A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

Start Date01 Jun 2027

Sponsor / Collaborator

CStone Pharmaceuticals Co. Ltd.

NCT07477418

/ Not yet recruitingPhase 1/2IIT

PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib/II Open-Label Trial

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor survival outcomes, even when treated with modern chemotherapy and radiation. Patients with borderline resectable PDAC often receive neoadjuvant systemic therapy to improve the likelihood of successful surgical removal of the tumor, but rates of incomplete tumor regression and positive surgical margins remain high.
This Phase Ib/II, single-arm study evaluates the safety and feasibility of adding trans-arterial microperfusion (TAMP) delivery of gemcitabine to standard neoadjuvant therapy for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX followed by stereotactic body radiation therapy (SBRT). After completion of chemoradiation, gemcitabine is delivered directly to the tumor through the arterial blood supply using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy drug for pancreatic cancer, and the study is evaluating a novel method of delivering the drug rather than a new medication.
The primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine in this treatment setting. Secondary objectives include evaluation of surgical margin status and pathologic tumor regression following surgical resection. Exploratory analyses will examine relapse-free survival. Results from this study will help determine whether this locoregional chemotherapy approach can be safely integrated into neoadjuvant treatment strategies for patients with borderline resectable PDAC.

Start Date01 Dec 2026

Sponsor / Collaborator

University of Vermont

NCT07189793

/ Not yet recruitingPhase 2IIT

Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive/-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study

This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with/without Ta/T1) and (2) non-CIS cohort (high-risk Ta/T1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (
month 3), monthly maintenance continues up to 24 months or until progression/unacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression/unacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression/unacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS/HG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.

Start Date01 Dec 2026

Sponsor / Collaborator

The First Affiliated Hospital of Wenzhou Medical College

100 Clinical Results associated with Gemcitabine

100 Translational Medicine associated with Gemcitabine

100 Patents (Medical) associated with Gemcitabine

23,958

Literatures (Medical) associated with Gemcitabine

31 Dec 2026·Future Science OA

Clinical efficacy of 2-week and 3-week albumin-bound paclitaxel therapy for advanced pancreatic cancer

Article

Author: Su, Zhimin ; Li, Zhiyong ; Shen, Feng ; Jiang, Jiana

OBJECTIVE:

We aim to compare the clinical efficacy and safety of albumin-bound paclitaxel (nab-PTX) (125 mg/m2, q2w) for two weeks and (125 mg/m2, d1, d8, q3w) for three weeks in the first-line treatment of advanced pancreatic cancer.

METHODS:

The medical records of patients with advanced pancreatic cancer who received nab-PTX for 2 weeks and 3 weeks, combined with gemcitabine, from July 2018 to January 2023, were retrospectively analyzed. The efficacy and adverse reactions of the two groups of patients were compared.

RESULT:

A total of 64 patients were included. The median progression-free survival (mPFS) of the 2-week group was 5.6 months, while the 3-week group was 7.8 months. The median overall survival (mOS) of the 2-week group was 14.0 months, while the 3-week group was 14.7 months. The multivariate analysis showed that a physical fitness status score of 0-1 was an independent factor with better OS, while metastatic sites ≥ 3 were related to poor OS. The incidence of leukopenia or neutropenia, neurotoxicity, fatigue, and poor appetite in the 2-week group was lower than that in the 3-week group.

CONCLUSION:

The clinical efficacy of nab-PTX in the 2-week and dose intensive 3 week did not show significant difference, but the 2-week treatment group had better tolerance and safety.

31 Dec 2026·Autophagy reports

TFEB confers resistance against the chemotherapeutic agent CX-5461

Article

Author: Boucher, Marie-Josée ; Bessy, Laure ; McDuff, Florence ; Marchand, Benoît ; Rolland, Marjorie

Identifying mechanisms underlying chemoresistance is essential for improving the efficacy of chemotherapeutic drugs. Previously, we showed that cancer cells respond to gemcitabine by activating protective signals dependent on the master regulator of autophagy and lysosomal biogenesis, transcription factor EB (TFEB). However, how gemcitabine triggers these protective responses remains elusive. While gemcitabine primarily aims at disrupting DNA replication, it is also suspected to induce nucleolar stress. In this study, we aimed to examine the effect of gemcitabine on nucleolar stress and investigate whether nucleolar stress inducers could trigger TFEB-dependent protective signals. Besides gemcitabine causing nucleolar stress, the anticancer agent CX-5461, primarily designed to induce nucleolar stress, promoted TFEB nuclear accumulation. Interfering with TFEB improved the sensitivity of cancer cells to both CX-5461 and gemcitabine. Our findings suggest that TFEB provides broad protection against the stress caused by chemotherapeutic drugs, representing a promising target for intercepting chemoresistance and improving the efficacy of anticancer agents.

31 Dec 2026·Gut Microbes

Exploring the gut microbiome and metabolomic interactions of antimetabolite drugs to optimize therapy

Review

Author: Zhao, Libo ; Chen, Jingyang ; Wang, Yanan ; Xu, Lei ; Li, Xiaona

Antimetabolite drugs are cornerstones in treating various cancers and autoimmune diseases; however, their clinical utility is often hampered by systemic toxicity caused by drug-induced gut microbiota dysbiosis. Predicting patient responses remains a significant challenge. Several studies have highlighted the influence of gut microbiota on antimetabolite treatment outcomes, revealing complex bidirectional interactions between the drugs and microbial communities. This review synthesizes the effects of common antimetabolites (including 5-fluorouracil, methotrexate, gemcitabine, capecitabine, 6-mercaptopurine, and thioguanine) on gut microbial communities and outlines a framework (pharmacokinetics, endogenous metabolite production, immune modulation, and apoptotic pathway modulation) for assessing chemotherapy-microbiota interactions. Additionally, potential microbial biomarkers for predicting treatment responses and strategies for manipulating the gut microbiota to enhance therapeutic efficacy are discussed. Therefore, advances in methodologies such as metagenomics and real-time microbial monitoring will be essential for unraveling these interactions and promoting the precise application of antimetabolite drugs.

1,128

News (Medical) associated with Gemcitabine

03 Sep 2026

·www.prnewswire.com

Osteosarcoma Market is Set to Rise by 2036 as 8 Emerging Therapies Set to Drive Future Growth | DelveInsight

The osteosarcoma treatment pipeline is gradually expanding, with emerging therapies such as OST-HER2 (OS Therapies), DANYELZA (naxitamab-gqgk; SERB Pharmaceutical), Vactosertib (MedPacto), Risvutatug rezetecan (GSK), Olaparib with Ceralaserti (AstraZeneca), OMO-103 (Peptomyc), Eflornithine (DFMO) and AMXT 1501 (Aminex Therapeutics), PEEL-224 (Peel Therapeutics), ADCE-D01 (ADCendo), Dendritic cell-based vaccine (CellxLife), LNTH-2403 (Lantheus), and other investigational agents representing promising assets that could reshape the future treatment landscape, particularly in relapsed and metastatic settings. LAS VEGAS, Sept. 3, 2026 /PRNewswire/ -- Osteosarcoma management generally relies on a multimodal treatment strategy that integrates surgery with chemotherapy and, in selected cases, radiotherapy. According to the NCCN Guidelines, commonly recommended chemotherapeutic agents include methotrexate, doxorubicin, cisplatin, and ifosfamide. For patients with relapsed, refractory, or metastatic osteosarcoma, second-line options recommended by the NCCN include high-dose ifosfamide, etoposide, regorafenib, sorafenib, radium-223 dichloride, and everolimus. Despite these treatment options, the osteosarcoma therapeutic landscape remains relatively limited, with few therapies specifically approved for the disease. In the United States, levoleucovorin (KHAPZORY) has received FDA approval, whereas mifamurtide (MEPACT) has been authorized by the European Commission for use across the European Union. Find out the major differences between osteosarcoma vs Ewing sarcoma @ The emerging osteosarcoma pipeline is increasingly exploring targeted therapies and immunotherapeutic strategies. Key candidates include OST-HER2, which employs HER2-directed cellular immunotherapy to stimulate antitumor immune responses; naxitamab-gqgk (DANYELZA), which targets GD2-expressing tumor cells through antibody-mediated cytotoxicity; Vactosertib, an inhibitor of TGF-β signaling associated with tumor progression and metastasis; and Risvutatug Rezetecan, an antibody-drug conjugate (ADC) designed to deliver targeted cytotoxic activity to tumor cells. However, osteosarcoma drug development remains predominantly concentrated in early-stage clinical trials, particularly Phase II studies. The limited number of late-stage trials restricts the availability of large, randomized datasets capable of demonstrating statistically significant improvements in overall survival, event-free survival, and durable response rates. Consequently, the lack of robust confirmatory evidence continues to present a major challenge to regulatory approval and contributes to differences in treatment availability across regions. Aparna Thakur, an oncology expert at DelveInsight, said that increasing research efforts in targeted therapies, immunotherapies, tyrosine kinase inhibitors, and cell-based therapies are expanding the future therapeutic landscape and creating opportunities for innovation. Reflecting ongoing therapeutic innovation and increasing unmet medical needs, DelveInsight estimates that the osteosarcoma market across the seven major markets, comprising the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 60 million in 2025. The market is projected to expand at a CAGR of 9% during the forecast period through 2036, driven by the development of novel targeted therapies, advances in multimodal treatment approaches, increasing investment in osteosarcoma research, and growing efforts to address treatment-resistant and relapsed disease. Below, we highlight 8 promising emerging therapies poised to reshape the future of the osteosarcoma market. OS Therapies' OST-HER2 HER2-targeted cancer vaccine OST-HER2 is an investigational HER2-targeted immunotherapy being developed for HER2-expressing malignancies, including osteosarcoma. The therapy is designed to stimulate an anti-tumor immune response by activating HER2-specific T cells, enabling them to recognize and eliminate cancer cells. Following intravenous administration, the OST-HER2 vector is rapidly taken up by antigen-presenting cells (APCs), which subsequently initiate a targeted immune response against HER2-positive tumors. Translational studies, including research in canine osteosarcoma, have demonstrated the therapy's potential to reduce disease recurrence and suppress metastatic progression. OST-HER2 is currently being evaluated as a second-line treatment in a Phase IIb clinical trial, with OS Therapies planning to pursue a Biologics License Application (BLA) under the U.S. FDA's Accelerated Approval pathway in the second half of 2026. In August 2026, OS Therapies, Inc. announced that the U.S. FDA had granted its request for a Type C Statistical Methods meeting to discuss 2.5-year overall survival data from the Phase IIb trial evaluating OST-HER2 for recurrence prevention in patients with fully resected pulmonary metastatic osteosarcoma. The meeting is expected to take place in mid-September 2026 with representatives from the Center for Biologics Evaluation and Research (CBER), alongside a pending Biomarker Data Review Meeting with members of the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program (BQP). CBER is responsible for the regulatory review and approval of gene-edited products such as OST-HER2. The company also expects to report interim 3-year overall survival data in early September 2026. Earlier, in March 2026, OS Therapies announced that the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) had granted Advanced Therapy Medicinal Product (ATMP) designation to OST-HER2 for the treatment of pulmonary recurrence in patients with resected osteosarcoma in the European Union. The designation followed the EMA's earlier Fast Track Designation for the same indication. In the United States, OST-HER2 has also received both Orphan Drug Designation and Fast Track Designation from the FDA for the treatment of osteosarcoma. The osteosarcoma market is expected to evolve gradually, with OST-HER2 projected to emerge as a potential key asset, generating approximately USD 37 million across the 7MM by 2036, as per Thakur. Iterion Therapeutics' Tegavivint TBL1X protein inhibitors Tegavivint targets TBL1, an essential co-activator of Wnt-driven gene transcription, thereby inhibiting the oncogenic activity of β-catenin while potentially avoiding the toxicities associated with upstream Wnt inhibition. This differentiated mechanism supports its development as a targeted therapeutic approach. Tegavivint, in combination with gemcitabine, is being investigated in pediatric osteosarcoma and has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD), with topline results anticipated in the second half of 2027. In February 2026, Iterion Therapeutics announced the dosing of the first patient in a clinical study evaluating tegavivint in combination with gemcitabine in patients with relapsed or refractory osteosarcoma. The study is sponsored by Emory University and is being conducted at Children's Healthcare of Atlanta. Discover more about the new treatment options for osteosarcoma @ Osteosarcoma Bone Cancer SERB Pharmaceutical's DANYELZA Antibody-dependent cell cytotoxicity (ADCC) DANYELZA (naxitamab-gqgk) is a fully humanized anti-GD2 monoclonal antibody developed to provide favorable pharmacokinetic characteristics and enhanced cytotoxic activity. Early clinical studies in pediatric patients have shown a manageable safety profile and encouraging therapeutic activity. However, its safety and tolerability in older patients with osteosarcoma remain insufficiently characterized. In September 2025, SERB Pharmaceuticals completed the acquisition of Y-mAbs Therapeutics, broadening its rare oncology portfolio through the addition of DANYELZA and reinforcing its capabilities in developing targeted therapies for rare cancers. Sadaf Javed, Functional Head of Forecasting and Analytics at DelveInsight, stated that the asset carries a "selective responder" profile rather than broad efficacy, with commercial potential constrained by small eligible populations and uncertain tolerability in older osteosarcoma patients. Overall, it is viewed as a niche orphan oncology product with modest expansion upside rather than a high-growth oncology franchise. Aminex Therapeutics' AMXT 1501 + DFMO Polyamine uptake inhibitors Aminex Therapeutics' immuno-oncology candidate is an oral, small-molecule therapy that combines AMXT 1501, the company's proprietary polyamine uptake inhibitor, with DiFluoroMethylOrnithine (DFMO, eflornithine), an off-patent inhibitor of polyamine synthesis. By targeting complementary pathways, the AMXT 1501 and DFMO combination is designed to work synergistically to enhance immune-mediated antitumor activity across a broad range of solid tumors. To know more about osteosarcoma drug development, visit @ Osteosarcoma Treatment Pipeline MedPacto's Vactosertib TGF-β1 kinase inhibitor Vactosertib (TEW-7197) is a TGF-β1 signaling inhibitor developed to modulate the tumor microenvironment. Although TGF-β signaling plays an important role in regulating cell proliferation and apoptosis under normal physiological conditions, its dysregulated activity in tumors can suppress antitumor immune responses, promote metastasis, and contribute to resistance to cancer therapies. TGF-β can also drive fibroblast proliferation within and surrounding tumor tissues, leading to excessive extracellular matrix deposition. This dense matrix can create a physical barrier around tumors, limiting immune-cell infiltration and reducing therapeutic access. By inhibiting stromal formation, vactosertib may improve the penetration of anticancer therapies and enhance their activity against tumor cells. In January 2023, MedPacto announced that the U.S. FDA had granted Fast Track Designation (FTD) to vactosertib as a monotherapy for patients with relapsed/refractory metastatic osteosarcoma. This followed the agency's grant of Rare Pediatric Disease Designation (RPDD) for the same indication in September 2022. In July 2023, the European Commission granted Orphan Drug Designation (ODD) to vactosertib for the treatment of osteosarcoma. The candidate had previously received ODD from the U.S. FDA in August 2021. According to Javed, vactosertib is a high-upside but still unproven platform asset, with valuation and outlook hinging on whether later-stage studies can confirm consistent response rates and clinically meaningful durability in a broader population. GSK's Risvutatug rezetecan ADC targeting B7-H3 Risvutatug rezetecan (Ris-Rez; GSK5764227; HS-20093) is an investigational antibody-drug conjugate (ADC) designed to selectively target B7-H3, a cell-surface protein highly expressed in numerous solid tumors. By binding to B7-H3-positive cancer cells, the ADC facilitates the targeted delivery of its cytotoxic payload to tumor cells, with the aim of maximizing antitumor efficacy while limiting exposure to healthy tissues. The therapy is being evaluated across multiple tumor types under GSK's global EMBOLD clinical development program. In 2025, the US FDA granted risvutatug rezetecan Breakthrough Therapy Designation (BTD) for patients with late-line relapsed or refractory osteosarcoma, underscoring its potential as a treatment option for this challenging and underserved patient population. Explore more about recent advancements in osteosarcoma treatments @ Osteosarcoma Treatment Market Peel Therapeutics' PEEL-224 DNA topoisomerase I inhibitors PEEL-224 is a polymer-based nanocarrier incorporating four small molecules and is being developed as a potential cancer therapy. Its active component is derived from camptothecin, a naturally occurring compound found in the Chinese Happy Tree, which is believed to have evolved as a plant defense mechanism. Camptothecin and its derivatives target topoisomerase 1 (TOP1), an enzyme involved in DNA replication, leading to DNA damage and ultimately the death of rapidly dividing cancer cells. By modifying this naturally derived molecule and conjugating it to a synthetic polymer, PEEL-224 is designed to enhance therapeutic efficacy while potentially reducing toxicity. Preclinical findings for PEEL-224 have been encouraging, with studies demonstrating sustained complete responses in some highly aggressive solid tumors, in certain cases lasting for more than six months. Importantly, the molecular design of PEEL-224 is intended to prevent its efflux from cancer cells through the ABCG2 multidrug transporter. This mechanism may help reduce the development of treatment resistance and potentially enable PEEL-224 to overcome resistance to irinotecan. ADCendo's ADCE-D01 DNA topoisomerase I inhibitors ADCE-D01 is a first-in-class antibody-drug conjugate (ADC) designed to target uPARAP, an endocytic receptor that is highly expressed across a broad range of mesenchymal cancers, including soft tissue sarcoma, osteosarcoma, gastrointestinal stromal tumors (GIST), mesothelioma, and glioblastoma. uPARAP represents a promising ADC target due to its rapid internalization, constitutive recycling, and distinct expression pattern between tumor and healthy tissues. ADCE-D01 incorporates a uPARAP-binding antibody engineered to preserve the receptor's interaction with its natural ligand, collagen, together with a clinically validated protease-cleavable linker and a potent deruxtecan payload. Preclinical studies have demonstrated robust antitumor activity across multiple in vivo models, along with an encouraging toxicology profile, supporting ADCE-D01's potential as a first- and best-in-class treatment option for patients with mesenchymal cancers characterized by significant unmet medical needs. ADCE-D01 is currently being evaluated in a multicenter Phase I/II clinical trial (NCT06797999) to assess its safety, tolerability, and optimal dose in patients with soft tissue sarcoma. The study is being conducted at clinical trial sites across the United States and Europe. The U.S. FDA has granted ADCE-D01 both Fast Track Designation and Orphan Drug Designation (ODD) for the treatment of soft tissue sarcoma. Download the report to understand the top emerging therapies in osteosarcoma treatment @ Osteosarcoma Clinical Trials Source: Osteosarcoma Market Report Osteosarcoma Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key osteosarcoma companies, including OS Therapies, SERB Pharmaceutical, MedPacto, GSK, AstraZeneca, Peptomyc, Iovance Biotherapeutics, Aminex Therapeutics, US WorldMeds, Peel Therapeutics, CellxLife, Lantheus, ADCendo, Iterion Therapeutics, iOncologi, Lisata Therapeutics, and others. Related Reports Osteosarcoma Clinical Trial Analysis Osteosarcoma Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key osteosarcoma companies, including Zentalis Pharmaceuticals, MedPacto, Salarius Pharmaceuticals, NextPoint Therapeutics, Base Therapeutics, EMD Serono, Hansoh BioMedical R&D Company, Cellectar Biosciences, OS Therapies, AlaMab Therapeutics , and others. Ewing Sarcoma Market Ewing Sarcoma Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ewing sarcoma companies, including Salarius Pharmaceuticals, Jazz Pharmaceuticals, Pharmamar, Eli Lilly, Pfizer, Bioatla, Cellectar Biosciences, Sumitomo Pharma Oncology, Inhibrx, and others. Soft Tissue Sarcoma Market Soft Tissue Sarcoma Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key STS companies, including Advenchen Laboratories, Philogen, Gradalis, Epizyme, Chugai Pharma France, CytRx, Taiho Pharmaceuticals, KaryoPharm Therapeutics, Nanobiotix, Apexigen, Lytix Biopharma, Incyte Corporation, Iovance Biotherapeutics, Aadi Bioscience, Inc., AVEO Pharmaceuticals, Bayer, VasGene Therapeutics, Mirati Therapeutics, Novartis Pharmaceuticals, Incyte Corporation, Tracon Pharmaceuticals, Jiangsu Hengrui Medicine, Exelixis, Qbiotics, AstraZeneca, Loxo Oncology, ImmunityBio, Monopar Therapeutics, Chipscreen Biosciences, Ltd., Agenus, C4 Therapeutics, Inc., Noxopharm Limited, Moleculin Biotech, Inc., Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., Tracon Pharmaceuticals Inc., Guangdong Xiangxue Precision Medical Technology Co., Ltd., Cornerstone Pharmaceuticals, Takara Bio Inc., Jazz Pharmaceuticals, Lyell Immunopharma, Telix Pharmaceuticals, and others. Chondrosarcoma Market Chondrosarcoma Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chondrosarcoma companies, including Aadi Bioscience Inc., Acrotech Biopharma LLC, ADC Therapeutics SA, Advenchen Laboratories LLC, Alkermes Plc, Astex Pharmaceuticals Inc., Atlanthera, Bayer AG, BioAtla Inc., BioMed, Valley Discoveries Inc., Bristol-Myers Squibb Co., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Eli Lilly and Co., ENB Therapeutics LLC, Epizyme Inc., Horizon Therapeutics Plc, Incyte Corp, Inhibrx Inc., Iovance Biotherapeutics Inc., Jiangsu Hengrui Medicine Co., Ltd., Karyopharm Therapeutics Inc., Les Laboratoires Servier SAS, Merck & Co., Inc., Nanode Therapeutics Inc., Nerviano Medical Sciences SRL, NKGen Biotech Inc., Novartis AG, Oncorus Inc., Ono Pharmaceutical Co. Ltd., Pfizer Inc., Pharma Mar SA, Rigel Pharmaceuticals Inc., Shanghai Affinity Biomedical Technology Co., Ltd, Shanghai De Novo Pharmatech Co., Ltd., Taiho Pharmaceutical Co., Ltd., and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Fast TrackImmunotherapyOrphan DrugPhase 2

01 Sep 2026

·www.fiercebiotech.com

Novocure hit by cyberattack exposing patient data

Novocure has become the latest medtech company to be hit by a cyberattack, with the oncology specialist revealing that unauthorized access to some of its information systems exposed patient and employee data. The company said in a Sept. 1 SEC filing that it “became aware of unauthorized access to some of its information systems” in mid-August. The exposed data included internal company patient ID numbers for more than 1,400 U.S. patient records. Novocure said those numbers are used only internally and that “no patient names or other identifying data for these was exposed.” Patient data for fewer than 50 other patients in the western U.S. was also exposed and “included additional identifying information.” The breach also exposed general contact information for healthcare providers the company works with, as well as general contact information for Novocure employees, including job titles and phone numbers. On the plus side, Novocure said no access to its medical treatment devices was obtained and that its “ability to operate has not been compromised and all of our systems are fully functional.” The company said it is continuing to investigate the incident and evaluate regulatory and legal notification requirements, including notifications to affected patients. It does not currently believe the incident will have a material impact on its financial condition or results of operations. The company markets Optune Pax , its tumor-treating fields device for locally advanced pancreatic cancer. The device is used in conjunction with gemcitabine and nab-paclitaxel. The disclosure comes just days after fellow medtech Boston Scientific was hit by a cyberattack that caused greater operational disruption, affecting manufacturing as well as the processing and shipping of customer orders. This year is turning into an annus horribilis for the medtech industry when it comes to cyberattacks. Novocure and Boston Scientific join Medtronic, Stryker, Abbott and iRhythm among medtech companies hit by cyber incidents in 2026.

25 Aug 2026

·www.biospace.com

RenovoRx Highlights Peer-Reviewed Publication of Pharmacokinetic and Pharmacodynamic (PK/PD) Data Supporting TAMP™ Platform’s Targeted Drug-Delivery in Locally Advanced Pancreatic Cancer

PK/PD Data is from a Sub-Study in the Phase III TIGeR-PaC Clinical Trial The Study Shows Approximately 51% Tumor-Site Drug Extraction, Decreased Systemic Exposure, and Significant Correlation Between Drug Metabolite Levels and Tumor Marker Reduction MOUNTAIN VIEW, Calif., Aug. 25, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT) , a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ® , a patented, FDA-cleared drug-delivery device, today announced the publication of pharmacokinetic and pharmacodynamic (PK/PD) data from a sub-study of its ongoing Phase III TIGeR-PaC clinical trial (NCT03257033) in the journal Cancer Chemotherapy and Pharmacology . The data shows that TAMP (Trans-Arterial Micro-Perfusion)-mediated delivery concentrated chemotherapy at the tumor site, extracting roughly 51% of the drug locally before it entered the bloodstream, meaningfully lowering systemic exposure in a way that could reduce systemic side effects. In addition, a statistically significant correlation between the drug's local metabolism and a drop in the CA 19-9 tumor marker provided an early indication of improved drug penetration into the tumor area and potential tumor response with intra-arterial delivery. RenovoRx also recently announced the closing of enrollment of the TIGeR-PaC trial, with trial completion expected in the first half of 2027 and expected initial top line data availability in the second half of 2027. “The findings from this PK/PD study provide additional meaningful mechanistic support for our TAMP platform’s targeted drug-delivery approach,” said Ramtin Agah, M.D., Executive Chairman, Chief Medical Officer, and Founder of RenovoRx. “The results provide direct pharmacokinetic evidence supporting TAMP’s potential to deliver chemotherapy more selectively to the tumor while limiting systemic exposure. These findings strengthen TAMP, enabled by our RenovoCath device, as a differentiated approach to improving the therapeutic index of chemotherapy in patients with LAPC.” The PK/PD study, titled “ Pharmacokinetic and Pharmacodynamic Sub-study of Trans-arterial vs Intravenous Gemcitabine in the TIGeR-PaC Phase 3 Clinical Trial ,” compared the systemic drug levels of intra-arterial gemcitabine (IAG) delivered via TAMP using RenovoCath against standard intravenous gemcitabine (IVG) delivered systemically in 16 patients with LAPC across six clinical sites (11 patients received IAG; 5 received IVG). Funding for this study was provided by RenovoRx. Key Findings: Reduced systemic exposure: IAG resulted in significantly lower total systemic gemcitabine exposure compared to IVG, despite being administered at a 50% higher infusion concentration rate, supporting the potential of TAMP to concentrate therapy at the intended treatment site while limiting systemic exposure. Substantial local drug extraction: A targeted extraction ratio of 0.511 was observed (derived from a bioavailability estimate of 0.489), indicating approximately 51% of the intra-arterially delivered gemcitabine was extracted at the site of intra-arterial delivery before entering systemic circulation. This finding provides direct pharmacokinetic evidence supporting the targeted drug-delivery mechanism underlying the TAMP platform. Tumor marker response: A statistically significant correlation was observed between higher systemic levels of dFdU and greater reductions in CA 19-9 tumor marker levels following IAG treatment (Pearson’s r = -0.75; P = 0.034; based on eight evaluable patients, with three excluded for normal baseline CA 19-9). dFdU is gemcitabine’s inactive metabolite, and higher dFdU levels are consistent with rapid local uptake and metabolism of gemcitabine at the treatment site, providing an initial pharmacodynamic signal linking drug exposure with a biomarker of tumor response. Consistent delivery across arterial sites: No statistically significant differences in gemcitabine or dFdU pharmacokinetic parameters were observed based on IAG delivery site, whether administered via the superior mesenteric artery or the celiac artery. The Company believes this data provides evidence that IAG delivery via the TAMP therapy platform achieves meaningful local drug extraction while reducing systemic gemcitabine exposure, supporting RenovoRx’s differentiated approach to targeted intra-arterial chemotherapy in patients with LAPC. Publication Details Title: Pharmacokinetic and Pharmacodynamic Sub-study of Trans-arterial vs Intravenous Gemcitabine in the TIGeR-PaC Phase 3 Clinical Trial Journal: Cancer Chemotherapy and Pharmacology DOI: 10.1007/s00280-026-04939-0 About RenovoCath Based on its FDA clearance, RenovoCath ® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: . About the TIGeR-PaC Clinical Trial TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s first investigational drug-device combination product candidate, using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath ® device, is designed for the intra-arterial administration of chemotherapy, gemcitabine (IAG). About RenovoRx, Inc. RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ® , a patented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales, followed by record quarterly revenue of $909,000 in the second quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers. RenovoRx is also evaluating its novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath (known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx achieved full enrollment in the TIGeR-PaC trial in August 2026, with completion of the trial expected in the first half of 2027 and topline data readout expected in the second half of 2027. The IAG combination product candidate, enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation (ODD) for pancreatic cancer and bile duct cancer, and oxaliplatin has received ODD for pancreatic cancer, each of which provides seven years of market exclusivity upon new drug application approval by the FDA. For more information, visit . Follow RenovoRx on Facebook , LinkedIn , and X . Cautionary Note Regarding Forward-Looking Statements This press release and statements of the Company’s management and third parties made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies (including the anticipated benefits to the Company of the published sub-study described herein and potential positive implications for the TAMP therapy platform and RenovoCath), (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and TAMP technology. Statements that are not purely historical are forward-looking statements. These and other forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control, and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections, and statements relating to our research and development plans, commercial and other plans and strategies, intellectual property development, clinical trials, our therapy platform, financing plans, objectives, and expected operating results, which are based on such current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” "aim," "goal," “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, although not all forward-looking statements contain these words. Risks, uncertainties and assumptions that could cause actual events to differ materially from those projected or indicated by forward-looking statements, include, without limitation: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding-; (iii) the timing of the initiation, progress, and potential results of our preclinical studies, clinical trials, and our research programs (notably with respect to our lead TIGeR-PaC trial); (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate; (v) that applicable regulatory authorities may disagree with our interpretation of the data, research, and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved (notably IAG); (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xx) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we time to time with the Securities and Exchange Commission, which can be accessed at . Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law. Investor Contact: KCSA Strategic Communications Valter Pinto or Jack Perkins T: 212-896-1254 renovorx@kcsa.com Media Contact: STiR Communications Hannah Williams T: 803-521-1214 hannah@stir-communications.com

100 Deals associated with Gemcitabine

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KEGG	Wiki	ATC	Drug Bank
D02368	Gemcitabine	L01BC05	DB00441

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	-	RenovoRx, Inc.	01 Jun 2023
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	Australia	Panbela Therapeutics, Inc.	04 Aug 2022
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	United States	RenovoRx, Inc.	12 Mar 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	Belgium	RenovoRx, Inc.	12 Mar 2018
Advanced Lung Squamous Cell Carcinoma	Phase 3	United States	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Belgium	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Canada	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	France	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Germany	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Hungary	Sanofi	01 Mar 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01261728 (CTgov)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma \| Urothelial Carcinoma of the Urinary Bladder	57	gemcitabine+cisplatin	iiauxqympg = fcahervpfo ezzyzeyhai (zpaxatuxsj, hmnmtrfeuw - fowwrdqssb) View more	-	02 Sep 2026
NCT00183820 (CTgov)	Phase 2	Testicular Neoplasms \| Refractory Malignant Germ Cell Tumor \| Testicular Germ Cell Tumor	30	paclitaxel+gemcitabine+oxaliplatin	mwhdehrccq(oxfehwxyce) = keuieuecwo iayzwnzihn (iipmkcujse, wbuchhlain - dppnuqtulv) View more	-	01 Jul 2026
NCT05712356 (BOLSTER, CTgov)	Phase 2	Intrahepatic Cholangiocarcinoma \| Advanced Malignant Solid Neoplasm \| Gallbladder Carcinoma	66	gemcitabine+Cisplatin+Durvalumab+certepetide (LSTA1 Arm for Untreated Cholangiocarcinoma)	ltkfqmabkg = namnletevz vxadnahxpf (puqfvzsfbv, czhodmqimq - vnxkxqmaqt) View more	-	26 May 2026
NCT05712356 (BOLSTER, CTgov)	Phase 2		66	FOLFOX regimen+certepetide (LSTA1 Arm for Second-Line Cholangiocarcinoma)	ltkfqmabkg = wwfswjnfgb vxadnahxpf (puqfvzsfbv, yeriijaelz - lxlxfkjmsz) View more	-	26 May 2026
NCT01270724 (CTgov)	Phase 2	Dermoid Cyst \| Teratoma \| Endodermal Sinus Tumor ... View more	10	Paclitaxel+Gemcitabine+Oxaliplatin	dytdcgznqc = nfhxcbhudl figieybdhc (gfhvslobfi, mivlbjtqvc - fbhbwqtwsz) View more	-	27 Oct 2025
ASCO2025	Not Applicable	Advanced biliary tract cancer First line	45	Cisplatin, Gemcitabine, Durvalumab	dhiqxdeewd(ohhhaegvbj) = jcpujghkfl plcobmmcva (fuwnmhojxb ) View more	Positive	30 May 2025
NCT02807181 (SIRCCA, CTgov)	Phase 2/3	Unresectable Intrahepatic Cholangiocarcinoma	89	gemcitabine+Cisplatin (Chemotherapy (Cisplatin-Gemcitabine))	elavsrusqb(jsxjdwvrzj) = vtlrgclnlv qxwbcnpkax (pokqaxomci, fcfihdyxyv - qzjtsvckta) View more	-	09 May 2025
NCT02807181 (SIRCCA, CTgov)	Phase 2/3	Unresectable Intrahepatic Cholangiocarcinoma	89	Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)+gemcitabine+Cisplatin (Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine))	elavsrusqb(jsxjdwvrzj) = useifvlrao qxwbcnpkax (pokqaxomci, losrxodeiv - mkewwmiulb) View more	-	09 May 2025
NCT04602078 (AUREA \| SOGUG-AUREA, CTgov)	Phase 2	Urothelial Carcinoma of the Urinary Bladder \| Locally Advanced Urothelial Carcinoma \| Metastatic urothelial carcinoma	82	Cisplatin 70 mg/m2+Gemcitabine 1000 mg/m2+Atezolizumab 1200 mg/m2	easoouqnfa = faymknmrfp lkovemxnpm (bbafsiajqb, yuikyruxgk - fzogaadtij) View more	-	24 Apr 2025
NCT01972919 (CTgov)	Phase 2	Pancreatic carcinoma non-resectable	23	Radiation Therapy+Gemcitabine+Capecitabine	urbzjxjmgv = fcbrdcdtbo acjdzooeah (eejhzmkpcq, mvrmlttdov - dmdptwrezx) View more	-	10 Feb 2025
ACTRN12623000223639 (ASCO_GI2025)	Not Applicable	Advanced Pancreatic Ductal Adenocarcinoma	30	Gemcitabine + Nab-paclitaxel + LSTA-1 + Durvalumab	horkuxfenm(sljqhihhfj) = tdwihlmnxy jyjqofrwih (rsqqziznuu )	Positive	23 Jan 2025
NCT04229004 (Precision Promise (PrP), ASCO_GI2025)	Phase 2/3	Metastatic Pancreatic Cancer Second line	317	Pamrevlumab plus nab-paclitaxel/gemcitabine (Pam + GA)	fapjdxawal(pjpnfpxfxt): HR = 1.18 (95% CI, 0.88 - 1.56), P-Value = 0.14 View more	Negative	23 Jan 2025
NCT04229004 (Precision Promise (PrP), ASCO_GI2025)	Phase 2/3	Metastatic Pancreatic Cancer Second line	317	Gemcitabine/Abraxane (GA)		Negative	23 Jan 2025

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