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Last update 22 Oct 2026

Irinotecan Hydrochloride Lioposome

Last update 22 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug, Liposomal Drug

Synonyms

Irinotecan Liposome, Nanoliposomal Irinotecan, 伊立替康纳米脂质体

+ [12]

Target

Top I

Action

inhibitors

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Pancreatic adenocarcinoma metastaticPancreatic adenocarcinomaPancreatic Cancer+ [13]

Inactive Indication

Advanced Bile Duct CarcinomaAdvanced Malignant Solid NeoplasmBreast Carcinoma Metastatic in the Brain+ [28]

Originator Organization

Merrimack Pharmaceuticals, Inc.

Active Organization

Les Laboratoires Servier SAS

Servier Pharmaceuticals LLC

Ipsen SA

+ [4]

Inactive Organization

Merrimack Pharmaceuticals, Inc.

PharmaEngine, Inc.

Shire Plc

+ [4]

License Organization

Ipsen SA

Yakult Honsha Co., Ltd.

PharmaEngine, Inc.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (22 Oct 2015),

Pancreatic Cancer

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (European Union), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC33H45ClN4O9

InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N

CAS Registry136572-09-3

206

Clinical Trials associated with Irinotecan Hydrochloride Lioposome

NCT07819019

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study of Irinotecan Liposome Combined With Fruquintinib and Sintilimab as Second-Line Therapy for PD-L1-Positive (CPS ≥ 1) Advanced Gastric Cancer

English Translation (for ClinicalTrials.gov Patient-Friendly Summary):
This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer). We are looking for participants whose cancer has progressed after one prior standard chemotherapy regimen and whose tumors test positive for the PD-L1 protein.
This study is testing the effectiveness of a combination of three medications:
1. Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues.
2. Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply.
3. Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells.
The primary goal of this study is to evaluate how well this three-drug combination works and to monitor its safety. Participants will receive the study drugs via intravenous infusion or oral tablets according to the protocol. Their progress will be tracked with CT scans and blood tests every three months. Regular follow-up visits will continue even after stopping treatment to monitor long-term outcomes.
Who can participate? Participants must be adults diagnosed with advanced gastric cancer who have progressed after only one prior first-line standard therapy, have PD-L1-positive tumors, and have no severe heart, liver, or kidney disease. Pregnant or breastfeeding women cannot participate.
Possible side effects Potential side effects may include nausea, vomiting, diarrhea, hand-foot swelling, low blood cell counts (which can increase infection risk), and fatigue. The research team will closely monitor all participants and provide prompt treatment for any side effects.
Important note This study is still in the clinical trial phase. While it offers a potential new treatment option beyond standard care, there is no guarantee that the drugs will be effective for every participant.
For more information, please contact the research team.

Start Date01 Oct 2026

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

[+1]

NCT07782346

/ Not yet recruitingPhase 1

Phase I Trial to Evaluate Safety and Efficacy of Combination of Liposomal Irinotecan (Nal-IRI; ONIVYDE®) and Cisplatin in Patients With Advanced or Metastatic Solid Malignancies (ICONIC Study)

Phase I trial, Multiple centers, open-label, non-randomized single-arm study

Start Date01 Oct 2026

Sponsor / Collaborator

National Health Research Institutes

[+7]

NCT07060014

/ RecruitingPhase 1IIT

Liposomal Irinotecan (Nal-IRI) Plus 5-fluorouracil and Leucovorin (5-FU/LV) Plus Oxaliplatin (NALIRIFOX) as First-Line Chemotherapy for Patients With Advanced Small Intestine and Appendiceal Cancers

This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study.

Start Date18 Sep 2026

Sponsor / Collaborator

The Methodist Hospital Research Institute

100 Clinical Results associated with Irinotecan Hydrochloride Lioposome

100 Translational Medicine associated with Irinotecan Hydrochloride Lioposome

100 Patents (Medical) associated with Irinotecan Hydrochloride Lioposome

5,983

Literatures (Medical) associated with Irinotecan Hydrochloride Lioposome

06 Aug 2026·ONCOLOGIST

Use of liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in neoadjuvant pancreatic adenocarcinoma: NEO-Nal-IRI trial

Article

Author: Rogers, Sherise C ; Turk, Anita A ; Jang, Tim ; Hughes, Steven J ; Lee, Ji-Hyun ; Fabregas, Jesus ; DeRemer, David L ; Liu, Gonghao ; Sahin, Ilyas ; Lin, Tuo ; Russell, Karen B ; George, Thomas J ; Ramnaraign, Brian H ; Fan, Z Hugh ; Nassour, Ibrahim ; Hitchcock, Kathryn ; Thomas, Ryan M ; Kayaleh, Omar

Abstract:

Background:

While neoadjuvant FOLFIRINOX is an effective regimen for pancreatic ductal adenocarcinoma (PDAC), toxicity frequently limits its use. Nanoliposomal irinotecan (nal-IRI) offers improved pharmacokinetic properties and may mitigate some of the side effects. We conducted a multi-institutional, phase II study to evaluate the safety and clinical activity of neoadjuvant NALIRIFOX (nal-IRI, 5-fluorouracil, leucovorin, and oxaliplatin) in patients with resectable and borderline resectable (R/BR) PDAC.

Methods:

Patients with untreated R/BR PDAC received 8 cycles of neoadjuvant NALIRIFOX. The primary endpoint was the 30-day post-operative major complication rate among resected patients. Secondary endpoints included treatment completion rate, R0 resection rate, objective response rate (ORR), biochemical (CA19-9) and radiographic responses, nodal downstaging, and quality of life (QoL by FACT-G).

Results:

Of the 45 enrolled patients, 73% completed all 8 cycles of neoadjuvant NALIRIFOX. 34 patients (76%) underwent attempted surgery, of whom 29 (64%) had complete resection (15 BR patients and 14 R patients). The 30-day post-operative major complication rate was 10% (95% CI, 2.2-27%, P = .012), meeting the pre-specified threshold. R0 resection was achieved in 90% of resected patients. The radiographic ORR was 45% (95% CI, 29-62%), and the clinical benefit rate was 73% (95% CI, 58-85%).

Conclusion:

Neoadjuvant NALIRIFOX is a safe and active regimen in R/BR PDAC with a low post-operative complication rate, high treatment completion and R0 resection rates, and meaningful clinical responses. These findings support further investigation of NALIRIFOX as part of a total neoadjuvant therapy approach in PDAC. [ClinicalTrials.gov identifier: NCT03483038].

01 Aug 2026·ESMO Open

Impact of prior conventional irinotecan use on nanoliposomal irinotecan efficacy in advanced pancreatic cancer: a meta-analysis

Review

Author: Peters, M L ; Roshan, K ; Keko, M ; Lee, S ; Modest, A M ; Correa, T L ; Bockorny, B ; Birda, V

BACKGROUND:

Nanoliposomal irinotecan (nal-IRI) has become an established therapy for advanced pancreatic ductal adenocarcinoma (PDAC), both in the post-gemcitabine setting and, more recently, in the first-line NALIRIFOX regimen. Concerns remain regarding cross-resistance in patients previously exposed to conventional irinotecan. We performed a systematic review and meta-analysis to evaluate the impact of prior irinotecan exposure on outcomes with nal-IRI.

MATERIALS AND METHODS:

We conducted a systematic literature search of PubMed, Embase, and the Cochrane Library through July 2025 following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Eligible studies included patients with advanced PDAC treated with nal-IRI-containing regimens and reported outcomes stratified by prior irinotecan exposure. Data extraction and risk of bias assessments were performed independently by two reviewers. Hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) were pooled using random-effects models. Sensitivity and publication bias analyses were conducted.

RESULTS:

Thirteen retrospective studies comprising 2271 patients were included. One-third (33.1%) had received conventional irinotecan before nal-IRI. Prior irinotecan exposure was associated with inferior outcomes: pooled unadjusted and adjusted HRs for OS were 1.48 [95% confidence interval (CI) 1.24-1.76, P = 0.001] and 1.42 (95% CI 1.03-1.96, P = 0.030), respectively. For PFS, pooled unadjusted and adjusted HRs were 1.45 (95% CI 1.28-1.64, P < 0.001) and 1.72 (95% CI 1.16-2.54, P = 0.007), respectively. Patient-level subgroup analyses indicated that patients discontinuing prior irinotecan due to progression had significantly worse OS compared with those discontinuing for other reasons (HR 1.97, 95% CI 1.10-3.52). Most studies were high quality, and sensitivity analyses confirmed the robustness of the findings.

CONCLUSION:

Prior exposure to conventional irinotecan, particularly discontinuation for progression, reduced clinical benefit from subsequent nal-IRI therapy in advanced PDAC in observational cohorts. These findings support caution when considering nal-IRI soon after irinotecan progression and highlight the need for prospective sequencing studies.

01 Aug 2026·DRUG DEVELOPMENT RESEARCH

Applications of Bioinorganic Nano‐Based Delivery Systems—Diagnostics and Therapeutics

Review

Author: Fernandes, Donald ; Ssengooba, Frank ; Andrew, Jubilee

ABSTRACT:

Nanotechnology has emerged as a promising avenue for producing nanomedicines as alternatives to conventional drugs. Many organic nanoparticles, such as liposomes used in formulations like Doxil, Onivyde, and Marqibo, are approved by the Food and Drug Administration (FDA) and instrumental in treating various types of cancers. However, due to the many challenges associated with these formulations, alternative delivery systems have been explored, particularly those derived from inorganic sources. In particular, bioinorganic nano‐based delivery systems (BNDSs) such as gold, silver, platinum, silicon‐based, metal oxide and hybrid nanoparticles have been found to be useful in treating cancer and infectious and noncommunicable diseases. This review presents the most commonly used BNDSs, providing an in‐depth discussion on their use as therapeutic and imaging agents, the challenges associated with their use and current trends and future perspectives in their development for enhancing efficacy.

134

News (Medical) associated with Irinotecan Hydrochloride Lioposome

23 Sep 2026

·www.biospace.com

HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2026

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Congress 2026, taking place on October 23-27, 2026, in Madrid, Spain. Notably, results from two positive Phase III studies evaluating the savolitinib and osimertinib combination have been selected for oral presentations. Results from the global SAFFRON study will be featured in the Presidential Symposium session, while results from the SANOVO study in China will be presented in a Proffered Paper session, both highlighting important new clinical data. Having two Phase III studies featured as late-breaking abstracts underscores the potential of this all-oral, chemo-free combination to deliver meaningful advancements for patients with non-small cell lung cancer (“NSCLC”). The SAFFRON Global Phase III Study has been selected for a Presidential Symposium oral presentation. The study evaluated the combination in patients with epidermal growth factor receptor (EGFR)-mutated NSCLC with MET overexpression or amplification following disease progression on osimertinib. The trial reported positive high-level results on August 17, 2026, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) and overall survival (“OS”) compared to doublet platinum-based chemotherapy. The SANOVO China Phase III Study has been selected for a Proffered Paper oral presentation. The study evaluated the combination in previously untreated patients with locally advanced or metastatic NSCLC harboring activating EGFR mutations and MET overexpression. The trial reported positive high-level results on August 31, 2026, demonstrating a statistically significant and clinically meaningful improvement in PFS and a clinically meaningful benefit in OS versus osimertinib monotherapy. Details of the presentations are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results Shun Lu (Shanghai, China) LBA6 Presidential Symposium II Alicante Auditorium - Hall 6 Sunday, October 25, 2026 16:30 - 18:15 CEST Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study Yi-Long Wu (Guangzhou, China) LBA69 Proffered paper 2: NSCLC, metastatic Alicante Auditorium - Hall 6 Monday, October 26, 2026 08:30 - 10:00 CEST Updated results from a fruquintinib Expanded Access Program for patients with previously treated metastatic colorectal cancer Stefan Kasper (Essen, Germany) 848P Poster Session: Colon cancer Association between dose adjustment and treatment outcomes in patients with advanced renal cell carcinoma receiving fruquintinib plus sintilimab: A post-hoc analysis of the FRUSICA-2 trial Yuanyuan Qu (Shanghai, China) 3655eP E-poster Session: Renal cancer Efficacy of fruquintinib plus sintilimab in special populations with advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang (Beijing, China) 3667eP E-poster Session: Renal cancer Final phase 2 analysis of surufatinib plus camrelizumab, nab-paclitaxel and gemcitabine in first-line metastatic pancreatic cancer Shukui Qin (Nanjing, China) 3156P Poster Session: Pancreatic cancer INVESTIGATOR-INITIATED STUDIES Fruquintinib plus capecitabine maintenance after first-line anti-EGFR antibody plus chemotherapy in RAS/BRAF wild-type metastatic colorectal cancer: A phase Ib/II study Lin Yang/ Letian Zhang (Beijing, China) 877eP E-poster Session: Colon cancer Real-world effectiveness and safety of fruquintinib in patients with metastatic colorectal cancer in Spain: The FrESP study Ana Fernandez Montes (Ourense, Spain) 880eP E-poster Session: Colon cancer CONCEPT (COmbinatioN of CEtuximab Plus fruquintinib Treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Kefeng Ding (Hangzhou, China) 890eP E-poster Session: Colon cancer A real-world study of low-dose fruquintinib combined with trifluridine/tipiracil hydrochloride (TAS-102) in the third-line and beyond treatment of metastatic colorectal cancer Yuehong Cui/ Li Liang (Shanghai, China) 903eP E-poster Session: Colon cancer Real-world outcomes with fruquintinib in heavily pretreated metastatic colorectal cancer: Impact of patient and disease characteristics Maria Maddalena Laterza (Pozzuoli, Italy) 964eP E-poster Session: Colon cancer A phase II, open-label, randomized study of doublet chemotherapy (FOLFOX or FOLFIRI) plus fruquintinib compared with doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab in second line setting for a metastatic colorectal cancer: ULYSSE- FFCD2406 - PRODIGE115 (trials in progress) Jean Marc Phelip (Saint-Étienne, France) 991eTiP E-poster Session: Colon cancer Phase II study of fruquintinib plus utidelone in platinum-resistant recurrent ovarian cancer (FRUTD Trial) Zheng Feng (Shanghai, China) 1283P Poster Session: Gynaecological cancers Fruquintinib plus eribulin in patients with metastatic HR+, HER2 - breast cancer after progression on endocrine therapy plus CDK4/6 inhibitor: Updated results from a phase II study Yuan Yuan (Nanjing, China) 1896eP E-poster Session: HR+ breast cancer Fruquintinib plus sintilimab and XELOX as first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase II study Hua Wang (Nanchang, China) 2980eP E-poster Session: Oesophagogastric cancer Fruquintinib plus cadonilimab and S-1 in previously treated unresectable locally advanced or metastatic esophageal squamous cell carcinoma: preliminary efficacy and safety results from a phase Ib/II study Huiyan Luo (Guangzhou, China) 2981eP E-poster Session: Oesophagogastric cancer Nanoliposomal irinotecan (nal-IRI) combined with fruquintinib as second-line treatment for advanced gastric cancer: A single-arm, open-label, dose-escalation and expansion phase I/II trial Jieer Ying/ Qi Xu (Hangzhou, China) 2986eP E-poster Session: Oesophagogastric cancer FRUQUITAS trial: ENGIC intergroup randomized phase III of trifluridine/tipiracil +/- fruquintinib in pre-treated metastatic gastro-oesophageal adenocarcinoma David Tougeron (Poitiers, France) 3079eTiP E-poster Session: Oesophagogastric cancer CHOICE III: short-course preoperative radiotherapy followed by fruquintinib plus anti–PD-1 antibody (serplulimab) for neoadjuvant treatment of pMMR/MSS mid-to-low locally advanced rectal cancer: A single-arm, single-center, prospective phase II study Wei Zhang (Shanghai, China) 3582eTiP E-poster Session: Rectal and anal cancer First-line fruquintinib plus serplulimab for metastatic non-clear cell renal cell carcinoma: Updated results from the phase II FRONTIER study Jiwei Huang (Shanghai, China) 3614P Poster Session: Renal cancer Latest efficacy and safety analysis of surufatinib combined with EP regimen and serplulimab as first-line treatment for extrapulmonary neuroendocrine carcinoma Tao Zhang/ Zhenyu Lin (Wuhan, China) 2394RO Rapid Oral Session: NETs and endocrine tumours Pamplona Auditorium - Hall 5 Friday, October 23, 2026 16:15 - 17:45 CEST Surufatinib combined with toripalimab and nab-paclitaxel/ gemcitabine chemotherapy as first-line treatment for advanced pancreatobiliary-type ampullary carcinoma: A prospective phase II Clinical Trial Juan Du (Nanjing, China) 507eP E-poster Session: Biliary tract cancer, incl. cholangiocarcinoma Efficacy and safety of surufatinib in combination with CAPTEM in advanced G2/G3 Neuroendocrine Tumors: Results from a single-arm, phase II Trial Wei Wang (Guangzhou, China) 2403P Poster Session: Neuroendocrine tumours Surufatinib plus S-1/temozolomide as first-line therapy in MGMT-low advanced pancreatic neuroendocrine tumours (SUSTEM-p): An open-label, single-centre phase Ib/II trial Yihebali Chi (Beijing, China) 2411P Poster Session: Neuroendocrine tumours Updated results of a prospective, open-label study of surufatinib plus CAPTEM as conversion therapy for unresectable pancreatic neuroendocrine tumors Ziyao Wang (Chengdu, China) 2412P Poster Session: Neuroendocrine tumours Matching-adjusted indirect comparison of surufatinib versus high-dose OCT-LAR in patients with advanced GEP-NETs who progressed on prior SSA Therapy Jianming Xu (Beijing, China) 2415P Poster Session: Neuroendocrine tumours Surufatinib combined with octreotide LAR for the treatment of G1/G2 GEP-NETs: A single-arm, prospective, open-label phase II study Xiaofeng Sun (Nanjing, China) 2439eP E-poster Session: Neuroendocrine tumours Six weeks of induction gemcitabine plus nab paclitaxel (AG) followed by sequential surufatinib plus AG or AG alone as first line therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC): A single center, two cohort, phase II study Jin Xu/ Jialin Li (Shanghai, China) 3168P Poster Session: Pancreatic cancer A phase Ib/II study of radiotherapy combined with surufatinib and sintilimab for localized high-risk limb and trunk soft tissue sarcomas: A prospective single-center trial Yan Wang (Shanghai, China) 3739P Poster Session: Sarcoma Surufatinib plus serplulimab, etoposide, and carboplatin as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC): Updated results from a single-arm, phase Ia/Ib trial Haipeng Xu/ Longfeng Zhang (Fuzhou, China) 3831P Poster Session: Small cell lung cancer About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE ® . 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 ® . About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS ® . About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA ® . HUTCHMED currently retains all rights to surufatinib worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first four 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: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether any studies on fruquintinib, surufatinib and savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib and savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib and savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab and toripalimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

Clinical ResultPhase 2Phase 3ImmunotherapyLicense out/in

24 Aug 2026

·allsci.com

Columbia-led trial reports 64% response rate in small Phase II for four-drug CXCR4 regimen

A four-drug regimen combining the CXCR4 antagonist motixafortide (APHEXDA) with cemiplimab and chemotherapy produced responses in seven of 11 treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (PDAC), according to Phase II pilot data published August 21 in Nature Communications. The study pairs the early clinical signal with single-cell evidence that CXCR4 blockade may help reshape the immune-resistant PDAC tumor microenvironment. The study enrolled 11 treatment-naïve patients with metastatic PDAC and treated them with the four-agent combination — referred to as MCGN — comprising motixafortide, cemiplimab, gemcitabine, and nab-paclitaxel. Corresponding authors Kenneth P. Olive, Benjamin Izar, and Gulam A. Manji led the work through Columbia University Irving Medical Center's Herbert Irving Comprehensive Cancer Center, with collaborators at Brown University's Legorreta Cancer Center, Memorial Sloan Kettering Cancer Center, the Huntsman Cancer Institute at the University of Utah, the University of North Carolina, and the Case Comprehensive Cancer Center. In the 11-patient pilot cohort, the regimen produced an objective response rate (ORR) of 64%, a confirmed partial response rate of 55%, and a disease control rate (DCR) of 91%, according to the paper. Four of the 11 patients remained progression-free after more than one year. Median progression-free survival and overall survival figures from the pilot phase have been reported at scientific meetings, though these are from a small, single-arm cohort without a contemporaneous comparator. Motixafortide is FDA-approved under the brand name APHEXDA — in combination with filgrastim — for hematopoietic stem cell mobilization in multiple myeloma, marketed by BioLineRx. In the metastatic PDAC context it remains investigational. Cancer-associated fibroblasts in the PDAC tumor microenvironment (TME) secrete CXCL12, which signals through CXCR4 on immune cells to physically exclude cytotoxic T cells from the tumor — a principal reason checkpoint inhibitors have failed in this disease. Motixafortide blocks CXCR4, with the goal of disrupting this exclusion barrier and permitting T-cell infiltration that cemiplimab can then sustain. Single-nucleus RNA sequencing (snRNA-seq) of serial biopsies in responding patients revealed decreased tumor heterogeneity and reduced epithelial-to-mesenchymal transition states compared with resistant patients. Responders showed enrichment of CXCL12-expressing cancer-associated fibroblasts, the paper reported, consistent with the proposed mechanism and potentially identifying a TME-based biomarker of response. Two prior attempts to combine CXCR4 blockade with checkpoint inhibition in PDAC produced limited clinical benefit. The MORPHEUS-PDAC trial of motixafortide plus the anti-PD-L1 antibody atezolizumab in pretreated patients showed insufficient efficacy across all atezolizumab combinations, according to results published in The Oncologist in April 2026. A Phase II study at Johns Hopkins (NCT04177810) pairing plerixafor, a different CXCR4 antagonist, with cemiplimab confirmed T-cell recruitment but identified immunosuppressive macrophage infiltration as a co-resistance mechanism, according to results published in OncoImmunology in 2025. The addition of gemcitabine and nab-paclitaxel in the current regimen addresses the hypothesis that chemotherapy-mediated cytotoxic activity and potential immunogenic priming are necessary to overcome residual resistance. An earlier proof-of-concept for the CXCR4-plus-checkpoint-plus-chemotherapy approach came from the COMBAT/KEYNOTE-202 trial (NCT02826486), sponsored by Israel-based BioLineRx (Nasdaq: BLRX), which used motixafortide with pembrolizumab and a nanoliposomal irinotecan plus 5-FU/leucovorin backbone in previously treated patients. BioLineRx also provides motixafortide as drug supply for the current Columbia-sponsored trial; Regeneron provides cemiplimab. Based on the pilot results, the trial (NCT04543071) has been amended to a randomized, multicenter Phase II expansion comparing MCGN against gemcitabine and nab-paclitaxel alone in treatment-naïve patients. BioLineRx has described this as the first large, multicenter, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line chemotherapy in metastatic PDAC. A prespecified interim/futility analysis was anticipated to read out in 2026, according to BioLineRx's 2025 annual financial results published in March 2026. The study is limited by the small pilot cohort size, the absence of a randomized comparator in the reported data, and the single-institution design of the pilot phase. Spot something wrong? Report an issue with this article

Phase 2Clinical ResultDrug ApprovalPhase 1Financial Statement

01 Jun 2026

·allsci.com

ASCO: Revolution Med posts full Phase III pancreatic cancer data set for daraxonrasib

Revolution Medicines (Nasdaq: RVMD) released the full Phase III dataset at this year’s American Society of Clinical Oncology (ASCO) meeting showing that daraxonrasib, an oral RAS(ON) multi-selective inhibitor, cut the risk of death by 60% compared to standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The results confirm the earlier release of topline figures, and represent one of the largest survival improvements ever reported in a Phase III trial for previously treated metastatic PDAC and could establish the first broadly applicable targeted therapy for the majority of patients with RAS-driven disease. The RASolute 302 trial is a global, randomized Phase III study that enrolled 500 patients with previously treated metastatic PDAC, including those with RAS G12 mutations and a smaller group without an identified tumor RAS mutation. Patients were randomized to 300 mg oral daraxonrasib once daily or investigator’s choice of four cytotoxic chemotherapy regimens. At a February 2026 data cutoff, median OS in the RAS G12 population reached 13.2 months with daraxonrasib versus 6.6 months with chemotherapy (HR 0.40; 95% CI: 0.30–0.54; p \< 0.0001); results in the intent-to-treat population were nearly identical. Median PFS doubled as well, at 7.3 versus 3.5 months in the RAS G12 group (HR 0.45; p \< 0.0001), and objective response rates were 33.2% versus 11.8%. The safety profile favored daraxonrasib on most measures: Grade 3 or higher treatment-related adverse events occurred in 43.6% of patients on daraxonrasib versus 57.5% on chemotherapy, and treatment discontinuation due to adverse events was strikingly low at 1.2% versus 11.2%. The most common high-grade events with daraxonrasib were rash and stomatitis; one fatal pneumonitis was reported. Results were simultaneously published in The New England Journal of Medicine as well as featuring in the ASCO 2026 Annual Meeting plenary session. Daraxonrasib works by blocking the interaction between active RAS(ON) proteins — both wild-type and mutant forms — and their downstream effectors, a mechanistic approach distinct from the allele-specific KRAS(OFF) inhibitors that have reshaped lung cancer treatment. In the broader PDAC landscape, current second-line treatment largely relies on chemotherapy regimens such as Onivyde-based combinations and fluoropyrimidine-containing protocols, which typically deliver median overall survival measured in months rather than years. Biomarker-selected approvals for Merck’s Keytruda (pembrolizumab) and AstraZeneca’s Lynparza (olaparib) reach perhaps 10% of patients collectively. Cross-trial comparisons are limited, but no prior Phase III trial in any line of PDAC therapy has reported a median OS exceeding one year. Revolution Medicines intends to file a New Drug Application with the FDA under the Commissioner’s National Priority Voucher program; an expanded access protocol is already open. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3Clinical ResultASCOAccelerated ApprovalDrug Approval

100 Deals associated with Irinotecan Hydrochloride Lioposome

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	Australia	Servier Laboratories (Australia) Pty Ltd.	19 Dec 2016
Pancreatic adenocarcinoma	European Union	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Iceland	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Liechtenstein	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Norway	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic Cancer	United States	Ipsen Biopharmaceuticals, Inc.	22 Oct 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Ductal Adenocarcinoma	NDA/BLA	United States	Ipsen SA	14 Jun 2023
Extensive stage Small Cell Lung Cancer	Phase 3	United States	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	China	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Australia	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	France	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Germany	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Hungary	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Italy	Ipsen SA	25 Apr 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06662006 (ESMO2026)	Phase 2	Metastatic Pancreatic Cancer Second line	50	Nal-IRI/5-FU/LV + Benmelstobart + Anlotinib	ayjgszjtof(hfttbxquzr) = nppdmkusvb qidwicybqd (cjivjnrzrv ) View more	Positive	23 Oct 2026
NCT06662006 (ESMO2026)	Phase 2	Metastatic Pancreatic Cancer Second line	50	Nal-IRI/5-FU/LV + Benmelstobart + Anlotinib (SBRT)	ayjgszjtof(hfttbxquzr) = susupqgvun qidwicybqd (cjivjnrzrv ) View more	Positive	23 Oct 2026
ESMO2026	Phase 1	Locally Advanced Soft Tissue Sarcoma Second line	10	Nanoliposomal irinotecan + vincristine	hjhzisndwv(vastyegoup) = nal-IRI 40 mg/m2combined with vincristine 1.5 mg/m2 ymjcxzqqtr (ctyvsbvxwh )	Positive	23 Oct 2026
NCT06258642 (ESMO2026)	Phase 2	Recurrent Lung Small Cell Carcinoma Second line	36	Irinotecan liposome plus anlotinib	kmiuuakgmj(pysdprpnjk) = uaqzcaarfh bivvdbzbip (utafhzmiyd ) View more	Positive	23 Oct 2026
ESMO2026	Phase 2	RAS/BRAF Wild Type Colorectal Cancer First line RAS \| BRAF wild-type	31	Nanoliposomal irinotecan (nal-IRI) + 5-fluorouracil/leucovorin + cetuximab	elgduwcvjq(jursoujohy) = ojifknfjoh cyueztglkt (itenybnocx ) View more	Positive	23 Oct 2026
IRLCRC-1 (ESMO_GI2026)	Phase 2	Metastatic Colorectal Carcinoma First line	68	Irinotecan liposome + 5-FU/LV + bevacizumab	hohiiiynok(tnjbbfmgfx) = yvtcjllirh lugwtbebfl (qxutpwgrkc ) View more	Positive	02 Jul 2026
NCT03693677 (PRODIGE 61—FUNGEMAX, Pubmed \| EClinicalMedicine)	Phase 2	Metastatic Pancreatic Cancer First line	288	nal-IRI/5-FU + gemcitabine/nab-paclitaxel	mtkungocmk(gxxawnydvk) = xrolbmcwzt txekudiacz (kzmqvgadqn )	Positive	01 Jun 2026
	Phase 2	Metastatic Pancreatic Cancer First line	288	nal-IRI/5-FU	mtkungocmk(gxxawnydvk) = ojxplianwh txekudiacz (kzmqvgadqn )	Positive	01 Jun 2026
ASCO2026	Not Applicable	Pancreatic adenocarcinoma metastatic Second line	68	Nanoliposomal irinotecan + fluorouracil and leucovorin (nal-IRI+5-FU/LV)	gxivsunefm(eduzauyrgh) = ifowtakvkw fgvcgrdrgm (owyqasuadv, 4.5 - 6.7) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Pancreatic adenocarcinoma metastatic Second line	68	Nanoliposomal irinotecan + fluorouracil and leucovorin (nal-IRI+5-FU/LV) (>65 years old + gemcitabine-refractory metastatic pancreatic adenocarcinoma)	uvncqwwctf(ooovudafik) = mxeejejsvn itqqlpmstd (xhrsgbcqik )	Positive	29 May 2026
NCT04005339 (NAPOLI-2, ASCO2026)	Phase 2	Biliary Tract Neoplasms Second line	48	Nanoliposomal irinotecan + leucovorin + fluorouracil	cdogbwdwiq(rrifgniepk) = fdjpujrtfo ejaerxwojp (ismzefqbqo ) View more	Positive	29 May 2026
NCT06662006 (ASCO2026)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma Second line	46	NAL-IRI/5-FU/LV + benmelstobart + anlotinib (Cohort A)	iqwmafakyt(vfmrphydnp) = diyllwbaan weqgzfrxqi (bjiyyakibn, 1.9 - 32.9) View more	Positive	29 May 2026
NCT06662006 (ASCO2026)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma Second line	46	NAL-IRI/5-FU/LV + benmelstobart + anlotinib (Cohort B)	iqwmafakyt(vfmrphydnp) = hcjgqilckz weqgzfrxqi (bjiyyakibn, 12.0 - 64.9) View more	Positive	29 May 2026
NCT03785873 (BilT-03 \| BilT03, CTgov)	Phase 1/2	Advanced biliary tract cancer	34	Nivolumab+leucovorin+Nanoliposomal-Irinotecan+5-fluorouracil	drixgjfsjm = ebzrlzkfpn nyridjyjjr (frwmhooclc, fijqqdkosw - gascbreddx) View more	-	13 Feb 2026

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