Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.

Start Date31 Dec 2025

Sponsor / Collaborator

The Holden Comprehensive Cancer Center

NCT06498648

/ RecruitingPhase 1/2IIT

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas

This phase 1/2 trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.

Start Date14 Oct 2025

Sponsor / Collaborator

National Cancer Institute

NCT06858735

/ Not yet recruitingPhase 2

HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.

Start Date01 Aug 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

19,412

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Jul 2025·BIOMATERIALS

High-density lipoprotein-based nanoplatform reprograms tumor microenvironment and enhances chemotherapy against pancreatic ductal adenocarcinoma

Article

Author: Chen, Jun ; Zhou, Songlei ; Xie, Xiaoying ; Yu, Minghua ; Huang, Yukun ; Chen, Yu ; Xie, Jing ; Chen, Liang

Pancreatic ductal adenocarcinoma (PDAC) is highly aggressive, with limited success in traditional therapies due to the fibrotic, immunosuppressive, pro-metastatic tumor microenvironment (TME), which collectively impede the drug accumulation and accelerate the tumor progression. In this work, we developed a PDAC-customized nutrient-mimicking reconstituted high-density lipoprotein (rHDL) capable of efficiently co-encapsulate versatile TME regulating cannabidiol and cytotoxic gemcitabine to simultaneously reprogram TME while suppressing PDAC progression. Specifically, a small-sized, nutrient-like rHDL was constructed to realize deep PDAC parenchyma penetration and efficient intra-tumoral uptake. Next, natural herbal compound cannabidiol was screened and incorporated into rHDL to regulate TME via attenuating fibrosis, reliving immunosuppression and mitigating metastatic tendency. At last, gemcitabine, the PDAC gold standard first-line therapy was co-delivered by the PDAC-customized rHDL to overcome drug resistance and amplify its PDAC suppression. Our findings demonstrate the feasibility of an integrated multi-stage TME regulation strategy for improved PDAC therapy, and might represent a modality in promoting chemotherapy against PDAC.

24 May 2025·Journal of biomolecular structure & dynamics

Integration analysis of PLAUR as a sunitinib resistance and macrophage related biomarker in ccRCC, an in silicon and experimental study

Article

Author: Gan, Sishun ; Li, Lin ; Jiang, Aimin ; Chu, Jian ; Yang, Qiwei ; Cao, Jianwei ; Ye, Fangdie ; Tian, Yijun

Sunitinib remains the preferred systemic treatment option for specific patients with advanced RCC who are ineligible for immune therapy. However, it's essential to recognize that Sunitinib fails to elicit a favourable response in all patients. Moreover, most patients eventually develop resistance to Sunitinib. Therefore, identifying new targets associated with Sunitinib resistance is crucial. Utilizing multiple datasets from public cohorts, we conducted an exhaustive analysis and identified a total of 8 microRNAs and 112 mRNAs displaying significant expression differences between Sunitinib responsive and resistant groups. A particular set of six genes, specifically NIPSNAP1, STK40, SDC4, NEU1, TBC1D9, and PLAUR, were identified as highly significant via WGCNA. To delve deeper into the resistance mechanisms, we performed additional investigations using cell, molecular, and flow cytometry tests. These studies confirmed PLAUR's pivotal role in fostering Sunitinib resistance, both in vitro and in vivo. Our findings suggest that PLAUR could be a promising therapeutic target across various cancer types. In conclusion, this investigation not only uncovers vital genes and microRNAs associated with Sunitinib resistance in RCC but also introduces PLAUR as a prospective therapeutic target for diverse cancers. The outcomes contribute to advancing personalized healthcare and developing superior therapeutic strategies.

01 May 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Mn-doped MOF nanoparticles mitigating hypoxia via in-situ substitution strategy for dual-imaging guided combination treatment of microwave dynamic therapy and chemotherapy

Article

Author: Jiang, Guihua ; Wang, Haiying ; Qu, Hong ; Hang, Lifeng ; Meng, Xianwei ; Li, Hong ; Diao, Yanzhao ; Fang, Laiping ; Sun, Hui ; Liu, Jinwu ; Liu, Wangzi ; Wang, Jizhuang

Microwave dynamic therapy (MWDT) destroy tumor cells using reactive oxygen species (ROS), but its effectiveness is limited by low ROS production and intracellular oxygen (O₂) availability. This study presents a novel strategy using manganese (II) ion (Mn²⁺) doped iron (Fe)-based metal-organic framework (Fe MOF) nanoparticles (NPs) to enhance both O₂ generation and ROS production for improved MWDT. Incorporating Mn²⁺ into Fe MOF narrows the bandgap from 0.673 eV to 0.429 eV, improving the separation of electronic-hole pair and increasing ROS yield. Meanwhile, Mn-porphyrin nanocomplexes facilitate the decomposition of hydrogen peroxide to O₂in situ. Additionally, encapsulating the chemotherapeutic drug gemcitabine (GEM) within NPs and surface-modifying with Pluronic F127 creates Mn-Fe MOF@GEM@F127 (MMGF) NPs, which are suitable for photoacoustic/magnetic resonance imaging guidance (relaxivity, r₁: 2.007 mM^-1s^-1). The microwave (MW)/pH dual responsive GEM release works synergistically with MWDT, thereby more effectively disrupting tumor cells. This strategy differs from monotherapy by using MW sensitizers to enhance O₂ production, which not only increases the efficiency of ROS generation in MWDT but also makes subsequent chemotherapy more effective while reducing the side effects of conventional chemotherapy. This combined treatment reduced HONE-1 cell proliferation and tumor growth by 89.95 % and 96.12 %, respectively. The study proposes a versatile strategy to significantly improve both MWDT and chemotherapy efficacy with potential applications to various cancers.

686

News (Medical) associated with Gemcitabine Hydrochloride

31 Mar 2025

·pipelinereview.com

Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer

Based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone LONDON, UK I March 31, 2025 I AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapyafter radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and was based on results from the NIAGARA Phase III trial which were presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine . In 2024, over 20,000 people in the US were treated for MIBC. 1 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases. 2 This represents a curative-intent setting, where the current standard of care is neoadjuvant chemotherapy and radical cystectomy. 3 However, even after surgery, patients experience high rates of disease recurrence and have a poor prognosis. 3 Matthew ND. Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and NIAGARA investigator and steering committee member, said: “This approval for the durvalumab-based perioperative regimen is a major breakthrough for people with muscle-invasive bladder cancer, nearly half of whom see their cancer return despite chemotherapy and surgery with curative-intent. This durvalumab regimen significantly extended patients’ lives in the NIAGARA trial and has the potential to transform care.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant need for better treatment options. The NIAGARA trial showed more than 80 per cent of patients were still alive at two years, underscoring the potential of this innovative perioperative regimen to become a new standard of care in this setting.” Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, said: “More than 20,000 people in the US were treated for muscle-invasive bladder cancer last year and there is a significant need for new treatment options that improve patient outcomes. The approval of the durvalumab perioperative regimen is welcome news, transforming how clinicians will tackle this disease in future and offering new hope to patients and their loved ones.” In the trial, patients were treated with four cycles of Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy before radical cystectomy. In a planned interim analysis, the Imfinzi -basedperioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm. Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi -based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm. Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events (imAEs) were consistent with the known profile of Imfinzi , manageable and mostly low-grade. In February 2025, perioperative treatment with durvalumab ( Imfinzi ), neoadjuvant cisplatin-based chemotherapy and cystectomy was added to the NCCN Clinical Practical Guidelines in Oncology (NCCN Guidelines ® ) as a NCCN Category 1 Recommended regimen for patients with MIBC based on the data from NIAGARA. 4 Imfinzi is also approved in Brazil in this setting based on the NIAGARA results. Regulatory applications are currently under review in the EU, Japan and several other countries. Notes Muscle-invasive bladder cancer Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year. 5 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract. 6 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence. 3 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting. NIAGARA NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by Imfinzi, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting. The trial is being conducted at 192 centres across 22 countries including in North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response (pCR) at the time of cystectomy. Key secondary endpoints are OS and safety. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. In addition to the indication in bladder cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC. In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of event-free survival in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1 st -line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan. Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi . As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . References SOURCE: AstraZeneca

Clinical ResultPhase 3ImmunotherapyDrug Approval

31 Mar 2025

·www.globenewswire.com

Junshi Biosciences Announces Toripalimab’s Approval in Singapore

March 26, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the New Drug Application (the “NDA”) for toripalimab (Singapore trade name: LOQTORZI®) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (“NPC”) has been approved by the Singapore Health Sciences Authority (the HSA). Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore. NPC is a malignant tumor that occurs in the epithelium mucosae of the nasopharynx and is one of the most common types of head and neck cancers. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Toripalimab is the only preferred regimen recommended for the comprehensive treatment of recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers. The approval is primarily based on the results from JUPITER-02 (NCT03581786), the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size. JUPITER-02 is also the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) demonstrating a significant overall survival (“OS”) benefit for first-line immunotherapy combined with chemotherapy compared to chemotherapy alone in NPC. JUPITER-02’s results were presented in an oral report during a Plenary Session at the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2). These results were subsequently featured on the cover of Nature Medicine and published in full in the Journal of the American Medical Association (JAMA). The results of the study showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (“ORR”) and longer duration of response (“DoR”), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data was presented at ASCO 2024, with a 5-year survival rate of 52%. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “Toripalimab’s approval in Singapore represents our formal entry into the Southeast Asian market. Southeast Asia is a region with a high incidence of NPC, and we are proud to introduce this groundbreaking therapy to address unmet medical needs and transform the local treatment landscape. As of now, toripalimab has received marketing authorization in over 35 countries and regions across four continents. We remain committed to our ‘In China, For Global’ strategy, advancing innovative medicines from China to improve healthcare for patients across the globe.” The NDA was submitted under Project Orbis. Project Orbis, initiated and advocated by the Oncology Center of Excellence (OCE) of the U.S. Food and Drug Administration (the “FDA”), provides a collaborative mechanism and framework among the FDA and regulatory authorities in other countries and regions, allowing different regulatory authorities to jointly review the applications for registration of oncology drugs. Toripalimab was the first domestic oncology drug to be included in Project Orbis. Previously, the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”) approved two New Chemical Entity applications for toripalimab in NPC under Project Orbis. Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are eleven approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC); in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC; in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC); in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC); in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries or regions around the global. Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalImmunotherapyClinical ResultASCO

31 Mar 2025

·www.astrazeneca.com

Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer

AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and was based on results from the NIAGARA Phase III trial which were presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine. In 2024, over 20,000 people in the US were treated for MIBC.1 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.2 This represents a curative-intent setting, where the current standard of care is neoadjuvant chemotherapy and radical cystectomy.3 However, even after surgery, patients experience high rates of disease recurrence and have a poor prognosis.3 Matthew ND. Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and NIAGARA investigator and steering committee member, said: “This approval for the durvalumab-based perioperative regimen is a major breakthrough for people with muscle-invasive bladder cancer, nearly half of whom see their cancer return despite chemotherapy and surgery with curative-intent. This durvalumab regimen significantly extended patients’ lives in the NIAGARA trial and has the potential to transform care.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant need for better treatment options. The NIAGARA trial showed more than 80 per cent of patients were still alive at two years, underscoring the potential of this innovative perioperative regimen to become a new standard of care in this setting.” Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, said: “More than 20,000 people in the US were treated for muscle-invasive bladder cancer last year and there is a significant need for new treatment options that improve patient outcomes. The approval of the durvalumab perioperative regimen is welcome news, transforming how clinicians will tackle this disease in future and offering new hope to patients and their loved ones.” In the trial, patients were treated with four cycles of Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy before radical cystectomy. In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm. Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm. Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events (imAEs) were consistent with the known profile of Imfinzi, manageable and mostly low-grade. In February 2025, perioperative treatment with durvalumab (Imfinzi), neoadjuvant cisplatin-based chemotherapy and cystectomy was added to the NCCN Clinical Practical Guidelines in Oncology (NCCN Guidelines®) as a NCCN Category 1 Recommended regimen for patients with MIBC based on the data from NIAGARA.4 Imfinzi is also approved in Brazil in this setting based on the NIAGARA results. Regulatory applications are currently under review in the EU, Japan and several other countries. Notes Muscle-invasive bladder cancer Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.5 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.6 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.3 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting. NIAGARA NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by Imfinzi, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting. The trial is being conducted at 192 centres across 22 countries including in North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response (pCR) at the time of cystectomy. Key secondary endpoints are OS and safety. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. In addition to the indication in bladder cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC. In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of event-free survival in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan. Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Adrian Kemp Company Secretary AstraZeneca PLC Oncology Corporate and financial

Clinical ResultPhase 3ImmunotherapyDrug ApprovalPriority Review

100 Deals associated with Gemcitabine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	Australia	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	Japan	Eli Lilly & Co.	25 Nov 2008
Biliary Tract Neoplasms	Japan	Eli Lilly & Co.	31 Aug 2001
Lymphoma	Japan	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	Japan	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	United States	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	United States	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	United States	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	United States	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	NDA/BLA	United States	Johnson & Johnson (China) Investment Ltd.	15 Jan 2025
Diffuse Large B-Cell Lymphoma	Phase 3	United States	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	China	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	Australia	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	Belgium	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	Denmark	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	France	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	Germany	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	Poland	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	Spain	Hoffmann-La Roche, Inc.	23 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase II study on maintenance gemcitabine (ESMO_ELCC2025)	Phase 2	Malignant Pleural Mesothelioma Maintenance complete blood count with leukocyte differential \| lactate dehydrogenase (LDH) \| erythrocyte sedimentation rate (ESR) ... View more	64	Gemcitabine maintenance	vjmlsedxmw(owmayqtwtz) = dfzvjlbyjo jdifnkdrly (pvlywrxaba, 2.7 - 369.0) View more	-	26 Mar 2025
				gemcitabine (Best supportive care)	vjmlsedxmw(owmayqtwtz) = gnproeagxe jdifnkdrly (pvlywrxaba, 0.8 - 25.0) View more
NCT04480372 (SAKK 17/18 ORIGIN, ESMO_ELCC2025)	Phase 2	Malignant Pleural Mesothelioma	30	Gemcitabine + Atezolizumab	bpxovojbfa(odzqpgklhn) = jvkvrkchqm nvwsxrgmgt (qxtkagmdwp, 5.9%, 3.8% - 30.7%) View more	Positive	26 Mar 2025
NCT02506959 (CTgov)	Phase 2	Recurrent Multiple Myeloma \| Relapse multiple myeloma \| Refractory Multiple Myeloma ... View more	83	Peripheral Blood Stem Cell Transplantation+Panobinostat+Busulfan+Melphalan+Gemcitabine Hydrochloride (Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel)	bwhctvbyum = urfilirack rlofyhquio (dvoopqkqoj, zuvdlbppyh - wmnjfqljmq) View more	-	25 Mar 2025
				Peripheral Blood Stem Cell Transplantation+Panobinostat+Busulfan+Melphalan+Gemcitabine Hydrochloride (Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel)	bwhctvbyum = zuieywerhn rlofyhquio (dvoopqkqoj, ubmwmwadcj - mxedawosnq) View more
NCT03137771 (NRG-LU002, CTgov)	Phase 2	metastatic non-small cell lung cancer \| Recurrent Non-Small Cell Lung Cancer	218	Erlotinib Hydrochloride+Gemcitabine+Docetaxel+pembrolizumab+Pemetrexed Disodium (Arm 1 (Systemic Maintenance Chemotherapy))	qqngftojuk(mbsmiwclef) = jpzjaqtfpl hubldihygd (hoetagqesh, elqbvowrmo - rixznybbtx) View more	-	25 Mar 2025
				Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + Systemic Maintenance Chemotherapy))	qqngftojuk(mbsmiwclef) = ibplojufak hubldihygd (hoetagqesh, mpfuufmucb - zwjxkdifsw) View more
NCT03317158 (HCRN GU16-243: ADAPT-BLADDER Cohort 4, ASCO_GU2025) Manual	Phase 1/2	Non-Muscle Invasive Bladder Neoplasms	40	Durvalumab + gemcitabine + docetaxel	myripzaisa(icxkoizpot) = ojemmwscnp bsmcacdyqy (jumceuuyxe ) View more	Positive	13 Feb 2025
NCT02705508 (Pubmed \| Hematology) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma First line	34	PEG (pegaspargase, etoposide, gemcitabine)	oxkqkqpvjl(lvayvmylml) = ghxgqvdveg fwtsdohgln (sbfzsilvgo ) View more	Positive	31 Dec 2024
ESMO_IO2024	Not Applicable	Advanced Bile Duct Carcinoma First line CEA \| albumin \| GGT ... View more	319	gemcitabine (Low Risk Group)	dtkgvhmblg(vlvfpsospo) = xpoxvsasvv hikaynkzom (pnsdtunvev ) View more	Positive	12 Dec 2024
				gemcitabine (Intermediate Risk Group)	dtkgvhmblg(vlvfpsospo) = prfhqmbhat hikaynkzom (pnsdtunvev ) View more
ESMO_ASIA2024	Not Applicable	Biliary Tract Neoplasms Adjuvant	302	Gemcitabine plus Capecitabine (GEMCAP)	uzxmfymeza(bvlwyfzcbf) = ufpchwiqqu pyzxmqhsbf (uuwjqiengo )	Positive	07 Dec 2024
				Capecitabine (CAP)	uzxmfymeza(bvlwyfzcbf) = drzysdviok pyzxmqhsbf (uuwjqiengo )
ESMO_ASIA2024	Not Applicable	Advanced biliary tract cancer First line CEA \| albumin \| GGT ... View more	319	gemcitabine (Low Risk Group)	pgxucwdaqg(dxllfupode) = hoqmslmdgs fxdiaycayz (kwfcadiney ) View more	Positive	07 Dec 2024
				gemcitabine (Intermediate Risk Group)	pgxucwdaqg(dxllfupode) = hrbkjsxtkk fxdiaycayz (kwfcadiney ) View more
NCT02312245 (CTgov)	Phase 2	Platinum-Resistant Fallopian Tube Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma	13	Paclitaxel+Bevacizumab (Arm A (Avatar-directed Paclitaxel))	dgxolgpqji = ilcpembxrq jcgwvkgomj (tjgofeuzmx, ogguoiznef - pkcywlpltp) View more	-	05 Dec 2024
				Gemcitabine Hydrochloride (Arm B (Avatar-directed Gemcitabine Hydrochloride))	dgxolgpqji = ddrxouduiz jcgwvkgomj (tjgofeuzmx, oekldkeozp - waabmfvryv) View more

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