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)

+ [11]

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+ [11]

Active Indication

Advanced Endometrial CarcinomaRecurrent Endometrial CancerThymus Neoplasms+ [89]

Inactive Indication

Anaplastic Thyroid CarcinomaEGFR-mutated non-small Cell Lung CancerEstrogen receptor positive breast cancer+ [20]

Originator Organization

Eisai Co., Ltd.

Active Organization

Merck Sharp & Dohme Corp.

The General Hospital Corp.

Eisai, Inc.

+ [37]

Inactive Organization

Third Affiliated Hospital of Nanjing Medical University

Merck & Co., Inc.

Shanghai Chest Hospital

Drug Highest PhaseApproved

First Approval Date

US (13 Feb 2015),

Thyroid Cancer

RegulationBreakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Special Review Project (CN), Orphan Drug (JP), Orphan Drug (AU), Priority Review (AU)

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Structure

Molecular FormulaC22H23ClN4O7S

InChIKeyHWLFIUUAYLEFCT-UHFFFAOYSA-N

CAS Registry857890-39-2

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 Mar 2025

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT06409637 / Not yet recruitingPhase 1/2IIT

A Prospective, Single-arm Clinical Study of FOLFOX Combined With Lenvatinib as Adjuvant Chemotherapy to Prevent Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria

Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.

Start Date01 Jan 2025

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

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 2024

Sponsor / Collaborator

Evergreen Therapeutics, Inc

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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2,236

Literatures (Medical) associated with Lenvatinib mesylate

31 Dec 2024·Bioengineered

Establishment and characterization of a highly metastatic hepatocellular carcinoma cell line

Article

Author: Hu, Zhenhua ; Zhang, Yu ; Sun, Mengqing ; Qiao, Yiting ; Yu, Anning ; Zheng, Huilin ; Huang, Jiacheng ; Bu, Chiwen ; Wang, Menglan ; Zhou, Jie

The prevalence of alcohol-related hepatocellular carcinoma (HCC) has been increasing during the last decade. Cancer research requires cell lines suitable for both in vitro and in vivo assays. However, there is a lack of cell lines with a high in vivo metastatic capacity for this HCC subtype. Herein, a new HCC cell line was established, named HCC-ZJ, using cells from a patient diagnosed with alcohol-related HCC. The karyotype of HCC-ZJ was 46, XY, del (p11.2). Whole-exome sequencing identified several genetic variations in HCC-Z that occur frequently in alcohol-associated HCC, such as mutations in TERT, CTNNB1, ARID1A, CDKN2A, SMARCA2, and HGF. Cell counting kit-8 assays, colony formation assays, and Transwell assays were performed to evaluate the proliferation, migration, and sensitivity to sorafenib and lenvatinib of HCC-Z in vitro. HCC-ZJ showed a robust proliferation rate, a weak foci-forming ability, a strong migration capacity, and a moderate invasion tendency in vitro. Finally, the tumorigenicity and metastatic capacity of HCC-Z were evaluated using a subcutaneous xenograft model, an orthotopic xenograft model, and a tail-veil injection model. HCCZJ exhibited strong tumorigenicity in the subcutaneous xenograft and orthotopic tumor models. Moreover, HCC-ZJ spontaneously formed pulmonary metastases in the orthotopic tumor model. In summary, a new HCC cell line derived from a patient with alcohol-related HCC was established, which showed a high metastatic capacity and could be applied for in vitro and in vivo experiments during pre-clinical research.Highlights• An alcohol-related HCC cell line, HCC-ZJ, was established• HCC-ZJ was applicable for in vitro functional experiment and gene editing• HCC-ZJ was applicable for in vivo tumor growth and spontaneous metastasis models.

15 Mar 2024·International journal of cancer

α‐FAtE: A new predictive score of response to atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Article

Author: Cascinu, Stefano ; Niizeki, Takashi ; Finkelmeier, Fabian ; Montes, Margarida ; Yasuda, Satoshi ; Tsuji, Kunihiko ; Hiasa, Yoichi ; Ochi, Hironori ; Kawata, Kazuhito ; Naganuma, Atsushi ; Presa, José ; Itobayashi, Ei ; Piscaglia, Fabio ; Kakizaki, Satoru ; Kariyama, Kazuya ; Okubo, Tomomi ; Vitiello, Francesco ; Nishimura, Takashi ; Casadei-Gardini, Andrea ; Scartozzi, Mario ; Takaguchi, Koichi ; Soldà, Caterina ; Bergamo, Francesca ; Hirooka, Masashi ; Lim, Ho Yeong ; Itokawa, Norio ; Toyoda, Hidenori ; Suda, Goki ; Vivaldi, Caterina ; Sakamoto, Naoya ; Hatanaka, Takeshi ; Amadeo, Elisabeth ; Kosaka, Hisashi ; Nagano, Takuya ; Nakamura, Shinichiro ; Steup, Christoph ; Morishita, Asahiro ; Kudo, Masatoshi ; Shimada, Noritomo ; Imai, Michitaka ; Kumada, Takashi ; Sho, Takuya ; Tada, Toshifumi ; Tada, Fujimasa ; Himmelsbach, Vera ; Iwamoto, Hideki ; Nishida, Naoshi ; Chon, Hong Jae ; Nouso, Kazuhiro ; Burgio, Valentina ; Kaibori, Masaki ; Koizumi, Yohei ; Rimini, Margherita ; Tani, Joji ; Persano, Mara ; Ohama, Hideko ; Tsutsui, Akemi ; Cheon, Jaekyung ; Tajiri, Kazuto ; Masi, Gianluca ; Fukunishi, Shinya ; Shimose, Shigeo ; Iavarone, Massimo ; Iijima, Hiroko ; Cabibbo, Giuseppe ; Hiraoka, Atsushi ; Aoki, Tomoko ; Atsukawa, Masanori ; Foschi, Francesco Giuseppe ; Ishikawa, Toru ; Rossari, Federico ; Yoo, Changhoon ; Ogawa, Chikara

Abstract:

Atezolizumab plus bevacizumab (AB) and lenvatinib can be alternatively used as first‐line systemic treatment of unresectable hepatocellular carcinoma (HCC). However, no direct comparison of the two regimens has been performed in randomized clinical trials, making the identification of baseline differential predictors of response of major relevance to tailor the best therapeutic option to each patient. Baseline clinical and laboratory characteristics of real‐world AB‐treated HCC patients were analyzed in uni‐ and multivariate analyses to find potential prognostic factors of overall survival (OS). Significant variables were incorporated in a composite score (α‐FAtE) and it was tested for specificity and sensitivity in receiver operating characteristic (ROC) curve and in multivariate analysis for OS. The score was applied in uni‐ and multivariate analyses for OS of a comparable lenvatinib‐treated HCC population. Finally, comparison between treatments was performed in patients with low and high α‐FAtE scores and predictivity estimated by interaction analysis. Time‐to‐progression (TTP) was a secondary endpoint. OS of AB‐treated HCC patients was statistically longer in those with α‐fetoprotein <400 ng/mL (HR 0.62, p = .0407), alkaline phosphatase (ALP) <125 IU/L (HR 0.52, p = .0189) and eosinophil count ≥70/μL (HR 0.46, p = .0013). The α‐FAtE score was generated by the sum of single points attributed to each variable among the above reported. In ROC curve analysis, superior sensitivity and specificity were achieved by the score compared to individual variables (AUC 0.794, p < .02). Patients with high score had longer OS (HR 0.44, p = .0009) and TTP (HR 0.34, p < .0001) compared to low score if treated with AB, but not with lenvatinib. Overall, AB was superior to lenvatinib in high score patients (HR 0.55, p = .0043) and inferior in low score ones (HR 1.75, p = .0227). At interaction test, low α‐FAtE score resulted as negative predictive factor of response to AB (p = .0004). In conclusion, α‐FAtE is a novel prognostic and predictive score of response to first‐line AB for HCC patients that, if validated in prospective studies, could drive therapeutic choice between lenvatinib and AB.

01 Mar 2024·Gynecologic oncology

Cost-effectiveness of lenvatinib plus pembrolizumab versus chemotherapy for recurrent mismatch repair-proficient endometrial cancer after platinum-based therapy

Article

Author: St Clair, Caryn M ; Hershman, Dawn L ; Hou, June Y ; Chen, Ling ; Khoury-Collado, Fady ; Dioun, Shayan ; De Meritens, Alexandre Buckley ; Wright, Jason D ; Pua, Tarah

OBJECTIVE:

The recent Study 309-KEYNOTE-775 showed improved survival for lenvatinib plus pembrolizumab compared to chemotherapy in patients with recurrent endometrial cancer. We created a decision model to compare the cost-effectiveness of lenvatinib plus pembrolizumab in patients with recurrent mismatch repair-proficient (pMMR) endometrial cancer who had progressed after first-line chemotherapy.

METHODS:

A Markov model was created to simulate the clinical trajectory of 10,000 patients with recurrent pMMR endometrial cancer. The initial decision point in the model was treatment with ether lenvatinib plus pembrolizumab or chemotherapy (doxorubicin or dose-dense paclitaxel). Model probabilities, utility values and costs were derived with assumptions drawn from published literature. A cycle length of 3 months and a time horizon of 2 years was used. The effectiveness was calculated in terms of average quality adjusted life years (QALYs) gained. The primary outcome was incremental cost-effectiveness ratios (ICERs), expressed in 2020 US dollars/QALYs. One-way, two-way and probabilistic sensitivity analyses were performed.

RESULTS:

Chemotherapy was the least costly strategy at $66,693 followed by lenvatinib plus pembrolizumab ($193,590). Lenvatinib plus pembrolizumab resulted in more patients being alive at 2 years (lenvatinib plus pembrolizumab: 367, chemotherapy: 109). Chemotherapy was cost-effective compared with lenvatinib plus pembrolizumab (ICER: $164,493/QALYs). Lenvatinib plus pembrolizumab became cost-effective when its cost was reduced by $1553 per month (7.8% reduction).

CONCLUSION:

For patients with recurrent pMMR endometrial cancer Lenvatinib plus pembrolizumab is associated with greater survival but is more costly than chemotherapy. The cost of lenvatinib and pembrolizumab would have to be reduced by approximately 7% to be considered cost-effective.

217

News (Medical) associated with Lenvatinib mesylate

19 Jun 2024

·www.prnewswire.com

Medivir selects global CRO partner for upcoming phase 2b study in HCC with fostrox + Lenvima and initiates study feasibility

STOCKHOLM, June 19, 2024 /PRNewswire/ -- Medivir AB (NASDAQ: MVIR) (STOCKHOLM: MVIR) , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that it has selected a global CRO partner for the planned phase 2b study evaluating fostroxacitabine bralpamide (fostrox) + Lenvima® vs Lenvima alone in second line HCC. In the next phase of development, Medivir is planning for a global, randomized phase 2b study aligned with its recent supportive Type C interaction with the FDA. The objective is to evaluate the combination of fostrox + Lenvima in second line advanced HCC with the aim of becoming the first, approved treatment alternative after current first line treatment. The study is planned to enroll patients broadly in the US, EU and Asia, building on countries and sites participating in currently ongoing phase 1b/2a, which will ensure that recruitment requirements for a potential accelerated or conditional approval are fulfilled. A key next step is to initiate study feasibility to identify optimal sites and investigators to enable study start in early 2025. Already now, we have received high level of interest from experts in HCC regarding potential participation in the study. - "With the selection of a CRO partner, following our recent Type C meeting with the FDA, we are confidently moving forward with the enhanced phase 2b study design. It has been a thorough process to select the best possible partner to ensure optimal execution of the upcoming study across all geographies. The selected CRO partner has a global footprint, with a strong track record in performing oncology studies in general and HCC studies in particular. We are now moving forward with next steps, which include performing the feasibility, operational and regulatory study preparations as well as finalisation of the study protocol to open an IND in the USA.", says Malene Jensen, VP Clinical Development at Medivir. For additional information, please contact Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100 E-mail: [email protected] About fostrox Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing harmful effects on normal livercells. This is achieved by coupling a chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in advanced HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile. About primary liver cancer Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. The unmet medical need is especially high in second line where there are no approved treatments post first line standard of care. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. . 1) Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118. This information was brought to you by Cision The following files are available for download: SOURCE Medivir

Phase 2Phase 1

18 Jun 2024

·pmlive.com

Merck’s Keytruda regimen granted FDA approval to treat endometrial cancer

Merck & Co – known as MSD outside the US and Canada – has received expanded approval from the US Food and Drug Administration (FDA) for the use of Keytruda in endometrial cancer. The anti-PD-1 therapy can now be used in combination with carboplatin and paclitaxel, and then as a single agent, to treat adults with primary advanced or recurrent endometrial carcinoma. Approximately 67,880 new cases of uterine cancer will be diagnosed in the US this year and endometrial carcinoma is the most common type. Administered as an intravenous infusion, Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells. The therapy already holds a range of approvals in the US, including for two other endometrial carcinoma indications as a monotherapy and in combination with Eisai’s Lenvima (lenvatinib). The FDA’s latest decision was supported by positive results from the late-stage KEYNOTE-868 trial, in which the Keytruda regimen reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient (pMMR) and by 70% in those with mismatch repair deficient (dMMR) disease, compared to placebo plus carboplatin and paclitaxel followed by placebo alone. For patients whose cancer was pMMR, median progression-free survival (PFS) in the Keytruda regimen group was 11.1 months versus 8.5 months for the placebo plus carboplatin and paclitaxel arm. For those with dMMR disease, median PFS was not reached in the Keytruda group versus 6.5 months for the placebo. Dr Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, said: “This approval represents the first and only anti-PD-1-based option for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status, building on the established role of Keytruda in certain types of advanced endometrial carcinoma as [a] monotherapy and in combination with Lenvima.” Beyond endometrial carcinoma, Keytruda holds approvals to treat a wide range of cancers, including specific cases of cervical cancer, bladder cancer, biliary tract cancer, non-small cell lung cancer and renal cell carcinoma. There are also currently more than 1,600 trials studying the therapy, including one evaluating it in combination with Merck and Moderna’s investigational skin cancer vaccine .

Clinical ResultDrug ApprovalVaccine

18 Jun 2024

·www.pharmaceutical-technology.com

FDA approves MSD’s KEYTRUDA for advanced endometrial cancer

In a Phase III trial, significant improvements in progression-free survival for patients treated with KEYTRUDA plus chemotherapy were observed. Credit: Nemes Laszlo / Shutterstock. The US Food and Drug Administration (FDA) has approved MSD’s anti-PD-1 therapy KEYTRUDA for use with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, to treat primary advanced or recurrent endometrial carcinoma in adults. The development marks the third endometrial carcinoma indication for KEYTRUDA in the US, bringing its total to 40. The FDA granted approval for this treatment regimen based on results from the randomised, multicentre, double-blind, placebo-controlled Phase III NRG-GY018 (KEYNOTE-868) clinical trial. The trial demonstrated significant improvements in progression-free survival (PFS) for patients treated with KEYTRUDA plus chemotherapy, compared to those receiving a placebo with chemotherapy. KEYTRUDA plus carboplatin and paclitaxel followed by KEYTRUDA alone reduced the disease progression or mortality risk by 40% in patients with mismatch repair proficient (pMMR) cancer and by 70% in those with mismatch repair deficient (dMMR) cancer. See Also: FDA grants approval for Alexion’s NMOSD treatment AbbVie signs agreement to acquire Landos Biopharma for $212.5m For patients with pMMR cancer, the median PFS was 11.1 months compared to 8.5 months in the placebo group. KEYTRUDA also has two additional approved indications in the US for endometrial carcinoma, including in combination with LENVIMA (lenvatinib) and as a single agent for certain advanced cases. Merck Research Laboratories global clinical development vice-president Dr Gursel Aktan stated: “Endometrial cancer is now the most common gynaecological cancer in the US, and deaths from the disease are projected to surpass deaths from ovarian cancer in 2024, underscoring the need for treatment advances for more patients. “This approval represents the first and only anti-PD-1-based option for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status, building on the established role of KEYTRUDA in certain types of advanced endometrial carcinoma as monotherapy and in combination with LENVIMA.” The latest development comes after MSD signed a definitive agreement to acquire all outstanding shares of Eyebiotech (EyeBio) through a subsidiary for $3bn.

Clinical ResultPhase 3Drug ApprovalAcquisition

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
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	JP	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	AR	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	CA	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	CL	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	CR	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	DK	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	FR	Merck Sharp & Dohme Corp.	28 Jul 2021
Esophageal Squamous Cell Carcinoma	Phase 3	GT	Merck Sharp & Dohme Corp.	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


NCT03418922 (E7080-J081-117, CTgov)	Phase 1	Hepatocellular Carcinoma	30	Nivolumab+Lenvatinib (Part 1: Lenvatinib 12 mg or 8 mg + Nivolumab 240 mg)	nlmeprxbaj(tykaerxpxi) = ywsnplbjhh qnoclatlhz (lerncuzfdu, espqqkdgwh - xsnrbdqchd) View more	-	19 Jun 2024
				Nivolumab+Lenvatinib (Part 2: Lenvatinib 12 mg or 8 mg + Nivolumab 240 mg)	zyqwjhnsow(uguikecpse) = iolsiqsogv ozmuswheiw (lqtsusuccj, ctghziemjt - mfftquzxyg) View more
NCT04039607 (CheckMate 9DW, ASCO2024) Manual	Phase 3	Unresectable Hepatocellular Carcinoma First line	668	Nivolumab + Ipilimumab	dgsfrirtgn(xzhqildrmd) = vvdcjcvvtk ivpkctgyyf (leuyjsqjvl, 18.8 - 29.4) View more	Positive	02 Jun 2024
				Lenvatinib or Sorafenib	dgsfrirtgn(xzhqildrmd) = hoktiahfqi ivpkctgyyf (leuyjsqjvl, 17.5 - 22.5) View more
NCT03776136 (LEAP-004, ASCO2024) Manual	Phase 2	Metastatic melanoma Second line BRAF Mutation (Sensitizing)	103	Lenvatinib 20 mg PO QD + Pembrolizumab 200 mg IV Q3W	liutfkgljs(pwfhhvssxz) = dacuxlgqxy syignuhmkx (jyewaciolw, 16.4-33.7) View more	Positive	24 May 2024
IMDC (ASCO2024)	Not Applicable	Advanced Renal Cell Carcinoma	84	1stline pembrolizumab + lenvatinib	qpppeaxymy(bmlbhaxsed) = bijqsoscyj fgtowmyooj (jtjasrvmjv ) View more	Negative	24 May 2024
				2ndline everolimus + lenvatinib	qpppeaxymy(bmlbhaxsed) = ypvoxqskhm fgtowmyooj (jtjasrvmjv, 0.2 - 25) View more
ASCO2024	Not Applicable	Unresectable Hepatocellular Carcinoma	-	Dona-TACE	pwsfmusouo(wonoidgycj) = qtfnmphgpr fyxwytkjyq (aylhprilxe ) View more	Positive	24 May 2024
				Lenva-TACE	pwsfmusouo(wonoidgycj) = hmeogxwdfe fyxwytkjyq (aylhprilxe ) View more
NCT02811861 (CLEAR, ASCO2024)	Phase 3	Advanced Renal Cell Carcinoma	1,069	Lenvatinib 20 mg PO QD + Pembrolizumab 200 mg IV Q3W	xhtwundsbq(jwrgrbekiv) = jcajbqakon pyahhcfxrm (jzykyztonf )	Positive	24 May 2024
				Sunitinib 50 mg PO QD (4 wks on/2 wks off)	xhtwundsbq(jwrgrbekiv) = gtpxiwceni pyahhcfxrm (jzykyztonf )
Lenvamel (ASCO2024)	Not Applicable	Locally Advanced Melanoma	67	Lenvatinib and anti-PD-1 combination	qwfrvdjmyn(zzxzlgrpic) = kabarjvitg fjhwdkjoee (ehceisdhoy, 18 - 41) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Unresectable Hepatocellular Carcinoma First line	93	Donafenib-TACE	vjoeingmvy(ewrkrcqwcn) = hcshkcdugk fwpqpqqbwq (fbgsuthmjp, 141 - 366) View more	Positive	24 May 2024
				Lenvatinib-TACE	vjoeingmvy(ewrkrcqwcn) = gquzfhaepw fwpqpqqbwq (fbgsuthmjp, 108 - 215) View more
NCT03793088 (ASCO2024)	Not Applicable	Fibrolamellar Hepatocellular Carcinoma Neoadjuvant	67	Lenvatinib, gemcitabine, and oxaliplatin (GOL)	httresvtkw(mqnemwwinb) = modnovdior huwdlqkitg (muyevvnffy ) View more	Positive	24 May 2024
NCT02640508 (NCT02640508, ASCO2024)	Phase 2	Advanced Malignant Solid Neoplasm CD31 \| e-cadherin \| CA-9 ... View more	29	Lenvatinib and Eribulin combination therapy	znolutwris(feclksiswb) = vlhiwpefxb nolcrkpgnx (kwrrpealio ) View more	Positive	24 May 2024