RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Conditional marketing approval (China)

Structure/Sequence

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Sequence Code 27958L

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Sequence Code 319372635H

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125

Clinical Trials associated with Sacituzumab govitecan-hziy

NCT07134556

/ Not yet recruitingPhase 2

A Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as First-line Therapy for PD-L1 Positive Advanced Triple-negative Breast Cancer

The ADJUNCT is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer.

Start Date08 Dec 2025

Sponsor / Collaborator

Medica Scientia Innovation Research SL

NCT07011654

/ Not yet recruitingPhase 1/2IIT

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

This phase I/II trial tests the safety, best dose, and effectiveness of naxitamab in combination with sacituzumab govitecan in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic).

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06524544

/ Not yet recruitingPhase 3IIT

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan vs Sacituzumab Govitecan Alone in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan to sacituzumab govitecan alone in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan to kill them. Giving pembrolizumab and sacituzumab govitecan may be more effective than sacituzumab govitecan alone in treating patients with locally advanced or metastatic urothelial cancer.

Start Date01 Nov 2025

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Sacituzumab govitecan-hziy

100 Translational Medicine associated with Sacituzumab govitecan-hziy

100 Patents (Medical) associated with Sacituzumab govitecan-hziy

2,317

Literatures (Medical) associated with Sacituzumab govitecan-hziy

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

01 Oct 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

PBPK-PD model for predicting pharmacokinetics, tumor growth inhibition, and toxicity risks of topoisomerase inhibitor ADCs in mice and humans

Article

Author: Wang, Zehua ; Tang, Linxiu ; Tan, Yongmei ; Zhang, Sasa ; Sang, Lan ; Zhao, Yanlin ; Hao, Kun ; Zhu, Jinwei

BACKGROUND:

Antibody-drug conjugates (ADCs) are composed of monoclonal antibodies conjugated to potent cytotoxic payloads via linkers for cancer treatment. However, the ADCs are also associated with the risk of drug-induced interstitial lung disease (ILD), primarily due to off-target payload distribution.

OBJECTIVES AND METHODS:

This study aimed to develop a whole-body physiologically based pharmacokinetic and pharmacodynamic (PBPK-PD) model to simultaneously predict the pharmacokinetics, therapeutic efficacy and associated risks of ILD using trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) as model drugs. The model was initially validated in corresponding tumor-bearing mice and subsequently scaled up to breast cancer patients. Plasma concentrations of ADCs and their released payloads as well as progression-free survival (PFS) following treatment with the ADCs were simulated in patients using the developed PBPK-PD model.

RESULTS:

The results showed that most of the observed plasma concentrations of ADCs and their payloads fell within the 5th-95th percentiles derived from simulations of 1000 virtual patients, with the predicted AUC_0-t and C_max were all within 0.5-fold to 2-fold of the observations. The predicted PFS values were also consistent with clinical observations. Data from Sobol' global sensitivity analysis showed that tumor surface antigen expression levels and the internalization rate of the antigen-ADC complex are the primary factors influencing ADCs distribution. A relationship between payload concentration in lungs and the risk of ILD was also documented, showing that the risk increased with advancing patient age and elevated dosage.

CONCLUSIONS:

All these results give a conclusion that the developed PBPK-PD model may be applied to predict the pharmacokinetics and therapeutical efficacy of T-DXd and SG as well as risk of ILD.

01 Sep 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Antibody-drug conjugates in gynecologic cancer: current landscape, clinical data, and emerging targets

Review

Author: Wang, Ying ; Jia, Li ; Chen, Mi ; He, Jinhui

Antibody-drug conjugates (ADCs) are an emerging class of targeted therapies that combine monoclonal antibodies with potent cytotoxic payloads, demonstrating significant potential in the treatment of gynecologic malignancies. By selectively targeting tumor-associated antigens, ADCs enable precise drug delivery while minimizing off-target toxicity. Currently, mirvetuximab soravtansine and tisotumab vedotin have been approved by the Food and Drug Administration for the treatment of folate receptor-alpha-positive, platinum-resistant ovarian cancer and recurrent cervical cancer, respectively, exhibiting promising objective response rates and manageable toxicity profiles in pivotal clinical trials. However, ADC therapy faces challenges, including ocular toxicity, pulmonary toxicity, peripheral neuropathy, tumor antigen heterogeneity, and acquired resistance. Additionally, multiple investigational ADCs, such as upifitamab rilsodotin (targeting NaPi2b), trastuzumab deruxtecan (targeting HER2), and sacituzumab govitecan (targeting trophoblast cell surface antigen 2), have demonstrated preliminary efficacy in ongoing clinical trials, offering new therapeutic opportunities for gynecologic malignancies. This review comprehensively summarizes the current clinical applications and research progress of ADCs in gynecologic cancers, including key clinical trials, therapeutic efficacy, safety profiles, and associated challenges. Furthermore, we discuss future optimization strategies, including the identification of novel targets, rational combination therapies, and molecular design improvements to advance ADC-based precision treatment in gynecologic oncology.

446

News (Medical) associated with Sacituzumab govitecan-hziy

09 Sep 2025

·endpoints.news

Ideaya touts trio of cancer drugs as it eyes spot in precision oncology market

Ideaya Biosciences reiterated its goal of becoming a “global leader” in precision oncology over the next decade as it shared data from three early- to mid-stage cancer trials. Since its inception a decade ago, the California biotech has focused on pursuing new targets, narrowing down patient biomarkers and exploring “transformative” combinations in cancer, Ideaya CEO Yujiro Hata said Monday on its R&D day call. He believes the company has developed “one of the broadest and deepest pipelines” within precision oncology. Ideaya kicked off its 10-year anniversary, detailing results from a Phase 2 study of darovasertib in patients who’ve had surgery for primary uveal melanoma, a form of rare eye cancer. The drug is designed to selectively inhibit protein kinase C. Just over 20 patients received a year of neoadjuvant treatment with darovasertib before switching to a type of radiation therapy called plaque brachytherapy. The trial assessed how well darovasertib shrank tumors, preserved eyesight and reduced the need for high-dose radiation. About 76% of patients saw their tumors shrink by at least 20% and almost half of them reduced their dose of stimulated radiation to key parts of the eye by at least 20%. Thirteen patients reported improvements in their vision during the neoadjuvant treatment period, gaining an average of six letters in a visual acuity test. The data derisk the plaque brachytherapy cohort of an ongoing Phase 3 trial, according to TD Cowen analysts. Four patients reported grade 3 or higher side effects. Ideaya recently started the Phase 3 trial of darovasertib, called OptimUM-10. The study aims to reduce the loss of three lines of vision (or 15 letters) in the treatment arm versus control in at least 20% of patients, chief medical officer Darrin Beaupre said on the call. The company’s share price closed down 13% on Monday. Jefferies analysts said this was likely due to “profit-taking” rather than some particular element of the data. Ideaya also shared first-in-human data for a DLL3-targeting ADC that it licensed from Hengrui Pharma late last year for $75 million upfront and up to $1.04 billion in milestones. The Phase 1 study was conducted in China. It tested IDE849, administered every three weeks, in patients with DLL3 upregulated solid tumors. Ideaya highlighted results from 87 of those patients with small cell lung cancer (SCLC), all of whom saw their disease progress after first-line treatment. The results were presented on Sunday at the World Conference on Lung Cancer in Barcelona. Around 58% of the 19 patients given a 2.4 mg/kg dose of IDE849 had a confirmed response, with three more responses pending confirmation at the data cutoff. The response rate was lower — at about 48% — when looking across all cohorts of 2.4 mg/kg and higher. Ten patients in the broader group are still pending confirmation. Ideaya could struggle to differentiate IDE849 in an “increasingly crowded ADC competitive landscape,” Leerink analysts said Tuesday. There are several similar candidates in the clinic for SCLC, including Zai Lab’s DLL3-targeting ADC called ZL-1310. That said, the difference in response rates for ZL-1310 and IDE849 in the second-line setting in particular is narrow, according to the analysts. Ideaya’s drug also had higher rates of some grade 3 or more serious side effects compared with ZL-1310, including white blood cell decrease (27%) and neutrophil count decrease (33%). The company recently initiated a global trial of IDE849 with the first patient to be dosed “very soon.” Last but not least, Ideaya presented data from a Phase 1/2 trial of its MAT2A inhibitor called IDE397 in combination with Gilead’s Trodelvy in urothelial cancer patients with MTAP deletions. There are currently no FDA-approved treatments for solid tumors with this particular type of genetic alteration. The study evaluated two treatment regimens in 19 patients. The regimens consisted of 15 mg of IDE397 plus 10 mg/kg of Trodelvy and 30 mg of IDE397 plus 7.5 mg/kg of Trodelvy, respectively. The low-dose IDE397 regimen achieved a 33% response rate and 100% disease control rate. Meanwhile, the high-dose IDE397 regimen attained a 57% response rate, including one unconfirmed partial response. The DCR for this cohort came in at 71%. Ideaya expects to select a regimen for further development by the end of the year, according to remarks made on the call by Jasgit Sachdev, head of oncology clinical development. The company is aiming for a confirmed response rate of at least 40% and durability of more than six months, she added.

Clinical ResultPhase 2Phase 3Radiation TherapyPhase 1

08 Sep 2025

·www.prnewswire.com

Breakthrough Therapy Designations Surge as $50B Cancer Drug Partnerships Reshape Market

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 8, 2025 /PRNewswire/ -- USA News Group News Commentary – The FDA's unprecedented wave of Breakthrough Therapy Designations through August has accelerated development timelines for life-saving cancer treatments[1], while major pharmaceutical companies deployed several multi-billion-dollar strategic partnerhips (with one topping $11 billion) to secure next-generation immunotherapies[2]. These recent designations are creating momentum for companies advancing breakthrough oncology platforms including Oncolytics Biotech Inc. (NASDAQ: ONCY), HUTCHMED (China) Limited (NASDAQ: HCM), CG Oncology, Inc. (NASDAQ: CGON), C4 Therapeutics, Inc. (NASDAQ: CCCC), and IDEAYA Biosciences, Inc. (NASDAQ: IDYA). Industry analysts expect the antibody-drug conjugate market to reach $50 billion by 2030[3], driven by 16 approved therapies and accelerating clinical pipelines. Immuno-oncology revenues jumped from $94 billion to $109.39 billion in 2025 alone[4], as leading institutions recognize the transformative potential of precision-targeted therapies and combination treatment approaches for previously untreatable cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space." The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: HUTCHMED (China) Limited (NASDAQ: HCM) highlighted clinical data from multiple oncology studies at the 2025 World Conference on Lung Cancer and CSCO Annual Meeting, showcasing updated analysis from savolitinib's SACHI, SAVANNAH and Phase IIIb confirmatory studies in non-small cell lung cancer patients. The company will present first-time clinical data of HMPL-653, a novel CSF-1R inhibitor, from a Phase I study in patients with tenosynovial giant cell tumor. Savolitinib, an oral and highly selective MET tyrosine kinase inhibitor being jointly developed with AstraZeneca, continues advancing through multiple clinical programs targeting various lung cancer indications. According to Hutchmed's announcement, updated analysis from savolitinib's SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer patients will be presented at WCLC 2025. The comprehensive clinical program spans investigator-initiated studies of fruquintinib and surufatinib across multiple cancer types, with HUTCHMED positioning itself as an innovative commercial-stage biopharmaceutical company committed to bringing targeted therapies from in-house discovery to patients worldwide. The company has successfully marketed its first three medicines in China, with its lead compound also approved globally, including in the US, Europe and Japan. CG Oncology, Inc. (NASDAQ: CGON) continues to demonstrate best-in-disease durability with its cretostimogene immunotherapy, reporting an additional 12 patients achieving complete response at 24 months in the BOND-003 Cohort C study. The robust 24-month complete response rate of 41.8% observed in 46 out of 110 patients with high-risk non-muscle invasive bladder cancer unresponsive to BCG treatment represents unprecedented durability in this heavily pretreated patient population. Notably, 90% of 12-month responders remained disease-free at 24 months, while 96.6% of patients were free from progression to muscle-invasive disease at 24 months. "Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG," said Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center. "In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results." The company is preparing to initiate its BLA submission for cretostimogene in the fourth quarter of 2025, with the Phase 3 BOND-003 Cohort C representing the largest study in this patient population to date. Cretostimogene's safety profile remains consistent with no Grade 3 or greater treatment-related adverse events or deaths reported, supporting its potential as a breakthrough backbone treatment for bladder cancer patients. C4 Therapeutics, Inc. (NASDAQ: CCCC) completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in multiple myeloma, with the investigational MonoDAC degrader continuing to demonstrate a well-tolerated safety profile and compelling response rates. The company will present comprehensive data from all safety and efficacy evaluable multiple myeloma patients across all dose levels studied in the cemsidomide with dexamethasone cohort at the International Myeloma Society Annual Meeting on September 20, 2025. Cemsidomide is designed as a more potent and selective degrader of IKZF1/3 transcription factors that drive multiple myeloma and non-Hodgkin's lymphomas, with unique pharmacokinetic properties and demonstrated anti-myeloma activity and immunomodulatory effects. C4 Therapeutics will host an investor webcast on September 20, 2025, at 3 PM ET to highlight the data presentation and provide additional detail on the planned next steps of clinical development. The company is progressing its TORPEDO platform to efficiently design and optimize small-molecule degrader medicines targeting difficult-to-treat diseases, with cemsidomide representing a key advancement in harnessing the body's natural protein recycling system. IDEAYA Biosciences, Inc. (NASDAQ: IDYA) enrolled their first patient with non-small cell lung cancer in the ongoing Phase 1/2 combination trial of IDE397 and Trodelvy® in patients with MTAP-deletion solid tumors, expanding beyond the initial focus on MTAP-deletion urothelial cancer. IDE397, a potential first-in-class small molecule MAT2a inhibitor, is being combined with Gilead's Trop2-directed antibody-drug conjugate Trodelvy under a clinical study collaboration and supply agreement. MTAP-deletion is found in up to 20% of non-small cell lung cancer cases and represents an area with no approved targeted therapies, creating a significant opportunity for this novel therapeutic approach. "We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion." IDEAYA retains commercial rights to IDE397 while Gilead provides Trodelvy supply, with the precision medicine oncology company building a deep pipeline focused on synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications. The expansion into NSCLC represents a significant milestone in the company's mission to develop tailored, potentially first-in-class targeted therapies aligned to genetic drivers of disease. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 1Phase 3Fast Track

08 Sep 2025

·www.prnewswire.com

IDEAYA Biosciences Announces Positive Data From Phase 1/2 Combination Trial of IDE397, a potential first-in-class MAT2A inhibitor, and Trodelvy® in MTAP-Deletion Urothelial Cancer

Overall response rate (ORR) of 57% (4/7; 3cPR+1uPR) in patients treated with a combination of 30 mg IDE397 plus 7.5mg/kg Trodelvy ® (Dose level 2); ORR of 33% (3/9; 3cPR) at 15 mg IDE397 plus 10mg/kg Trodelvy ® (Dose level 1) Manageable safety profile at both expansion doses, consistent with known adverse events observed with each agent alone, with no treatment related serious adverse events observed at the IDE397 30mg and Trodelvy® 7.5 mg/kg expansion dose Selection of recommended Phase 2 dose is targeted by end of 2025, with next update planned for a medical conference in H1 2026 SOUTH SAN FRANCISCO, Calif., Sept. 8, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, will present initial data at their 10-Year Anniversary R&D Day from two expansion cohorts in their Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2A) inhibitor, in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with late-line methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC). MTAP-deletion is estimated to occur in approximately 25-30% of UC and 15-20% of non-small cell lung cancer (NSCLC) patients. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) for patients with MTAP-deletion solid tumors. Data in the presentation were as of a cut-off date of August 29, 2025, and included a total of 19 patients with late-line MTAP-deletion UC who received the combination of IDE397 and Trodelvy. Of the 19 patients, 16 (Cohort 1: n=9; Cohort 2: n=7) were evaluable for efficacy having received at least one post-baseline tumor assessment per RECIST v1.1. Of the patients evaluated in the combination trial, 68% (13/19) had progressed after two or more prior therapies, with 84% (16/19) having received an immune-oncology therapy and 32% (6/19) having received enfortumab vedotin (EV). "We are pleased with the progress we are making with the Trodelvy and IDE397 combination and are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer. These results set the stage for further testing of the combination in non-small cell lung cancer, where we have just dosed the first patient in our clinical trial," said Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences. Summary of key findings To date, median progression free survival (PFS) and duration of response (DOR) has not been reached. 33% ORR at DL1 (3/9); 3 confirmed partial responses (cPR), including one patient with a confirmed response after the cut-off date, and 57% ORR at DL2 (3 cPR and 1 unconfirmed partial response (uPR)). The preliminary combination data is trending favorably versus historical Trodelvy monotherapy efficacy reported in metastatic UC, including 11% ORR in patients post-EV therapy (Sternschuss et al., 2025) and 23% ORR in predominantly EV-naïve patients (Powles et al., 2025). Manageable safety profile consistent with known adverse events of both drugs as single agents, with no treatment related serious adverse events observed at the IDE397 30mg and Trodelvy® 7.5 mg/kg expansion dose. The most common Grade 3 or greater treatment-related adverse events seen in DL1 were anemia and neutropenia, and in DL2 were anemia, asthenia, and diarrhea. Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA. Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. The use of Trodelvy in MTAP-deletion UC and NSCLC is investigational, and the safety and efficacy of this use have not been established. IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established. Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies. IDEAYA will review this data at their 10-Year Anniversary R&D Day on September 8th in New York. A link to the webcast is available on the Investor Relations page of the IDEAYA corporate website: . About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of IDE397 and Trodelvy combination; (ii) the timing and content of data at the IDEAYA 10 -Year Anniversary R&D Day and an update at a later medical conference; and (iii) the timing of the selection of go-forward combination dose of IDE397/ Trodelvy®. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultADCDrug ApprovalImmunotherapy

100 Deals associated with Sacituzumab govitecan-hziy

External Link

KEGG	Wiki	ATC	Drug Bank
-	Sacituzumab govitecan-hziy	L01	DB12893

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic Triple-Negative Breast Carcinoma	European Union	Gilead Sciences Ireland UC	22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma	Iceland	Gilead Sciences Ireland UC	22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma	Liechtenstein	Gilead Sciences Ireland UC	22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma	Norway	Gilead Sciences Ireland UC	22 Nov 2021
Breast Cancer	Switzerland	Gilead Sciences, Inc.	09 Sep 2021
Hormone receptor positive HER2 negative breast cancer	Australia	Gilead Sciences Pty Ltd.	06 Sep 2021
Transitional Cell Carcinoma	United States	Gilead Sciences, Inc.	13 Apr 2021
Triple Negative Breast Cancer	United States	Gilead Sciences, Inc.	22 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	NDA/BLA	China	Genting Pharmaceutical (Suzhou Co Ltd.	17 May 2021
Extensive stage Small Cell Lung Cancer	Phase 3	United States	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Japan	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Argentina	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Australia	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Canada	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	France	Gilead Sciences, Inc.	04 Apr 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Germany	Gilead Sciences, Inc.	04 Apr 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04639986 (EVER-132-002, ESMO_TAT Asia2025) Manual	Phase 3	Metastatic breast cancer HR Positive \| HER2 Negative	232	Sacituzumab govitecan (SG)	argfzjliqw(bkgyuzfsar) = wlmtlpgviy xfhmbzqsfz (nnghonzmgt, 4.2 - 6.7) View more	Positive	01 Aug 2025
				Treatment of physician’s choice (TPC)	argfzjliqw(bkgyuzfsar) = zknmapemby xfhmbzqsfz (nnghonzmgt, 2.8 - 4.2) View more
NCT05327530 (JAVELIN Bladder Medley, ASCO2025) Manual	Phase 2	Advanced Urothelial Carcinoma First line \| Maintenance	-	Avelumab + Sacituzumab Govitecan	cypztzlaqq(pqhnnctagr) = rjhmokgfef nvierdaoxn (qiysxexhmp, 7.43 - NE) View more	Positive	30 May 2025
				Avelumab	cypztzlaqq(pqhnnctagr) = rtldbppzlc nvierdaoxn (qiysxexhmp, 3.32 - 6.77) View more
NCT05382286 (ASCENT-04/KEYNOTE-D19, ASCO2025 \| NEWS) Manual	Phase 3	PD-L1 positive Triple Negative Breast Cancer First line PD-L1 Positive	443	Sacituzumab govitecan + pembrolizumab	wvtfoewtzs(hfcvvwhymi) = vdywbydxpj erqhclvpad (vtkagacoqh, 9.3 - 16.7) View more	Positive	30 May 2025
				chemotherapy + pembrolizumab	wvtfoewtzs(hfcvvwhymi) = qgrxmqakye erqhclvpad (vtkagacoqh, 7.3 - 9.3) View more
NCT04230109 (NeoSTAR, ASCO2025) Manual	Phase 2	Triple Negative Breast Cancer Neoadjuvant PR Negative \| HER2 Negative \| ER Negative	50	Sacituzumab govitecan + Pembrolizumab	quhdftulnn(iimlopsntl) = atorpkzgwb gqquaansly (oatnwuerjx, 19.5 - 46.7) View more	Positive	30 May 2025
				Sacituzumab govitecan + Pembrolizumab + additional neoadjuvant chemotherapy	quhdftulnn(iimlopsntl) = faqoqpoger gqquaansly (oatnwuerjx, 35.5 - 64.5)
NCT05535218 (SURE-02, ASCO2025) Manual	Phase 2	Muscle Invasive Bladder Carcinoma Neoadjuvant	31	Neoadjuvant Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro)	gjnadkyyzy(hmejlgiuco) = gfnztwstyd faedbnytuv (xylivihykf, 21.8 - 57.8) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Triple Negative Breast Cancer	83	sacituzumab govitecan (Underweight)	lgmwtylsjh(wfvihxrbsi) = The most common grade ≥2 AE was neutropenia (63.9%), with no BMI or weight change association xpigwftmdn (wlqbjughir )	Negative	30 May 2025
				sacituzumab govitecan (Normal weight)
TRACIE (ASCO2025)	Not Applicable	Advanced Triple-Negative Breast Carcinoma Second line BRCA1/2 pathogenic variant \| hormone receptor negative \| HER2 negative ... View more	150	Sacituzumab govitecan (SG)	ggshwwmloh(nhjpimihwl) = wpdcvugqtm irynoculxy (obitgnfgel, 9.5 - 17.5) View more	Positive	30 May 2025
Real world evidence for patients with advanced and metastatic pancreatic cancer treated with sacituzumab govitecan (ASCO2025)	Not Applicable	Metastatic Pancreatic Cancer Trop - 2	19	Sacituzumab govitecan (SG) monotherapy	nxhugyaedk(izznfzfpuk) = Grade 3 or higher adverse reactions were noted in 4 out of 19 patients, all of which were neutrophil decreases xttpbztsdx (zclmvtbxdr ) View more	Positive	30 May 2025
				Combined treatment with SG
ASCO2025	Not Applicable	Metastatic HER2-Negative Breast Carcinoma Trop-2	-	Sacituzumab govitecan	matstzxnvt(cexvnwvcar) = 22.4% of patients experienced diarrhea, with a grade ≥3 rate of 6.9% hkukrmlbty (gajllunfvj ) View more	Positive	30 May 2025
				PD-1 inhibitors + Sacituzumab govitecan
NCT06040970 (Basket Trial, ASCO2025)	Phase 1	Ovarian Cancer \| Endometrial Carcinoma Trop-2	-	Sacituzumab govitecan + Cisplatin	yjqikwygwn(ydhtrkuvhj) = zrhistqbmb lzarmorwwr (wfoxhayxgj, 6.4 - 47.6) View more	Positive	30 May 2025

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