive	24 Nov 2025
				pembrolizumab
NCT04152499 (MK-2870-001 \| KL264-01, Ann Oncol \| Pubmed \| PRNewswire) Manual	Phase 1/2	Advanced Urothelial Carcinoma	49	Sacituzumab Tirumotecan 5 mg/kg	nldcapkwoa(klxgrzvhch) = wwonzruwkn fcvnfgwmkj (jjqtvkqilq, 18 - 45) View more	Positive	20 Nov 2025
NCT05351788 (OptiTROP-Lung01, Pubmed \| Nat Med)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	103	Tagitanlimab 1,200 mg every 3 weeksvery 3 weeks + Tagitanlimab 1,200 mg every 3 weeks	uhcwsekdmg(xamsuvcfry) = ajxonmjkdb yasenxzugq (itnqeeatyo ) View more	Positive	01 Nov 2025
				Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks + Tagitanlimab 900 mg every 2 weeks	uhcwsekdmg(xamsuvcfry) = bxwtrvvfpy yasenxzugq (itnqeeatyo ) View more
NCT05870319 (OptiTROP-Lung04, Pubmed \| N Engl J Med) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	376	Sacituzumab tirumotecan (sac-TMT)	vbgdkvfyvw(yjpflsgriy) = dfgvvstbce drjvsciged (tcskzpolbw ) View more	Positive	19 Oct 2025
				Pemetrexed + platinum-based chemotherapy	vbgdkvfyvw(yjpflsgriy) = papyfckreo drjvsciged (tcskzpolbw ) View more
NCT06081959 (OptiTROP-Breast02, ESMO2025) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Second line HR Positive \| HER2 Negative	399	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W	cjaoqqnmyg(jjcknvlhnl) = utickmtqrj wkbhjbdqhp (pdgdqzrxbs ) View more	Positive	17 Oct 2025
				Investigator's choice of chemotherapy (ICC)	cjaoqqnmyg(jjcknvlhnl) = elrphajxyh wkbhjbdqhp (pdgdqzrxbs ) View more
NCT04152499 (ESMO2025)	Phase 1/2	Advanced Cervical Carcinoma TROP2 expression	58	Sacituzumab tirumotecan (Sac-TMT) 4 mg/kg	xnrigkogpl(tvegzegwod) = tqiwsqicqx xrkefmdfjc (ahnvsiomii, 17 - 41) View more	Positive	17 Oct 2025
NCT05816252 (MK-2870-003, ESMO2025)	Phase 2	PD-L1 positive Lung Cancer First line PD-L1-positive	50	Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro)	lvkvpqicho(fsafsialra) = mvejtvcdib tlhzplqrer (rziaxokexe ) View more	Positive	17 Oct 2025
				Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) (PD-L1 TPS ≥50%)	lvkvpqicho(fsafsialra) = dowxxlfiyc tlhzplqrer (rziaxokexe ) View more
NCT05642780 (MK-2870-002, ESMO2025)	Phase 2	Metastatic castration-resistant prostate cancer	46	Sacituzumab Tirumotecan (sac-TMT) 4 mg/kg + Pembrolizumab (Pembro)	mgxqlxhyph(fyjuxjfosw) = rihxgcywuy kprjilznsz (fvbdmrvcrp, 12.2–73.8) View more	Positive	17 Oct 2025
				Sacituzumab Tirumotecan (sac-TMT) 5 mg/kg + Pembrolizumab (Pembro)	mgxqlxhyph(fyjuxjfosw) = vkzlcatwxt kprjilznsz (fvbdmrvcrp, 20.8–53.8) View more

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