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Last update 27 Jun 2025

Irinotecan Hydrochloride

Last update 27 Jun 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ASC-201 - Ascelia Pharma, irinotecan, Irinotecan hydrochloride (USP)

+ [35]

Target

Top I

Action

inhibitors

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [7]

Active Indication

Childhood Malignant Solid NeoplasmIntestinal NeoplasmsColonic Cancer+ [29]

Inactive Indication

AdenocarcinomaAdenocarcinoma of EsophagusAdenocarcinoma of large intestine+ [62]

Originator Organization

Yakult Honsha Co., Ltd.

Active Organization

Yakult Honsha Co., Ltd.Hoffmann-La Roche, Inc.

Alfresa Pharma Corp.

+ [10]

Inactive Organization

Sanofi

Bristol Myers Squibb Co.

AstraZeneca PLC

+ [13]

License Organization

Hanmi Pharmaceutical Co., Ltd.Athenex Pharmaceuticals Co. Ltd.

Daiichi Sankyo Co., Ltd.

+ [5]

Drug Highest PhaseApproved

First Approval Date

Japan (19 Jan 1994),

Non-Small Cell Lung CancerOvarian CancerPancreatic Cancer+ [3]

RegulationAccelerated Approval (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC33H45ClN4O9

InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N

CAS Registry136572-09-3

1,547

Clinical Trials associated with Irinotecan Hydrochloride

NCT06620302

/ RecruitingPhase 1/2IIT

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.

Start Date21 Feb 2026

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT06998940

/ Not yet recruitingPhase 3IIT

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil [5-FU] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

Start Date06 Jan 2026

Sponsor / Collaborator

SWOG

[+1]

NCT06846346

/ Not yet recruitingPhase 2IIT

Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients

The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.

Start Date01 Sep 2025

Sponsor / Collaborator

UNICANCER

[+1]

100 Clinical Results associated with Irinotecan Hydrochloride

100 Translational Medicine associated with Irinotecan Hydrochloride

100 Patents (Medical) associated with Irinotecan Hydrochloride

12,528

Literatures (Medical) associated with Irinotecan Hydrochloride

31 Dec 2025·AUTOIMMUNITY

Deciphering distinct pathogenic mechanisms of ankylosing spondylitis and systemic sclerosis via shared biomarkers ZSWIM6 and CCL3L3: Insights from an integrative bioinformatics approach

Article

Author: Zhou, Chenxing ; Chen, Jiarui ; Zhan, Xinli ; Xue, Jiang ; Shi, Jianjun ; Zhou, Zhongxian ; Yang, Renbang ; Huang, Liangyu ; Huang, Chengqian ; Liu, Chong ; Chen, Tianyou ; Feng, Sitan ; Huang, Jieping ; Wu, Shaofeng ; Zhu, Jichong

Ankylosing Spondylitis (AS) and Systemic Sclerosis (SSc) are both autoimmune diseases, albeit with distinct anatomical targets. AS primarily affects the spine and sacroiliac joints, triggering inflammation and eventual fusion of the vertebrae. SSc predominantly impacts the skin and connective tissues, leading to skin fibrosis, thickening, and potential damage to vital organs such as the lungs, heart, and kidneys. Despite their differing anatomical manifestations, inflammation serves as a pivotal factor in both conditions. Exploring the causes of the different pathogenesis of inflammation in AS and SSc could provide new insights into their treatment. We selected RNA-seq profiles of peripheral blood mononuclear cells (PBMCs) from the GEO datasets GSE73754 and GSE19617. DEGs were identified using the Limma R package with an adjusted p-value cutoff of < 0.05. Gene Ontology pathway analysis, SVM recursive feature elimination, and Gene Set Enrichment Analysis (GSEA) were conducted to analyze the DEGs. CIBERSORT was applied to estimate immune cell composition and its correlation with hub genes. Single-cell RNA sequencing data from peripheral blood mononuclear cells in the GSE194315 dataset were included to support differential expression analysis and biomarker identification. Additionally, single-cell RNA sequencing data from bone marrow blood samples were utilized to further validate these findings, offering complementary insights into biomarker expression across distinct sample types. A total of 762 DEGs were identified between AS patients and controls, and 441 DEGs between SSc patients and controls. Both conditions showed enrichment in the Natural killer cell mediated cytotoxicity pathway. ZSWIM6 and CCL3L3 were identified as potential biomarkers in AS and SSc, with significant diagnostic capabilities demonstrated by ROC analysis. Correlation analysis revealed associations between these biomarkers and specific immune cell types. The study utilizing ZSWIM6 and CCL3L3 as potential biomarkers provides deep insights into the distinct molecular mechanisms of SSc and AS. These findings lay the foundation for future research on targeted therapies and enhance our understanding of immune cell interactions in these autoimmune diseases.

01 Sep 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Tectorigenin alleviates irinotecan-induced intestinal inflammation by activating the Nrf2/Keap1 pathway and synergistically enhances the anti-colon cancer efficacy of irinotecan

Article

Author: Zhang, Chaojun ; Ma, Rui ; Zheng, Peng ; Zou, Guijun ; Liu, Xiaoya

BACKGROUND:

Gastrointestinal toxicity, primarily manifesting as colitis, is one of the most common adverse events during irinotecan (CPT-11) treatment for colon cancer, significantly impacting therapeutic efficacy and the general condition of patients. Tectorigenin (TEC) is a flavonoid compound extracted from Bupleurum and saponins, which are traditional Chinese medicines with anti-inflammatory properties. Previous experiments have found that it can alleviate CPT-11-induced diarrhoea and synergistically inhibit tumor growth with CPT-11, but the specific mechanisms remain unknown.

METHODS:

A CPT-11-induced diarrhoea mouse model was used to study the protective effect of TEC on CPT-11-induced diarrhoea in mouse by measuring levels of inflammatory cytokines and intestinal tight junction-related proteins in colon tissues. The chemopreventive effect of TEC was evaluated by measuring levels of inflammatory cytokines and intestinal tight junction-related proteins in Caco-2 cells exposed to CPT-11 and lipopolysaccharide (LPS). Finally, the synergistic effect of TEC combined with CPT-11 on tumor growth was investigated in a mouse model of colon tumors induced by subcutaneous implantation of CT26 colon cancer cells.

RESULTS:

TEC inhibited CPT-11-induced intestinal toxicity, as evidenced by reduced weight loss, decreased diarrhoea scores, and less intestinal shortening in mouse. Histological analysis demonstrated that TEC alleviated CPT-11-induced intestinal barrier damage. Additionally, TEC activated the nuclear factor erythroid 2-related factor 2/Kelch-like ECH-associated protein 1 (Nrf2/Keap1) signalling pathway, reduced the expression of inflammatory cytokines both in vivo and in vitro, alleviated intestinal inflammation, and increased the expression of intestinal tight junction proteins, thereby enhancing intestinal barrier function. Furthermore, TEC exhibited a synergistic effect with CPT-11 in anti-tumor therapy.

CONCLUSIONS:

This study confirmed that TEC alleviates CPT-11-induced intestinal inflammation by activating the Nrf2/Keap1 signalling pathway and enhances the anti-tumor effect of CPT-11 in colon cancer.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part I: Optimization of chromatographic separation

Article

Author: Guillarme, Davy ; Rudaz, Serge ; Fleury-Souverain, Sandrine ; Nguyen, Nathalie ; Bonnabry, Pascal

This work presents a generic SFC-MS method for the simultaneous analysis of 22 anticancer drugs (fluorouracil, busulfan, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine). The separation conditions were optimized by screening nine stationary phases (2-picolylamine, bare hybrid silica, 2-ethylpyridine, fluoro-phenyl, octadecyl, diethylamine, diol, 1-aminoanthracene, zwitterionic modification), evaluating additives effects (2-5 % water, 20-50 mM ammonium formate, 0-1 mM ammonium fluoride), and adjusting the organic modifier composition (methanol, ethanol, isopropanol, acetonitrile). The optimized SFC-MS method successfully analyzed 22 anticancer drugs, along with 5 additional challenging compounds (azacitidine, mitomycin, cisplatin, oxaliplatin, carboplatin), in 12 min, using a diol column (100 × 3 mm, 1.7 µm) and a gradient of 2-100 % methanol containing 2 % water and 50 mM ammonium formate. To overcome overpressure generated by high organic solvent content, a backpressure gradient (110-150 bar) and a flow rate gradient (0.6-1.5 mL/min) were applied. The diol column was selected as the most promising based on five predefined chromatographic criteria. Additives with 5 % water or ammonium fluoride were excluded due to overpressure and signal loss, respectively. Increasing ammonium formate concentration improved peak symmetry by 29 %. For the organic modifier, pure methanol was chosen since ternary mixtures led to system overpressure without improving separation. Comparison with the LC-MS method using real samples confirmed the potential applicability of the SFC method, as the same trace compounds were detected with comparable concentrations. Sensitivity optimization and method validation will be discussed separately in a later paper.

552

News (Medical) associated with Irinotecan Hydrochloride

05 Jun 2025

·www.prnewswire.com

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Renal Cell Carcinoma

SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the New Drug Application (NDA) for the combination of sintilimab and fruquintinib for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). The NDA is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma. The study has met its primary endpoint of progression free survival (PFS), as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. The combination also demonstrated improvements in secondary endpoints including objective response rate (ORR) and duration of response (DoR). The safety profile was tolerable and no new safety signals were observed. Data from FRUSICA-2 will be submitted for presentation at an upcoming scientific conference. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231. Dr Hui Zhou, Senior Vice President of Innovent, stated: "The second NDA acceptance of sintilimab and fruquintinib combination represents a significant step toward providing a more effective treatment option for patients with second line advanced renal cell carcinoma in China . Our PD-1 inhibitor, sintilimab (TYVYT®), has solidified its position as a cornerstone of immuno-oncology (IO) therapy with this NDA as its 10th indication, marking a meaningful milestone in lifecycle management and clinical value optimization." Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated: "Kidney cancer continues to pose significant challenges in China, with limited treatment options for patients who fail first-line therapies. Submitting this NDA for the fruquintinib and sintilimab combination for advanced renal cell carcinoma marks an important step in our efforts to address this unmet need. We are dedicated to making this combination therapy available to patients with renal cell carcinoma. At the same time, through ongoing research, we remain focused on exploring the full potential of this combination, as well as advancing our broader pipeline across multiple cancer types, to provide more patients with new and effective treatment options." In December 2024, the combination of sintilimab and fruquintinib received conditional approval from the China NMPA for the treatment of patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705). About Kidney Cancer and Renal Cell Carcinoma It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[ii] Approximately 90% of kidney tumors are RCC. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed and co-commercialized by Innovent and Eli Lilly and Company, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[iii] In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. Two NDAs for sintilimab are currently under the NMPA review, including: In combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation; In combination with fruquintinib for the treatment of patients with locally advanced or metastatic renal cell carcinoma who failed prior treatment with one TKI. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 clinical study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 clinical study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.[iv] About Fruquintinib Approvals Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. The combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US, Europe, Japan and many other countries around the world. The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated: About Fruquintinib for Second-line Treatment of RCC Single-agent targeted therapy continues to be one of the primary choices for first-line treatment of advanced RCC in China. Notably, advanced RCC patients who have experienced failure with single-agent targeted therapy previously still indicate an unmet medical need. Results from a proof-of-concept Phase Ib/II study of fruquintinib plus sintilimab were published in Targeted Oncology in January 2025. The combination demonstrated promising efficacy and a tolerable safety profile in this setting. At the data cutoff of October 9, 2024, all 20 enrolled previously treated patients were evaluable for efficacy, with a median follow-up duration of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and median PFS was 15.9 months. Overall survival (OS) was not reached, and the 36-month OS rate was 58.3%.[v] About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception, HUTCHMED has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit ‑med.com or follow us on LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3License out/inDrug ApprovalPhase 2

04 Jun 2025

·www.globenewswire.com

Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma

Phase III NAPOLI 3 trial is the largest and has the longest follow-up for an interventional study in metastatic pancreatic adenocarcinoma1 Post-hoc analysis of NAPOLI 3 study determined characteristics associated with long-term survival, with median overall survival of 19.5 months amongst long-term survivors receiving Onivyde® plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy2 Dose reductions and/or treatment delays for the management of adverse events enabled patients to stay on treatment longer and achieve high cumulative doses of liposomal irinotecan and oxaliplatin2 31 May 2025 – Late-breaking (LBA4175) post-hoc analysis data from the Phase III NAPOLI 3 study were presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These results found a median overall survival (mOS) of 19.5 months among long-term survivors (n=15) with metastatic pancreatic adenocarcinoma (mPDAC) treated with the Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line treatment (n=120), with younger age at diagnosis, and certain tumor and metastasis locations associated with long-term survivorship.2 Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed annually in the U.S. and nearly 500,000 people globally.3,4 It is often detected after the disease has spread to other parts of the body (metastatic or stage IV)5 and fewer than 20% of people diagnosed with metastatic pancreatic adenocarcinoma (mPDAC) survive longer than one year.5,6 Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.5,6 “When people are diagnosed with metastatic pancreatic adenocarcinoma, the most important question remains: how long will they have with their loved ones,” said Dr. Vincent Chung, Medical Oncologist, City of Hope. “Findings from the NAPOLI 3 post-hoc analysis provide important context on long-term overall survival with the Onivyde (NALIRIFOX) treatment regimen.” The analysis included patients who survived for 18 months or longer (N=15), with findings showing long-term survivors living with mPDAC had a mOS of 19.5 months (interquartile range [IQR]: 18.8–22.6).2 Clinical and pathological factors of long-term survivors included younger than average age at time of diagnosis (median age 61.0 (IQR: 49.0–70.5) as well as tumor location.2 Fewer patients had tumors in the head or tail of the pancreas (53.3% had the main pancreatic tumor located in the body of the pancreas), a substantial proportion had liver metastasis (66.7%) and ≥3 metastatic sites (53.3%).2 Additionally, findings indicate dose reduction and treatment delays resulted in prolonged exposure and higher cumulative doses of the Onivyde (NALIRIFOX) regimen.1 Liver metastasis and ≥3 metastatic sites, dose modifications and an otherwise good clinical profile enabled people to achieve a long mOS.2 Consideration should be taken when interpreting these results as a post-hoc analysis with a small sample size. "Data from the Phase III NAPOLI 3 trial were the first positive data of its kind in a decade and continue to reinforce the potential for long-term outcomes with the Onviyde (NALIRIFOX) regimen,” said Sandra Silvestri, MD, PhD, Executive Vice President, Chief Medical Officer, Ipsen. “With people on average living just 4-6 months following diagnosis with pancreatic adenocarcinoma, these data help us to understand the characteristics associated with long-term survival seen in the NAPOLI trial, an important advancement for this difficult-to-treat cancer where data of this kind are scarce.” Onivyde is a long-circulating liposomal topoisomerase inhibitor. In Onivyde, irinotecan is enclosed in tiny fat particles called liposomes which accumulate in the tumor and release slowly over time. Onivyde is administered via intravenous infusion over 90 minutes every two weeks with recommendations on dosing modifications. Onivyde, as part of the NALIRIFOX regimen (combined with oxaliplatin, fluorouracil (FU) and leucovorin (LV)), is for people living with mPDAC who are treatment naïve or used in combination with FU and LV following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of adult patients with metastatic pancreatic adenocarcinoma. Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company governed by a foundation and with an international presence in 140 countries, is responsible for the commercialization of Onivyde outside of the U.S., Taiwan and Canada. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan. NAPOLI 3 is a randomized, open-label Phase III trial of an Onivyde treatment regimen (NALIRIFOX) in treatment-naïve mPDAC. NAPOLI 3 enrolled 770 patients across 187 trial site locations in 18 countries across Europe, North America, South America, Asia, and Australia. Patients were randomized to receive Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle). We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. References 1 Wainberg et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. 2 Chung et al. NAPOLI 3 phase 3 study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): final overall survival (OS) analysis and characteristics of the long-term survivors. As presented at ASCO Congress 2025 Chicago, USA 3 American Cancer Society – Cancer Facts and Figures 2024. Available : https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf 4 https://www.cancer.net/cancer-types/pancreatic-cancer/statistics 5 Orth, M., Metzger, P., Gerum, S. et al. Pancreatic ductal adenocarcinoma: biological hallmarks, current status, and future perspectives of combined modality treatment approaches. Radiat Oncol 14, 141 (2019). https://doi-org.libproxy1.nus.edu.sg/10.1186/s13014-019-1345-6 The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCO

22 May 2025

·www.fiercepharma.com

ASCO: Roche, Jazz's Zepzelca small cell lung cancer win leaves room for improvement

For Roche, adding Zepzelca as a combination partner could help shore up Tecentriq in first-line ES-SCLC in its competition with AstraZeneca’s Imfinzi. Roche’s plan to bolster Tecentriq’s position in small cell lung cancer with Jazz Pharmaceuticals’ Zepzelca has paid off. But the pair’s success leaves room for improvement for future contenders.Adding Zepzelca on top of Tecentriq as maintenance treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) significantly reduced patients’ risk of death by 27% compared with Tecentriq alone, according to data from the phase 3 IMforte trial.Patients who received the combo lived a median 13.2 months, versus 10.6 for those who got Tecentriq alone. The results will be presented at the 2025 American Society of Clinical Oncology annual meeting.Besides hitting its overall survival goal, IMforte also showed that by taking Zepzelca, patients had a 46% lower risk of cancer progression or death. The median progression-free survival time was 5.4 months for the combo versus 2.1 months in the Tecentriq-alone arm.For Roche, adding Zepzelca as a combination partner could help shore up Tecentriq in first-line ES-SCLC in its competition with AstraZeneca’s Imfinzi. For Jazz, the phase 3 win could move Zepzelca from the post-chemo setting to first-line treatment and maybe also turn the drug’s accelerated approval into a full nod.But as ASCO Chief Medical Officer Julie Gralow, M.D., remarked during a press briefing, there’s still room for improvement.“While this is a next step, progression-free survival is still quite low in both arms, and we need to work on additional ways of advancing this even further,” she said. And a better therapy is desired not just on the efficacy side. The addition of Zepzelca during the maintenance phase more than doubled the rate of treatment-related adverse events to 83.5%, compared with 40% in the control group. The rate of grade 3 or 4 adverse events was also notably higher, at 25.6% for the combo, versus 5.8% for Tecentriq alone. But most adverse events were manageable, which is “one of the reasons that Zepzelca was a really good choice for a maintenance regimen,” Jazz’s R&D head, Rob Iannone, M.D., said in an interview with Fierce Pharma.Adverse events led 6.2% of patients in the experimental arm to discontinue treatment, versus 3.3% in the control arm. Iannone described the rate as “very low.” The Zepzelca arm also saw marginally more frequent treatment-related deaths, at 0.8% versus 0.4%, respectively.For existing first-line ES-SCLC regimens involving Tecentriq or Imfinzi, patients receive chemotherapies only during the induction phase because continued dosing in the maintenance phase turned out to be detrimental due to toxicities, Iannone noted.But once that chemo is taken off, there’s a notable worsening of progression curves. That’s why Jazz and Roche figured patients still need another active therapy that’s better tolerated than traditional chemo that can be given as maintenance treatment, Iannone explained.However, as Gralow pointed out, Zepzelca, as a DNA transcription inhibitor, is still a type of chemotherapy, albeit a safer one.More novel agents are emerging. The DLL3 drug class, led by Amgen’s bispecific Imdelltra, has attracted much enthusiasm—including recently from Roche—for its potential in SCLC. Last year, Amgen launched the phase 3 DeLLphi-305 trial adding Imdelltra to Imfinzi as first-line maintenance treatment of ES-SCLC, with an estimated primary completion date in July 2027.Imdelltra’s future looks promising after Amgen recently reported a positive readout in a phase 3 trial in second-line SCLC. It marked the first overall survival win for a T-cell engager in a solid tumor. At least for now, Zepzelca is the first one to have a positive phase 3 readout in this disease setting, and Iannone argued that the results are practice-changing and serve as a new paradigm for future drugs in the space. Jazz has submitted the IMforte results to the FDA, which has yet to set a target decision date, according to Iannone.IMforte is one of two phase 3 trials that the FDA has agreed could potentially confirm Zepzelca’s clinical benefit after a lower dose of the drug failed to move the needle against chemo in second-line SCLC in the phase 3 Atlantis study. IMforte was sponsored by Roche.The other phase 3 trial that the FDA said could give Zepzelca a traditional approval, Lagoon, finished enrollment in December and could read out topline data in the first quarter of 2026, according to PharmaMar. The three-arm trial evaluates Zepzelca either as monotherapy or in combination with irinotecan against the physician’s choice of topotecan or irinotecan.Jazz in-licensed U.S. rights to Zepzelca from PharmaMar in 2019 by paying $200 million upfront and committing up to $800 million in potential milestones.Jazz has a good track record in licensing cancer drugs. The company’s HER2-targeted bispecific Ziihera, licensed from Zymeworks, recently won FDA approval in HER2-positive biliary tract cancer and is moving toward gastric cancer and breast cancer.After CEO Bruce Cozadd highlighted the company’s continued interest in dealmaking, Jazz agreed to buy Chimerix for $935 million to get hold of dordaviprone, a near-approval small molecule being evaluated by the FDA in recurrent H3 K27M-mutant diffuse glioma.As to Jazz’s future business development plan in oncology, Iannone said: “We are agnostic to modality, again, focused on drugs that will make a meaningful difference for patients, where Jazz really has the capability to develop and commercialize.”

Phase 3Clinical ResultDrug ApprovalAcquisitionASCO

100 Deals associated with Irinotecan Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D01061	Irinotecan Hydrochloride	L01XX19	DBSALT000103

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Childhood Malignant Solid Neoplasm	Japan	Yakult Honsha Co., Ltd.	25 Mar 2013
Childhood Malignant Solid Neoplasm	Japan	Daiichi Sankyo Co., Ltd.	25 Mar 2013
Intestinal Neoplasms	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 1998
Colonic Cancer	United States	Pfizer Inc.	14 Jun 1996
Rectal Cancer	United States	Pfizer Inc.	14 Jun 1996
Breast Cancer	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Breast Cancer	Japan	Alfresa Pharma Corp.	29 Sep 1995
Breast Cancer	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Colorectal Cancer	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Colorectal Cancer	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Colorectal Cancer	Japan	Alfresa Pharma Corp.	29 Sep 1995
Lymphoma	Japan	Alfresa Pharma Corp.	29 Sep 1995
Non-Hodgkin Lymphoma	Japan	Alfresa Pharma Corp.	29 Sep 1995
Non-Hodgkin Lymphoma	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Non-Hodgkin Lymphoma	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Squamous Cell Carcinoma	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Squamous Cell Carcinoma	Japan	Alfresa Pharma Corp.	29 Sep 1995
Squamous Cell Carcinoma	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Stomach Cancer	Japan	Alfresa Pharma Corp.	29 Sep 1995
Stomach Cancer	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
RAS Wild Type Colorectal Cancer	Phase 3	France	Hoffmann-La Roche, Inc.	30 Oct 2013
RAS Wild Type Colorectal Cancer	Phase 3	Ireland	Hoffmann-La Roche, Inc.	30 Oct 2013
RAS Wild Type Colorectal Cancer	Phase 3	Israel	Hoffmann-La Roche, Inc.	30 Oct 2013
Esophageal Carcinoma	Phase 3	Canada	Pfizer Inc.	01 Apr 2009
Colorectal Liver Metastases	Phase 3	France	Sanofi	01 Apr 2004
Colorectal Liver Metastases	Phase 3	France	Pfizer Inc.	01 Apr 2004
Colorectal Liver Metastases	Phase 3	France	Chugai Pharmaceutical Co., Ltd.	01 Apr 2004
Liver metastases	Phase 3	France	Chugai Pharmaceutical Co., Ltd.	01 Apr 2004
Liver metastases	Phase 3	France	Pfizer Inc.	01 Apr 2004
Liver metastases	Phase 3	France	Sanofi	01 Apr 2004

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04554836 (CTgov)	Phase 2	Rectal Adenocarcinoma \| RAS mutant Colorectal Cancer \| Colonic Cancer	6	Cetuximab+Leucovorin Calcium+Irinotecan Hydrochloride+Fluorouracil (FOLFIRI + Cetuximab)	rrwzzrromq = rjskarseyv vsqnqzkffr (gbhkrgzihs, xpuslwweag - urddvgjmbl) View more	-	08 Jun 2025
				Leucovorin Calcium+Irinotecan Hydrochloride+Fluorouracil (FOLFIRI)	rrwzzrromq = nfhrpfpwid vsqnqzkffr (gbhkrgzihs, qyzmmsscay - bywvlnvytz) View more
NCT04059562 (TRITICC, ASCO2025) Manual	Phase 2	Bile Duct Neoplasms Second line	28	Trifluridine/tipiracil + Irinotecan	rtnjccbswd(tjejqxbwmj) = xugblayyll nqlekjsjrq (vwmjlfotjn, 2.0 - 7.5) View more	Positive	30 May 2025
LITTORAL study (ASCO2025)	Not Applicable	Mouth Neoplasms	182	ONCORAL (Patients with sufficient HL score)	yuelfnpukt(mufmcreydx) = qvinvmiwzh qhzrbmorsh (byghjrcqng )	Positive	30 May 2025
NCT04625907 (FaR-RMS, ASCO2025)	Phase 1	FOXO1 fusion-positive	22	Irinotecan 50 mg/m²/day	wdrzajdurv(usrzsjawup) = 45.5% vqzpfknpaa (lpeluzaevz ) View more	Positive	30 May 2025
ASCO2025	Phase 2	High Risk Neuroblastoma	34	HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)	igkzefzkmt(uuxaiffffa) = ukazmyknrr uaagnmnlyw (uwhnfinudp ) View more	Positive	30 May 2025
				NICE (Naxitamab, GM-CSF, Ifosfamide, Carboplatin, Etoposide)	igkzefzkmt(uuxaiffffa) = omxqbcrwis uaagnmnlyw (uwhnfinudp ) View more
NCT00545545 (CTgov)	Phase 1/2	Colorectal cancer recurrent \| Colorectal Cancer	32	PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan)	xuqocgfmmr = sbylmfpzma wmdioqdaiw (ekpworcwpl, qfxsfzlghw - tcvkcytguz) View more	-	19 Mar 2025
				PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan)	xuqocgfmmr = vaaskargqv wmdioqdaiw (ekpworcwpl, xvhmjotmbt - fnswfmcztc) View more
NCT04380337 (SHORT-FOX, CTgov)	Phase 2	Rectal Cancer \| Rectal Adenocarcinoma	38	IMRT+LEUCOVORIN CALCIUM+irinotecan+oxaliplatin+capecitabine+Fluorouracil	hnanoecbtr = rxpbrldtzt dskoewkgze (oqsntgagtq, ozkkxcqhuw - mcdamxwndm) View more	-	25 Feb 2025
NCT05229003 (ZL-IRIAN, ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Second line pMMR \| MSS	23	Anlotinib 10mg daily + Irinotecan 180mg/m	uanuzghwjw(nvfphagmez) = iamcdixaqn jifuolimus (wmvdhhkzlc, 9.43 - 34.03) View more	Positive	23 Jan 2025
				Anlotinib 8mg daily + Irinotecan 180mg/m + Penpulimab 200mg	uanuzghwjw(nvfphagmez) = alpvnqgvxl jifuolimus (wmvdhhkzlc, 11.44 - 26.90) View more
NCT05462236 (ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma KRAS-mut	22	Tinodasertib monotherapy	ektxkqiozg(pzdeqfrepg) = Grade 3 treatment-related adverse events (TRAEs) were observed in 2 (9%) patients and were related to irinotecan while no Grade 3 AEs were attributed to Tinodasertib by either the investigator or the sponsor. Most common TRAEs were related to gastrointestinal system organ class. There were no Grade 4-5 TRAEs. oqktinbolt (yniuotflwl ) View more	Positive	23 Jan 2025
ESMO_ASIA2024	Not Applicable	Extensive stage Small Cell Lung Cancer	676	Irinotecan/carboplatin	srubazddws(tbxyazmciv): RR = 0.55 (95% CI, 0.38 - 0.78), P-Value = 0.0008 View more	Positive	07 Dec 2024
				Etoposide/carboplatin

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