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Last update 14 Mar 2026

Sacituzumab tirumotecan

Last update 14 Mar 2026

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

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+ [78]

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)

Structure/Sequence

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Sequence Code 27958L

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Sequence Code 319372635H

Source: *****

111

Clinical Trials associated with Sacituzumab tirumotecan

ACTRN12625001382460

/ Not yet recruitingPhase 2IIT

Phase 2 trial of SaciTuzumAb TirumotEcan (sac-TMT) in patients with MetastAtic castration resistant prostate cancer (mCRPC): a high dimeNesional collection and characterization Platform (STATEsMAN)

Start Date01 Jun 2026

Sponsor / Collaborator-

NCT07438626

/ Not yet recruitingPhase 2IIT

Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma

To learn if sacituzumab tirumotecan can help to control advanced or metastatic SMARCB1-deficient RMC in patients whose disease has progressed after receiving at least 1 treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT07458113

/ Not yet recruitingPhase 2IIT

Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer

This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death.

Start Date01 May 2026

Sponsor / Collaborator

Yale University

[+2]

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

01 Mar 2026·ANNALS OF ONCOLOGY

Sacituzumab tirumotecan in participants with advanced or metastatic urothelial carcinoma and disease progression after chemotherapy and immune checkpoint inhibitors

Article

Author: Ge, Y ; Liu, T ; Zhang, S ; Wang, X ; Seneviratne, L ; Yuan, F ; Li, Y ; Li, X ; Jiang, K ; Wang, S ; Chen, X ; Zhang, M ; Ge, J ; Blumenthal, G ; Zhou, F ; Ye, D ; Liu, Y ; Zhang, X ; Akala, O ; Chen, M ; Jiang, S ; Shi, Y ; Yu, G ; Zhu, Y

BACKGROUND:

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.

105

News (Medical) associated with Sacituzumab tirumotecan

04 Mar 2026

·www.fiercebiotech.com

Pfizer\'s oncology R&D strategy: Jeff Legos on speed, breadth and novel combinations

Pfizer’s urgency to quickly expand the clinical program of its PD-1xVEGF bispecific antibody highlights a thrilling race to develop a successor to displace Keytruda, the current immuno-oncology king.\n Oncology projects currently take up about 40% of Pfizer’s overall R&D budget. Behind this construction is Jeff Legos, Ph.D., who became the firm’s chief oncology officer last year following a high-profile move from Novartis.After steering positive key pivotal readouts for a trio of Novartis’ blockbusters—Kisqali, Pluvicto and Scemblix—Legos is now tasked with fleshing out Pfizer’s $43 billion Seagen acquisition into an antibody-drug conjugate empire while accelerating a PD-1xVEGF bispecific licensed from 3SBio toward 2028 readouts.For the closely watched PD-1xVEGF competition, Legos’ strategy for Pfizer is anchored by three pillars: speed, breadth and novel combinations.“We are operating under very expedited timelines in terms of the first wave of studies,” Legos said in an interview with Fierce Biotech. Slamming the gasPfizer cleared regulatory requirements and completed the licensing agreement for 3SBio\'s PD-1xVEGF bispecific toward the end of July 2025. For an upfront payment of $1.25 billion and potential milestones of up to $4.8 billion, Pfizer gained ex-China rights to SSGJ-707, now also known as PF-08634404.By the end of 2025, Pfizer would have had regulatory discussions with the FDA and launched seven clinical trials, including three phase 3 studies, for the PD-1xVEGF drug. And the company plans to start another five studies by June this year. Normally, it would take about a year from clinical ideation to a study start, Legos noted.As to breadth, Pfizer is examining all of the existing indications of Merck & Co.’s Keytruda, trying to figure out where the PD-1xVEGF inhibitor can go, with additional considerations paid to disease prevalence and unmet medical need, Legos said. The urgency to quickly expand PF-08634404’s clinical program highlights a thrilling race to develop a successor to displace Keytruda, the current immuno-oncology king. To justify its price tag, Pfizer has talked about how PF-08634404 is differentiated from other candidates from a chemistry and biological mechanism perspective. But the phase 3 programs that Pfizer has outlined so far appear similar—if not identical—to what its rivals Summit Therapeutics/Akeso and BioNTech/Bristol Myers Squibb are undertaking for their PD(L)1xVEGF candidates.Some of the same settings where Pfizer is running phase 3 include a first-line non-small cell lung cancer study pitting PF-08634404 against Keytruda in their respective combinations with chemotherapy across both squamous and nonsquamous histologies, against Roche’s Tecentriq and chemo in first-line extensive-stage small cell lung cancer, and phase 3 tests in first-line gastric cancer and first-line colorectal cancer. PF-08634404 is a tetravalent antibody with four binding domains, two each for PD-1 and VEGF. The structure provides more robust cooperative binding and create a so-called “daisy chain” effect that could bring more cancer-killing T cells to the tumor microenvironment, Legos explained.“Despite that [scientific rationale], it does come down to clinical data, and that’s why we are required to test it in these very well-defined patient populations,” Legos said.Even though Keytruda has established itself as the standard of care in first-line NSCLC, only about 30% of patients benefit from immunotherapy, and only 30% of those patients benefitting experience long-term, durable responses, Legos observed. And in colorectal cancer, immunotherapy remains less effective in microsatellite-stable tumors. The unmet need prompted Pfizer to study whether PF-08634404 can improve patients’ outcomes, he said. Can PD-1xVEGF live up to its promise?Despite billions of dollars being poured into the PD-(L)1xVEGF space, the main criticism against the class is its seemingly weak ability to turn slowing tumor progression into prolonging patients’ lives. Summit and Akeso’s first-in-class ivonescimab recently showed a 26% death risk reduction in Chinese patients with previously treated EGFR-mutated NSCLC at the final analysis of the phase 3 HARMONi-A trial. But when it comes to the global HARMONi trial, the overall survival data failed to meet statistical significance.Legos argues that those data shouldn’t discount the broader potential of the PD-1xVEGF mechanism. Neither PD-1 nor VEGF inhibitor works very well separately in EGFR-mutated NSCLC, so it’s “not so surprising that the overall survival data is more borderline,” he said.And the problem may not be PD-1xVEGF anyway.“When you design a study with smaller patient numbers, in order to meet predefined endpoint around progression-free survival, you may not have enough power to sufficiently demonstrate the overall survival benefit,” Legos said.For PF-08634404, Pfizer plans to make overall survival at least a primary endpoint in all its phase 3 trials.“It comes down to the intention of the trial and your statistical analysis plan up front, and then ultimately the patient population that we are studying,” he said. Answers to the question of whether Pfizer’s PD-1xVEGF drug can be the next Keytruda will start to emerge in 2028, when the company expects readouts from the first wave of its phase 3 programs.However, the landscape of cancer care is forever evolving, and PD-(L)1xVEGF is not the only force that has its eyes on the prize. Notably, Merck is investing aggressively in its Kelun Biotech-partnered TROP2 antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) but has been quiet on its own PD-1xVEGF bispecific after licensing the asset from China’s LaNova Medicines—now part of Sino Biopharm—in late 2024.“I’m not sure it’s an either-or, because they’re doing two very different things,” Legos said of a potential showdown between PD-1xVEGF bispecifics and TROP2 ADCs.ADCs, as targeted missiles to deliver a cancer-killing payload, can achieve immediate cytotoxic cell death.“But frankly, we’re not just looking for improvements in response rates,” Legos continued. “Without engaging the immune system, I think the benefit of just a single modality may be limited in terms of its fullest potential.”Merck is already pairing sac-TMT with Keytruda in phase 3 trials in multiple tumor settings. As to whether a TROP2 ADC can be combined with a PD-1xVEGF bispecific, “those experiments would have to be done,” Legos said. Expanding Pfizer’s oncology pipelineCombination with other novel agents, including ADCs, is already on Legos’ agenda, forming the third pillar of his strategy in hopes of truly differentiating PF-08634404 from its peers. One of the phase 3 studies being planned pairs PF-08634404 with Pfizer’s Astellas-partnered ADC Padcev in first-line bladder cancer, a setting where the Padcev-Keytruda combo has recorded standing ovation-worthy data. Following the Seagen buy, questions persist regarding Pfizer’s ability to build a sustainable ADC pipeline while avoiding the path of Gilead Sciences, which has not produced a new ADC beyond the TROP2-directed Trodelvy in the six years since its $21 billion acquisition of Immunomedics. Pfizer discontinued a B7-H4 ADC a year ago and has repeatedly pared back efforts around its RemeGen-partnered HER2 ADC disitamab vedotin.Legos remains optimistic that new ADCs are coming out of Pfizer. Among eight key readouts that Pfizer expects this year across the group, sigvotatug vedotin, an ADC targeting integrin-beta6, is expected to report phase 3 data in second-line nonsquamous NSCLC in the first half of 2026.With its biology experts and partners, Pfizer is profiling novel antigens to target for next-generation ADCs and is examining “a variety of permutations,” such as bispecific antibody constructions and novel payloads, Legos said.“Instead of just focusing on traditional cytotoxic payloads, which I think have done very well, we’re now leveraging our small-molecule chemistry, and these could be low molecular weight inhibitors, they could be molecular glues, they could be targeted protein degraders,” Legos said. “These can become the basis of payloads where you can deliver very high dose, high concentration of a specific inhibitor directly to the cancer cells, thereby minimizing any safety or tolerability challenges but optimizing a therapeutic index.”The mix-and-match has already begun. Instead of the vedotin payload, Pfizer is testing another integrin beta6 candidate with a TOPO1 payload in phase 1 dose escalation, and is developing a third intravesical molecule with a unique payload in non-muscle invasive bladder cancer to complement Padcev, according to Legos.“We are working on modifying all of those different variables to bring forward what we believe to be a potentially practice-changing ADC in our priority disease areas,” Legos said. The Pfizer oncology pipeline currently includes traditional small molecules, regular antibodies, ADCs and bispecifics, including T-cell engager. But the company does not have any CAR-T projects. Pfizer Ventures was a top investor in Capstan Therapeutics, an in vivo CAR-T biotech that was recently bought by AbbVie. Legos said he’s “fairly agnostic to” modalities and is “completely open […] to pursue innovation wherever it originates.”“We have all of the building blocks that hopefully helps us accelerate the time to patient, but we are open and interested to explore all types of innovation, irrespective of modality,” he said.While the large deals for Seagen and 3SBio’s PD-1xVEGF drug have put rejuvenation of oncology at the top of Pfizer investors’ mind, obesity has grabbed their attention lately in the forms of Pfizer’s $10 billion takeover of Metsera and a $1.9 billion biobucks deal for new GLP-1 therapies from Fosun Pharma.Pointing to oncology’s 40% allocation of Pfizer’s entire R&D budget, Legos said he’s not worried about competition for resources internally with metabolic diseases but sees potential for mutual lessons sharing.“I’m very hopeful about the potential intersections of cancer and the insulin axis as it relates to the future of care,” Legos said. “For a company that actually can be a leader in obesity and in oncology, it’s an opportunity to think about how cancer care is done on the backbone of GLP-1, amylin, GIP as part of the future.”

$Pfizer\'s oncology R&D strategy: Jeff Legos on speed, breadth and novel combinations$

Phase 3ImmunotherapyLicense out/inAcquisitionPhase 1

12 Feb 2026

·www.biospace.com

Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium

Late-breaking KEYNOTE-B15 data show KEYTRUDA ® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for patients with certain types of bladder cancer New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG ® (belzutifan) plus KEYTRUDA and progression-free survival benefit of WELIREG in combination with LENVIMA ® (lenvatinib), respectively All three studies will be featured in the official ASCO GU Press Program RAHWAY, N.J.--(BUSINESS WIRE)-- $MRK #MRK --Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that data across multiple genitourinary cancers from several approved and investigational medicines will be presented at the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium from Feb. 26-28. These data, including three studies that will be featured in the symposium’s press program, underscore Merck’s commitment to advancing research across its broad portfolio to improve patient outcomes. “We’re excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers, with new data in muscle invasive bladder cancer and earlier stages of renal cell carcinoma,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The results we’re presenting at ASCO GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients.” Data presentations will feature new findings from Merck’s broad portfolio of cancer medicines, including key data for KEYTRUDA ® (pembrolizumab), WELIREG ® (belzutifan) and LENVIMA ® (lenvatinib), in collaboration with Eisai, as well as new results for the investigational antibody-drug conjugate (ADC) from Merck’s innovative pipeline: sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech. Key data from Merck’s portfolio and pipeline to be presented at the 2026 ASCO GU Cancers Symposium: First-time data from the Phase 3 KEYNOTE-B15/EV-304 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev ® (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment (before and after surgery) for patients with muscle-invasive bladder cancer who are eligible for cisplatin (abstract #LBA630, Oral abstract session B: Urothelial carcinoma), which will be featured in the official ASCO GU Press Program. 1 Results from the first interim analysis of the Phase 3 LITESPARK-022 trial evaluating KEYTRUDA in combination with WELIREG, Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a treatment for patients with clear cell renal cell carcinoma (RCC) following nephrectomy (abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. First presentation of data from the Phase 3 LITESPARK-011 trial evaluating WELIREG plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a treatment for patients with advanced RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy (abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. 2 First-time data presentation for the Phase 2 MK-2870-002 study evaluating sac-TMT plus KEYTRUDA for patients with advanced urothelial carcinoma (abstract #744, Poster session B: Prostate cancer and urothelial carcinoma). 3 Details on abstracts listed above and additional key abstracts for Merck Bladder cancer Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, Phase 3 KEYNOTE-B15 study. M. D. Galsky. 1 Abstract #LBA630, Oral abstract session B: Urothelial carcinoma Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from the Phase 2 2870-002/SKB264-II-06 study. X. Bian. 3 Abstract #744, Poster session B: Prostate cancer and urothelial carcinoma Pathological outcomes and disease-free survival (DFS) in KEYNOTE-905: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible. To be determined. 1 Abstract #638, Rapid oral abstract session B: Urothelial carcinoma KEYMAKER-U04 substudy 04B: First-line (1L) enfortumab vedotin (EV) plus pembrolizumab (pembro)-based immune checkpoint inhibitor (ICI) combinations for advanced urothelial cancer (UC). A. Peer. 1 Abstract #634, Rapid oral abstract session B: Urothelial carcinoma SWOG 2427: Single arm Phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT). L. K. Ballas. 4 Abstract #TPS913, Trials in progress poster session B: Urothelial carcinoma Kidney cancer Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized Phase 3 LITESPARK-022 study. T. K. Choueiri. Abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy: Open-label Phase 3 LITESPARK-011 study. R. J. Motzer. 2 Abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer Ascending dose escalation of belzutifan plus palbociclib for previously treated advanced clear cell renal cell carcinoma (ccRCC): Phase 1/2 LITESPARK-024 study Part 1. D. F. McDermott. 5 Abstract #423, Rapid oral abstract session C: Renal cell cancer and testicular cancer KEYMAKER-U03 substudy 03B: Novel investigative regimens for previously treated advanced clear cell renal cell carcinoma (ccRCC). L. Albiges. Abstract #505, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers Phase 2 trial of belzutifan in participants from China and Japan with von Hippel-Lindau disease-associated tumors: Results from LITESPARK-015 cohort B1. G. Naik. Abstract #494, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers Prostate cancer Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). H. Beltran. 6 Abstract #182, Poster session A: Prostate cancer 1 In collaboration with Astellas/Pfizer 2 In collaboration with Eisai 3 Led by Kelun-Biotech, conducted in China 4 Sponsored by National Cancer Institute 5 In collaboration with Pfizer 6 In collaboration with Daiichi Sankyo About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About Merck’s research in genitourinary cancers Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers. About KEYTRUDA ® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients. Hepatotoxicity and Immune-Mediated Hepatitis KEYTRUDA as a Single Agent KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients. KEYTRUDA With Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event. Immune-Mediated Endocrinopathies Adrenal Insufficiency KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypophysitis KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Thyroid Disorders KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism. Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Immune-Mediated Nephritis With Renal Dysfunction KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients. Immune-Mediated Dermatologic Adverse Reactions KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. Contacts Media Contacts: Julie Cunningham (617) 519-6264 John Infanti (609) 500-4714 Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Read full story here

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06 Feb 2026

·www.prnewswire.com

Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) Approved by NMPA in HR+/HER2- Breast Cancer

CHENGDU, China, Feb. 6, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application for its TROP2-directed ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been approved by the National Medical Products Administration (NMPA) of China for treatment of adult patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer (BC) who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting. This approval for HR+/HER2- BC after at least one prior line of chemotherapy marks the fourth indication for sac-TMT approved for marketing in China. The approval is based on the positive results from the Phase III OptiTROP-Breast02 study which was selected as a Late-Breaking Abstract (LBA) and presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Congress. The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT monotherapy compared to investigator's choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- BC. Of the patients enrolled in this Phase III study, 95.7% had visceral metastases, 75.9% had liver metastases; 52.9% were HER2-zero (IHC 0), while 47.1% were HER2-low (IHC 1+ or IHC 2+/ISH-). All patients had received prior CDK4/6 inhibitor and taxane therapy; 56.6% had received ≥2 lines of prior chemotherapy in the advanced or metastatic setting. Results showed that sac-TMT demonstrated a statistically significant and clinically meaningful increase in progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared to chemotherapy (8.3 vs. 4.1 months; hazard ratios (HR), 0.35; 95% CI: 0.26-0.48; p<0.0001). Consistent PFS benefits were observed across all pre-specified subgroups, including HER2-zero and HER2-low, number of chemotherapy lines received in the advanced or metastatic setting, presence of baseline visceral and liver metastases and previous CDK4/6 inhibitor use. According to BICR-assessed PFS results, the hazard ratios in the HER2-zero and HER2-low (IHC 1+ or IHC 2+/ISH-) subgroups were 0.39 (95% CI: 0.26-0.57) and 0.31 (95% CI: 0.20-0.48), respectively. A trend towards overall survival (OS) benefit and a significantly higher objective response rate (ORR) (41.5% vs. 24.1%) were also observed compared with chemotherapy. [1] Currently, Phase III clinical studies of sac-TMT with or without pembrolizumab (KEYTRUDA®[2]) for the treatment of chemotherapy-naïve HR+/HER2- BC who have received prior ET have been initiated globally (NCT06312176) and in China (NCT07071337). About HR+/HER2- Breast Cancer Breast cancer is one of the most common malignant tumors that seriously threaten women's health worldwide. In 2022, there were about 2,297,000 new cases of breast cancer and 666,000 deaths worldwide. Among them, HR+/HER2- breast cancer is the most common subtype, accounting for about 70% of all breast cancer cases, and advanced HR+/HER2- breast cancer has a poor prognosis. This subtype is typically sensitive to hormonal therapy, and therefore, endocrine therapy combined with a CDK4/6 inhibitor constitutes the standard treatment. However, for patients with HR+/HER2- advanced breast cancer whose disease progresses on endocrine therapy, chemotherapy is widely used in clinical while it is associated with low response rate (ORR approximately 14%-22.9%) and limited survival benefit (mPFS approximately 4.0-4.9 months). 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 the payload 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 (which includes Mainland China, Hong Kong, Macao and Taiwan). To date, four indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 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); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications listed above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA. Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating16 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer 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, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . SOURCE Kelun-biotech 21% more press release views with Request a Demo

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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

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	-	Merck Sharp & Dohme LLC	17 Mar 2026
Locally Advanced Urothelial Carcinoma	Phase 3	-	Merck Sharp & Dohme LLC	17 Mar 2026
HRD-positive Ovarian Cancer	Phase 3	United States	Merck Sharp & Dohme LLC	16 Feb 2026
HRD-positive Ovarian Cancer	Phase 3	Japan	Merck Sharp & Dohme LLC	16 Feb 2026
HRD-positive Ovarian Cancer	Phase 3	Israel	Merck Sharp & Dohme LLC	16 Feb 2026
HRD-positive Ovarian Cancer	Phase 3	Taiwan Province	Merck Sharp & Dohme LLC	16 Feb 2026
Mismatch repair-deficient Endometrial Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	22 Aug 2025
Mismatch repair-deficient Endometrial Carcinoma	Phase 3	China	Merck Sharp & Dohme LLC	22 Aug 2025
Mismatch repair-deficient Endometrial Carcinoma	Phase 3	Japan	Merck Sharp & Dohme LLC	22 Aug 2025
Mismatch repair-deficient Endometrial Carcinoma	Phase 3	Argentina	Merck Sharp & Dohme LLC	22 Aug 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06952504 (GOG-3119, ESGO2026)	Phase 3	Endometrial Carcinoma First line \| Maintenance pMMR	529	Sacituzumab tirumotecan + Pembrolizumab	gxshkqdhpq(imeyehxkaf) = tdsuainxrx fbmbmktpem (fgbkjdnmnp ) View more	Positive	28 Feb 2026
				Pembrolizumab	pzecfbaybn(psjeyhjglu) = uwaslfysnu gcritculzh (xstigwqiwi ) 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	zyiaeylbye(kgvdunpjai) = 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. lxzzvruifn (kjovaucijf ) 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	kdxzsrrxch(zlxzugrcjd) = onvjkfxtrf tvuggrucce (sqwjqxazpa, 18 - 45) View more	Positive	20 Nov 2025
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)	otjvkirife(tjraepipin) = nheoxvpwam nubpgwftpq (gnqbgakjqd ) View more	Positive	19 Oct 2025
				Pemetrexed + platinum-based chemotherapy	otjvkirife(tjraepipin) = kpuvmvccuy nubpgwftpq (gnqbgakjqd ) 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	arajhaydij(jyjjbkpinv) = jzoyxxnzsz dbsrlfccnn (vgnuontbcp ) View more	Positive	17 Oct 2025
				Investigator's choice of chemotherapy (ICC)	arajhaydij(jyjjbkpinv) = bhvwqrjwng dbsrlfccnn (vgnuontbcp ) View more
NCT05642780 (MK-2870-002, ESMO2025)	Phase 2	Metastatic castration-resistant prostate cancer	46	Sacituzumab Tirumotecan (sac-TMT) 4 mg/kg + Pembrolizumab (Pembro)	dqoqqehnse(gdpddcftyr) = liipfxourk bsllwcwwux (hptlxpecpp, 12.2–73.8) View more	Positive	17 Oct 2025
				Sacituzumab Tirumotecan (sac-TMT) 5 mg/kg + Pembrolizumab (Pembro)	dqoqqehnse(gdpddcftyr) = fhgpdhfhpi bsllwcwwux (hptlxpecpp, 20.8–53.8) View more
NCT04152499 (ESMO2025)	Phase 2	Advanced Endometrial Carcinoma	128	Sacituzumab tirumotecan 4 mg/kg	zjqjjiihnk(hcfpaxrtbo) = iqnxtigawl xokpezfbcs (sbpqbpbrpg ) View more	Positive	17 Oct 2025
				Sacituzumab tirumotecan 5 mg/kg	zjqjjiihnk(hcfpaxrtbo) = yzrobesuit xokpezfbcs (sbpqbpbrpg ) View more
NCT04152499 (ESMO2025)	Phase 1/2	Advanced Cervical Carcinoma TROP2 expression	58	Sacituzumab tirumotecan (Sac-TMT) 4 mg/kg	ofqhojrprv(dpinrauijb) = pbshxehjea bfdvfzcqxd (gqskffpeqr, 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)	parxbcurss(wfahfijyiw) = gfbgbulytt xdknfbewoi (kkthlwgrpk ) View more	Positive	17 Oct 2025
				Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) (PD-L1 TPS ≥50%)	parxbcurss(wfahfijyiw) = uccgvvyruw xdknfbewoi (kkthlwgrpk ) View more
NCT05351788 (OptiTROP-Lung01, Nat Med) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	103	sacituzumab tirumotecan+tagitanlimab (Cohort 1A)	puffoxcane(qqofnledbd) = tskivkjjuo uzdgdzndtg (hekrczunma ) View more	Positive	19 Aug 2025
				sacituzumab tirumotecan+tagitanlimab (Cohort 1B)	puffoxcane(qqofnledbd) = cygvxdyqie uzdgdzndtg (hekrczunma ) View more

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