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Last update 27 Oct 2025

Sacituzumab tirumotecan

Last update 27 Oct 2025

Overview

R&D Status

Clinical Result

Translational Medicine

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

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [4]

Active Indication

EGFR-mutated non-small Cell Lung CancerEGFR positive Non-squamous non-small cell lung cancerTriple Negative Breast Cancer+ [55]

Inactive Indication-

Originator Organization

Sichuan Kelun Pharmaceutical Co., Ltd.

Active Organization

MSD R&D (China) Co. Ltd.Merck Sharp & Dohme LLC

Sichuan Kelun Pharmacy Institute Co., Ltd.

+ [3]

Inactive Organization-

License Organization

Sichuan Kelun Botai Biomedicine Co., Ltd.

Merck Sharp & Dohme Corp.

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)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 27958L

Source: *****

Sequence Code 319372635H

Source: *****

Clinical Trials associated with Sacituzumab tirumotecan

NCT07216703

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.
Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goals of this study are to learn:
* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and
* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

Start Date18 Nov 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT07193160

/ Not yet recruitingPhase 2IIT

A Multicenter, Single-arm, Phase II Clinical Study of Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

This study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation EGFR-TKI therapy.

Start Date01 Nov 2025

Sponsor / Collaborator

Fudan University

NCT07054242

/ Not yet recruitingPhase 2IIT

A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)

This is a prospective, single center, phase II study to enroll participants with stage II or III TNBC who have not previously undergone systemic therapy. The primary endpoint is pCR in the ITT population. The study aims to enroll 52 participants. Eligible participants will receive a combination therapy of SKB264 and Pembrolizumab.
Experimental arm: SKB264 will be administered intravenously (IV) at a dose of 4 mg/kg every two weeks (Q2W); Pembrolizumab will be administered intravenously at a dose of 200mg every three weeks (Q3W) All enrolled participants will initially receive SKB264 plus Pembrolizumab for 8 weeks. Based on early imaging and biopsy assessment, patients who deemed as responders continue to receive combined drug therapy for 10 weeks, followed by surgical treatment. Patients who assessed as non-responders will be treated at the discretion of the physician.
Participants will undergo regular tumor assessments based on RECIST 1.1 criteria. Imaging assessments will be conducted every 9 weeks (±1 week) for the first 18 weeks following treatment initiation, and every 12 weeks (±1 week) thereafter, until confirmed disease progression, initiation of a new antitumor treatment, withdrawal of consent, loss to follow-up, death, or study end, whichever occurs first. After termination of the study treatment, participants must complete the EOT visit and a safety follow-up, and undergo survival visits every 3 months (±14 days) post the last dose to collect information on survival, new antitumor treatments received.

Start Date30 Oct 2025

Sponsor / Collaborator

Yantai Yuhuangding Hospital

[+1]

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

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

01 Oct 2025·BREAST

Cost-effectiveness of sacituzumab tirumotecan versus chemotherapy for patients with metastatic triple-negative breast cancer in China

Article

Author: Ding, Yiling ; Zhang, Qilin ; Tang, Ying ; Shu, Yamin ; Xu, Pingping

PURPOSE:

Sacituzumab tirumotecan (sac-TMT), a trop-2-targeted antibody-drug conjugate, has demonstrated significant clinical benefit in the OptiTROP-Breast01 trial for patients with advanced or metastatic triple-negative breast cancer (TNBC). This study evaluated the cost-effectiveness of sac-TMT compared with chemotherapy from the perspective of the Chinese healthcare system.

METHODS:

A partitioned survival model incorporating multiple survival extrapolation approaches was developed to estimate long-term clinical and economic outcomes. Survival data were reconstructed from the OptiTROP-Breast01 trial, while cost and utility inputs were derived from publicly databases and literature. Outcomes included life-years, quality-adjusted life-years (QALYs), total costs, and key economic endpoints: incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), incremental net monetary benefit (INMB), and expected value of perfect information (EVPI). Sensitivity, scenario, and subgroup analyses were conducted to assess uncertainty.

RESULTS:

In the base-case analysis, sac-TMT yielded an additional 0.32 QALYs and 0.35 life-years compared with chemotherapy, with an incremental cost of $31815.17, resulting in an ICER of $98796.02 per QALY, exceeding the $40763.34 threshold in China. One-way sensitivity analysis identified the dose intensity, utility for PFS, patient weight, and price of sac-TMT as key drivers of ICER. Scenario analysis showed that reducing the drug price to 20 % of the current level would lower the ICER to $13319.46/QALY, with a 99.82 % probability of cost-effectiveness. EVPI was estimated at $33.69 per person.

CONCLUSION:

While sac-TMT offers survival benefits in metastatic TNBC, it is unlikely to be cost-effective at current pricing. Substantial price reductions and optimized use may improve its economic value and support reimbursement.

01 Jun 2025·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 ; Lai, Shuzhen ; Li, Yongsheng ; 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 Oct 2025

·www.fiercepharma.com

Fierce Pharma Asia—Licensing deal flow, China crackdown warning and ESMO readouts

A group of licensing agreements, a CEO's warning about overenforcement of China dealmaking and multiple ESMO readouts made our news this week. Among a string of licensing deals from last week, Takeda's tie-up with Innovent stole the show. Nkarta CEO Paul Hastings recently spoke to the importance of the industry's collaborations with Chinese biopharma companies. Asian biopharmas had a large presence at a major cancer conference over the weekend. Plus more.1. Takeda pays Innovent $1.2B upfront, offers whopping $10B-plus in biobucks for cancer assets In a year full of billion-dollar licensing deals involving Chinese biotechs, Takeda’s tie-up with Innovent stands out. The Japanese pharma giant agreed to put down $1.2 billion upfront and offered up more than $10 billion in potential milestones to get its hands on a pair of cancer assets from the Chinese drug developer. For Takeda, the deal represents an effort to identify sources of growth for the next decade as inflammatory bowel disease medicine Entyvio creeps toward its patent cliff. 2. ‘We can have TikTok. Why can’t we have drugs?’: Nkarta CEO Hastings warns against China biotech penalties At Fierce Biotech Week earlier this month, Nkarta CEO Paul Hastings urged the federal government to not crack down on the industry’s licensing of drug candidates from China. “We can have TikTok,” the biotech CEO explained, so “why can’t we have drugs?” The comments come at a time of geopolitical tensions, but China's licensing deals represent a critical source of innovation for the U.S. biopharma industry. 3. Licensing galore: Roche ties up with Hansoh on ADCs as Rani rounds out week with Chugai pact 4. Kite puts $1.6B on the line to pair up with China’s Pregene for another in vivo CAR-T deal Toward the end of last week, several Asian biopharma companies inked high-dollar licensing deals. In one deal, Roche agreed to pay up to $1.45 billion in exchange for an ex-China license to develop, manufacture and sell Hansoh's experimental CDH17-targeted antibody-drug conjugate (ADC) dubbed HS-20110. In addition to that deal, Rani Therapeutics linked up with Japan’s Chugai, a Roche subsidiary, in an oral delivery technology pact that could climb to more than $1 billion in value. Rounding out the action, Gilead’s Kite Pharma showcased its interest in in vivo CAR-T tech by striking an agreement with China’s Pregene. 5. Merck grows more ambitious about 'workhorse' TROP2 ADC as partner Kelun posts phase 3 wins The European Society for Medical Oncology (ESMO) congress over the weekend featured data presentations from numerous Asian biopharmas, including Merck’s ADC partner Kelun-Biotech. Sacituzumab tirumotecan (sac-TMT), developed by China’s Kelun and licensed by Merck, excelled in separate studies in lung cancer and breast cancer, according to data presented at ESMO. The results contribute to Merck’s optimism about the candidate, Marjorie Green, M.D., Merck’s senior vice president and head of oncology global clinical development, told Fierce. 6. ESMO: Daiichi, Merck power ovarian cancer ADC toward pivotal test after passing phase 2 Also at ESMO, Merck and partner Daiichi Sankyo released new data for their CDH6-directed ADC raludotatug deruxtecan (R-DXd). In a phase 2 study assessing the candidate in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer that was resistant to platinum chemotherapy, investigators recorded an overall response rate of 50.5%. The partners are now readying a push into phase 3. 7. ESMO: AZ, Daiichi’s Datroway outshines Gilead’s Trodelvy in first global TROP2 showdown 8. ESMO: AZ, Daiichi unleash Enhertu's 2-fisted power, aiming to reshape early breast cancer landscape Daiichi Sanyko’s presence at ESMO wasn’t limited to the R-DXd presentation. In fact, the Japanese company’s ADC alliance with AstraZeneca yielded two more impressive showings. As the partners duel with Gilead Sciences in the TROP2 ADC field, a new round of readouts points to an advantage for Datroway. And for the older Enhertu, a pair of trial readouts in early breast cancer open the door to a potential opportunity to advance patient care—while raising a new question. 9. China pricing pressure continues to weigh on Roche's diagnostics business Even as Roche contends with pricing pressures in China, the company’s diagnostics division was able to eke out 1% sales growth during the first 9 months of 2025. Overall, Roche’s diagnostic sales in the Asia-Pacific region were down 15% during the period, while sales in all other geographic regions were up. Year-to-date, Roche’s China diagnostic sales fell 27%, Matt Sause, CEO of Roche Diagnostics, said on Thursday. 10. ESMO: Akeso, Summit's ivonescimab beats PD-1 in first chemo combo win in 1st-line NSCLC As China’s Akeso and its U.S. partner Summit Therapeutics continue to break new ground with their PD-1xVEGF bispecific ivonescimab, the drug delivered another first at ESMO. Data revealed at the conference show that the therapy can delay tumor progression versus a PD-1 inhibitor as part of a combination with chemotherapy. The results come from a study limited to China.Other News of Note: 11. Lilly, Cipla link up in India tirzepatide distribution pact (release) 12. Japan VC firm Fast Track Initiative raises roughly $130M (release) 13. ESMO: GSK says 'stay tuned' for more ADC data after partner Hansoh posts 49% response rate 14. Regeneron settles Eylea patent dispute with Celltrion, allowing another biosimilar to launch at end of 2026 15. Astellas walks away from gene therapy pact with Taysha before pivotal trial launch

License out/inPhase 2Phase 3Clinical ResultADC

21 Oct 2025

·endpoints.news

Post-Hoc: As China moves beyond ‘me-too,’ do Western regulators need to reconsider?

BERLIN — At Europe’s largest cancer conference, Sunday’s main stage belonged to China. Medical conferences use their keynote sessions to highlight results from what the top researchers in the world think are the most important trials in their field. And at the European Society for Medical Oncology’s annual meeting, three of the four presentations during Sunday’s presidential symposium were for studies conducted in China, by Chinese companies. In the previous four years at ESMO, there wasn’t a single such high-level presentation from a China-only study. It’s yet another proof point for the rise of China biotech (not that the biopharma industry needed the reminder). One particularly striking China-run study at ESMO showed that, in certain lung cancer patients, an antibody-drug conjugate developed by Sichuan-based Kelun-Biotech cut the risk of death by 40% compared to chemotherapy, eliciting a round of applause from the thousands of audience members. The antibody drug-conjugate, known as sac-TMT, was approved in China for this indication earlier this month, but likely won’t get that same approval in the West for years. Kelun’s global partner Merck is running an analogous global Phase 3 trial that’s not expected to read out until 2028. That’s a long time for patients to wait for a therapy that seems likely to save lives. And at ESMO this weekend, it forced the question of whether Western regulators should reconsider their stances around China-only data. “With this level of evidence in the context of a Chinese trial, is a confirmation within a global study truly required for FDA and/or EMA approval?” Italian oncologist Antonio Passaro asked in his discussion of the trial results on stage after they were presented. And as more new and promising drugs emerge from China — sometimes at costs far below the US — will the FDA’s stance keep patients from benefiting? The FDA is highly unlikely to be open to the idea. In 2022, the agency notoriously rejected Eli Lilly’s application that used China-only data, which also effectively shut down a slew of US price disruption efforts using China-discovered drugs. On the other hand, the EMA has given approvals to two checkpoint drugs based on China data. But with Kelun’s drug, the question isn’t about a “me-too” medicine — like those EMA-approved checkpoint drugs. It’s about therapies that could meaningfully change the trajectory of patients’ disease. Another presentation on Sunday at ESMO was about ivonescimab, a PD-1xVEGF bispecific antibody from Chinese biotech Akeso, that’s seeking to rival those very checkpoint drugs. While it’s not approved in the US or Europe, CEO Michelle Xia told Endpoints News ahead of the symposium that ivonescimab has already been used to treat 40,000 patients in China since it was approved last year. The idea of changing how the US and Europe consider these types of drugs comes at a time when US-China geopolitics are particularly tense, making it even more unlikely. And the approach wouldn’t be without risk: One major safety, efficacy or data problem from a China-only trial could spoil future hopes. And in the US, others have argued for fully banning clinical trial data from studies conducted only in China. But for a very long time now, US patients have been able to access the newest, best drugs first — one argument companies here use for steep drug prices. What happens when the US drugmakers aren’t always first to the finish line anymore? — Lei Lei

Drug ApprovalPhase 3ADC

21 Oct 2025

·endpoints.news

'Decade of the ADCs' continues as AstraZeneca, Kelun and Merck take the stage at ESMO

Two years ago at the European Society for Medical Oncology’s annual meeting, a prominent oncologist predicted that the 2020s would be the “decade of the ADCs.” There were several high-value ADC-focused deals in 2023 ahead of that meeting, a trend that continued through the rest of 2023 and into 2024. While dealmaking has since slowed, the hype around ADCs has not. They’re still expected to become the backbone of care for many cancers in place of traditional chemotherapy, thanks to their ability to deliver cytotoxic payloads in a more targeted way. And they’re still a hot topic at this year’s meeting in Berlin. We’ve rounded up the most impactful ADC data presented at ESMO this year: AstraZeneca and Daiichi’s Enhertu took center stage at a presidential symposium on Saturday, when the companies shared topline data from the DESTINY-Breast11 trial. The study evaluated the drug, which is the best-selling ADC out of the 17 approved globally, in the potentially “curative” neoadjuvant setting of early breast cancer. In the same session, the companies reported results from a second Phase 3 study called DESTINY-Breast05, which enrolled a slightly more advanced group of early breast cancer patients. They had residual invasive disease after surgery and neoadjuvant treatment, and were at a high risk of disease recurrence. Enhertu cut the risk of recurrence or death in these patients by 53% compared with Roche’s Kadcyla, the standard of care. The readouts “underscore the potential of Enhertu to become a foundational treatment in early-stage breast cancer,” AstraZeneca head of oncology R&D Susan Galbraith said in a release. But Enhertu has competition in China for one of its current indications: previously treated unresectable or metastatic HER2+ breast cancer. Sichuan Kelun-Biotech’s HER2-targeting ADC trastuzumab botidotin clinched an approval in that setting just days ago. That decision was based on data from Kelun’s Phase 3 study, which were presented on Monday. More than 75% of patients who received the China drug saw their tumors shrink compared with 53% of those given Kadcyla. Trastuzumab botidotin also achieved a median progression-free survival of 11.1 months versus 4.4 months for Kadcyla. Meanwhile, Merck said its Kelun-partnered TROP-2-directed ADC called sacituzumab tirumotecan, also known as sac-TMT, reduced the risk of death in a Phase 3 trial in certain previously treated non-small cell lung cancer patients. The study , also conducted in China, enrolled patients with EGFR-mutated NSCLC who had failed on treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. At a median follow-up of 18.9 months, Sac-TMT achieved an 8.3-month median progression-free survival compared to 4.3 months for patients who received chemotherapy. Median overall survival was not reached in the sac-TMT arm at a pre-specified interim analysis, versus 17.4 months in the chemotherapy arm. Merck struck a deal with Kelun for exclusive rights to develop, manufacture and commercialize sac-TMT outside of Greater China. Bispecific approaches were also hot at the confab, including an EGFRxHER3-targeting ADC developed by Bristol Myers Squibb and SystImmune. The companies on Friday shared the first data from a global Phase 1 trial of iza-bren. The 2.5 mg/kg dose produced confirmed responses in 11 out of 20 patients with previously treated EGFR-mutated non-small cell lung cancer. Separate from its work with Daiichi , AstraZeneca has seven in-house ADC assets, including one directed at FRα. In 56 platinum-resistant ovarian cancer (PROC) patients with high FRα expression enrolled in a first-in-human trial, AZD5335 achieved response rates of about 61% among patients who took one of three dose levels. The overall response rate in patients with low FRα expression at those dose levels was almost 48%, according to a congress abstract. Elsewhere in the FRα pipeline , Genmab’s rinatabart sesutecan is already in Phase 3 development. The company previously reported the drug hit a 50% ORR in heavily pretreated advanced endometrial cancer patients enrolled in a Phase 1/2 study. On Saturday, it was revealed that more than 60% of responders maintained their responses for about a year. Eli Lilly’s contender with the same target , known as LY4170156, also had new early-stage data to share. The drug achieved ORRs ranging from 33% to 61% depending on the dose. Lilly’s Phase 1 study was in patients with PROC, according to a congress abstract. Tubulis is also trying to treat PROC with an ADC , albeit with a different target. The biotech’s NaPi2b-directed candidate, TUB-040, attained a 50% confirmed ORR in a first-in-human study. Last week, the company bagged $361 million in a Series C raise, becoming the latest ADC company to pull in big bucks in recent years. Nicole DeFeudis contributed reporting.

Clinical ResultPhase 1Phase 3ADCLicense out/in

100 Deals associated with Sacituzumab tirumotecan

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	NDA/BLA	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 May 2025
Metastatic breast cancer	Phase 3	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	18 Jul 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	United States	MSD R&D (China) Co. Ltd.	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	China	MSD R&D (China) Co. Ltd.	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	China	Merck Sharp & Dohme LLC	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	Japan	MSD R&D (China) Co. Ltd.	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	Japan	Merck Sharp & Dohme LLC	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	Argentina	MSD R&D (China) Co. Ltd.	30 Jun 2025
HR-positive/HER2-low Breast Carcinoma	Phase 3	Argentina	Merck Sharp & Dohme LLC	30 Jun 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06081959 (OptiTROP-Breast02, ESMO 12025 \| ESMO 22025) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	399	Sacituzumab tirumotecan (5 mg/kg Q2W)	ixhsmlazeu(uaaibouqfw) = unmovwjtdu lakdwninvn (xhttdmdyhu ) View more	Positive	13 Oct 2025
				Chemo (eribulin, vinorelbine, capecitabine, or gemcitabine)	ixhsmlazeu(uaaibouqfw) = fuvxhzvkqs lakdwninvn (xhttdmdyhu ) View more
NCT05351788 (OptiTROP-Lung01, Nat Med) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	103	sacituzumab tirumotecan+tagitanlimab (Cohort 1A)	gygzhgozgy(bentvavtyl) = mjwpntkecw rkrxccympk (fplwdfqail ) View more	Positive	19 Aug 2025
				sacituzumab tirumotecan+tagitanlimab (Cohort 1B)	gygzhgozgy(bentvavtyl) = vhrwtqzoal rkrxccympk (fplwdfqail ) View more
NEWS 1 \| NEWS 2	Not Applicable	Non-Small Cell Lung Cancer EGFR Mutation	-	Sacituzumab tirumotecan	rkeqsmbztx(yvtsfdpsva) = vepllmpkki cmgcguvqoq (mehcrpszip ) View more	Positive	18 Aug 2025
				Docetaxel	rkeqsmbztx(yvtsfdpsva) = iodloclsfy cmgcguvqoq (mehcrpszip ) View more
NCT04152499 (MK-2870-001, Pubmed \| J Hematol Oncol)	Phase 1/2	Solid tumor TROP2	-	Sacituzumab tirumotecan 2 mg/kg	rlvcfjgdsg(zgpwcavvvr) = wvhqkmcmjh pjeipvkbtf (szvblwtzjq )	Positive	06 Jun 2025
				Sacituzumab tirumotecan 4 mg/kg	ywimvbomra(trtvtkgiix) = uzxkpagcjl cjhmvstrfn (mgjesmixli, 16.4% - 57.3%) View more
NCT05445908 (OptiTROP-Breast05, ASCO2025) Manual	Phase 2	Triple Negative Breast Cancer First line PR Negative \| ER Negative \| HER2 Negative	41	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W	ppclozqxit(fdhqvcceil) = akyrnadjdd nbanjntlab (xqvqvvnlus, 45.0 - 78.7) View more	Positive	30 May 2025
				Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (PD-L1 CPS < 10)	ppclozqxit(fdhqvcceil) = ndqbxastpk nbanjntlab (xqvqvvnlus, 37.1 - 75.7) View more
NCT05631262 (OptiTROP-Lung03, ASCO2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line EGFR Mutation	137	Sacituzumab tirumotecanSacituzumab tirumotecan (sac-TMT) 5 mg/kg	drhvpnqwny(zyosbecvbt) = sfhtaobgxr ibdyckutqk (aqnfrixkcd ) View more	Positive	30 May 2025
				DocetaxelDocetaxel 75 mg/m^2	drhvpnqwny(zyosbecvbt) = pzykhidyki ibdyckutqk (aqnfrixkcd ) View more
NCT05351788 (OptiTROP-Lung01, ASCO2025) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	81	Sacituzumab tirumotecan (sac-TMT) + Tagitanlimab	wijqlrfmyb(danpwavtze) = xrsgbvcuwn zsngmohsor (dstibpurem ) View more	Positive	30 May 2025
NCT06393374 (Phase 3 Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Participants with Triple-Negative Breast Cancer, ASCO2025)	Phase 3	Triple Negative Breast Cancer Adjuvant TROP2 expression	-	Sacituzumab tirumotecan + Pembrolizumab	yfatxcoxum(bgequhdagt): HR = 0.53 (95% CI, 0.36 - 0.78), P-Value = 0.0005 View more	-	30 May 2025
				Treatment of physician’s choice (TPC)
NCT05631262 (Phase 2 study, ASCO2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer uncommon EGFR mutations \| G719X \| S768I ... View more	42	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg	eqpqtgabvk(dtfwxqyvtm) = Grade ≥3 treatment-related adverse events (TRAEs) occurred in 52.4% of pts. The most frequent grade ≥3 TRAEs (≥5%) were neutrophil count decreased (45.2%), WBC count decreased (21.4%), anemia (14.3%), and stomatitis (9.5%). No TRAE led to treatment discontinuation or death. No cases of interstitial lung disease/pneumonitis were reported. lcvpzqkjxj (aszbtuqlpg ) View more	Positive	30 May 2025
NCT05347134 (OptiTROP-Breast01, Pubmed \| Nat Med) Manual	Phase 3	Metastatic Triple-Negative Breast Carcinoma Second line	263	Sacituzumab tirumotecan (sac-TMT)	kurnfcfaff(gxonwjwcwc) = ngnzasjpfs atbmnqcmbt (dyytndxkve, 5.5 - 8.0) Met View more	Positive	11 Apr 2025
				Chemotherapy	kurnfcfaff(gxonwjwcwc) = nopvfenhwx atbmnqcmbt (dyytndxkve, 1.7 - 2.7) Met View more

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