Delving into the Latest Updates on Lenvatinib mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

lenvatinib, lenvatinib mesilate, Lenvatinib mesilate (JAN)

+ [17]

Target

FGFR1 x FGFR2 x FGFR3 x FGFR4 x PDGFRα x RET x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit

Mechanism

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+ [84]

Inactive Indication

Advanced breast cancerAdvanced gastric carcinomaAdvanced Lung Non-Small Cell Carcinoma+ [29]

Originator Organization

Eisai Co., Ltd.

Active Organization

Merck Sharp & Dohme Corp.

Eisai, Inc.Eisai GmbH

+ [7]

Inactive Organization

Merck & Co., Inc.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Drug Highest PhaseApproved

First Approval Date

US (13 Feb 2015),

Thyroid Cancer

RegulationAccelerated Approval (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Orphan Drug (AU), Priority Review (AU), Special Review Project (CN), Breakthrough Therapy (US), Orphan Drug (US)

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Structure

Molecular FormulaC22H23ClN4O7S

InChIKeyHWLFIUUAYLEFCT-UHFFFAOYSA-N

CAS Registry857890-39-2

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

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 2025

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT06068153 / WithdrawnPhase 2IIT

A Multicentre, Single-arm Phase II Trial of Sotorasib Plus Lenvatinib, As Second-line Treatment in Patients with KRASG12C-mutant, Metastatic NSCLC

AMBER is a multicentre, single-arm phase II trial. The protocol treatment consists of of sotorasib plus lenvatinib, as a second-line treatment. The primary objective of the trial is to evaluate the clinical efficacy of sotorasib plus lenvatinib, in terms of objective response rate, for patients with KRASG12C-mutant, metastatic NSCLC.

Start Date01 Mar 2025

Sponsor / Collaborator

Amgen, Inc.

[+1]

100 Clinical Results associated with Lenvatinib mesylate

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100 Translational Medicine associated with Lenvatinib mesylate

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100 Patents (Medical) associated with Lenvatinib mesylate

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2,503

Literatures (Medical) associated with Lenvatinib mesylate

01 Mar 2025·Annals of Hepatology

Camrelizumab combined with transcatheter arterial chemoembolization and sorafenib or lenvatinib for unresectable hepatocellular carcinoma: A multicenter, retrospective study

Article

Author: Li, Han ; Wang, Fei ; Su, Ke ; Liu, Yu ; Wang, Pan ; Xu, Ke ; Chi, Hao ; Jiang, Xiumei

INTRODUCTION AND OBJECTIVES:

We initiated this study to explore the efficacy of camrelizumab combined with transcatheter arterial chemoembolization (TACE) plus sorafenib or lenvatinib versus TACE plus sorafenib or Lenvatinib for unresectable hepatocellular carcinoma (HCC).

MATERIALS AND METHODS:

From June 2019 to November 2022, 127 advanced HCC patients were retrospectively analyzed in this study. This consisted of 44 patients that received camrelizumab plus TACE plus sorafenib or lenvatinib (triple therapy group) and 83 patients that received TACE plus sorafenib or lenvatinib (double treatment group). The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) were compared between the two patient groups.

RESULTS:

Our findings demonstrated that patients received the triple therapy exhibited superior median OS (15.8 vs. 10.3 months, P=0.0011) and median PFS (7.2 vs. 5.2 months, P=0.019) compared to the double treatment group. In addition, the triple therapy group exhibited better 6-month (93.5% vs. 66.3%), 12-month (67.2% vs. 36.3%), and 24-month (17.2% vs. 7.6%) survival rates than the double treatment group. However, the ORR (43.2% vs. 28.9%, P = 0.106) and DCR (93.2% vs. 81.9%, P = 0.084) of the two groups were similar. Subgroup analysis showed that compared with the double treatment group, the triple therapy group had a better mOS for HCC with HBV (15.8 vs. 9.6 months, P = 0.0015) and tumor diameter ≥ 5cm (15.3 vs. 9.6 months, P = 0.00055).

CONCLUSIONS:

Camrelizumab plus TACE and sorafenib or lenvatinib may be a promising treatment approach for the clinical management of unresectable HCC patients.

01 Feb 2025·Clinical Genitourinary Cancer

Cost-Effectiveness Analysis of Lenvatinib plus Pembrolizumab or Everolimus as First-Line Treatment for Advanced Renal Cell Carcinoma

Article

Author: Zheng, Huanrui ; Zhang, Jinhua ; Tong, Yao ; Zhou, Jin

BACKGROUND:

Recently, due to its promising efficacy against advanced renal cell carcinoma (RCC), the combination therapy with lenvatinib and pembrolizumab or everolimus has been approved as a first-line treatment for patients with advanced RCC in China and the United States. However, the high costs of combination therapies, especially of those new drugs, may limit their viability as clinical treatment options. Thus, our study aimed to evaluate the cost-effectiveness of using lenvatinib plus pembrolizumab or everolimus as a first-line treatment for patients with advanced RCC from the perspective of the Chinese healthcare system and US third-party payers.

METHODS:

We established a Markov model using TreeAge Pro 2022 software to estimate and compare the cost and effectiveness of the therapy with lenvatinib plus pembrolizumab or everolimus with those of sunitinib therapy for treating advanced RCC based on the clinical data derived from a phase III randomized controlled trial (CLEAR, ClinicalTrials.gov number NCT02811861). Transition probabilities and other data were calculated and obtained by using parametric survival modeling. The direct medical costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were used as economic indicators in this analysis. The robustness of the model was assessed by performing one-way and probability sensitivity analyses (PSA).

RESULTS:

Among the 3 treatment strategies, the sunitinib 1 was the least expensive option. All ICERs were far higher than the thresholds of $38,024 and $100,000 selected for China and the United States, respectively. The ICERs of the therapy with lenvatinib plus pembrolizumab versus sunitinib therapy were 106,749.06 US$/QALY and $414,672.19 US$/QALY in China and the United States, respectively. Thus, among these 2, the former strategy was less cost-effective than the latter. In addition, the ICERs of the lenvatinib plus everolimus treatment vs. sunitinib treatment were $44,353.18 US$/QALY and $292,653.10 US$/QALY in China and the United States, respectively. Thus, among these 2 strategies, the former was less cost-effective than the latter. The total cost of the lenvatinib plus everolimus treatment strategy was lower than that of lenvatinib plus pembrolizumab; however, the former treatment was less effective than the latter.

CONCLUSION:

The treatment with lenvatinib plus pembrolizumab or everolimus is less cost-effective than the sunitinib treatment for patients with advanced RCC in China and the United States.

01 Feb 2025·BIOMATERIALS

A versatile nanoplatform carrying cascade Pt nanozymes remodeling tumor microenvironment for amplified sonodynamic/chemo therapy of thyroid cancer

Article

Author: Wang, Yufeng ; Jiao, Lianying ; Sun, Lei ; Zhou, Qi ; Wang, Dan ; Zhang, Yujie ; Ma, Wenqi ; Jiang, Jue ; Zhang, Yuanyuan ; Li, Runqing ; Zhang, Mingzhen

Thyroid cancer is increasing globally, with anaplastic thyroid carcinoma (ATC) being the most aggressive type and having a poor prognosis. Current clinical treatments for thyroid cancer present numerous challenges, including invasiveness and the necessity of lifelong medication. Furthermore, a significant portion of patients with ATC experience cancer recurrence and metastasis. To overcome this dilemma, we developed a pH-responsive biomimetic nanocarrier (CLP@HP-A) through the incorporation of Chlorin e6 (Ce6) and Lenvatinib (Len) within hollow polydopamine nanoparticles (HP) that were further modified with platinum nanoparticles (Pt), enabling synergistic chemotherapy and sonodynamic therapy. The CLP@HP-A nanocarriers exhibited specific binding with galectin-3 receptors, facilitating their internalization through receptor-mediated endocytosis for targeted drug delivery. Upon exposure to ultrasound (US) irradiation, Ce6 rapidly generated reactive oxygen species (ROS) to induce significant oxidative stress and trigger apoptosis in tumor cells. Additionally, Pt not only alleviated tumor hypoxia by catalyzing the conversion of H₂O₂ to oxygen (O₂) but also augmented intracellular ROS levels through the production of hydroxyl radicals (•OH), thereby enhancing the efficacy of sonodynamic therapy. Moreover, Len demonstrated a potent cytotoxic effect on thyroid cancer cells through the induction of apoptosis. Transcriptomics analysis findings additionally corroborated that CLP@HP-A effectively triggered cancer cell apoptosis, thereby serving as a crucial mechanism for its cytotoxic effects. In conclusion, the integration of sonodynamic/chemo combination therapy with targeted drug delivery systems offers a novel approach to the management of malignant tumors.

261

News (Medical) associated with Lenvatinib mesylate

11 Dec 2024

·www.prnewswire.com

Caris Life Sciences Publishes Large-Scale Study Demonstrating the Critical Role of Next-Generation Sequencing in Microsatellite Instability Testing

The study demonstrates high concordance between next-generation sequencing-based MSI and immunohistochemistry-based MMR measurements across more than 190,000 patients IRVING, Texas, Dec. 11, 2024 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced the publication of a large-scale study showing the critical role of next-generation sequencing (NGS) in assessing microsatellite instability (MSI) and, consequently, mismatch repair deficiency (dMMR) in solid tumors. High MSI (MSI-H) and dMMR are key biomarkers that help identify patients who may benefit from immune checkpoint inhibitor (ICI) therapies. Continue Reading Published in JCO Precision Oncology, the study was performed by Caris in collaboration with leading cancer centers, including those within the Caris Precision Oncology Alliance™ (Caris POA). The results demonstrate high concordance between NGS assessment of MSI (NGS-MSI) and immunohistochemistry analysis of MMR (IHC-MMR) in over 190,000 solid tumors across a broad range of cancer types. Furthermore, the findings show that NGS offers valuable information on other actionable biomarkers beyond MMR status. Our study highlights the importance of NGS for comprehensive molecular profiling Post this "Accurate MMR assessment is critical to ensure patients receive the most appropriate treatment, but there has been industry debate over the best method," said George W. Sledge, Jr., MD, EVP and Chief Medical Officer of Caris and study author. "Caris has addressed this question by leveraging its extensive clinico-genomic database and comprehensive molecular profiling expertise to demonstrate that NGS is not only a robust alternative to IHC-MMR but also offers additional advantages, such as the ability to identify other biomarkers critical for guiding therapy selection." Defective MMR can lead to the accumulation of DNA errors, making the genome unstable and driving cancer development. IHC-MMR detects defective MMR proteins, while NGS-MSI measures MSI, the genomic result of dMMR. By directly comparing the concordance of NGS-MSI and IHC-MMR results in tumor samples tested by a single laboratory, Caris has provided the most comprehensive evidence to date supporting the non-inferiority of NGS-MSI to IHC-MMR in identifying dMMR-driven tumors. In the analysis of 191,767 solid tumors, only 0.31% discordance was observed between NGS-MSI and IHC-MMR, with no difference in overall survival between discordant tumors. "Our study highlights the importance of NGS for comprehensive molecular profiling and its non-inferiority to IHC for identifying MMR-driven cancer," said Caris President and study author David Spetzler, MS, PhD, MBA. "NGS can detect dMMR cases that IHC misses, while IHC can identify some cases that NGS may not. Although neither technology can capture all dMMR cases, our findings show that NGS is a valuable tool for determining a patient's eligibility for not only ICIs but other targeted therapies as well." The study also assessed the molecular characteristics, immunological landscape and clinical outcomes of the patients. As expected, dMMR/MSI-H tumors had better overall and post-immunotherapy survival compared to MMR-proficient/MSI-Stable tumors. Furthermore, analysis of NGS data showed that high tumor mutational burden, another biomarker for immunotherapy response, was more prevalent in dMMR/MSI-H tumors, supporting their eligibility for ICI therapy. These NGS-based findings provide valuable insights for personalized cancer therapy, especially in identifying high-risk patients who might benefit from immunotherapy based on their biomarker status. Caris recently received approval from the U.S. Food and Drug Administration (FDA) for MI Cancer Seek™ as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. MI Cancer Seek is the first and only simultaneous whole exome sequencing (WES) and whole transcriptome sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies, including pembrolizumab in MSI-H solid tumors and pembrolizumab plus lenvatinib in 'not MSI-H' endometrial carcinomas. MSI status is assessed by MI Cancer Seek using NGS-based WES. Optional add-on testing beyond MI Cancer Seek is also available, including IHC for more than fifteen tumor-specific proteins. IHC-MMR is offered for colorectal, endometrial, gastric, and uterine cancers. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition, and we value our employees as much as we do our patients of every creed, color, sex, sexual orientation and religion. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

14 Nov 2024

·www.biopharmadive.com

Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

Merck & Co. has bought into the kind of drug that has emerged as a top threat to its dominant cancer immunotherapy Keytruda.The company said Thursday it agreed to pay privately-held LaNova Medicines $588 million in cash for worldwide rights to a cancer therapy called LM-299,which is currently in Phase 1 testing in China. LaNova, which is based in Shanghai, could receive up to $2.7 billion in additional payments should the drug hit various development and sales milestones across multiple indications.The deal makes Merck the latest company to acquire a type of dual-pronged cancer immunotherapy thats fast become a top target of drugmakers. These so-called bispecific therapies simultaneously home in on the proteins PD-1 and VEGF, which help tumors grow and evade detection from the immune system.This year, one such drug, ivonescimab, from China-based Akeso and development partner Summit Therapeutics, bested Mercks Keytruda in a late-stage trial in lung cancer the first time thats happened since Keytrudas arrival a decade ago. Though the results came with notable limitations and are unlikely to support a U.S. approval, since then, an array of drugmakers have either acquiredPD-1 and VEGF-targeting bispecifics or built new companiesaround them. Just yesterday, BioNTech agreed to pay $800 million to buy biotech Biotheus, giving it a PD-1 and VEGF drug the companies have been co-developing.Merck has a particularly vested interest in the progress of PD-1 and VEGF bispecifics. Keytruda is the worlds most widely used cancer immunotherapy, having earned 40 approvals since its first in 2014. The drug accounted for $25 billion of Mercks $60 billion in revenue last year, when it officially became the worlds best-selling medicine.But there is still room for improvement, as the majority of people dont durably respond to Keytruda and other drugs like it. Keytruda will also lose patent protection in the U.S. in 2028, after which Merck will be pressed to replace lost revenues.Merck, for its part, has been leaning on a pipeline of drugs for cancer, heart and immune diseases to cover some of those anticipated losses, as well as a formulation of Keytruda administered via subcutaneous injection instead of intravenously. Its also been pairing Keytruda with medicines that target VEGF or related pathways. One such combination, with Eisais Lenvima, is approved for a few tumor types, though it failed to extend survival in a late-stage trial in lung cancer. The company has made a substantial investment in that pathway, said Merck research chief Dean Li, referring to VEGF, on a conference call with analysts last month. Li, at the time, pointed out some key unknowns in Summit and Akesos data, such as whether ivonescimab will prolong survival and how the drug will perform when compared to the Keytruda-chemotherapy regimen thats now standard treatment for most lung cancer cases. I think its really important for all of us to watch carefully, and we are watching carefully, he told analysts. That Merck quickly turned to acquire an ivonescimab-like drug suggests it was either looking for an insurance policy or now has greater conviction on Akeso and Summits results, wrote Evercore ISI analyst Umer Raffat in a Thursday note to investors.Should ivonescimab pan out, for example, the deal will have created the most direct path for Merck to hold on to a very large chunk of the Keytruda franchise, Raffat wrote. Though LaNovas drug is well behind many others in development, among them ivonescimab, Merck will very likely progress very rapidly.However you look at it, this is incredibly savvy [business development] for a very reasonable price, Raffat added.In its statement, Merck said LM-299 has a differentiated molecular design than others in development, consisting of an anti-VEGF antibody fused to two PD-1-targeting antibodies. '

ImmunotherapyDrug ApprovalPhase 1AcquisitionADC

20 Sep 2024

·www.fiercepharma.com

Fierce Pharma Asia—Merck's collabs with Daiichi, Eisai deliver readouts; Granules hit with FDA manufacturing observations

Positive phase 3 trials testing Merck and Daiichi's HER3 ADC and the Eisai-partnered Keytruda-Lenvima combo made our news this week. Merck and Daiichi Sankyo's HER3 antibody-drug conjugate reported a positive phase 3 result in EGFR-mutated lung cancer. Merck and Eisai's Keytruda-Lenvima combo delivered a win in liver cancer. An FDA document details shortfalls at a Granules plant in India. Plus more.1. Merck, Daiichi rack up phase 3 ADC lung cancer win but report 2 deaths, immature OS dataMerck and Daiichi Sankyo’s HER3 antibody-drug conjugate patritumab deruxtecan reported a positive phase 3 trial in EGFR-mutated non-small cell lung cancer following previous treatment with EGFR tyrosine kinase inhibitor. While progression-free survival was significantly longer in the ADC group than in the chemotherapy arm, overall survival data remained immature. Two deaths were chalked up to interstitial lung disease.2. ESMO: Despite checkered past, Merck's Keytruda-Lenvima pairing looks to change practice in liver cancer subtypeA combination of Merck’s Keytruda and Eisai-partnered Lenvima significantly reduced the risk of disease progression or death by 34% when added to transarterial chemoembolization in intermediate-stage liver cancer in the phase 3 LEAP-012 trial. The positive readout came after the Keytruda-Lenvima combo failed to outperform Lenvima alone in advanced liver cancer in the LEAP-002 trial.3. Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspectionThe FDA recently slapped Granules with a Form 483 reprimand. During an inspection of the firm’s Telangana facility in India last year, FDA staffers saw trucks carrying torn and crumpled materials attempting to leave the plant, according to the document. In these scraps, the FDA found signed manufacturing documents, handwritten worksheets and a large number of uncontrolled papers.4. ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value from new cancer medsAstellas and Daiichi Sankyo are among drugmakers that have delivered some of the highest benefit approvals in the past four years, according to a Harvard University study using a scoring system by the European Society of Medical Oncology. Astellas benefited from its Pfizer-partnered Padcev in bladder cancer, and Daiichi from its AstraZeneca-partnered Enhertu in breast cancer.5. ESMO: Innovent links cytokine fusion protein to responses in colorectal cancerInnovent Biologics shared promising data for its PD-1/IL-2 bispecific, IBI363, in colorectal cancer, reporting a 22% response rate from its combination with Avastin in 32 patients with microsatellite stable or mismatch repair proficient tumors. The median duration of response and progression-free survival were 8.1 months and 4.1 months, respectively.Other News of Note6. ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases7. Trispecific antibody from Ichnos Glenmark Innovation beats J&J's Tecvayli at treating multiple myeloma in mice

Clinical ResultPhase 3ADCDrug Approval

100 Deals associated with Lenvatinib mesylate

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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	EU	Eisai GmbH	25 Jul 2023
Advanced Endometrial Carcinoma	IS	Eisai GmbH	25 Jul 2023
Advanced Endometrial Carcinoma	LI	Eisai GmbH	25 Jul 2023
Advanced Endometrial Carcinoma	NO	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	EU	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	IS	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	LI	Eisai GmbH	25 Jul 2023
Recurrent Endometrial Cancer	NO	Eisai GmbH	25 Jul 2023
Thymus Neoplasms	JP	Eisai Co., Ltd.	23 Mar 2021
Advanced Renal Cell Carcinoma	EU	Eisai GmbH	25 Aug 2016
Advanced Renal Cell Carcinoma	IS	Eisai GmbH	25 Aug 2016
Advanced Renal Cell Carcinoma	LI	Eisai GmbH	25 Aug 2016
Advanced Renal Cell Carcinoma	NO	Eisai GmbH	25 Aug 2016
Endometrial Carcinoma	AU	Eisai Co., Ltd.	28 Jan 2016
Renal Cell Carcinoma	AU	Eisai Co., Ltd.	28 Jan 2016
Advanced Hepatocellular Carcinoma	EU	Eisai GmbH	28 May 2015
Advanced Hepatocellular Carcinoma	IS	Eisai GmbH	28 May 2015
Advanced Hepatocellular Carcinoma	LI	Eisai GmbH	28 May 2015
Advanced Hepatocellular Carcinoma	NO	Eisai GmbH	28 May 2015
Differentiated Thyroid Gland Carcinoma	EU	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	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	28 Oct 2021
Esophageal Squamous Cell Carcinoma	Phase 3	US	Eisai, Inc.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	US	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	CN	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	CN	Eisai, Inc.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	JP	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	JP	Eisai, Inc.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	AR	Eisai, Inc.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	AR	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	CA	Eisai, Inc.	28 Jul 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03884101 (LEAP-001, Pubmed \| J Clin Oncol)	Phase 3	Endometrial Carcinoma First line mismatch repair-proficient (pMMR)	-	Lenvatinib 20 mg + Pembrolizumab 200 mg	uyrjmzkrql(jwieckmjcm) = yqjwyfhqsy sngbrvdvsf (dyjvwlpkjd, 25.4 - 37.7) View more	Negative	26 Nov 2024
				Paclitaxel 175 mg/m2 + Carboplatin AUC 6 mg/mL/min	uyrjmzkrql(jwieckmjcm) = eolpcxidzj sngbrvdvsf (dyjvwlpkjd, 26.2 - 35.4) View more
NCT03526679 (LEADER, CTgov)	Phase 1/2	Leiomyosarcoma \| Advanced Liposarcoma \| Soft Tissue Sarcoma ... View more	30	Eribulin+Lenvatinib	jpzbjbmsyr(eaknacajuv) = tzmmerpths uldmbbpsxj (zziqnrelhs, krsgdvmhld - bnvsouqvtk) View more	-	25 Nov 2024
NCT05523323 (CTgov)	Phase 3	Recurrent Squamous Cell Carcinoma of the Head and Neck	112	pembrolizumab+Lenvatinib (Pembrolizumab + Lenvatinib)	djnrkjicha(rabytedabk) = mwxvtaxwwx ttkmfhkhqm (nvqlxhawjf, bzjdtervol - mdhhxhnwoq) View more	-	18 Oct 2024
				Placebo+pembrolizumab (Pembrolizumab + Placebo)	djnrkjicha(rabytedabk) = hpjjeofjkl ttkmfhkhqm (nvqlxhawjf, aizpfgndtn - llqmiaffru) View more
NCT04865289 (MK-7902-001 \| LEAP-001 \| ENGOT-en9, CTgov)	Phase 3	Recurrent Endometrial Cancer	130	pembrolizumab+Lenvatinib (Lenvatinib + Pembrolizumab)	wudespscme(wltmgnpxwf) = rrhefmmbvj wxsrqfzxto (fxnrpscxoo, olbtonbytj - msckpzgnzy) View more	-	18 Oct 2024
				Carboplatin+Paclitaxel (Paclitaxel + Carboplatin)	wudespscme(wltmgnpxwf) = ajbsenmvep wxsrqfzxto (fxnrpscxoo, oybofpkzpr - haleolbylf) View more
NCT04154189 (OLIE, Pubmed \| JAMA Oncol)	Phase 2	Osteosarcoma, Recurrent Second line	81	Lenvatinib + Ifosfamide and Etoposide	zmjbcjhzpu(xyqdrkjsrl) = xrfnqnwrhe bkmcufdnsf (ytrgpconih, 59.3 - 86.9) View more	Negative	17 Oct 2024
				Ifosfamide and Etoposide	zmjbcjhzpu(xyqdrkjsrl) = ntwpezesip bkmcufdnsf (ytrgpconih, 47.7 - 79.2) View more
NCT03884101 (MK-7902-001 \| ENGOT-en9/LEAP-001 \| LEAP-001 \| ENGOT-en9, CTgov)	Phase 3	Recurrent Endometrial Cancer	842	pembrolizumab+Lenvatinib (Lenvatinib + Pembrolizumab)	lhulydgfxv(mxhmgthwyy) = xqgrtlmfav gwmdfsttwu (veusuxfjba, mkgvebralf - qougcjqhox) View more	-	16 Oct 2024
				Carboplatin+Paclitaxel (Paclitaxel + Carboplatin)	lhulydgfxv(mxhmgthwyy) = fgqdgxntuz gwmdfsttwu (veusuxfjba, qjnyfdhkfm - nywnqcnxcu) View more
NCT03776136 (LEAP-004 \| E7080-G000-225 \| 7902-004 \| MK-7902-004, CTgov)	Phase 2	Melanoma \| Metastatic melanoma \| Locally Advanced Melanoma	103	Pembrolizumab+Lenvatinib	malsvbafiu(ykcizsrzmg) = gkconggnuc fqstspnfhr (maziirrwfx, crbfrjblbl - hpgpaupikl) View more	-	09 Oct 2024
NCT04716933 (MK-7902-006 \| E7080-G000-315 \| LEAP-006, CTgov)	Phase 3	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	201	Carboplatin+Cisplatin+pembrolizumab+Pemetrexed+Lenvatinib (Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib)	mcukmkrtgg(ttiilhbkpz) = nhsyvrvehn fdcdbrxtwi (jixcbpwigt, qahyzvrmss - mhyljvzwvd) View more	-	04 Oct 2024
				Placebo matching lenvatinib+Carboplatin+Cisplatin+pembrolizumab+Pemetrexed (Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo)	mcukmkrtgg(ttiilhbkpz) = gvabtylzav fdcdbrxtwi (jixcbpwigt, phfqskltiz - xglivtvsyu) View more
NCT05042336 (BRHCC, ESMO2024) Manual	Phase 1/2	Hepatocellular Carcinoma	54	TACE combined with Lenvatinib and Camrelizumab	(qrpnwmciqk) = geqyspewxc miyjtrmtyz (yzqdgkpvou ) View more	Positive	16 Sep 2024
				TACE combined with Lenvatinib and Camrelizumab (Phase Ib)	(qrpnwmciqk) = udbofxnaoh miyjtrmtyz (yzqdgkpvou ) View more
ESMO2024 Manual	Not Applicable	Hepatocellular Carcinoma First line	1,361	Lenvatinib (LEN)	mqtnxygosa(msnalccluf) = ehhmavymwn opgtodzqbf (nfeoikovyi, 8.3 - 10.8) View more	Positive	16 Sep 2024
				Sorafenib (SOR)	mqtnxygosa(msnalccluf) = ldrnxfktmp opgtodzqbf (nfeoikovyi, 6.4 - 9.3) View more