Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

Start Date01 Dec 2025

Sponsor / Collaborator

Sonire Therapeutics Inc

NCT05700448

/ Not yet recruitingPhase 3

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 Dec 2025

Sponsor / Collaborator

CStone Pharmaceuticals Co. Ltd.

NCT07129772

/ Not yet recruitingPhase 2IIT

A Multicenter, Single Arm Phase II Study on Pembrolizumab and Chemotherapy as Perioperative Treatment Followed by Nasopharyngectomy and Maintenance Pembrolizumab for Locally Recurrent Nasopharyngeal Carcinoma (PINNACLE)

Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China and southeast Asia. Despite intensive radical therapy, between 15% and 30% of NPC patients develop relapse. Recent phase III randomized-controlled trials conducted in China demonstrated an improvement of progression-free survival with combinational therapy immune checkpoint inhibitors (ICI) (camrelizumab, toripalimab, and tislelizumab, respective) and chemotherapy gemcitabine (G) and cisplatin (P) compared with chemotherapy GP alone for recurrent or metastatic NPC. However, none of these studies have described in details the treatment outcomes of those subjects with locally recurrent NPC only, and whether any of these patients would undergo radical surgery to remove the residual locally recurrent NPC after ICI and chemotherapy. Continuation of the same ICI as maintenance therapy may only be the treatment option for these patients who were recruited into these phase III trials, unless if they withdrew from the study and opted for radical resection. While continuing the same ICI may still lead to persistent objective response and disease control, there is a possibility of tumor recurrence leading to unresectable disease and a worse survival outcome, or unexpected, rare but recognized immune-related emergent adverse events with ICI. Radical resection after maximal response to ICI and chemotherapy for patients with locally recurrent NPC only may provide a chance of cure of the disease and these patients may be obviated from continuous exposure to ICI therapy.
In view of the above, we are now proposing a phase II single-arm study on perioperative pembrolizumab and chemotherapy followed by radical surgery for locally recurrent NPC. As a collateral study, we will also perform single-cell DNA and RNA sequencing and proteomics study to observe the tumor and immune microenvironment which certainly helps us decipher the mechanisms of tumor response at genomic, transcriptomic and proteomic levels.

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Hong Kong

[+3]

100 Clinical Results associated with Gemcitabine

100 Translational Medicine associated with Gemcitabine

100 Patents (Medical) associated with Gemcitabine

27,015

Literatures (Medical) associated with Gemcitabine

01 Mar 2026·BIOMATERIALS

Temperature-activated in situ hydrogel augments tumor treatment

Article

Author: Yang, Haojian ; Yu, Qianqian ; Yang, Ting ; Zhang, Cuiyun ; Wu, Qi ; Liu, Jihong ; Liang, Jiahui ; Wang, Qi ; Lin, Jiangtao ; Shi, Yiqi ; Xu, Shiyun ; Zhu, Wei-Hong ; Yao, Chenxing

In situ gels with tumor-targeted therapy often struggle with precise spatiotemporal drug release, compromising their efficacy in complex and heterogenous tumors. Here, we present a temperature-activated in situ hydrogel (PTT-Br@mPEG-PLGA and Gem@TCM-TK-PEG in chitosan and PF127 gel, denoted as PP + GC gel. Therein, the photothermal compound PTT-Br is fully named 6-bromo-1-ethyl-2-(2-(6-hydroxy-2,3-dihydro-1H-xanthen-4-yl)vinyl)quinolin-1-ium, while the reactive oxygen species (ROS)-responsive polymer TCM-TK-PEG is fully named tricyano methylene pyridine-thioketal-polyethylene glycol.) with the physiological temperature/photothermal/ROS-responsive drug store and release, thereby maximizing treatment outcomes. After intratumoral injection, PP + GC gel undergoes physiological temperature (37 °C)-responsive sol-gel phase transition, forming stable drug depot for enhanced tumor retention. Upon 635 nm laser irradiation, loaded photothermal agent converts light energy into heat (∼45 °C), triggering photothermal-responsive gel-sol phase transition for actively controlling encapsulated ROS-responsive therapeutic agents release, coupled with photothermal therapy. Subsequently, high levels of ROS in tumor cells disrupt the structure of ROS-responsive therapeutic agents, switching on the chemotherapeutic drug gemcitabine release and further stimulating immune response. Remarkably, laser irradiation of multiple short-duration induces a stronger immune response than that of single long-duration, thus achieving superior treatment outcomes. Benefiting from the smart control of photothermal therapy, chemotherapy, and immunotherapy, active PP + GC gel exhibits a tumor inhibition rate of approximately 82.25 % in melanoma-bearing mouse models, demonstrating significant antitumor efficacy while maintaining excellent biosafety.

01 Feb 2026·BIOMATERIALS

Mitocytosis-inducing nanoparticles alleviate gemcitabine resistance via dual disruption of pyrimidine synthesis and redox homeostasis in pancreatic ductal adenocarcinoma

Article

Author: Song, Haolin ; Sun, Tao ; Jiang, Chen ; Fan, Hongrui ; Cheng, Leilei ; Chen, Qinjun ; Su, Boyu ; Li, Xuwen ; Wang, Yu

Metabolic reprogramming in pancreatic ductal adenocarcinoma (PDAC) poses a significant challenge to the efficacy of gemcitabine-based chemotherapy. Aberrant activation of intracellular pyrimidine metabolism is a key factor contributing to the reduced effectiveness of gemcitabine. Combining gemcitabine with metabolic regulators targeting critical pathways may alleviate gemcitabine resistance. In this study, we focus on the abnormal activation of dihydroorotate dehydrogenase (DHODH) in PDAC cells, a pivotal enzyme in the de novo pyrimidine synthesis pathway that diminishes cellular sensitivity to gemcitabine and catalyzes the reduction of ubiquinone to ubiquinol, playing an essential role in maintaining cellular redox homeostasis. To address these challenges, we developed GE11 peptide-modified polyphenol-iron chelate nanoparticles for co-delivery the long carbon chain-modified gemcitabine and the DHODH inhibitor leflunomide, with peptide modification enabling nanoparticles to target PDAC cells with high expression of epidermal growth factor receptor. The nanoparticles demonstrated the ability to induce mitocytosis and achieve deep tumor penetration in PDAC tissues. Upon drug release at the core lesion, the three components, modified gemcitabine, leflunomide and iron ions synergistically enhanced tumor cell killing by alleviating gemcitabine resistance and disrupting cellular redox homeostasis to induce multimodal cell death. In an in situ pancreatic cancer mouse model, this strategy exhibited superior anti-tumor efficacy compared to the standard AG chemotherapy regimen (nab-paclitaxel and gemcitabine), even at a 6.3-fold lower gemcitabine concentration. These findings underscore the potential of this approach as a highly effective therapeutic strategy for PDAC treatment.

31 Dec 2025·Molecular & Cellular Oncology

CHK1 inhibition overcomes gemcitabine resistance in non-small cell lung cancer cell A549

Article

Author: Ma, Xuan ; Liang, Ai-Ling ; Fu, Tian ; Wang, Wen-Xuan ; Ke, Zhi-Yin ; Wang, Xue-Chun ; Liu, Yong-Jun ; Yin, Hai-Han

The purpose of the study is mainly to investigate anti proliferation of non-small cell lung cancer A549 cells and its mechanism by inhibition of CHK1 expression combined with gemcitabine. The mRNA and protein levels of genes were analyzed by RT-qPCR and Western blot, respectively. Cell viability was detected by CCK-8 assay and clone formation assay. The detection of the cell cycle was used by Annexin V/7-amino-actinomycin D apoptosis detection kit. Analysis of DNA damage was done by immunofluorescence and alkaline comet assay. The results showed that inhibition of CHK1 and gemcitabine combination significantly reduced the proliferation ability of the two cell lines. We also revealed the degradation of full-length PARP and reduced Bcl-2/Bax ratio on increased apoptosis. Inhibition of CHK1 expression leads to DNA damage, induces phosphorylation of γ-H2AX, and affects the repair of homologous recombination ability through Rad51. Mechanistically, gemcitabine increased phosphorylation-ATR and phosphorylation-CHK1, indicating activation of the DNA repair system and ATR-CHK1-CDC25A pathway. Inhibition of CHK1 resulted in increased synthesis of CDK2/Cyclin A2 and CDK2/Cyclin E1 complexes, and more cells entered the subsequent cell cycle, leading to S phase arrest and mitotic catastrophe. We identified inhibition of CHK1 as a potential treatment for NSCLC and confirmed that inhibition of this kinase could overcome acquired gemcitabine resistance.

926

News (Medical) associated with Gemcitabine

16 Sep 2025

·www.prnewswire.com

Oncolytics Biotech® Provides Update on GOBLET Study Progress and U.S. Site Expansion

SAN DIEGO, Sept. 16, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network (PanCAN). "The GOBLET trial is designed to rigorously evaluate pelareorep's potential across gastrointestinal cancers," said Dr. Dirk Arnold, Director of Asklepios Tumorzentrum Hamburg and Primary Investigator of the GOBLET study. "The strong early efficacy signals give us confidence that pelareorep may become a foundational immunotherapy for these difficult-to-treat tumors, and expanding enrollment into the U.S. will broaden the scope and impact of these data." Cohort 4 (Second-Line or later Squamous Cell Carcinoma of the Anal Canal, "SCAC") Pelareorep is being studied in combination with atezolizumab in the rare but deadly relapsed, unresectable SCAC indication. In January, the Company released efficacy data showing a 33% overall response rate (ORR) in 12 patients. This nearly triples the ORR achieved by retifanlimab in second-line or later SCAC patients. Enrollment is currently at 20 evaluable patients and is expected to be completed by the end of 2025. The Company expects to provide an efficacy update regarding ORR in Cohort 4 in the fourth quarter of 2025. Cohort 5 (First-Line Metastatic Pancreatic Ductal Adenocarcinoma, "mPDAC") In a randomized two-arm cohort, pelareorep is being evaluated in combination with modified FOLFIRINOX with or without atezolizumab to gain greater clarity regarding the contribution of the checkpoint inhibitor to the efficacy achieved in GOBLET Cohort 1. In that cohort, pelareorep combined with gemcitabine/nab-paclitaxel and atezolizumab achieved a 62% ORR in 13 evaluable patients. Enrollment into Cohort 5 is approximately 40% complete and is expected to be fully enrolled by the end of 2026. The Company anticipates providing a Cohort 5 interim efficacy update, including overall survival, in the first quarter of 2026. GOBLET Expansion to U.S. Sites The Company recently submitted a protocol amendment to allow the GOBLET study to open U.S. clinical sites within the next few months. Upon approval, Northwestern University and other academic institutions are expected to serve as U.S. sites for GOBLET. "We are pleased to bring this important study to U.S. patients with pancreatic cancer, a population urgently in need of novel immunotherapy strategies," said Dr. Devalingam Mahalingham, who is expected to lead the Cohort 5 study at Northwestern University. "The combination of pelareorep and a checkpoint inhibitor with chemotherapy has shown early signs of durability, and I am excited to be part of advancing this program toward registration." "We expect to build on this clinical momentum to lay the foundation for our regulatory strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "It's imperative that we leverage our clinical data to obtain regulatory clarity and position pelareorep as a platform immunotherapy in these gastrointestinal tumors where patients desperately need treatment options." About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated promising results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics' plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; its expectations regarding the efficacy, enrollment, and results of pelareorep in future studies and partnerships for future studies; and its belief in the clinical promise of pelareorep in metastatic colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Owen Blaschak LifeSci Communications [email protected] Logo: SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 2Fast Track

15 Sep 2025

·www.merck.com

Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated with Bevacizumab

September 15, 2025 7:00 am EDT First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s raludotatug deruxtecan based on phase 1 trial and REJOICE-Ovarian01 phase 2/3 trial Second Breakthrough Therapy Designation since the start of the Daiichi Sankyo and Merck collaboration Fifteenth Breakthrough Therapy Designation granted by FDA across the oncology portfolio of Daiichi Sankyo BASKING RIDGE, N.J. AND RAHWAY, N.J., September 15, 2025 – Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab. Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. The FDA granted this BTD based on data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 trial. A subgroup analysis of the phase 1 trial was presented at the 2023 European Society for Medical Oncology meeting (#ESMO23). Subsequent subgroup analyses of the phase 1 trial were presented at the 2024 Society for Gynecologic Oncology Annual Meeting on Women’s Cancer and the 2025 European Society for Medical Oncology Gynaecological Cancers Congress. This is the first BTD for raludotatug deruxtecan and represents the second BTD since the start of the Daiichi Sankyo and Merck collaboration. “Patients have limited treatment options once ovarian cancer becomes resistant to platinum-based chemotherapy, highlighting the urgent need for new medicines that can improve patient outcomes,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The receipt of Breakthrough Therapy Designation represents an important step forward in our efforts to advance raludotatug deruxtecan as a novel medicine for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab.” “The FDA’s Breakthrough Designation is a reflection of our commitment to advancing research for patients impacted by women’s cancers,” said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “Raludotatug deruxtecan has the potential to one day become an important option for the treatment of patients with CDH6-expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab, and we are excited to share data from REJOICE-Ovarian01 with the scientific community at an upcoming medical meeting and to continue working closely with the FDA.” About the Phase 1 Trial The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of investigational raludotatug deruxtecan in adult patients with advanced ovarian cancer previously treated with platinum-based chemotherapy and a taxane. Patients with renal cell carcinoma resistant or refractory to standard of care therapy were originally included, but that component of the study was discontinued. The primary objective of the first part of the study (dose escalation) was to assess the safety and tolerability of increasing doses of raludotatug deruxtecan to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The primary objective of the second part of the study (dose expansion) is to further evaluate the safety and efficacy of raludotatug deruxtecan in patients with advanced ovarian cancer and in patients with advanced renal cell carcinoma. The study will evaluate safety endpoints, including dose-limiting toxicities and adverse events and efficacy endpoints, including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), clinical benefit rate, time to response and progression free survival (PFS). Pharmacokinetic and exploratory biomarker endpoints also will be assessed. The phase 1 trial enrolled 179 patients in Asia and North America. For more information, please visit ClinicalTrials.gov. About REJOICE-Ovarian01 REJOICE-Ovarian01 is a global, multicenter, randomized, open-label phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan in patients with platinum-resistant, high-grade ovarian primary peritoneal or fallopian tube cancer, with disease progression following at least one but no more than three prior systemic lines of therapy, including prior treatment with mirvetuximab soravtansine for those with documented high-folate receptor alpha expression. Maintenance therapy (e.g., bevacizumab, poly ADP-ribose polymerase [PARP] inhibitors) is considered part of the preceding line of therapy. The phase 2 part of REJOICE-Ovarian01 is assessing the safety and tolerability of three doses of raludotatug deruxtecan (4.8 mg/kg, 5.6 mg/kg, or 6.4 mg/kg) to identify the recommended dose for the phase 3 part of the trial. The primary endpoint of the phase 2 part of the trial is ORR as assessed by blinded independent central review (BICR). Secondary endpoints include ORR as assessed by investigator, DoR, PFS and DCR – all assessed by both BICR and investigator – and overall survival (OS). The phase 3 part of REJOICE-Ovarian01 is assessing the efficacy and safety of raludotatug deruxtecan at the selected dose (5.6 mg/kg) compared to investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine or topotecan). The dual primary endpoints of the phase 3 part of the trial are ORR and PFS as assessed by BICR. Secondary endpoints include PFS and ORR as assessed by investigator, DoR and DCR as assessed by both BICR and investigator, and OS. Pharmacokinetic and biomarker endpoints also will be assessed in both parts of the trial. REJOICE-Ovarian01 is expected to enroll approximately 710 patients across Asia, Europe, North America, and Oceania. For more information, please visit ClinicalTrials.gov. About Ovarian Cancer More than 324,000 women were diagnosed with ovarian cancer worldwide in 20221. The median overall survival for advanced ovarian cancer following recurrence can be as little as two years, with a five-year survival rate of 31.8% for those with distant stage disease.2,3 The introduction of targeted therapies has expanded treatment options and improved survival outcomes for some patients with ovarian cancer, but additional options are needed for patients with tumors that progress on available medicines4. Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens5. For patients who develop platinum-resistant ovarian cancer, defined as disease progression less than six months after completion of last platinum-based chemotherapy, prognosis is particularly poor and treatment options are limited.6,7 About CDH6 CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, including ovarian tumors.8 An estimated 65% of patients with ovarian cancer have tumors that express CDH6. In addition, CDH6 expression is observed more frequently in high-grade serous carcinomas.8,9 There is currently no CDH6 directed medicine approved for treatment of any cancer. About Raludotatug Deruxtecan Raludotatug deruxtecan is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU®, a HER2 directed ADC, and DATROWAY®, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J., USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com. Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit www.merck.com/research/oncology/. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Media Contacts: Merck Media: Julie Cunningham (617) 519-6264 julie.cunningham@merck.com John Infanti (609) 500-4714 john.infanti@merk.com Investors: Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Steven Graziano (732) 594-1583 steven.graziano@merck.com Daiichi Sankyo Global/US: Jennifer Brennan Daiichi Sankyo jennifer.brennan@daiichisankyo.com +1 (908) 900-3183 (mobile) Japan: Daiichi Sankyo Co., Ltd. DS-PR_jp@daiichisankyo.com Investor Relations Contact: DaiichiSankyoIR_jp@daiichisankyo.com References:

Phase 1Drug ApprovalPhase 2Clinical ResultBreakthrough Therapy

11 Sep 2025

·endpoints.news

Revolution’s lead RAS blocker heads into Phase 3 in frontline pancreatic cancer after early data

Revolution Medicines said it will begin a late-stage test of its lead asset as a first-line treatment for a form of pancreatic cancer, after a Phase 1 study in this setting yielded promising data. The early-stage trial studied daraxonrasib in patients with treatment-naïve RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). The drug works by inhibiting a protein called RAS that causes unchecked cell growth. The trial investigated the candidate as both monotherapy and in combination with chemotherapy. In the monotherapy cohort of 38 evaluable patients given a 300 mg daily oral dose of daraxonrasib, the objective response rate (ORR) was 47% , and the disease control rate (DCR) was 89%, Revolution said on Wednesday. As of the cutoff date of July 28, most patients remained on treatment, with a median follow-up of 9.3 months. Meanwhile, in the chemo combo arm, daraxonrasib was dosed at 200 mg per day with gemcitabine nab-paclitaxel (GnP) given every two weeks. In 31 patients with sufficient follow-up, the ORR was 55% and the DCR was 90%, with a median follow-up of 6.9 months. Revolution’s stock $RVMD ticked up by as much as 9% before market open on Thursday. Based on these data, the drugmaker is planning to start a global Phase 3 trial in first-line metastatic PDAC towards the end of this year. Dubbed RASolute 303, the trial will have monotherapy and GnP combo arms, which will be compared with a GnP control arm. In the combo arm, the Phase 3 trial will dose daraxonrasib at 200 mg per day, plus GnP, for six months, followed by 300 mg per day as monotherapy, according to a company presentation . Revolution also shared an update from a trial of daraxonrasib in the second-line RAS-mutant PDAC setting. As of June 30, a 300 mg daily pill resulted in ORRs of 35% and 29% in patients with a RAS G12X mutation or any RAS mutation, respectively. DCRs were 92% and 95%, in those respective groups. The median OS was 13.1 months in the RAS G12X mutant patients and 15.6 months in participants with any RAS mutation. Progression-free survival was 8.5 and 8.1 months, respectively. Median follow-up was 16.7 months. OS “compares very favorably” to the six to seven months seen in historic chemo trials, analysts from Jefferies wrote in a Wednesday note. The analysts said that the first-line PDAC opportunity is bigger and underappreciated compared with the second-line setting, where daraxonrasib is already in a pivotal trial and could yield data next year. Another pivotal trial, called RASolute 304, is planned for the fourth quarter of this year and will test daraxonrasib in the adjuvant setting. And the drug is also being tested in non-small cell lung cancer. Revolution recently formed a funding pact with Royalty Pharma for up to $2 billion, which should allow it to fund this suite of late-stage studies.

Clinical ResultPhase 3Phase 1Phase 2Clinical Trial Termination

100 Deals associated with Gemcitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D02368	Gemcitabine	L01BC05	DB00441

R&D Status

10 top R&D records.

to view more data

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


ASCO2025	Not Applicable	Advanced biliary tract cancer First line	45	Cisplatin, Gemcitabine, Durvalumab	tmscxcvrnf(rddowuksbf) = mesjugtxfl jajgeklnhu (thahujrmis ) View more	Positive	30 May 2025
NCT02807181 (SIRCCA, CTgov)	Phase 2/3	Unresectable Intrahepatic Cholangiocarcinoma	89	gemcitabine+Cisplatin (Chemotherapy (Cisplatin-Gemcitabine))	rrdvinkysq(gafdibohyw) = cepsohqdqi idpiijyedp (wfyaqcpivi, jggchoshuu - oqpluriffx) 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))	rrdvinkysq(gafdibohyw) = vyfhzfpnli idpiijyedp (wfyaqcpivi, wxmhywjzjx - sogazqohkt) 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	pqdqjiexkt = nycwmclipy bdlstbtzyl (zmktswbkbs, siemfribax - fkggchgyda) View more	-	24 Apr 2025
NCT01972919 (CTgov)	Phase 2	Pancreatic carcinoma non-resectable	23	Radiation Therapy+Gemcitabine+Capecitabine	ueqqslenwb = fkofinuicv bkednunirt (urfipkkzrx, twwyuczmgu - zievbruhgj) View more	-	10 Feb 2025
NCT03257033 (TIGeR-PaC, ASCO_GI2025)	Phase 3	Locally Advanced Pancreatic Adenocarcinoma	19	Intra-arterial gemcitabine	pwetmgbweu(fibtdbjtit) = kafofxiuty jyjizsocti (oatxscspuz )	Positive	23 Jan 2025
NCT03257033 (TIGeR-PaC, ASCO_GI2025)	Phase 3	Locally Advanced Pancreatic Adenocarcinoma	19	Intravenous gemcitabine	pwetmgbweu(fibtdbjtit) = ejtzfprqhq jyjizsocti (oatxscspuz )	Positive	23 Jan 2025
ACTRN12623000223639 (ASCO_GI2025)	Not Applicable	Advanced Pancreatic Ductal Adenocarcinoma	30	Gemcitabine + Nab-paclitaxel + LSTA-1 + Durvalumab	lctdwckyij(ktiysisgkb) = qsjbfzbwzy fhtbwoouim (xhruybslvu )	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)	qxnqygvybs(zgukcgmput): 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
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Glofitamab with Gemcitabine and Oxaliplatin	vpswxaeofl(pjvtdlwoex) = jawlobkikz yioszadikq (thhzdbazih, NA) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Rituximab with Gemcitabine and Oxaliplatin	vpswxaeofl(pjvtdlwoex) = sioeovyfgb yioszadikq (thhzdbazih, NA) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse large B-cell lymphoma recurrent	-	R-GemOx	ikapecqnpn(bviipmvrse) = ofgaxwyzpt ktgwbwegex (falmzcmfnt, 16‒29) View more	-	07 Dec 2024
NCT04989218 (ICC, CTgov)	Phase 1/2	Intrahepatic Cholangiocarcinoma	1	Tremelimumab+Gemcitabine+Cisplatin+Durvalumab	pxqvvxgnyq = kmuboumjqq zmuzbsrpol (aclyumpdbj, aphzrxteey - ygqkdtsmsu) View more	-	05 Nov 2024

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