A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Start Date01 Jan 2030

Sponsor / Collaborator

Lisata Therapeutics, Inc.

NCT04910386

/ Not yet recruitingPhase 2

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Start Date01 Jun 2027

Sponsor / Collaborator

3D Medicines (Sichuan) Co., Ltd.

NCT07365306

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Start Date30 Dec 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

14,590

Literatures (Medical) associated with Gemcitabine Hydrochloride

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

Author: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Lotan, Yair ; Zhao, Angela

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

01 Mar 2026·JOURNAL OF CLINICAL ONCOLOGY

Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results

Article

Author: Sanchez de Llano, Cristina ; Necchi, Andrea ; Crispen, Paul L. ; Szabados, Bernadett ; Hasan, Mohamad ; Psutka, Sarah P. ; Battaglia, Sebastiano ; Peyton, Charles C. ; Bögemann, Martin ; Stitou, Hind ; Shore, Neal ; Preston, Mark A. ; Gong, Cinty ; Ku, Ja Hyeon ; Pradere, Benjamin ; Guerrero-Ramos, Félix ; Garje, Rohan ; Xylinas, Evanguelos ; Bhanvadia, Sumeet ; Sweiti, Hussein ; Urtishak, Karen ; Herrera-Imbroda, Bernardo

PURPOSE:

Standard of care for muscle-invasive bladder cancer (MIBC) is radical cystectomy (RC) with neoadjuvant cisplatin-based chemotherapy (NAC). However, many patients are ineligible for or refuse cisplatin. SunRISe-4 (ClinicalTrials.gov identifier: NCT04919512 ) is an open-label, multicenter, parallel-cohort phase II study assessing neoadjuvant gemcitabine intravesical system (TAR-200/gem-iDRS) plus cetrelimab or cetrelimab monotherapy in patients with MIBC.

METHODS:

Adults with Eastern Cooperative Oncology Group performance status 0-1, cT2-T4a N0M0, ineligible/refusing NAC, and planned for RC were randomly assigned 5:3, stratified by transurethral resection of bladder tumor completeness (residual tumor ≤3 cm permitted) and T stage, to receive TAR-200 plus cetrelimab (cohort 1) or cetrelimab monotherapy (cohort 2). The primary end point was pathologic complete response (pCR) at RC. Secondary end points included recurrence-free survival (RFS) and safety. Exploratory end points included pathologic overall response (pOR; ≤ypT1N0) and circulating tumor (ct) and urinary tumor (ut) DNA molecular residual disease (MRD). Side-by-side descriptive efficacy summary was planned.

RESULTS:

At the May 9, 2025, data cutoff, 159 patients were treated; 88 in cohort 1 and 46 in cohort 2 underwent RC. pCR, pOR, and 1-year RFS rates were 38%, 53%, and 77% in cohort 1 and 28%, 44%, and 64% in cohort 2, respectively. pCR rates were consistent across subgroups. No new safety signals were observed. Across cohorts, utDNA– status before RC (week 12) and utDNA clearance correlated with pCR ( P < 10 –5 and < 10 –3 , respectively). ctDNA– status at baseline and week 12 was associated with longer RFS compared with ctDNA+ status at the same time point ( P = .04 and 0.01, respectively).

CONCLUSION:

TAR-200 plus cetrelimab provided higher pCR, pOR, and 1-year RFS rates compared with cetrelimab monotherapy, supporting further investigation of the neoadjuvant combination in MIBC. utDNA and ctDNA MRD results support further investigation as biomarkers for residual local and nonlocal disease, respectively.

24 Feb 2026·CURRENT TOPICS IN MEDICINAL CHEMISTRY

An Expedition of FDA-Approved Anticancer Drugs in 2024: Synthetic Routes, Mechanisms of Action, and Clinical Indications.

Article

Author: Kurmi, Balak Das ; Priya, Sakshi ; Soni, Reena ; Cherian, Issac V ; Kasana, Shivani ; Islam, Md Mustahidul ; Das, Km Supriya ; Patel, Preeti

The year 2024 witnessed significant advancements in cancer therapy, with the U.S. Food and Drug Administration (FDA) approving 56 anticancer drugs for various malignancies. These approvals encompass 36 organic small molecules and 20 macromolecular monoclonal antibody conjugates, each with distinct mechanisms of action targeting key oncogenic pathways. Among the small molecules, kinase inhibitors such as Ribociclib, Imatinib Mesylate, and Nilotinib Hydrochloride Dihydrate modulate critical signaling cascades, while antimetabolites like Fluorouracil and Pemetrexed Disodium disrupt nucleotide biosynthesis. Other classes include DNA-damaging agents (Mitomycin, Gemcitabine Hydrochloride), immune modulators (Pomalidomide, Lenalidomide), and hormonal antagonists (Abiraterone Acetate, Erleada). The macromolecular therapeutics primarily consist of monoclonal antibody-based agents, such as Keytruda, Tecentriq, and Imfinzi, which enhance immune checkpoint inhibition, and antibody-drug conjugates like Enhertu and Elahere, which deliver cytotoxic payloads with high specificity. This review systematically examines the chemical synthesis, mechanisms of action, and therapeutic indications of these FDAapproved agents, emphasizing their role in improving patient outcomes. By analyzing their structural frameworks and biological targets, we aim to provide insights into current trends in anticancer drug development and potential future directions.

906

News (Medical) associated with Gemcitabine Hydrochloride

16 Apr 2026

·www.biospace.com

TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications

TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications Berlin, Germany , April 16, 2026, 08.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for braincancer and eye diseases, is pleased to announce a Nature Communications article on the results from the Phase 1/2 expansion Arm A cohort of the GLORIA trial testing NOX-A12 + radiotherapy + anti-VEGF “triple therapy” in glioblastoma patients. The article in the scientific peer-reviewed high-impact journal, Nature Communications, describes results of the expansion cohort Arm A in TME Pharma’s Phase 1/2 GLORIA trial. In this arm, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients with residual tumor after surgery received NOX-A12 + radiotherapy + anti-VEGF (bevacizumab) “Triple Therapy”. The authors noted that overall survival (OS) of patients receiving NOX-A12 Triple Therapy significantly outperformed two different cohorts of similar patients external to the trial who received standard of care treatment, and further noted that due to the conservative trial design, the study “likely underestimates survival compared with most contemporary trials.” As already disclosed in the March 5, 2024 press release, the GLORIA trial has been amended to allow inclusion of 100 additional patients in a randomized, controlled Phase 2 part of the trial composed of 5 additional arms (Expansion Group Arms D through H) to assess three different doses of NOX-A12 in the Triple Therapy, one dose of NOX-A12 + radiotherapy and standard of care. It is planned to initiate this Phase 2 part of the trial once appropriate partnerships are in place. The findings described in the publication demonstrate the potential and value of TME Pharma’s NOX-A12 asset. TME Pharma remains confident in its strategy to search for a strategic partner to outlicense NOX-A12with the goal of bringing NOX-A12 to market authorization. As communicated on January 5, 2026, TME Pharma continues its active discussions with potential partners for the NOX-A12 program. As indicated in its press release of March 9, 2026, TME Pharma’s financial runway now extends to Q2-2027, providing the company with the flexibility to identify the optimal partnership for NOX-A12. Diede van den Ouden, CEO of TME Pharma , said: "We are encouraged by the publication in Nature Communications, which underscore the scientific validity of our approach. We remain fully committed to bringing NOX-A12 to success and believe that a strategic partnership is the optimal path forward. With our extended cash runway, we are well-positioned to continue our negotiations with potential partners." The full article can be found for reading through the TME Pharma website. Through the TME Pharma website > Scientific Approach > Scientific Publications and on the landing page. For more information, please contact: TME Pharma N.V. Diede van den Ouden, CEO ir@tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO) Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company Leveraging tax loss carry forwards Potentially gaining exposure to digital assets Further information can be found at: . About the GLORIA Study GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab. About the OPTIMUS Study OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Disclaimer Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law. Management will now iParallel to its core biotechnology activities, the company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company's flagship products, NOXA12 and NOX-E36. Attachment ENG_TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1_2 Expansion Arm A Findings from GLORIA trial in Nature Communications

Phase 2Fast TrackOrphan DrugClinical Result

16 Apr 2026

·allsci.com

Partner Therapeutics seeking third indication for Bizengri in NRG1 fusion-positive cholangiocarcinoma

Partner Therapeutics submitted a supplemental Biologics License Application (sBLA) to the US FDA on April 14, 2026 for Bizengri (zenocutuzumab-zbco), seeking approval for adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion. The filing marks the first regulatory submission for Bizengri in this bile duct malignancy with the aim of adding a third indication to the molecule’s existing accelerated approvals in NRG1 fusion-positive non-small cell lung cancer and pancreatic adenocarcinoma. The sBLA seeks approval without restriction to a specific line of therapy, the company said. The filing is supported by data from the eNRGy study, a basket trial evaluating zenocutuzumab-zbco across NRG1 fusion-positive solid tumors. No priority review or accelerated pathway designation was disclosed in the announcement, and the company did not provide a projected PDUFA date. Bizengri’s cholangiocarcinoma data The cholangiocarcinoma cohort of the eNRGy study generated an overall response rate of 36.8% (95% CI: 16.3, 61.6%) and a median duration of response of 12.9 months, as assessed by blinded independent central review. No patients in that cohort discontinued therapy due to adverse events, the company said. The mechanism underlying the filing differs from all currently approved CCA therapies: zenocutuzumab-zbco is a bispecific antibody that simultaneously blocks HER2/HER3 heterodimerization and NRG1 fusion interactions with HER3, disrupting downstream signaling driven by NRG1 chimeric ligands rather than the chimeric receptors targeted by FGFR inhibitors such as pemigatinib and futibatinib. NRG1 fusions are estimated to occur in fewer than 2% of cholangiocarcinoma cases, and the source material states that no approved therapies currently target this molecular subgroup in the disease. The rarity of the alteration creates a diagnostic challenge: unlike NTRK, RET, or FGFR fusions, NRG1 fusions produce chimeric ligands that are frequently missed by DNA-only next-generation sequencing panels and require tissue-based RNA testing for reliable detection. Partner Therapeutics noted this in its announcement, with Chief Development Officer Pritesh Gandhi stating that RNA testing is essential to ensure patients with NRG1-driven tumors are identified. NCCN guidelines The filing arrives alongside a notable guideline development. The National Comprehensive Cancer Network added zenocutuzumab-zbco to its oncology clinical practice guidelines for biliary tract cancers as a Category 2A subsequent-line therapy and as a Category 2B recommendation for front-line treatment of NRG1 fusion-positive cholangiocarcinoma — the latter positioning preceding any formal regulatory approval for the indication. Dr. James Cleary of Dana-Farber Cancer Institute, commenting in the release, described NRG1 gene fusions as an actionable biomarker in this disease and said the eNRGy data suggest targeted inhibition with zenocutuzumab may represent a meaningful treatment approach. The cholangiocarcinoma treatment landscape has undergone substantial change since 2020, when pemigatinib became the first targeted therapy approved in the disease. Ivosidenib followed in 2021 for IDH1-mutant CCA, futibatinib in 2022 for FGFR2 fusion-positive intrahepatic disease, and durvalumab in combination with gemcitabine and cisplatin was approved the same year for first-line biliary tract cancer regardless of biomarker status. Pembrolizumab combined with gemcitabine and cisplatin received approval in 2023 for the same unselected population. Despite this expansion, the molecular subgroup defined by NRG1 fusions has remained without a specifically labeled therapy, and the eNRGy data represent the primary clinical evidence base for this population in CCA. The sBLA adds to a field where accelerated approval pathways have played a central role, and where the durability of those approvals has varied. Infigratinib, an FGFR1–3 inhibitor that received accelerated approval in 2021 for FGFR2 fusion-positive CCA, was voluntarily withdrawn in 2024 after a confirmatory trial failed to verify clinical benefit — a precedent that underscores the regulatory risk associated with response-rate-based submissions in this disease. The eNRGy cholangiocarcinoma cohort was small, as is typical for trials enrolling rare fusion-defined populations, and the 95% confidence interval for the reported ORR is correspondingly wide. Bizengri’s existing accelerated approvals in NSCLC and pancreatic adenocarcinoma were also granted based on overall response rate and duration of response, with continued approval in those indications contingent on confirmatory trial data. The cholangiocarcinoma sBLA follows the same evidentiary model. Partner Therapeutics holds exclusive US rights to develop and commercialize zenocutuzumab-zbco under an agreement with Merus B.V., a wholly owned subsidiary of Genmab. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

15 Apr 2026

·www.globenewswire.com

Genmab Presents the Safety and Tolerability of Rinatabart Sesutecan (Rina-S®) in Combination with Bevacizumab in Advanced Ovarian Cancer

Phase 1/2 RAINFOL™-01 data showed the combination of rinatabart sesutecan (Rina-S®) and bevacizumab was tolerable, with no new safety signals in patients with advanced ovarian cancer The ongoing Phase 3 RAINFOL-04 trial will further evaluate the combination in patients with recurrent platinum-sensitive ovarian cancer (PSOC) Genmab A/S (Nasdaq: GMAB) announced today new data demonstrating that rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL™-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in San Juan, Puerto Rico. “Advanced ovarian cancer is a complex and difficult-to-treat disease, and the ability for investigational therapies such as Rina-S to be safely combined with bevacizumab can provide clinicians with more options to help improve disease control and manage resistance,” said Cara Mathews, M.D., study investigator and Associate Professor, Obstetrics and Gynecology at the Women and Infants Hospital, Brown University. “Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care therapy such as bevacizumab without significantly increasing the risk of additional side effects.” As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S (120 mg/m2) plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events (AEs). The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common (≥25%) treatment-emergent AEs (TEAEs) included nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients (15.0%), and TEAEs leading to Rina-S dose reductions occurred in 11 patients (27.5%). Rina-S and bevacizumab discontinuation occurred in two patients (5%). No fatal TEAEs were reported. “Today’s safety results from RAINFOL-01 add to the growing body of clinical evidence supporting further development of Rina-S in advanced ovarian cancer, including its potential to be used in a combination regimen,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “Rina-S has the potential to meaningfully expand treatment possibilities for patients with certain gynecologic cancers, and we look forward to further investigating additional opportunities, alone and with other therapies, as Rina-S advances through late-stage clinical development.” Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial (NCT06619236) in patients with platinum-resistant ovarian cancer (PROC), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, and the Phase 3 RAINFOL-04 trial (NCT07225270) in patients with recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy. Rina-S is also being evaluated in the Phase 2 RAINFOL-05 study (NCT07288177) in patients with non-small cell lung cancer (NSCLC). RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of Rina-S Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part D combination therapy cohorts. Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Standard of care for PROC typically involves single-agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel) and mirvetuximab for FRα-positive (≥75% positive tumor cells) patients.iv,v Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.vi Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vii,viii Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial and other cancers with unmet need. Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody-drug conjugates (ADCs), immune-modulating antibodies, and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. i World Cancer Research Fund International. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/. Accessed Oct 2025. ii World Ovarian Cancer Coalition. https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/. Accessed Oct 2025. iii Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival - Population cohort study in the 'no screen' arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002. iv Eskander RN, Moore KN, Monk BJ, Herzog TJ, Annunziata CM, O’Malley DM and Coleman RL (2023) Overcoming the challenges of drug development in platinum-resistant ovarian cancer. Front. Oncol. 13:1258228. v National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients®: Ovarian Cancer. Version 3.2024. July 15, 2024. https://www.nccn.org/patients/guidelines/content/PDF/ovarian-patient.pdf vi Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/ vii European Institute of Women's Health. https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/. Accessed Oct 2025. viii American Cancer Society. Stages of Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html. Accessed Oct 2025. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCO

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
Non-Muscle Invasive Bladder Neoplasms	United States	Janssen Biotech, Inc.	09 Sep 2025
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
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	26 May 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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced biliary tract cancer	Phase 3	Taiwan Province	InnoPharmax, Inc.	01 May 2026
Recurrent Bladder Cancer	Phase 3	United States	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	China	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Japan	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Argentina	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Belgium	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Brazil	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	France	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Germany	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Italy	Janssen Research & Development LLC	09 Apr 2024

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05498220 (CTgov)	Phase 2	Diffuse large B-cell lymphoma recurrent	5	Hyaluronidase+Polatuzumab vedotin+GCSF+Gemcitabine+cisplatin+Dexamethasone+Rituximab+PV	zgjgizrxga = aligikvvak kdjhwegqhy (tjcjoontkc, jzmrmybibh - peadrmtfos) View more	-	16 Apr 2026
ESMO_SRC2026	Not Applicable	Leiomyosarcoma	336	Gemcitabine combined with docetaxel	oinatzmbpg(qujphqjaeb) = exlmaxhqee lrpjmgfxzb (bstlymjpvg ) View more	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Perivascular epithelioid cell tumour	3	sirolimus + exemestane + gemcitabine	tpqzkploun(djqnxepelx) = oimdfbpynt kpjslbggqs (oipltikeql ) View more	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Chondrosarcoma	10	Gemcitabine 1000 mg/m2 plus Oxaliplatin 100 mg/m2	oztgzwsscn(asyafefyxc) = Treatment was generally well tolerated, with limited grade 3 toxicity and one case of grade 5 thrombotic microangiopathy-associated to gemcitabine eolpczynbf (zotbwsfpgl )	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Leiomyosarcoma Second line	108	Trabectedin	tehloizqjy(igfkagezdz) = zxncgqbhxj ggoewazydx (tyvatbyopt, 5.5 - 15.2) View more	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Leiomyosarcoma Second line	108	gemcitabine-based chemotherapy	tehloizqjy(igfkagezdz) = dslvqqcpbt ggoewazydx (tyvatbyopt, 3.8 - 6.4) View more	Positive	09 Mar 2026
ASCO_GU2026	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	133	BCG	ktxigorpss(rfpbvxqcxz) = ccvbmlbtis yadmonpovz (hkjisjiekk ) View more	Negative	26 Feb 2026
ASCO_GU2026	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	133	sequential gemcitabine and docetaxel (Gem/Doce)	ktxigorpss(rfpbvxqcxz) = lztgfjmqqz yadmonpovz (hkjisjiekk ) View more	Negative	26 Feb 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma Neoadjuvant	517	Gemcitabine 800 mg/m2	ewcmjbuick(qbgumkydhq): P-Value = 0.012 View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma Neoadjuvant	517	Gemcitabine 1000 mg/m2	ewcmjbuick(qbgumkydhq): P-Value = 0.012 View more	Positive	26 Feb 2026
NCT04179162 (ALLIANCE A032303, ASCO_GU2026)	Phase 1/2	Recurrent Bladder Cancer	52	Gemcitabine + BCG	ftfnugnnop(pamkhazmcp) = dgokkkzjny ozcmvakasm (xbzbqgngyc ) View more	Positive	26 Feb 2026
NCT04628767 (EA8192, ASCO_GU2026)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma Neoadjuvant	30	Gemcitabine/Durvalumab	cyelguqlsy(vdfhygtwyc) = idgfaxovjz qywsqahdyw (pvrpppwbdd, 3.0 - 25.2) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma	98	Cisplatin	vitvysxwbn(gfkhtoytwx) = qithfnpeze wkgzbciscv (zjmhrxdcis ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma	98	5-FU+MMC	vitvysxwbn(gfkhtoytwx) = ujphtulvui wkgzbciscv (zjmhrxdcis ) View more	Positive	26 Feb 2026

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