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

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Sequence Code 27958L

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Sequence Code 319372635H

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115

Clinical Trials associated with Sacituzumab govitecan-hziy

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 Aug 2025

Sponsor / Collaborator

National Cancer Institute

NCT06616987

/ Not yet recruitingPhase 2IIT

A Multicenter, Open-label, Single-arm, Phase II Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens

Start Date30 Jun 2025

Sponsor / Collaborator

Samsung Medical Center

NCT06865677

/ RecruitingPhase 2IIT

Phase II Pilot Study of Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Background:
Cancers of the female reproductive organs often come back after treatment. A drug called sacituzumab govitecan (SG) has been approved for use in other types of cancers. Researchers want to see if SG can also help people with ovarian, endometrial, or cervical cancers.
Objective:
To test SG in people with ovarian, endometrial, or cervical cancers.
Eligibility:
People aged 18 years and older with ovarian, endometrial, or cervical cancer. Their cancers must have returned after at least 2 rounds of standard treatments.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They also will have biopsies to get new tissues samples taken from their tumors.
SG is infused through a tube attached to a needle inserted into a vein in the arm. Treatment will be given in 21-day cycles. Participants will receive SG on days 1 and 8 of each cycle. Each infusion takes 1 to 3 hours.
Participants may receive SG for up to 5 years. They can continue as long as the drug is helping them. Imaging scans and other tests will be repeated throughout the study period.
Participants will have an end-of-treatment visit within 2 weeks and a safety visit about 30 days after they stop treatment. Physical exams, blood tests, and imaging scans may be repeated.
Participants will then be contacted by phone every 6 months for up to 10 years after their first dose of SG.
Sponsoring Institution:
National Cancer Institute

Start Date10 Jun 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

2,836

Literatures (Medical) associated with Sacituzumab govitecan-hziy

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

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

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

01 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 Aug 2025·TOXICOLOGY

High-content screening morphological analysis to evaluate hepatic apoptosis induced by plant alkaloids in a Chang cell model

Article

Author: Choi, Hwa Young ; Jang, Sihyeon ; Park, Young Eun ; Chun, Hyang Sook ; Park, Su Been

As interest in plant-derived compounds and their application in the pharmaceutical and functional food industries has increased, the rapid detection of chemical toxicity has become increasingly important for developing safe products. High-content screening (HCS) can quantify cellular and organelle morphological changes through image analysis; however, most HCS studies on apoptosis, a key toxicological event, have focused on the expression of apoptosis-related genes or proteins. In this study, we aimed to verify whether apoptosis can be detected solely based on cellular morphological changes. Chang cells were treated with staurosporine (STS), a well-known apoptosis inducer, and the morphological changes in the cells were quantified using HCS assays. The correlation between these HCS morphological descriptors and apoptosis rates measured using flow cytometry was determined. Chang cells were also treated with several plant-derived alkaloids known to induce apoptosis, and the same process was performed. The correlation coefficients, which were used to evaluate the correlation between HCS descriptors and apoptosis rates after STS treatment, ranged from 0.64 to 0.98, with 13 descriptors showing significant correlations. In contrast, the highest correlation coefficients between HCS descriptors and apoptosis rates after treatment with 1 of the 12 alkaloids investigated were determined to be 0.75 (at 10 μg/ml) and 0.49 (at 100 μg/ml). The apoptosis-related morphological changes induced by STS and alkaloids were observed using confocal microscopy. The present study demonstrates that HCS assays can detect apoptosis solely based on cellular morphological changes, providing a potential tool for rapid toxicity screening in early product development.

423

News (Medical) associated with Sacituzumab govitecan-hziy

04 Jun 2025

·www.prnewswire.com

2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, June 3, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the third oral presentation of clinical data for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2025 American Society of Clinical Oncology (ASCO), following IBI363's other two oral presentations in colorectal cancer and melanoma. A manageable safety profile, encouraging efficacy, and trends in long-term survival benefits have been observed in both immunotherapy-resistant squamous non-small cell lung cancer (NSCLC) and wild-type lung adenocarcinoma. It is worth mentioning that Innovent's pipeline has a total of 8 oral presentations at this ASCO conference, representing approximately 2% of the conference's total oral presentations. Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, three oral presentations of IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—NSCLC, CRC, and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients with immunotherapy resistant advanced non-small cell lung cancer: results from a Phase 1 study Updated data on IBI363 monotherapy in patients with advanced NSCLC were reported (ClinicalTrials.gov, NCT05460767). As of the data cutoff date, April 7, 2025, a total of 136 patients with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W), including 67 with squamous cell carcinoma and 58 with EGFR wild-type adenocarcinoma. IBI363 showed breakthrough therapeutic potential from tumor response to long-term survival benefit in immuno-resistant squamous NSCLC All 67 squamous NSCLC patients were EGFR wild type. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportion of ≥2 lines of previous systemic therapy was 64.3% (18/28) vs 67.7% (21/31), the proportion of previous anti-PD-1/PD-L1 therapy was 100% (28/28) vs 96.8% (30/31) and the proportion of PD-L1 TPS<1% was 35.7% (10/28) vs 41.9% (13/31). In the 1/1.5 mg/kg dose group, promising ORR/DCR/PFS/OS were observed. Median OS achieved 15.3 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 1/1.5 mg/kg dose group, the 3 mg/kg Q3W dose group observed more prominent confirmed ORR (36.7%), DCR (90.0%), PFS (median PFS 9.3 months) and OS trends (median OS not reached, 12-month OS rate 70.9%) (see the table below). Among the patients with PD-L1 TPS<1%, IBI363 demonstrated outstanding efficacy signals: in the 1/1.5 mg/kg group (N=10), the confirmed ORR was 30.0% and the DCR was 90.0%, while that of the 3 mg/kg group (N=13) were 46.2% and 92.3%, suggesting the potential advantage of IBI363 in the population with low expression of PD-L1. IBI363 showed potential for long-term survival benefits in immuno-resistant wild-type lung adenocarcinoma, especially in patients with smoking history Among the 58 patients with EGFR wild-type lung adenocarcinoma, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, 25 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportions of ≥2 lines of previous systemic therapy were 80.0% (24/30) vs 64.0% (16/25), the proportions of previous anti-PD-1/PD-L1 therapy were both 100%, the proportions of PD-L1 TPS<1% were 26.7% (8/30) vs 40.0% (10/25) and the proportions of smoking history were 56.7% (17/30) vs 60.0% (15/25). In the 1/1.5 mg/kg dose group, median OS achieved 17.5 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 0.6/1/1.5 mg/kg dose group, the 3 mg/kg dose group observed higher confirmed ORR (24.0%), DCR (76.0%), PFS (median PFS 5.6 months) and OS trends (median OS not reached, 12-month OS rate 71.6%) (see the table below). Higher ORR and PFS were observed in lung adenocarcinoma patients with a history of smoking. Among them, the confirmed ORR in the 0.6/1/1.5 mg/kg group (N=17) was 23.5%, and the confirmed ORR in the 3 mg/kg group (N=15) was 33.3%. In all dose groups (N=32), the median PFS of smokers was longer than non-smokers: 5.3 (2.0, 7.0) vs 3.0 (1.6, 5.1) months. In terms of long-term survival benefits, after follow-ups of 12.0 and 13.7 months, the median OS for non-smokers was 13.6 months, whereas the median OS for smokers was not yet reached, with only 9 (28.1%) events occurring. IBI363 had a manageable safety profile in advanced NSCLC Among the 57 patients with NSCLC in the 3 mg/kg dose group, the most common treatment related adverse events (TRAEs) of grade 3 or above were arthralgia and rash. 7.0% of patients experienced TRAEs leading to discontinuation. The overall safety profile was manageable. In view of the encouraging efficacy signals and manageable safety demonstrated by IBI363 monotherapy, Innovent plans to conduct a Phase 3 registration clinical study in locally advanced or metastatic squamous NSCLC that has failed platinum-based chemotherapy and anti-PD-1 /PD-L1 immunotherapy. As of now, IBI363 has received Breakthrough Therapy (BTD) certification from China CDE and Fast Track Designation (FTD) from the US FDA for squamous NSCLC. Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Lung cancer is the malignant tumor with the highest incidence and mortality rate both globally and in China[1], and it is a major issue endangering public health. Although immunotherapy has completely transformed the treatment landscape of NSCLC, for patients with wild-type NSCLC who have failed immunotherapy, the current standard treatment regimen docetaxel has limited efficacy, with an ORR of less than 20%, a PFS of less than 4 months, and an OS of less than 12 months [2-7]. In recent years, although the exploration of new treatment regimens such as immune combination therapy and antibody drug conjugates (ADCs) has brought new hope, many large-scale Phase 3 clinical studies on NSCLC patients who have failed platinum-based chemotherapy and immunotherapy have not achieved satisfactory results, and most of these studies have not met the primary endpoints[2-6]. Although the TROPION-Lung01 study achieved the primary endpoint of PFS in NSCLC, it did not reach the primary endpoint of OS. Especially in squamous NSCLC, no improvement was observed in PFS/OS/ORR in the experimental group. Therefore, there was a huge and urgent unmet medical need in NSCLC that has failed immunotherapy. As a PD-1/IL-2α-bias bispecific molecule, IBI363 not only shows clinical benefits in both ORR and PFS in immune-resistant NSCLC, but also enables us to see the potential of the tailing effect of immunotherapy to bring long-term survival benefits to patients compared with chemotherapy. We are also more looking forward to the survival data of the long-term follow up in the high dose IBI363 group." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "It is a great pleasure to orally present the latest progress of IBI363 in the field of lung cancer at the ASCO conference. IBI363 shows remarkable efficacy in immune-resistant wild-type nsclc and clinical data suggests better trends in ORR, DCR, PFS and OS at higher doses. We expect longer-term follow-up to bring more mature data and look forward to seeing its potential as an immunotherapy for the long-term survival benefits of patients. Meanwhile, regardless of the expression level of PD-L1, IBI363 has demonstrated a powerful anti-tumor effect in immune-resistant NSCLC (especially squamous NSCLC), suggesting that the effect of IBI363 does not depend on the expression of PD-L1. In the future, it may also bring breakthroughs in cold tumors with low or no expression of PD-L1. We will continue to advance the clinical exploration of IBI363 in NSCLC and other tumor types." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References [1] Globocan 2022 (version 1.1) - 08.02.2024 [2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733 [3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166 [4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024. [5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023. [6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16. [7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544 SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Fast TrackPhase 1Immunotherapy

02 Jun 2025

·www.globenewswire.com

Precede Biosciences Presents ASCO 2025 Data Highlighting the Ability of its Liquid Biopsy Platform to Reveal the Biology Underlying Response and Resistance to ADCs and Radiopharmaceuticals

Using just 1mL of plasma, the Precede Bio platform identified key molecular pathways linked to response and resistance in patients with metastatic breast and prostate cancer treated with sacituzumab govitecan and 177Lu-PSMA-617, respectively BOSTON, June 02, 2025 (GLOBE NEWSWIRE) -- Precede Biosciences, a company impacting the development and use of precision medicines with a first-in-class comprehensive epigenomic liquid biopsy platform, today shared the company’s scientific presentations from the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting taking place from May 30 to June 3, 2025, in Chicago, Illinois. “In metastatic castration-resistant prostate cancer treated with 177Lu-PSMA-617, comprehensive epigenomic profiling of plasma not only captured PSMA expression, but also revealed that elevated Wnt signaling and reduced immune activity at baseline were associated with inferior outcomes,” said Jacob E. Berchuck, MD, Assistant Professor, Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University. “These findings highlight the potential of this approach to provide novel insights into molecular correlates of therapeutic response and resistance.” “Plasma-based comprehensive epigenomic profiling enables high-resolution characterization of tumor-intrinsic transcriptional programs and resistance pathways. In this study, we applied this approach to HR+/HER2- metastatic breast cancer patients treated with sacituzumab govitecan with or without pembrolizumab, revealing distinct immune and proliferative pathways associated with therapeutic response,” said Ana C. Garrido-Castro, MD, Medical Oncologist, Dana-Farber Cancer Institute, Assistant Professor of Medicine at Harvard Medical School. “These findings could guide future trial designs by informing selection of combination versus monotherapy strategies based on underlying tumor biology.” “Our ASCO presentations underscore the potential of the Precede Bio platform to decode the transcriptional biology underlying response and resistance to two leading next-generation precision therapies,” said Carl Barrett, Chief Scientific Officer of Precede Bio. “What sets our platform apart is its ability to deliver this level of biological insight through a minimally invasive and highly interpretable approach. We are excited to continue collaborating with drug developers and academic leaders to help guide the development and application of emerging precision medicines—including drug-, radio-, and immune-conjugates.” Data presented at the ASCO Annual Meeting can be found in the presentations section of the company website and below: Robust characterization of response & resistance to 177Lu-PSMA-617 in mCRPC by plasma-based epigenomic profiling Cell-free circulating chromatin profiles enable epigenomic characterization of mechanisms of response and resistance to sacituzumab govitecan in breast cancer About Precede Biosciences‍ Precede Biosciences is breaking down the barriers to precision medicine by redefining what can be learned from a simple blood draw. By understanding the fundamental biology behind disease at any given moment, researchers and clinicians can better target medicines to the right patients in both drug development and clinical practice. Precede Bio seeks to improve success rates in drug development and to be a part of building a future where every patient can receive a rapid, minimally invasive diagnosis and therapy that is precise to the biology of their disease. Precede Bio’s platform is available to drug developers and academic researchers. To learn more, visit www.precede.bio or follow us on LinkedIn. Media Contact:‍Donelle M. Gregorymedia@precede.bio

ASCO

01 Jun 2025

·firstwordpharma.com

ASCO25 readout roundup: PD-(L)1 inhibitors from Roche and BMS, plus AstraZeneca's oral SERD

A slew of late-breaking presentations were shared at the American Society of Clinical Oncology this weekend, featuring potentially practice-changing results in colorectal, breast and gastric cancers. ATOMICRoche reported results from the Phase III ATOMIC study evaluating the addition of its PD-L1 inhibitor Tecentriq (atezolizumab) to standard FOLFOX chemotherapy in 712 patients with DNA mismatch repair (dMMR) colon cancer.After a median follow-up of 37.2 months, patients given the Tecentriq combo had a 50% lower risk of recurrence and death compared to patients treated with FOLFOX alone.The data could "change the standard of care" for dMMR colon cancer patients by embracing the addition of Tecentriq to FOLFOX in the adjuvant setting, said Joel Saltzman, vice chair of regional oncology at the Cleveland Clinic's Taussig Cancer Center.NIVOPOSTOPBristol Myers Squibb said its PD-1 inhibitor Opdivo (nivolumab) lowered the risk of cancer recurrence when added to chemoradiotherapy (CRT), based on the results of the Phase III NIVOPOSTOP study in 666 patients with resected locally advanced head and neck squamous cell carcinoma (HNSCC). Patients who received Opdivo plus CRT had a 24% boost to disease-free-survival versus CRT alone after 30.3 months of median follow-up. Additionally, of those taking the combination, 63.1% had no signs of cancer recurrence three years post-treatment, compared with 52.5% for the CRT alone arm.SERENA-6AstraZeneca revealed findings from the Phase III SERENA-6 study, in which patients with HR-positive/HER2-negative advanced breast cancer who switched to treatment with the oral selective oestrogen receptor degrader (SERD) camizestrant following the emergence of an ESR1 mutation during first-line therapy had a 56% reduction in the risk of disease progression or death.SERENA-6 is the first registrational trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and ESR1 mutations in patients receiving first-line treatment with an aromatase inhibitor plus a CDK4/6 inhibitor. After mutation emergence, 157 patients continued with a CDK4/6 but were switched off the aromatase inhibitor and on to camizestrant, while 158 participants continued treatment with both an aromatase inhibitor and CDK4/6 inhibitor.Results showed that the camizestrant arm achieved progression-free survival (PFS) of 16 months, versus 9.2 months in the control group. At one-year, the PFS rate was 60.7% in the camizestrant group, compared to 33.4% for controls, while the rates at two years were 29.7% and 5.4%, respectively.MATTERHORNAstraZeneca's Imfinzi (durvalumab) became the first immunotherapy to demonstrate a statistically significant and clinically meaningful improvement in event-free survival (EFS) when used in the perioperative treatment setting for patients with early-stage gastric cancer and gastroesophageal junction cancer.Results from the Phase III MATTERHORN study showed that the addition of Imfinzi to standard FLOT chemotherapy before and after surgery, with follow-up treatment with AstraZeneca's PD-L1 inhibitor alone, led to a 29% improvement in EFS, as well as "a strong trend" in overall survival, compared to the FLOT regimen.Lead author Yelena Janjigian suggested that the findings "will change practice," noting that "the use of immunotherapy in earlier-stage cancers, as demonstrated in this perioperative approach…can reduce the risk of recurrence and improve cure rates."VERIFYTakeda and Protagonist presented detailed findings from the Phase III VERIFY study of rusfertide in polycythemia vera (PV), highlighting further benefits of the hepcidin mimetic beyond previously shared top-line results. New data showed significantly fewer rusfertide-treated patients required phlebotomy versus placebo recipients (27% vs 78%), and 62.6% of participants in the rusfertide group maintained haematocrit levels below 45% versus 14.4% in the placebo group. Safety outcomes were also shared for the first time in detail. No serious adverse events were linked to treatment, and the frequency of cancer events was significantly lower in the rusfertide group (0.7%) compared with placebo (4.8%).BREAKWATERPfizer said incorporating its kinase inhibitor Braftovi (encorafenib) into a combination therapy can cut the risk of death in half, based on results from the Phase III BREAKWATER study in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). Patients given Braftovi in combination with the EGFR inhibitor Erbitux (cetuximab) and chemotherapy had a 51% lower risk of dying and a 47% lower risk of progression than those treated with chemotherapy with or without Avastin (bevacizumab). Additionally, those taking the triplet achieved overall survival (OS) of 30.3 months and PFS of 12.8 months, versus 15.1 months and 7.1 months, respectively, for those in the control arm.ASCENT-04/KEYNOTE-D19Gilead Sciences reported that combining its Trop-2-directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab) improved survival in the 443-patient Phase III ASCENT-04/KEYNOTE-D19 study evaluating the duo in previously untreated, PD-L1-positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC).Trodelvy plus Keytruda cut the risk of disease progression or death by 35% compared with the current standard of Keytruda plus chemotherapy, extending median PFS to 11.2 months versus 7.8 months for the control arm.Editors Anna Bratulic, Matthew Dennis, Elizabeth Eaton and Pavan Kamat contributed to this report.

Clinical ResultASCOPhase 3ImmunotherapyADC

100 Deals associated with Sacituzumab govitecan-hziy

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

R&D Status

Approved

10 top approved records.

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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.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	China	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Japan	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Argentina	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Australia	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	Canada	Gilead Sciences, Inc.	25 Mar 2025
Extensive stage Small Cell Lung Cancer	Phase 3	France	Gilead Sciences, Inc.	25 Mar 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05535218 (SURE-02, ASCO2025) Manual	Phase 2	Muscle Invasive Bladder Carcinoma Neoadjuvant	31	Neoadjuvant Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro)	qdjvkurnha(ehciqulklk) = xsxfbulmtb gyjlxynwcu (nxgvjfjpto, 21.8 - 57.8) View more	Positive	30 May 2025
NCT05327530 (JAVELIN Bladder Medley, ASCO2025) Manual	Phase 2	Advanced Urothelial Carcinoma First line \| Maintenance	-	Avelumab + Sacituzumab Govitecan	qqkkeqcljv(kvcyqpjwof) = uxcohwmwfl mvitxjfuio (zblctawhzp, 7.43 - NE) View more	Positive	30 May 2025
				Avelumab	qqkkeqcljv(kvcyqpjwof) = apwumopdjw mvitxjfuio (zblctawhzp, 3.32 - 6.77) View more
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)	tzdjjpvozo(hjbeirahqv) = xadboqljjp radoziviwb (iacqlloibc, 9.5 - 17.5) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Metastatic Triple-Negative Breast Carcinoma	83	Sacituzumab govitecan 10 mg/kg	mhhawwphjh(lafrwekxrj) = sahlgtfhwl bmeezqpvdu (aobfauoaih ) View more	-	30 May 2025
				Sacituzumab govitecan (Initial dose reduction)	truvfhwxqw(ciwyyqsgqf) = htlhyovlds nonpwthdqw (pjvcxuiahg )
NCT06040970 (Basket Trial, ASCO2025)	Phase 1	Trop-2	-	Sacituzumab govitecan + Cisplatin	kavniintwz(svuazcwjln) = hedmtrwuqw rrjdciqqmp (yfxatrdomm, 6.4 - 47.6) View more	Positive	30 May 2025
NCT04448886 (SACI-IO HR+, ASCO2025)	Phase 2	Breast Cancer TROP2	95	Sacituzumab govitecan (SG) alone	bghfgitlsf(whqsrkovli) = anuapvvqfb nbgzamkcru (rjumtyabnl )	Positive	30 May 2025
				Sacituzumab govitecan (SG) combined with pembrolizumab (SG-pembro)	bghfgitlsf(whqsrkovli) = sycrhpayor nbgzamkcru (rjumtyabnl )
NCT05089734 (EVOKE-01, ASCO2025)	Phase 3	metastatic non-small cell lung cancer	-	Sacituzumab govitecan (SG)	cozgqnkaei(mjbubsfrze) = ritewxusru ejjmppherp (ormvhfdxyp ) View more	Positive	30 May 2025
				Docetaxel	cozgqnkaei(mjbubsfrze) = xvxwzeugmp ejjmppherp (ormvhfdxyp ) View more
NCT04448886 (SACI-IO HR+, CTgov)	Phase 2	HR-positive/HER2-low Breast Carcinoma \| HER2-negative breast cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast ... View more	110	Sacituzumab Govitecan+Pembrolizumab (Sacituzumab Govitecan + Pembrolizumab)	dnjeuadwsc(ghbkjdvtmq) = hznhwwnazd nrswrocdfx (erykxloipr, gvismzieic - pwkylkqpbg) View more	-	30 May 2025
				Sacituzumab Govitecan (Sacituzumab Govitecan)	dnjeuadwsc(ghbkjdvtmq) = ivgznqnltw nrswrocdfx (erykxloipr, jnxzvdcghn - huoqrihcyt) View more
NCT03901339 \| NCT05101096 \| NCT02574455 \| NCT04639986 \| NCT01631552 \| NCT04454437 (SG, ESMO_BC2025)	Not Applicable	Metastatic breast cancer	-	Sacituzumab govitecan (SG)	yvtijhpgtr(gntbjgsuvb) = gxylrgdrdd qototemenl (ufehompyyq ) View more	Positive	14 May 2025
				Placebo	yvtijhpgtr(gntbjgsuvb) = nhjnpfcmpo qototemenl (ufehompyyq ) View more
ESMO_BC2025	Not Applicable	Metastatic Triple-Negative Breast Carcinoma	149	Sacituzumab Govitecan	znwqnuihtg(nykiedsjrq) = The most common treatment-related adverse events (TRAEs) were: neutropenia (53.0% of pts) vulkfteukt (ohzgkgwhov )	Positive	14 May 2025

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