FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [12]

Active Indication

Advanced Endometrial CarcinomaRecurrent Endometrial CancerThymus Neoplasms+ [98]

Inactive Indication

Advanced breast cancerAdvanced gastric carcinomaAdvanced Lung Non-Small Cell Carcinoma+ [27]

Originator Organization

Eisai Co., Ltd.

Active Organization

Eisai, Inc.

Merck Sharp & Dohme Corp.

Eisai Co., Ltd.

+ [7]

Inactive Organization

Bristol Myers Squibb Co.

Merck & Co., Inc.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

License Organization

Biotoscana Investments SA

Merck & Co., Inc.

Novartis AG

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (13 Feb 2015),

Thyroid Cancer

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC22H23ClN4O7S

InChIKeyHWLFIUUAYLEFCT-UHFFFAOYSA-N

CAS Registry857890-39-2

608

Clinical Trials associated with Lenvatinib mesylate

NCT06669572

/ Not yet recruitingPhase 2IIT

A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

Start Date13 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT05077215

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab Vs. Lenvatinib Plus Pembrolizumab in Patients with Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

Start Date01 Dec 2025

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT07011849

/ Not yet recruitingPhase 2

A Multi-center, Open-label Phase II Study of Lenvatinib Plus Pembrolizumab (LEAP) in Renal Cell Carcinoma Patients With Brain Metastasis Previously Treated With Immune Checkpoint Blockade

This is a multi-center, open-label phase II study evaluating the efficacy and safety of pembrolizumab in combination with lenvatinib in patients with renal cell carcinoma (RCC) and brain metastasis who were previously treated with immune checkpoint blockade.

Start Date01 Nov 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Lenvatinib mesylate

100 Translational Medicine associated with Lenvatinib mesylate

100 Patents (Medical) associated with Lenvatinib mesylate

3,754

Literatures (Medical) associated with Lenvatinib mesylate

31 Dec 2025·ANNALS OF MEDICINE

Immune infiltration landscape and potential drug-targeted implications for hepatocellular carcinoma with ‘progression/hyper-progression’ recurrence

Article

Author: Qi, Lu-Nan ; Peng, Yu-Chong ; Su, Yue-Xiang ; Xu, Jing-Xuan ; Chen, Yuan-Yuan ; Chen, Zu-Shun ; Huang, Yi-Yue

BACKGROUND AND AIMS:

Hepatocellular carcinoma (HCC) recurrence was previously characterized into four types, and patients with progression/hyper-progression recurrence (type III-IV) have an extremely poor prognosis. However, the immune background of resectable HCC, particularly in patients who experience recurrence, remains underexplored. Therefore, this study aimed to describe the immune landscape of resectable HCC, especially postoperative type III-IV recurrent HCC, and explore potential immune-targeted anti-relapse strategies for treated populations.

METHODS:

The differences in gene expression in patients with recurrent HCC (type I-II (solitary or multi-intrahepatic oligo recurrence) vs. type III-IV) were investigated using bulk sequencing. Multiple immune infiltration methods (single-sample gene set enrichment analysis (GSEA), Microenvironment Cell Populations-counter and ESTIMATE) were used, and patients were divided into four groups to identify four distinct immune subtypes: immune-enrichment/matrix-poor (IE1), immune-enrichment/matrix-rich (IE2), immune intermediate/matrix-rich (ITM) and immune desert/matrix-poor (ID). Co-expression and protein interaction analyses were used to identify characteristic genes in ITM closely associated with type III-IV recurrence, which was matched with drug targets for Huaier granules (HG) and lenvatinib. Virtual docking was used to identify potential therapeutic targets, and the results were verified using single-nuclei RNA sequencing and histological analysis.

RESULTS:

ITM was closely related to type III-IV recurrence and exhibited immunotherapy potential. The potential efficacy of inhibiting CCNA2, VEGFA, CXCL8, PLK2, TIMP1, ITGB2, ALDOA, ANXA5 and CSK in ITM reversal was determined. Molecular docking demonstrated that the proteins of these genes could bind to HG or lenvatinib. The immunohistochemical findings demonstrated differential VEGFA (p < .01) and PLK2 (p < .001) expression in ITM type and ID in type III-IV recurrent HCC.

CONCLUSIONS:

Three primary immunotypes of resectable HCC (IE2, ITM and ID) were identified, and HG and lenvatinib could potentially overcome immune checkpoint blockade (ICB) resistance in ITM patients with HCC, particularly those classified as type III-IV.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Immunotherapy-induced microsatellite instability status shift in recurrent perihilar cholangiocarcinoma: A case report

Article

Author: Deng, Tan ; Liu, Hongbing ; Yu, Hailing

Immunotherapy revolutionized the treatment of biliary tract tumors and tumors with high microsatellite instability (MSI-H). This paper reports a 52-year-old woman with recurrent perihilar cholangiocarcinoma. The tumor was initially microsatellite stable (MSS) and proficient mismatch repair (pMMR) but shifted to MSI-H and deficient mismatch repair (dMMR) after combined immunotherapy. Following laparoscopic radical resection for jaundice, stage IV recurrence was diagnosed. Genetic testing revealed the MSS status. Subsequent treatment with camrelizumab and lenvatinib led to a partial response. Ovarian metastases, removed due to abdominal symptoms, exhibited dMMR and MSI-H. The mismatch in MSI status between the primary tumor and metastases suggests tumor heterogeneity and the influence of spatial or temporal factors. This shift can have important clinical significance since MSI-H is associated with significant responses to immune checkpoint inhibitors. MSI-H should be systematically tested in tumors and metastases to personalize treatments. MSI heterogeneity is not only rare but potentially has implications for treatment personalization and prognosis in patients with cholangiocarcinoma. This case highlights the dynamic changes in tumor characteristics during immunotherapy.

31 Dec 2025·ANNALS OF MEDICINE

Icaritin and lenvatinib treatment for unresectable localized progressive pancreatic cancer: a report of six cases

Article

Author: Zhang, Yizhuo ; Lu, Jianguo ; Dong, Xinyu ; Cao, Yanlong ; Hong, Defei ; Liu, Xiaolong ; Jiang, Guixing

BACKGROUND:

Pancreatic cancer is very difficult to detect in its early stages, and its rapid progression and poor prognosis make it a significant therapeutic challenge. Existing treatment modalities, whether standalone or combined, offer limited efficacy, highlighting an urgent need for more effective and less toxic therapeutic strategies.

PATIENTS:

We analyze six cases of pancreatic cancer, each undergoing a novel treatment regimen integrating chemotherapy, targeted therapy, immune therapy, and icaritin.

RESULTS:

The outcomes demonstrate varying degrees of improvement in all cases. Partial responses were observed in cases 1 and 3, with some tumor shrinkage. Cases 4 and 5 showed limited relief following a slight decrease in tumor size. In cases 2 and 6, no significant progression of the lesion was observed. These results highlight the potential efficacy of this multifaceted approach.

CONCLUSION:

Integrating icaritin with chemotherapy, immunotherapy, and/or targeted therapies shows potential as an exploratory approach in managing advanced, locally progressive, or metastatic pancreatic cancer, though further validation is required.

365

News (Medical) associated with Lenvatinib mesylate

04 Jun 2025

·www.prnewswire.com

2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, June 3, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the third oral presentation of clinical data for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2025 American Society of Clinical Oncology (ASCO), following IBI363's other two oral presentations in colorectal cancer and melanoma. A manageable safety profile, encouraging efficacy, and trends in long-term survival benefits have been observed in both immunotherapy-resistant squamous non-small cell lung cancer (NSCLC) and wild-type lung adenocarcinoma. It is worth mentioning that Innovent's pipeline has a total of 8 oral presentations at this ASCO conference, representing approximately 2% of the conference's total oral presentations. Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, three oral presentations of IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—NSCLC, CRC, and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients with immunotherapy resistant advanced non-small cell lung cancer: results from a Phase 1 study Updated data on IBI363 monotherapy in patients with advanced NSCLC were reported (ClinicalTrials.gov, NCT05460767). As of the data cutoff date, April 7, 2025, a total of 136 patients with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W), including 67 with squamous cell carcinoma and 58 with EGFR wild-type adenocarcinoma. IBI363 showed breakthrough therapeutic potential from tumor response to long-term survival benefit in immuno-resistant squamous NSCLC All 67 squamous NSCLC patients were EGFR wild type. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportion of ≥2 lines of previous systemic therapy was 64.3% (18/28) vs 67.7% (21/31), the proportion of previous anti-PD-1/PD-L1 therapy was 100% (28/28) vs 96.8% (30/31) and the proportion of PD-L1 TPS<1% was 35.7% (10/28) vs 41.9% (13/31). In the 1/1.5 mg/kg dose group, promising ORR/DCR/PFS/OS were observed. Median OS achieved 15.3 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 1/1.5 mg/kg dose group, the 3 mg/kg Q3W dose group observed more prominent confirmed ORR (36.7%), DCR (90.0%), PFS (median PFS 9.3 months) and OS trends (median OS not reached, 12-month OS rate 70.9%) (see the table below). Among the patients with PD-L1 TPS<1%, IBI363 demonstrated outstanding efficacy signals: in the 1/1.5 mg/kg group (N=10), the confirmed ORR was 30.0% and the DCR was 90.0%, while that of the 3 mg/kg group (N=13) were 46.2% and 92.3%, suggesting the potential advantage of IBI363 in the population with low expression of PD-L1. IBI363 showed potential for long-term survival benefits in immuno-resistant wild-type lung adenocarcinoma, especially in patients with smoking history Among the 58 patients with EGFR wild-type lung adenocarcinoma, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, 25 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportions of ≥2 lines of previous systemic therapy were 80.0% (24/30) vs 64.0% (16/25), the proportions of previous anti-PD-1/PD-L1 therapy were both 100%, the proportions of PD-L1 TPS<1% were 26.7% (8/30) vs 40.0% (10/25) and the proportions of smoking history were 56.7% (17/30) vs 60.0% (15/25). In the 1/1.5 mg/kg dose group, median OS achieved 17.5 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 0.6/1/1.5 mg/kg dose group, the 3 mg/kg dose group observed higher confirmed ORR (24.0%), DCR (76.0%), PFS (median PFS 5.6 months) and OS trends (median OS not reached, 12-month OS rate 71.6%) (see the table below). Higher ORR and PFS were observed in lung adenocarcinoma patients with a history of smoking. Among them, the confirmed ORR in the 0.6/1/1.5 mg/kg group (N=17) was 23.5%, and the confirmed ORR in the 3 mg/kg group (N=15) was 33.3%. In all dose groups (N=32), the median PFS of smokers was longer than non-smokers: 5.3 (2.0, 7.0) vs 3.0 (1.6, 5.1) months. In terms of long-term survival benefits, after follow-ups of 12.0 and 13.7 months, the median OS for non-smokers was 13.6 months, whereas the median OS for smokers was not yet reached, with only 9 (28.1%) events occurring. IBI363 had a manageable safety profile in advanced NSCLC Among the 57 patients with NSCLC in the 3 mg/kg dose group, the most common treatment related adverse events (TRAEs) of grade 3 or above were arthralgia and rash. 7.0% of patients experienced TRAEs leading to discontinuation. The overall safety profile was manageable. In view of the encouraging efficacy signals and manageable safety demonstrated by IBI363 monotherapy, Innovent plans to conduct a Phase 3 registration clinical study in locally advanced or metastatic squamous NSCLC that has failed platinum-based chemotherapy and anti-PD-1 /PD-L1 immunotherapy. As of now, IBI363 has received Breakthrough Therapy (BTD) certification from China CDE and Fast Track Designation (FTD) from the US FDA for squamous NSCLC. Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Lung cancer is the malignant tumor with the highest incidence and mortality rate both globally and in China[1], and it is a major issue endangering public health. Although immunotherapy has completely transformed the treatment landscape of NSCLC, for patients with wild-type NSCLC who have failed immunotherapy, the current standard treatment regimen docetaxel has limited efficacy, with an ORR of less than 20%, a PFS of less than 4 months, and an OS of less than 12 months [2-7]. In recent years, although the exploration of new treatment regimens such as immune combination therapy and antibody drug conjugates (ADCs) has brought new hope, many large-scale Phase 3 clinical studies on NSCLC patients who have failed platinum-based chemotherapy and immunotherapy have not achieved satisfactory results, and most of these studies have not met the primary endpoints[2-6]. Although the TROPION-Lung01 study achieved the primary endpoint of PFS in NSCLC, it did not reach the primary endpoint of OS. Especially in squamous NSCLC, no improvement was observed in PFS/OS/ORR in the experimental group. Therefore, there was a huge and urgent unmet medical need in NSCLC that has failed immunotherapy. As a PD-1/IL-2α-bias bispecific molecule, IBI363 not only shows clinical benefits in both ORR and PFS in immune-resistant NSCLC, but also enables us to see the potential of the tailing effect of immunotherapy to bring long-term survival benefits to patients compared with chemotherapy. We are also more looking forward to the survival data of the long-term follow up in the high dose IBI363 group." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "It is a great pleasure to orally present the latest progress of IBI363 in the field of lung cancer at the ASCO conference. IBI363 shows remarkable efficacy in immune-resistant wild-type nsclc and clinical data suggests better trends in ORR, DCR, PFS and OS at higher doses. We expect longer-term follow-up to bring more mature data and look forward to seeing its potential as an immunotherapy for the long-term survival benefits of patients. Meanwhile, regardless of the expression level of PD-L1, IBI363 has demonstrated a powerful anti-tumor effect in immune-resistant NSCLC (especially squamous NSCLC), suggesting that the effect of IBI363 does not depend on the expression of PD-L1. In the future, it may also bring breakthroughs in cold tumors with low or no expression of PD-L1. We will continue to advance the clinical exploration of IBI363 in NSCLC and other tumor types." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. 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 Eli Lilly, Sanofi, Incyte, Adimab, 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. 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. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References [1] Globocan 2022 (version 1.1) - 08.02.2024 [2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733 [3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166 [4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024. [5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023. [6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16. [7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544 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 3Fast TrackPhase 1Immunotherapy

02 Jun 2025

·www.prnewswire.com

ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025

CHICAGO, June 2, 2025 /PRNewswire/ -- ImmuneOncia Therapeutics, Inc. (CEO Heung-Tae Kim) announced interim results today from the ongoing Phase 1b clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC). The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA. The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anemia was observed in 2 of 13 patients (15%), and 96% of adverse events were Grade 1–2, occurring primarily in the first treatment cycle. Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit. AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumor cell membranes, whereas no response was observed in those with low expression - a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response. Professor Jeong-Yong Hong of Samsung Medical Center commented, "The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives. A 30% response rate is particularly promising, especially when compared to the approximately 10% typically observed with current second-line therapies for HCC." CEO Heung-Tae Kim stated, "Two of the three partial responders were resistant to first-line immunotherapy, suggesting IMC-002 may offer a new path forward via macrophage-based innate immunity. We are confident that this combination could redefine second-line treatment for HCC and will enhance our patient selection strategy through AI-driven biomarker analysis." IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimize binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia. ImmuneOncia is currently conducting Phase 1b trial of IMC-002 in patients with solid tumors. In 2021, the company out-licensed the asset to China's 3D Medicines in a deal worth up to $470 million. Its pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202. Following its KOSDAQ listing in May 2025, ImmuneOncia aims to strengthen its global presence in immuno-oncology. About IMC-002 IMC-002 is a novel immune checkpoint inhibitor targeting CD47, a "don't eat me" signal expressed on cancer cells. By blocking the CD47/SIRPα interaction, IMC-002 enhances macrophage-mediated phagocytosis. It is engineered to deliver high efficacy while minimizing binding to red blood cells and avoiding hematologic toxicity. About ImmuneOncia Therapeutics, Inc. Founded in 2016, ImmuneOncia is a South Korean clinical-stage biotech company specializing in immuno-oncology. With expertise in antibody development and translational science, the company is advancing a pipeline of checkpoint inhibitors and bispecific antibodies to address unmet needs in cancer treatment. Media Contact Jiwon Heo ImmuneOncia Therapeutics, Inc. Email: [email protected] Website: SOURCE ImmuneOncia Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Clinical ResultASCO

23 May 2025

·www.prnewswire.com

Eisai to Present E7386, Co-created by PRISM BioLab and Eisai, at the ASCO (American Society of Clinical Oncology) Annual Meeting

Abstract Released for E7386, Co-Developed Through Collaborative Research Between Eisai and PRISM TOKYO, May 22, 2025 /PRNewswire/ -- PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protein interaction (PPI) targets, today announced that the analysis of a combination study of E7386(*1), created through collaboration research with Eisai Co., Ltd. ("Eisai"), and Lenvatinib mesylate ("lenvatinib") (*2) will be presented by Eisai at the American Society of Clinical Oncology (ASCO) Congress 2025, held in Chicago, USA from May 30 to June 3, 2025. The abstract of the study has been released today. To determine the optimal dose of E7386 in combination with Lenvatinib in the open-label Phase Ib study (NCT04008797(*3)), expansion cohort of advanced endometrial cancer patients progressed following platinum-based chemotherapy and anti-PD-(L)1 immunotherapy have been implemented by Eisai and the enrollment of 30 patients was completed. By data cutoff (Oct 22, 2024), with 9 patients remaining on treatment, 30% (9 patients) showed the confirmed response (decrease of tumor size > 30%) for an overall response rate of 30.0%. Furthermore, among patients without prior Lenvatinib treatment, the overall response rate was 42.9%. Completing the enrollment of dose expansion cohort (n=30), the results confirmed promising preliminary antitumor activity of E7386 + Lenvatinib with a manageable safety profile. For the subsequent dose-optimization part for E7386 + LEN in advanced endometrial cancer, enrollment of patients had been initiated (NCT04008797). (*1) E7386 E7386 is an orally available small molecule CBP/ β-catenin inhibitor that inhibits protein-protein interactions between the transcription factor CBP and β-catenin, and regulates the Wnt signaling. E7386 achieved clinical POC (Proof of concept) in October 2021 and following clinical studies are ongoing including phase I for solid tumors as monotherapy, Phase Ib for solid tumors in combination with tyrosine kinase inhibitor Lenvatinib, Phase Ib/II for solid tumors in combination with pembrolizumab, the anti-PD-1 antibody from Merck & Co., Inc., Rahway, NJ, USA. (*2) Lenvatinib Lenvatinib is a multi-kinase inhibitor, discovered by Eisai and being co-developed and co-commercialized under a collaboration agreement with Merck & Co., Inc., Rahway, NJ, USA, which inhibits vascular endothelial growth factor receptors (VEGFRs),VEGFR1, VEGR2, VEGFR3 and fibroblast growth factor receptors (FGFRs), FGFR1, FGFR2, FGFR3, FGFR4, and other receptor tyrosine kinases, PDGFR-alpha, KIT, RET. Lenvatinib have been approved for thyroid cancer, hepatocellular carcinoma, thymic caner and renal cell carcinoma (in combination with Everolimus or pembrolizumab, the anti-PD-1 antibody from Merck & Co., Inc., Rahway, NJ, USA.). Lenvatinib is also approved for endometrium cancer in combination with pembrolizumab (*3) NCT04008797 NCT04008797 is an open-label Phase Ib study of E7386 in combination with other anticancer drug, Lenvatinib for the patients with solid tumors. The study has been implemented by Eisai in Japan, Korea, Taiwan region, US, and France determine the safety and the recommended phase 2 dose (RP2D) and also to see the pharmacokinetics and efficacy of E7386 + Lenvatinib. Enrolment of each cohort of hepatic, colon, endometrial cancers are ongoing. About PRISM BioLab PRISM BioLab is a discovery and development biotechnology company utilizing proprietary PepMetics® technology to discover orally available small molecule inhibitors of protein-protein interaction (PPI) targets and transform lives of patients suffering from cancer, autoimmune, fibrosis and other diseases. PepMetics® are a unique class of small molecules that mimic three-dimensional structures of alpha-helix and beta-turn, the peptide structures commonly found in intracellular PPI interphases and receptor-ligand interactions. By combining proprietary chemistry, know-how around PPI targets and AI-supported design, PepMetics® technology can deliver inhibitors of challenging PPI targets. The technology holds promise to expand the field of drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules and by generating oral small molecule alternatives for injectable biologics. PRISM BioLab is collaborating on new PPI targets with global and Japanese pharmaceutical companies. PepMetics® targeting CBP/beta-catenin PPIs licensed to Eisai Co., Ltd. and Ohara Pharmaceuticals Co., Ltd. are in clinical development for cancer and liver disease, respectively. SOURCE PRISM BioLab Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultASCODrug ApprovalImmunotherapy

100 Deals associated with Lenvatinib mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D09920	Lenvatinib mesylate	L01XE	DB09078

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	European Union	Eisai GmbH	25 Jul 2023
Advanced Endometrial Carcinoma	Iceland	Eisai GmbH	25 Jul 2023
Advanced Endometrial Carcinoma	Liechtenstein	Eisai GmbH	25 Jul 2023
Advanced Endometrial Carcinoma	Norway	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	European Union	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	Iceland	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	Liechtenstein	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	Norway	Eisai GmbH	25 Jul 2023
Thymus Neoplasms	Japan	Eisai Co., Ltd.	23 Mar 2021
Advanced Renal Cell Carcinoma	European Union	Eisai GmbH	25 Aug 2016
Advanced Renal Cell Carcinoma	Iceland	Eisai GmbH	25 Aug 2016
Advanced Renal Cell Carcinoma	Liechtenstein	Eisai GmbH	25 Aug 2016
Advanced Renal Cell Carcinoma	Norway	Eisai GmbH	25 Aug 2016
Endometrial Carcinoma	Australia	Eisai Co., Ltd.	28 Jan 2016
Renal Cell Carcinoma	Australia	Eisai Co., Ltd.	28 Jan 2016
Advanced Hepatocellular Carcinoma	European Union	Eisai GmbH	28 May 2015
Advanced Hepatocellular Carcinoma	Iceland	Eisai GmbH	28 May 2015
Advanced Hepatocellular Carcinoma	Liechtenstein	Eisai GmbH	28 May 2015
Advanced Hepatocellular Carcinoma	Norway	Eisai GmbH	28 May 2015
Differentiated Thyroid Gland Carcinoma	European Union	Eisai GmbH	28 May 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	28 Oct 2021
Metastatic Esophageal Carcinoma	Phase 3	United States	Eisai, Inc.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	United States	Merck Sharp & Dohme Corp.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	China	Eisai, Inc.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	China	Merck Sharp & Dohme Corp.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Japan	Eisai, Inc.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Japan	Merck Sharp & Dohme Corp.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Argentina	Eisai, Inc.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Argentina	Merck Sharp & Dohme Corp.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Canada	Merck Sharp & Dohme Corp.	28 Jul 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03838796 (Pubmed \| Hepatobiliary Pancreat Dis Int)	Not Applicable	Hepatocellular Carcinoma Adjuvant	297	Lenvatinib + TACE	eutamsnvfo(wnjpuuaety) = nfsigufpwu xtopmnnbic (sljiqcjcfn ) View more	Positive	01 Jun 2025
				lenvatinib (TACE)	eutamsnvfo(wnjpuuaety) = hcteblaffl xtopmnnbic (sljiqcjcfn ) View more
NCT04662710 (LEAP-015, Pubmed \| J Clin Oncol)	Phase 3	Metastatic gastroesophageal adenocarcinoma First line PD-L1 CPS ≥1	880	Lenvatinib plus Pembrolizumab and Chemotherapy	kmxtucfxvh(xpfmgjxgtv) = wbjesliguw ewddysvppt (gmcnyjkyst ) View more	Positive	31 May 2025
				Chemotherapy	kmxtucfxvh(xpfmgjxgtv) = dclxajjzmr ewddysvppt (gmcnyjkyst ) View more
ASCO2025	Not Applicable	Melanoma Neoadjuvant	64	PD1 alone	ssybslrjuc(ypfanwmtqj) = eukqdbhuwf nrpaenaxoa (kpeapnsqzs )	-	30 May 2025
				PD1+IPI	ssybslrjuc(ypfanwmtqj) = sxfpokiact nrpaenaxoa (kpeapnsqzs )
ASCO2025	Not Applicable	Advanced Hepatocellular Carcinoma Second line	388	Lenvatinib	kkvanpmnsb(hflurljjkz) = uksacpdjqo zyfhlobpof (vsrnawxwkx, 7.39 - 17.22) View more	Positive	30 May 2025
SELECT (ASCO2025)	Phase 3	Thyroid Cancer First line TP53	77	Lenvatinib 10 mg	hiymsfkzto(bxjvnpoupf) = zoatolgure dwkesknort (rrucdfwdwt ) View more	Positive	30 May 2025
				Lenvatinib 14 mg	hiymsfkzto(bxjvnpoupf) = khrhtywdsy dwkesknort (rrucdfwdwt ) View more
ASCO2025	Not Applicable	Hepatocellular Carcinoma First line	158	lenvatinib (Training cohort)	hiyomghfth(uixfbvylil) = cluiriqkyp zlivchqlzz (ttyiotartp )	Positive	30 May 2025
				lenvatinib (Validation cohort)	hiyomghfth(uixfbvylil) = yqgbcmamjz zlivchqlzz (ttyiotartp )
xCures database (ASCO2025)	Not Applicable	Fibrolamellar Hepatocellular Carcinoma	21	GEMOX	ripoyzzjxm(tybfsakwwl) = rcstbsfjms devimeevwi (pmlubpyfqy ) View more	Positive	30 May 2025
NCT04869137 (phase II study of neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma, ASCO2025)	Phase 2	Merkel Cell Carcinoma Neoadjuvant \| Adjuvant	26	Lenvatinib 20mg	fstpkcwgzw(cuegnyxzuw) = gcpsthuffj lzfasknscs (hnjhhoxpey )	Positive	30 May 2025
NCT05621499 (ASCO2025)	Phase 2	Neoadjuvant	54	HAIC-FOLFOX	jtstjzrzjn(bnbyckkjgw) = xyifqtwqjq qgwqpufsqz (uqrfvvayvm )	Positive	30 May 2025
				Sintilimab 200 mg Q3W + Lenvatinib 12 or 8 mg QD	jtstjzrzjn(bnbyckkjgw) = pawculjecs qgwqpufsqz (uqrfvvayvm ) View more
NCT04662710 (LEAP-015, ASCO2025)	Phase 3	Metastatic gastroesophageal adenocarcinoma First line HER-2 negative \| PD-L1 CPS ≥1	880	Pembrolizumab plus Lenvatinib and Chemotherapy	qarxitijbg(wwqpqtbwfu) = gehyzmlzym abmaxsnmke (wywljxzosq ) View more	Positive	30 May 2025
				Chemotherapy alone	qarxitijbg(wwqpqtbwfu) = odzvxemnic abmaxsnmke (wywljxzosq ) View more

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