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

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Sequence Code 27958L

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Sequence Code 319372635H

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130

Clinical Trials associated with Sacituzumab govitecan-hziy

NCT07339059

/ Not yet recruitingPhase 2IIT

Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination.
The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors.
Participants in the trial will:
* receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient.
* CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks.
* provide tissue (optional) and blood for additional testing (learn about the cancer).

Start Date01 Feb 2026

Sponsor / Collaborator

Henry Ford Health System

[+1]

NCT07178730

/ Not yet recruitingPhase 3IIT

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0/is ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio [HR] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% [REFs], whereas the addition of platinum increases pCR rates to approximately 50-55%.
The KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.
Despite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:
1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?
2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO/PAC + PEM.

Start Date31 Jan 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

CTIS2025-521489-80-00

/ 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 Study)

Start Date31 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Sacituzumab govitecan-hziy

100 Translational Medicine associated with Sacituzumab govitecan-hziy

100 Patents (Medical) associated with Sacituzumab govitecan-hziy

2,242

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 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Sacituzumab Govitecan initial dose reduction in polish patients with metastatic triple-negative breast cancer: impact on efficacy and safety

Article

Author: Łacko, Aleksandra ; Pieniążek, Małgorzata ; Las-Jankowska, Manuela ; Kubeczko, Marcin ; Polakiewicz-Gilowska, Anna ; Bielčiková, Zuzana ; Jarząb, Michał ; Püsküllüoğlu, Miroslawa ; Pacholczak-Madej, Renata

Abstract:

Background:

Sacituzumab govitecan (SG) is approved for metastatic triple-negative breast cancer in ≥ 2 line setting at 10 mg/kg IV on Days 1 and 8 (21-day cycle). Trials confirmed its superiority over 8 mg/kg with manageable safety. In practice, precautionary dose reductions are used despite no formal guidance. In Poland, fixed 200 mg vials and unreimbursed drug waste lead to early dose adjustments.

Methods:

This retrospective study evaluated the impact of initial SG dose reduction on treatment outcomes and tolerability in Polish patients. Medical records provided data on baseline features, treatment, survival, and safety. Kaplan-Meier and chi-square tests were used for survival and group comparisons. A multivariate Cox model assessed the independent effect of dose reduction on overall survival (OS) and progression-free survival (PFS). Significance was set at p < 0.05.

Results:

Among 83 patients (median age 55, range 30–86), initial dose reductions ≥ 10% were observed in 16 patients (19.3%), including 9 (10.8%) with dose reduced ≥ 20%. Administrative adjustments (reductions > 10% to flat doses of 200 mg multiplications) accounted for 18.1% of the entire cohort. Grade ≥ 2 and ≥ 3 adverse events occurred in 83.1% and 56.6%, respectively. In a multivariate analysis, a ≥ 20% initial dose reduction remained an independent predictor of shorter PFS (HR: 2.6; 95% CI: 1.1–6.6; p = 0.04) and OS (HR: 6; 95% CI: 2–17.5; p = 0.001). Initial dose reduction did not affect toxicity.

Conclusions:

In this preliminary report initial dose reduction of SG negatively impacted PFS and OS without reducing toxicity, highlighting the need for further studies and dosing policy adjustments.

01 Dec 2025·BREAST CANCER RESEARCH AND TREATMENT

Baseline hemoglobin and neutrophil-to-lymphocyte ratio as prognostic biomarkers in patients with metastatic triple negative breast cancer treated with sacituzumab govitecan in second line and beyond: a real-world analysis

Article

Author: Łacko, Aleksandra ; Püsküllüoğlu, Mirosława ; Pieniążek, Małgorzata ; Polakiewicz-Gilowska, Anna ; Las-Jankowska, Manuela ; Wronowicz, Jakub ; Jarząb, Michał

Abstract:

Purpose:

This study aimed to evaluate the prognostic significance of baseline laboratory parameters and inflammatory indices in patients with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) in the second line and beyond, potentially aiding personalized patient management.

Methods:

This retrospective cohort study analyzed data from 83 female patients with mTNBC who initiated SG therapy at four Polish oncology centers between August 2021 and September 2024. Hematological parameters—white blood cell count (WBC), hemoglobin (Hb), platelets (Plt) and inflammatory indices—neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) were assessed at baseline and before each dose of first four SG cycles. Median progression-free survival (mPFS) and overall survival (mOS) were estimated, and, as the primary objectives, associations between baseline laboratory variables and survival outcomes were assessed using multivariate Cox regression models ( α = 0.05). Secondary objectives included assessing their associations with patient and disease characteristics, prior treatment lines, and adverse events (AEs), which were classified using the National Cancer Institute Common Terminology Criteria for AEs (NCI‐CTCAE), version 5.0.

Results:

The mPFS was 4.07 months (95% CI 3.05–6.18), while the mOS was 8.01 months (95% CI 6.05–9.75). Lower baseline Hb was significantly associated with shorter PFS (HR = 0.82, p = 0.03) but not OS. Elevated baseline NLR predicted worse OS (HR = 1.18, p = 0.03), while PLR and SII lacked prognostic significance. Changes in blood parameters within initial four SG cycles showed no significant correlations with survival outcomes. Furthermore, baseline hematological markers and inflammatory indices showed no significant association with clinical characteristics, prior therapy lines, tumor burden, or the occurrence and severity of AEs.

Conclusions:

Baseline Hb and NLR were identified as independent prognostic biomarkers in patients with mTNBC receiving SG treatment, predicting PFS and OS, respectively. Other inflammatory indices (PLR, SII) did not demonstrate prognostic relevance. Prospective validation in larger cohorts is essential to confirm these findings and potentially guide personalized treatment strategies.

487

News (Medical) associated with Sacituzumab govitecan-hziy

14 Jan 2026

·www.fiercebiotech.com

JPM26: As lenacapavir momentum builds, Gilead eyes new deals from a \'position of strength\'

While Gilead Sciences\' focus on cancer and inflammation is fueled by external innovation, the pharma is looking inward to build on its long history in virology. \n Still riding the high of last year’s twice-yearly HIV PrEP approval of lenacapavir as Yeztugo, Gilead Sciences is approaching dealmaking from a “position of strength” as a more mature biopharma, according to CEO Daniel O’Day.“When you\'re a company that\'s cured a disease and showed curative potential in another disease and are on the verge of ending an epidemic, you\'re kind of bold about your aspirations,” said O\'Day, referring to the company’s hepatitis C and HIV medicines.Since O’Day joined Gilead from Roche in 2018, the California company has built three primary focus areas: virology, cancer and inflammation. In all three, Gilead’s recent successes have given the pharma the luxury of being selective in the external assets it considers, O’Day explained.“We hold the bar very high scientifically,” the CEO told journalists at a media event on the sidelines of the 2026 J.P. Morgan Healthcare Conference in San Francisco. “We have the financial ability to bring in important medicines in the organization, but they’ve got to fit our strategy, and they have to really have a significant patient impact.” Oncology was O’Day’s bread and butter at Roche, and a major part of his hiring at Gilead was an effort to boost cancer drug sales. One of his first big moves was a $21 billion buyout of Immunomedics, which gave Gilead the anti-TROP agent Trodelvy. The pharma is now looking ahead to a potential launch of Trodelvy in first-line metastatic breast cancer—though the blockbuster drug recently failed to improve progression-free survival in a phase 3 trial—and an upcoming phase 2 readout of the drug in non-small cell lung cancer.When it comes to isolating innovative new cancer candidates, Chief Medical Officer Dietmar Berger, M.D., Ph.D.—who joined a year ago—has his eyes on more precise approaches.“Gilead has classically been focusing a lot on immuno-oncology,” Berger said at the same JPM event. The CMO said he wants to “drive that a little more into direct tumor cell targeting,” while taking advantage of Gilead’s antibody-drug conjugate platform and relationship with cell therapy subsidiary Kite Pharma. Kite is poised to debut anito-cel, a CAR-T challenger to Johnson & Johnson’s Carvykti, in multiple myeloma this year.Cell therapy also comes into play in inflammation, Berger said, which is a more nascent area for Gilead. But the pharma’s growing collection of candidates hits “key nodes” of inflammation, he added, like a STAT6 degrader through a $1.7 billion deal with Leo Pharma unveiled at last year’s JPM.“That takes us into type 2 inflammation and is really an important addition to the portfolio,” he said, referring to the kind of inflammation underlying conditions like asthma and atopic dermatitis.While Gilead’s focus on both cancer and inflammation is fueled more by external innovation, the pharma is looking inward to build on its long history in virology. Gilead hopes to diversify the viruses it can treat, with the pharma’s efforts long centered on HIV and hepatitis. Berger pointed to December’s decision to opt in to two genital herpes candidates from Assembly Biosciences to the tune of $35 million as an example of Gilead’s efforts to expand in virology. Gilead originally paid $100 million for the option to license Assembly’s assets in October 2023.Related areas of interest include respiratory viruses and emerging viruses that could cause future pandemics, Berger told Fierce at the event.

AcquisitionPhase 3

11 Jan 2026

·www.prnewswire.com

IDEAYA Biosciences Provides a Business Update and Outlines 2026 Corporate Objectives at the 44th Annual J.P. Morgan Healthcare Conference

SOUTH SAN FRANCISCO, Calif., Jan. 11, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, provided a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST. "2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma - one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences. 2026 Corporate Objectives Darovasertib in uveal melanoma (UM) Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 '26 Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26 OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27 OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 '26 Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 '26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026 IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 '26 IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26 MTAP Pathway IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026 IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 '26 Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA's dual KAT6/7 inhibitor Next Generation Therapies IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 '26 Corporate ~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030 Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier IDEAYA's updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: . 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 IDEAYA therapeutics; (ii) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts, including those at medical conferences; (iii) the potential and timing for an accelerated approval filing for darovasertib; (iv) the timing of darovasertib in three Phase 3 registrational trials across all stages of UM; (v) the utilization of OS data to support a potential full approval filing for darovasertib; (vi) the timing of initiating registrational studies and other clinical trials for IDEAYA therapeutics; (vii) the timing of patient enrollments in clinical trials; (viii) the timing of IND submissions for IDEAYA therapeutics; and (iv) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its current operating plan. 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 current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo

Phase 1Phase 3Clinical ResultINDADC

12 Dec 2025

·www.prnewswire.com

Marengo to Present Initial Results from Invikafusp Alfa and TRODELVY® Combination Study, STARt-002, at the 2025 San Antonio Breast Cancer Symposium

Safety profile of Invikafusp alfa + TRODELVY ® is consistent with the known profiles of each agent Invikafusp alfa demonstrates selective expansion of Vβ6/10 T cells when combined with TRODELVY ® in previously treated metastatic breast cancer Early anti-tumor activity observed in majority of patients, recommended dose selected for phase 2 expansion cohorts currently enrolling at select North American cancer centers CAMBRIDGE, Mass., Dec. 12, 2025 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy for oncology and inflammation & immunology (I&I), today unveiled initial clinical results from its ongoing STARt-002 phase 1b/2 trial during a late breaking presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place December 9-12. Early findings from the combination study of Invikafusp alfa (Invika) and TRODELVY® (sacituzumab govitecan-hziy; SG) suggest that this novel regimen, which leverages two key modalities (immunotherapy and ADCs), is well tolerated and biologically active across all dose levels evaluated. The safety profile of the combination was consistent with the known profiles of each agent. "The early safety and pharmacodynamic data from STARt-002 are highly encouraging," said Steven Isakoff, M.D., Ph.D., Director of Breast Cancer Clinical Research at the Massachusetts General Hospital Cancer Center. "The combination of Invika with TRODELVY® is scientifically compelling — pairing targeted T cell activation with ADC-mediated tumor killing. Seeing consistent Vβ6/10 expansion alongside early tumor responses reinforces the potential of this regimen to meaningfully benefit patients with metastatic breast cancer, and I look forward to the results from the ongoing phase 2 cohorts." Pharmacodynamic analyses confirmed that Invika maintains its mechanism of action in combination with Trodelvy, inducing robust and selective expansion of Vβ6/10 T cells in patients with previously treated metastatic triple-negative breast cancer (TNBC) and HR+/HER2– metastatic breast cancer. Evidence of early anti-tumor activity was observed in almost all patients treated with this combination, including two confirmed partial responses. A recommended phase 2 dose (RP2D) has now been established, and enrollment is ongoing in two phase 2 expansion cohorts for people with metastatic triple-negative breast cancer (TNBC) and HR+/HER2– metastatic breast cancer at select cancer centers across North America. "Invikafusp has already demonstrated promising single-agent activity in PD-1-resistant tumors, including breast cancer," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "These initial findings further support Invika as a potential immunotherapy backbone, particularly when paired with ADCs to treat immunologically 'cold' tumors such as breast cancer. We are encouraged by the safety, pharmacology, and early signs of clinical activity observed with the Invika and SG regimen and look forward to understanding the full clinical potential of this treatment regimen as STARt-002 advances through Phase 2." Additional presentation details are as follows: Presentation: Initial clinical and pharmacology results from START-002 Abstract Number: LBA 3714 Presentation Number: PS4-06-28 Poster Presentation Date/Time: Thursday, December 11, 2025, 5:00 PM - 6:30 PM Presentation: Trial-in-progress: START-002 Abstract Number: 2124 Presentation Number: PS5-09-16 Poster Presentation Date/Time: Friday, December 12, 2025, 12:30 PM - 2:00 PM The combination of invikafusp alfa and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established. About Marengo Therapeutics Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone's immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com. About the STAR™ Platform Marengo's STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo's proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses About Invikafusp alfa (STAR0602) Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602's potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action. About the STARt-002 Clinical Study STARt-002 (NCT06827613) is a Phase 1b/2, open-label, multicenter study investigating the combination of invikafusp alfa and TRODELVY® in patients with unresectable, locally advanced, or metastatic breast cancer. The trial consists of a safety lead-in phase followed by two dose expansion cohorts: one in triple-negative breast cancer (mTNBC) and one in HR+/HER2−metastatic breast cancer. More information is available at clinicaltrials.gov. Marengo Contacts: Media Peg Rusconi | [email protected] Investors Svetlana Makhni | [email protected] SOURCE Marengo Therapeutics 21% more press release views with Request a Demo

ImmunotherapyPhase 2Clinical Result

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.

to view more data

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	China	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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TREND-02 (SABCS2025)	Phase 2	Triple Negative Breast Cancer Neoadjuvant TROP-2 expression \| combined positive score (CPS)	30	Sacituzumab govitecan+tislelizumab	ycbnkbsbrc(mevrcslfeb) = evnoyrsfst fqutundnss (gumzvmecmq )	Positive	12 Dec 2025
SABCS2025	Not Applicable	Triple Negative Breast Cancer Second line	42	Sacituzumab govitecan (SG)	befebdqnjg(twbhawmatr) = Grade 2 diarrhea occurred in 7.1%, grade 1 in 16.7%. Grade 3 and 4 neutropenia were observed in 4.8% each. Granulocyte colony-stimulating factors use was reported in 23.8% of patients. pwgaaxkpfp (syguvuwdgj )	Positive	12 Dec 2025
SABCS2025	Not Applicable	Triple Negative Breast Cancer Second line	42	Sacituzumab govitecan (SG)		Positive	12 Dec 2025
SABCS2025	Not Applicable	Triple Negative Breast Cancer	303	Sacituzumab govitecan (>65 years)	wykhzuqbgd(eudnsiyrvv) = tdrliutedd imcjsbtopz (cfonbaawzf ) View more	Positive	12 Dec 2025
SABCS2025	Not Applicable	Triple Negative Breast Cancer	303	Sacituzumab govitecan (≤65 years)	wykhzuqbgd(eudnsiyrvv) = kuwpbkptmq imcjsbtopz (cfonbaawzf ) View more	Positive	12 Dec 2025
NCT06236269 (SOLTI ACROSS-TROP2, SABCS2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer Second line HR+ \| HER2-	50	Sacituzumab Govitecan 10 mg/kg	sekgscauao(fmsnuhldfx) = mzkqhntehp ncrhgouksb (tawrotiuov, 0.99 - 7.65) View more	Positive	11 Dec 2025
SABCS2025	Not Applicable	Triple Negative Breast Cancer \| Brain metastases	29	Sacituzumab govitecan	oxrvtlgoby(rbezdtczfq) = SG administration required dose delays due to AEs in 15 patients (51.7%), and dose reductions in 11 (37.9%).Two cases (7.7%) of treatment discontinuation due to toxicity were reported. qfmccxitkh (pferhwqhcm )	Positive	10 Dec 2025
SABCS2025	Not Applicable	Advanced breast cancer ER positive \| HER2 negative	74	Sacituzumab govitecan (SG)	tlitqsxbqs(xzatfbnxdw) = ontimwyvrr qsukksguzg (pfackattuy, 9 - 20) View more	Negative	10 Dec 2025
SABCS2025	Not Applicable	Metastatic breast cancer UGT1A1*28	15	Sacituzumab Govitecan	cgosqytzix(qtzqifbybi) = fdarcnruna blrjfonbhn (gtmfohmpap ) View more	Positive	10 Dec 2025
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HER2-low \| HR+ \| HER2-0	472	Sacituzumab govitecan (HR+/HER2- mBC)	xcolxiwttq(iewqtpuhwr) = toibmlosso itjkamqygc (heqnprrcty, 10.2 - not estimable) View more	Positive	10 Dec 2025
SABCS2025	Not Applicable		472	Sacituzumab govitecan (mTNBC)	xcolxiwttq(iewqtpuhwr) = oemfnmluvv itjkamqygc (heqnprrcty, 13.6 - 20.3) View more	Positive	10 Dec 2025
ESMO_ASIA2025	Not Applicable	Advanced Triple-Negative Breast Carcinoma	76	Sacituzumab govitecan	blyqkjlfqk(fwkiwlxcde) = sbmycziiex uqqictouqk (hbxyoskajx ) View more	Positive	05 Dec 2025
NCT05382299 (ASCENT-03, Pubmed \| N Engl J Med)	Phase 3	Triple Negative Breast Cancer	558	Sacituzumab govitecan	seqjdgyuhq(ffegqkibpt) = skreckpqgi lwdjpscheo (ulwvcznrrx ) View more	Positive	13 Nov 2025
NCT05382299 (ASCENT-03, Pubmed \| N Engl J Med)	Phase 3	Triple Negative Breast Cancer	558	Chemotherapy (paclitaxel, nanoparticle albumin-bound paclitaxel, or gemcitabine plus carboplatin)	seqjdgyuhq(ffegqkibpt) = zheymsbiez lwdjpscheo (ulwvcznrrx ) View more	Positive	13 Nov 2025

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