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+ [95]

Inactive Indication

Advanced breast cancerAdvanced gastric carcinomaFallopian Tube Carcinoma+ [33]

Originator Organization

Eisai Co., Ltd.

Active Organization

Eisai, Inc.

Merck Sharp & Dohme Corp.Merck Sharp & Dohme LLC

+ [6]

Inactive Organization

Bristol Myers Squibb Co.

Merck & Co., Inc.

Jiangsu Simcere Pharmaceutical Co., Ltd.

+ [1]

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), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Special Review Project (China)

Structure/Sequence

Molecular FormulaC22H23ClN4O7S

InChIKeyHWLFIUUAYLEFCT-UHFFFAOYSA-N

CAS Registry857890-39-2

756

Clinical Trials associated with Lenvatinib mesylate

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 2026

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT07540832

/ Not yet recruitingPhase 1/2

An Open-Label Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy

This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer.

Start Date01 Sep 2026

Sponsor / Collaborator

Zhejiang Haichang Bio-Tech Co., Ltd.

NCT05106127

/ Not yet recruitingPhase 2

A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab

This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

Start Date01 Aug 2026

Sponsor / Collaborator

Evergreen Therapeutics, Inc

100 Clinical Results associated with Lenvatinib mesylate

100 Translational Medicine associated with Lenvatinib mesylate

100 Patents (Medical) associated with Lenvatinib mesylate

3,994

Literatures (Medical) associated with Lenvatinib mesylate

31 Dec 2026·ANNALS OF MEDICINE

Systematic meta-analysis of the toxicities and side effects of the targeted drug lenvatinib

Review

Author: Cui, Chao ; Liu, Huihui ; Wang, Kai ; Li, Qingwei ; Sun, Yu ; Gao, Shuai ; Shi, Jingfei

BACKGROUND:

Lenvatinib, an effective targeted drug for various cancers, has clinical medication safety concerns due to its toxicities and side effects.

OBJECTIVE:

This study evaluated lenvatinib-induced any adverse events (any AEs) and nine aspects: vascular toxicities related to the circulatory system (vascular toxicities, blood system, and heart), toxicities of the skin and its appendages (skin/subcutaneous tissue and taste system), toxicities of the respiratory system (respiratory, thoracic, and mediastinal and respiratory tract), toxicities of the nervous system (nervous system and general), toxicities of the digestive system (gastrointestinal and liver), toxicities of the urinary system, toxicities of the endocrine and metabolic system (endocrine and metabolism/nutrition), toxicities of the musculoskeletal system, and other severe toxicities. Toxicities and side effects were stratified by severity into any and ≥3 grades for analysis.

PATIENTS/MATERIALS AND METHODS:

Multiple databases were searched for lenvatinib cancer clinical studies (cohort studies and randomized controlled trials) from inception to December 31, 2024; toxicity and side effect data were extracted and analyzed.

RESULTS:

Nine high-quality studies were included, showing that lenvatinib is effective in cancers but has notable toxicities. Taking hypertension as an example, for any grade, the risk ratio (RR) was 2.34 with a 95% confidence interval (CI) of [2.09, 2.62], a Z-value of 14.74, and a P-value <0.00001; for grade ≥3, the RR was 2.60 with a 95% CI of [2.21, 3.06], a Z-value of 11.44, and a P-value <0.00001.

CONCLUSION:

Lenvatinib is effective for cancer but toxic, and this study supports its rational clinical use.

31 Dec 2026·CANCER BIOLOGY & THERAPY

Lenvatinib potentiates the antitumor efficacy of combined radiotherapy and PD-L1 blockade in lung adenocarcinoma

Article

Author: Zhang, Xue ; Li, Tao ; Zhang, Shichuan ; Li, Linjie ; Xiao, Ling ; Tang, Chengxi ; Liu, Yudi ; Nie, Xinyu ; Lyu, Jiahua ; Huang, Jianming

BACKGROUND:

The potential of Lenvatinib to synergize with combined radiotherapy and immunotherapy in LUAD remains incompletely characterized.

METHODS:

We investigated Lenvatinib's effects on radiation-induced PD-L1 in LUAD cells and VEGFR2 in HUVECs via Western blot, VEGFA expression via RT-qPCR/ELISA, and angiogenesis via immunofluorescence. LUAD-HUVEC crosstalk was modeled in vitro. In C57BL/6 mice bearing LUAD tumors, we evaluated the efficacy of RT and anti-PD-L1 with or without Lenvatinib, monitoring tumor growth, survival, and profiling the tumor microenvironment by mIHC and flow cytometry.

RESULTS:

Lenvatinib suppressed radiation-induced PD-L1 and VEGFR2 expression, inhibited angiogenesis, and disrupted HUVEC-facilitated LUAD proliferation. The triple-combination (RT + anti-PD-L1 + Lenvatinib) significantly suppressed tumor progression (P < 0.05) and extended median survival (34 vs. 29.5 days, P < 0.05) versus dual therapy. It also enhanced intratumoral CD8⁺ T-cell infiltration and cytotoxicity, promoted M1-like macrophage polarization, and reduced regulatory T cell frequency and microvessel density.

CONCLUSIONS:

Lenvatinib potentiates RT and anti-PD-L1 therapy in LUAD through dual immune-vascular modulation, supporting the clinical translation of this triple-combination strategy.

01 Dec 2026·JOURNAL OF MOLECULAR MEDICINE-JMM

Combined targeting poly (ADP-ribose) polymerase and receptor tyrosine kinase inhibits ovarian clear cell carcinoma progression through disrupted ribosome biogenesis

Article

Author: Chao, Angel ; Lai, Chyong-Huey ; Fu, Chiung-Hui ; Chao, An-Shine ; Yu, Alice L ; Teng, Yu-Chuan ; Wu, Ren-Chin ; Huang, Ruby Yun-Ju ; Lin, Chiao-Yun

OCCC has extremely poor prognosis. ARID1A mutation-related chromatin remodeling errors are key molecular features of OCCC. Dysregulation of receptor tyrosine kinases-related signaling pathways is common in OCCC. Here we show that combination of niraparib and lenvatinib exhibits significant synergistic inhibitory effects against platinum-resistant OCCC cell lines, xenografts, patient-derived tumoroid (PDT) models, and prolonged survival in the platinum-refractory patient-derived xenograft (PDX) model. RNA-sequencing revealed the most differently expressed genes in PDX treated with a combination of niraparib and lenvatinib versus control were in structural ribosomal components. Selected differently expressed ribosomal proteins (RPs: RPS2, RPS5, RPS9, and RPL3) was validated using quantitative polymerase chain reaction. Nucleophosmin (NPM1) expression, which is involved in ribosome biogenesis, was inhibited by niraparib and lenvatinib. Our findings imply that combined niraparib and lenvatinib reduces platinum-resistant OCCC progression by attenuating Src phosphorylation, NPM1 expression and ribosome biogenesis. These results highlight the necessity for continued exploration of this promising treatment strategy, particularly in future clinical trials for platinum-resistant or platinum-refractory OCCC. KEY MESSAGES: The combination of niraparib and lenvatinib synergistically inhibits platinum-resistant OCCC. This combination prolongs survival in a platinum-refractory PDX model. RNA sequencing revealed that the most differentially expressed genes in PDX models treated with this combination were associated with structural ribosomal components. This combination suppresses Src phosphorylation, NPM1 expression, and ribosomal protein levels in OCCC.

449

News (Medical) associated with Lenvatinib mesylate

22 May 2026

·www.biospace.com

AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026

EMERALD-3 late-breaking presentation will showcase benefit of IMFINZI ® (durvalumab) and IMJUDO ® (tremelimumab-actl) in early liver cancer Phase III data from SERENA-6, DESTINY-Breast09 and TROPION-Breast02 span all three major subtypes of metastatic breast cancer CARES Phase III results will demonstrate highly clinically meaningful benefit of anti-fibril therapy, anselamimab, for kappa light chain amyloidosis WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca advances its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 29 to June 2, 2026. More than 85 abstracts will feature 10 approved and 13 potential new medicines from the Company, including 25 oral presentations. Highlights include: EMERALD-3: Phase III trial of IMFINZI ® (durvalumab) in combination with IMJUDO ® (tremelimumab-actl), with or without lenvatinib, and transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolization (Oral Abstract #LBA4000). CARES: Phase III clinical program of anselamimab, a potential first-in-class anti-fibril therapy from Alexion, AstraZeneca Rare Disease, in newly diagnosed patients with light chain (AL) amyloidosis receiving standard of care for underlying plasma cell dyscrasia, including results from a prespecified subgroup analysis based on involved kappa (κ) or lambda (λ) free light chain (Oral Abstract #7501). SERENA-6: Final progression-free survival 2 (PFS2) results and circulating tumor DNA (ctDNA) clearance data linked to longer-term efficacy outcomes from the SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation (Oral Abstract #LBA1007). BLUESTAR: Updated safety and efficacy results from the BLUESTAR Ph I/IIa trial of the B7-H4-directed ADC puxitatug samrotecan (Puxi-Sam) in patients with relapsed/metastatic B7-H4-positive endometrial and ovarian cancer who progressed on prior standard-of-care therapy (Rapid Oral Abstract #5515). Puxi-Sam was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in this setting. PRIMAVERA: Safety and preliminary efficacy from the first-in-human Phase I PRIMAVERA trial of the protein arginine methyltransferase 5 (PRMT5) inhibitor AZD3470 as monotherapy in relapsed/refractory classic Hodgkin lymphoma (Oral Abstract #7003). Phase I initial results for NT-175 T-cell receptor therapy in TP53 R175H-mutated unresectable, advanced and/or metastatic solid tumors including pancreatic adenocarcinoma (Oral Abstract #2506). TROPION-Breast02: Additional efficacy endpoints from the TROPION-Breast02 Phase III trial of DATROWAY ® (datopotamab deruxtecan-dlnk) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors (Oral Abstract #1002). DESTINY-Breast09: Exploratory analysis of treatment duration and clinical outcomes by complete response, partial response or stable/progressive disease in the DESTINY-Breast09 Phase III trial of ENHERTU ® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Rapid Oral Abstract #1021). POTOMAC: Five-year overall survival and patient-reported outcomes from the Phase III POTOMAC trial of IMFINZI plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (Rapid Oral Abstract #4624). Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The data at ASCO for our innovative medicines and next-wave assets further our strategy to redefine patient outcomes by taking novel combinations into earlier stages of disease and advancing new modalities. New data for ENHERTU, DATROWAY and camizestrant reinforce their transformational potential in breast cancer. We’re also excited to share first clinical data for our T-cell receptor therapy, NT-175, and our PRMT5 inhibitor, AZD3470, as well as updated data for our most advanced in-house antibody drug conjugate, Puxi-Sam, which was recently granted Breakthrough Therapy Designation by the FDA. Collectively, these datasets underscore the strength and depth of our oncology pipeline.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The EMERALD-3 data for IMFINZI and IMJUDO in early liver cancer exemplify our successful strategy to move immunotherapy regimens into earlier stages of cancer where we can further improve outcomes for patients. With more than a dozen different indications approved across five cancer medicines in the last six months alone, we are reaching more patients with our growing portfolio, underscoring both the quality of our innovation and the strength of our business.” Gianluca Pirozzi, Head of Development, Regulatory and Safety, Alexion, said: "Results from the CARES Phase III clinical program highlight the pioneering potential of anselamimab as a first-in-class, anti-fibril therapy for patients with kappa light chain amyloidosis. Its novel mechanism of action is designed to target and deplete amyloid deposits in affected organs, with potential to extend survival and reduce cardiovascular hospitalizations." AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialize ENHERTU and DATROWAY. Key AstraZeneca presentations during ASCO 2026 1 Lead Author Abstract Title Presentation details (CDT) Antibody drug conjugates Loi, S Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07. Abstract #1012 Clinical Science Symposium May 31, 2026 9:18am Cescon, DW First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study. Abstract #1002 Oral Abstract Session June 2, 2026 10:09am Mileshkin, LR Updated safety and efficacy of puxitatug samrotecan (Puxi-Sam, AZD8205) in patients (pts) with endometrial cancer (EC) or ovarian cancer (OC): Phase 1/2a BLUESTAR study. Abstract #5515 Rapid Oral Abstract Session May 30, 2026 9:00am Park, YH A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P). Abstract #1021 Rapid Oral Abstract Session May 31, 2026 12:42pm Untch, M Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP). Abstract #516 Rapid Oral Abstract Session June 1, 2026 10:57am Shitara, K Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2–positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01. Abstract #4023 Poster Session May 30, 2026 9:00am Janjigian, Y First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4. Abstract #4022 Poster Session May 30, 2026 9:00am Zhang, Y Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis. Abstract #3026 Poster Session May 30, 2026 1:30pm Immuno-oncology Abou-Alfa, GK Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC). Abstract #LBA4000 Oral Abstract Session June 1, 2026 9:45am Skoulidis, F Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) vs pembrolizumab (P) + CT in 1L non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11 , KEAP1 , and/or KRAS mutations (mut): Interim analysis (IA) of the phase 2b TRITON study. Abstract #8515 Rapid Oral Abstract Session May 30, 2026 1:45pm Heymach, JV Impact of neoadjuvant durvalumab (D) on tumor microenvironment (TME) features and their association with event-free survival (EFS) in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial. Abstract #8015 Rapid Oral Abstract Session May 31, 2026 5:30pm De Santis, M Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. Abstract #4624 Rapid Oral Abstract Session June 1, 2026 8:12am IO Bispecifics O’Sullivan, CC Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial. Abstract #LBA514 Rapid Oral Abstract Session June 1, 2026 10:45am Zhou, J First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A. Abstract #88 Poster Session May 30, 2026 9:00am Guo, Y Volrustomig monotherapy for recurrent/metastatic HNSCC: Substudy 2 of the eVOLVE-02 phase 2 study. Abstract #482 Poster Session May 30, 2026 1:30pm Tumor drivers and resistance Wang, Z Osimertinib with/without chemotherapy in patients with persistent ctDNA EGFR mutant (EGFRm) NSCLC at 3 weeks after 1L osimertinib: A randomized phase II study (FLAME study). Abstract #LBA101 Clinical Science Symposium May 30, 2026 8:40am Bidard, FC First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations ( ESR1 m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial. Abstract #LBA1007 Oral Abstract Session June 2, 2026 11:57am Peng, Z A phase 2 pivotal study of savolitinib in patients with MET -amplified gastric cancer or gastroesophageal junction adenocarcinomas. Abstract #4011 Rapid Oral Abstract Session June 1, 2026 1:27pm Cell Therapy Surana, R Initial phase 1 study results of NT-175 engineered T-cell therapy in TP53 R175H–mutated unresectable advanced solid tumors. Abstract #2506 Oral Abstract Session May 31, 2026 10:00am Epigenetics Derenzini, E A phase 1 study of the PRMT5 inhibitor AZD3470 in patients with relapsed/refractory classic Hodgkin lymphoma (PRIMAVERA). Abstract #7003 Oral Abstract Session May 30, 2026 4:00pm Rare Disease Wechalekar, AD Phase 3 randomized trial to evaluate the impact of anselamimab on all-cause mortality in κ light chain amyloidosis. Abstract #7501 Oral Abstract Session May 29, 2026 2:57pm Chen, AP Final analysis of KOMET (NCT04924608), a phase 3 study of selumetinib in adults with NF1-PN. Abstract #3110 Poster Session May 30, 2026 1:30pm 1 More than 85 abstracts at ASCO 2026 will feature AstraZeneca medicines and pipeline molecules IMPORTANT SAFETY INFORMATION FOR IMFINZI ® (durvalumab) There are no contraindications for IMFINZI ® (durvalumab) or IMJUDO ® (tremelimumab-actl). Severe and Fatal Immune-Mediated Adverse Reactions Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. IMFINZI as a Single Agent In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy. IMFINZI with IMJUDO Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions. Immune-Mediated Colitis IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. IMFINZI as a Single Agent Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients. Immune-Mediated Hepatitis IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal. IMFINZI as a Single Agent Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions. Immune-Mediated Endocrinopathies Adrenal Insufficiency : IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. IMFINZI as a Single Agent Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. Hypophysitis : IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. IMFINZI as a Single Agent Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. IMFINZI with IMJUDO Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism) : IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. IMFINZI as a Single Agent Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis : Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. IMFINZI as a Single Agent Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. IMFINZI with IMJUDO Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions. Immune-Mediated Nephritis with Renal Dysfunction IMFINZI and IMJUDO can cause immune-mediated nephritis. IMFINZI as a Single Agent Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-Mediated Dermatology Reactions IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. IMFINZI as a Single Agent Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

Phase 3Clinical ResultPhase 2ASCOPhase 1

21 May 2026

·www.eisai.com

Eisai Deepens Body of Clinical Evidence for LENVIMA® (Lenvatinib) Across Established Indications at ASCO 2026

Full text（304KB） Our news releases are intended to disclose corporate information and are not intended for the promotion or advertising of prescription pharmaceuticals or investigational products, nor are they intended to provide medical advice. Please note that the information contained in news releases is current as of the date of publication.

21 May 2026

·www.medivir.com

Medivir announces first patient enrolled in FLEX-HCC study

The study is an investigator-initiated study led by Dr. Hong Jae Chon from CHA Bundang Hospital within the Korean Cancer Study Group. The study will be performed at 12 major hospitals in Korea. The primary objective of the study is to confirm superior efficacy with fostrox + lenvatinib over lenvatinib monotherapy, with objective response rate (ORR) as the primary endpoint and secondary endpoints that includes progression free survival (PFS), time to progression (TTP) and overall survival (OS). Evaluation of response/disease progression will be carried out with MRI and/or CT every 6 weeks. “The inclusion of the first patient in the FLEX-HCC study is an important step for the continuous development of fostrox in advanced liver cancer, where there is still a significant unmet medical need for therapies that will provide long-term tumor control while preserving liver function. The early clinical experience of the fostrox + lenvatinib combination showed far more encouraging results compared to traditional second-line lenvatinib monotherapy. In order to objectively validate and confirm these promising data, a randomized comparative study with fostrox + lenvatinib versus lenvatinib monotherapy in a larger patient population is needed. I am pleased that we now have the opportunity to run this important phase 2 study within the Korean Cancer Study Group.” says Dr. Hong Jae Chon, principal investigator of FLEX-HCC, CHA Bundang Hospital in Korea. "It is truly gratifying to see the FLEX-HCC study up and running in Korea and we are delighted to collaborate with the passionate and hard-working Dr. Chon, his team at CHA Bundang University Hospital and the Korean Cancer Study Group. We just had the opportunity to experience first-hand the dedication to FLEX-HCC and the high quality of the different teams and hospitals participating in the study, on our recent visits to 8 of the 12 hospitals participating in the study. We look forward with great anticipation to the progress and results of the study, which, if successful, will add an important treatment option for patients suffering from advanced liver cancer." says Dr. Pia Baumann, CMO at Medivir. For additional information, please contact; Jens Lindberg, CEO, Medivir AB Telephone: +46 8 5468 3100. E-mail: jens.lindberg@medivir.com

Phase 2Clinical Result

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.

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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	Merck Sharp & Dohme Corp.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	United States	Eisai, Inc.	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	Merck Sharp & Dohme Corp.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Argentina	Eisai, Inc.	28 Jul 2021
Metastatic Esophageal Carcinoma	Phase 3	Canada	Merck Sharp & Dohme Corp.	28 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04199104 (LEAP-010, Pubmed \| J Clin Oncol)	Phase 3	Squamous cell carcinoma of head and neck metastatic First line PD-L1 CPS ≥1	511	Lenvatinib 20 mg + Pembrolizumab 200 mg	lgabrrytgv(xjgobvcrph) = ruiscnzbdi tpdzaiqilf (twkqergcwn ) View more	Positive	20 Apr 2026
NCT04199104 (LEAP-010, Pubmed \| J Clin Oncol)	Phase 3		511	Placebo + Pembrolizumab 200 mg	lgabrrytgv(xjgobvcrph) = twruqbyerw tpdzaiqilf (twkqergcwn ) View more	Positive	20 Apr 2026
NCT04393350 (Winship4955-20, CTgov)	Phase 2	Locally Advanced Clear Cell Renal Cell Carcinoma	18	Quality-of-Life Assessment+Pembrolizumab+Lenvatinib	jmjklrktpm = fwjlazmxrw ljreffcdli (dfcfxsusqn, rzqpwyawzb - jnhjnizkhc) View more	-	20 Apr 2026
NCT04869137 (phase II study of neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma, CTgov)	Phase 2	Resectable Merkel Cell Carcinoma	26	Pembrolizumab+Lenvatinib Oral Product	mdivbrjfsq = mhkwytefyc wwznxwhzfv (xlkjhlshgz, yvbshrjgbh - kcthdkiezh) View more	-	08 Apr 2026
ESMO_TAT2026	Not Applicable	Recurrent Endometrial Cancer Second line	47	Lenvatinib plus Pembrolizumab	xuauednzba(gqehdctjei) = mshdpcnons dtobhhwcqa (irxywwbhnl ) View more	Negative	16 Mar 2026
LARENA (ESGO2026)	Not Applicable	Uterine Carcinosarcoma p53 mutation \| MSI \| POLE mutation	31	Pembrolizumab-lenvatinib (P/L)	yafwussggq(ufmvawbvrp) = qpptjpcigi diawifvsez (bfifqbzoly ) View more	Positive	28 Feb 2026
NCT04626518 (KEYMAKER-U03 substudy 03B, ASCO_GU2026)	Phase 1/2	Locally Advanced Clear Cell Renal Cell Carcinoma	263	Pembro + Qmab	zmvhzwipkk(lwtkhkmgsn) = xdkyxobold rskxzzdzku (yhlcbnucwy, 12 - 54) View more	Positive	26 Feb 2026
NCT04626518 (KEYMAKER-U03 substudy 03B, ASCO_GU2026)	Phase 1/2	Locally Advanced Clear Cell Renal Cell Carcinoma	263	Pembro + Fave	zmvhzwipkk(lwtkhkmgsn) = bmnenxyllk rskxzzdzku (yhlcbnucwy, 0 - 17) View more	Positive	26 Feb 2026
LASER (ASCO_GU2026)	Phase 2	Metastatic Renal Cell Carcinoma First line	150	Lenvatinib plus pembrolizumab plus stereotactic body radiotherapy (Len+P+SBRT)	nwjuqdltiy(dzcsqmeahd) = bxpnyirjjz zfanhwctbx (pdmloqxtop )	Positive	26 Feb 2026
LASER (ASCO_GU2026)	Phase 2	Metastatic Renal Cell Carcinoma First line	150	Lenvatinib plus pembrolizumab (Len+P)	nwjuqdltiy(dzcsqmeahd) = qnavqtyyek zfanhwctbx (pdmloqxtop )	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Renal Cell Carcinoma First line	632	Pembrolizumab-axitinib (PA)	vzrurokzbj(tfmfearwby) = szkeiayukb wjhhvwnxpd (mymmqkphik ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Renal Cell Carcinoma First line	632	Pembrolizumab-lenvatinib (PL)	vzrurokzbj(tfmfearwby) = sjateonsyg wjhhvwnxpd (mymmqkphik ) View more	Positive	26 Feb 2026
PELET (ASCO_GU2026)	Not Applicable	Advanced Renal Cell Carcinoma	20	Lenvatinib 20 mgPembrolizumab 200 mg + Lenvatinib 20 mgPembrolizumab 200 mg	lbffxkojwy(qnqqdqwumf) = dsuuttigml mfzphnvzib (pwdhxtnwlx ) View more	Positive	26 Feb 2026
NCT04848337 (PLANE-PC, CTgov)	Phase 2	Neuroendocrine Tumors \| Metastatic Prostate Carcinoma \| Prostate Neuroendocrine Carcinoma	45	Pembrolizumab+Lenvatinib	bpzwcirrer(wzomskfcbk) = cgrsagvbsu zoldydqmbm (oirvejexrk, zndoebcnau - lsohfjcrxw) View more	-	12 Feb 2026

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