Findings from the Phase 3 LITESPARK-011 and LITESPARK-012 studies reflect continued research into LENVIMA® (lenvatinib)-based combination regimens for patients with advanced renal cell carcinoma

Exploratory biomarker analysis from the Phase 3 LEAP-001 study adds to translational insights in advanced or recurrent endometrial cancer, alongside new findings from “Patients Raise Their Voices” survey

NUTLEY, N.J., Oct. 15, 2026 /PRNewswire/ — Eisai announced today the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2026, taking place in Madrid from October 23 to 27. Together, the presentations reflect Eisai’s ongoing commitment to generating evidence that can help inform treatment decisions for patients facing difficult-to-treat cancers.

“The research we are presenting at ESMO spans the full arc of a patient’s journey, from first-line treatment of advanced disease through disease progression, and reflects our commitment to driving progress in patient care at every stage,” said Corina Dutcus, M.D., Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. “In advanced renal cell carcinoma, this means continuing to generate new evidence across the continuum of care, building on the established role of LENVIMA-based combinations. In endometrial cancer, we will present exploratory biomarker findings from the Phase 3 LEAP-001 study and a patient advocacy-led survey highlighting the experiences of people living with the disease across their care journey. Across both areas, this work reflects our human health care mission, which places patients at the center of everything we do and guides our efforts to deliver meaningful innovations that can improve their lives.”

Renal Cell Carcinoma (RCC) Research
Among the notable presentations are new analyses from the Phase 3 LITESPARK-011 (NCT04586231) and LITESPARK-012 (NCT04736706) studies evaluating LENVIMA^® (lenvatinib)-based regimens in advanced RCC. The final analysis from LITESPARK-011 will be presented in a proffered paper session (Presentation #3587O). Data from the Phase 3 LITESPARK-011 study supported the recent U.S. Food and Drug Administration (FDA) approval of WELIREG^® (belzutifan), Merck’s (known as MSD outside of the United States and Canada) oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for adult patients with advanced RCC with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor [see FDA news release here]. Additional LITESPARK-011 research includes a rapid oral presentation examining the relationship between health-related quality of life (HRQoL) and efficacy in the trial (Presentation #3595RO).

A proffered paper featuring findings from the Phase 3 LITESPARK-012 study evaluating two investigational regimens for the first-line treatment of patients with advanced ccRCC compared to KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA (Presentation #3586O) will also be presented. KEYTRUDA plus LENVIMA is recommended as a preferred Category 1 first-line systemic therapy regimen for the treatment of patients with advanced ccRCC and a preferred Category 2A systemic therapy regimen for the treatment of patients with advanced non-clear cell RCC in the National Comprehensive Cancer Network^® (NCCN^®)* Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Kidney Cancer.

Endometrial Cancer Research
Eisai will highlight an exploratory biomarker analysis from the Phase 3 LEAP-001 (NCT03884101) study that evaluated patients with advanced or recurrent endometrial cancer treated with first-line KEYTRUDA plus LENVIMA versus chemotherapy (Presentation #4360P). These exploratory findings add to the translational insights generated from LEAP-001 and reflect ongoing efforts by Eisai to learn from every clinical study to help deepen understanding of endometrial cancer biology and treatment response.

Eisai will also present findings from a survey examining the perspectives and experiences of people living with endometrial cancer in the U.S. across the care journey (Presentation #1256P). Conducted in collaboration with leading patient advocacy organizations, the survey explored topics including the impact of treatment on daily life, treatment preferences, and the role of shared decision-making between patients and physicians.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. All regular abstracts accepted for presentation at the ESMO Congress 2026 will be published online via the ESMO website at 6:05 PM EDT on Sunday, October 18, 2026 (12:05 AM CEST on Monday, October 19, 2026). Posters will be on display from 9:00 AM – 5:00 PM local time in Madrid on the day of their poster session.

In March 2018, Eisai and Merck, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, and HIF-2α inhibitor, WELIREG.

The following presentation includes findings from a survey examining the perspectives and experiences of people living with endometrial cancer across the care journey.

* NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

About LENVIMA^® (lenvatinib); available as 10 mg and 4 mg capsules

LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. The combination of LENVIMA and everolimus showed increased antiangiogenic and antitumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signaling in vitro and tumor volume in mouse xenograft models of human renal cell cancer greater than each drug alone. 

Indications for LENVIMA^® (lenvatinib) in the U.S. 

• For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
• In combination with KEYTRUDA or KEYTRUDA QLEX, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
• In combination with WELIREG, for the treatment of adult patients with advanced RCC with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
• In combination with everolimus for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.
• For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
• In combination with KEYTRUDA or KEYTRUDA QLEX, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Selected Safety Information for LENVIMA 
Warnings and Precautions 

Hypertension. In differentiated thyroid cancer (DTC), hypertension occurred in 73% of patients on LENVIMA (44% Grade 3; <1% Grade 4). In advanced renal cell carcinoma (RCC), hypertension occurred in 42% of patients on LENVIMA + everolimus (13% Grade 3). Systolic blood pressure ≥160 mmHg occurred in 29% of patients, and 21% had diastolic blood pressure ≥100 mmHg. In unresectable hepatocellular carcinoma (HCC), hypertension occurred in 45% of LENVIMA-treated patients (24% Grade 3). Grade 4 hypertension was not reported in HCC.

Serious complications of poorly controlled hypertension have been reported. Control blood pressure prior to initiation. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Withhold and resume at reduced dose when hypertension is controlled or permanently discontinue based on severity.

Cardiac Dysfunction. Serious and fatal cardiac dysfunction, including heart failure with reduced left ventricular ejection fraction (LVEF), and cardiomyopathy, can occur with LENVIMA. The safety of LENVIMA either as monotherapy or in combination with WELIREG has not been established in patients with LVEF below 50%. In patients with DTC, RCC, or HCC treated with LENVIMA, Grade 3 or higher cardiac dysfunction adverse events occurred in 1% of patients. The median time to onset of Grade 3 or higher cardiac dysfunction was 35 weeks (range 7 to 63 weeks). An absolute decrease in LVEF >20% with or without clinical symptoms occurred in 1% of LENVIMA-treated patients. The median time to onset of LVEF decrease >20% was 33 weeks (range 4 to 83 weeks).

In patients treated with LENVIMA in combination with WELIREG for ccRCC, Grade 3 or higher cardiac dysfunction adverse events occurred in 6% of patients. The median time to onset of Grade 3 or higher cardiac dysfunction was 26 weeks (range 1 to 192 weeks). An absolute decrease in LVEF >20% with or without clinical symptoms occurred in 6% of patients and the median time to onset of LVEF decrease >20% was 29 weeks (range 2 to 192 weeks).

Consider obtaining a baseline echocardiogram or Multigated Acquisition (MUGA) imaging. Monitor patients for symptoms or signs of heart failure and if present, reassess LVEF. Withhold and resume at a reduced dose upon recovery to baseline or Grade 1 or permanently discontinue LENVIMA based on severity.

Arterial Thromboembolic Events. Among patients receiving LENVIMA or LENVIMA + everolimus, arterial thromboembolic events of any severity occurred in 2% of patients in RCC and HCC and 5% in DTC. Grade 3-5 arterial thromboembolic events ranged from 2% to 3% across all clinical trials.

Arterial thrombotic events of any severity occurred in 5% of patients with RCC receiving LENVIMA + KEYTRUDA, including myocardial infarction (3.4%) and cerebrovascular accident (2.3%).

Permanently discontinue following an arterial thrombotic event. The safety of resuming after an arterial thromboembolic event has not been established and LENVIMA has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.

Hepatotoxicity. Serious hepatic adverse reactions occurred in 1.4% of LENVIMA-treated patients with malignancies other than HCC. Fatal events, including hepatic failure, acute hepatitis and hepatorenal syndrome, occurred in 0.5% of patients. In HCC, hepatic encephalopathy occurred in 8% of LENVIMA-treated patients (5% Grade 3-5), and Grade 3-5 hepatic failure occurred in 3% of patients. 2% of patients discontinued LENVIMA due to hepatic encephalopathy and 1% discontinued due to hepatic failure.

Monitor liver function prior to initiation, then every 2 weeks for the first 2 months, and at least monthly thereafter during treatment. Monitor patients with HCC closely for signs of hepatic failure, including hepatic encephalopathy. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Renal Failure or Impairment. Serious including fatal renal failure or impairment can occur with LENVIMA. Renal impairment was reported in 14% and 7% of LENVIMA-treated patients in DTC and HCC, respectively. Grade 3-5 renal failure or impairment occurred in 3% of patients with DTC and 2% of patients with HCC, including 1 fatal event in each study. In RCC, renal impairment or renal failure was reported in 18% of LENVIMA + everolimus–treated patients (10% Grade 3).

Initiate prompt management of diarrhea or dehydration/hypovolemia. Withhold and resume at reduced dose upon recovery or permanently discontinue LENVIMA for renal failure or impairment based on severity.

Proteinuria. In DTC and HCC, proteinuria was reported in 34% and 26% of LENVIMA-treated patients, respectively. Grade 3 proteinuria occurred in 11% and 6% in DTC and HCC, respectively. In RCC, proteinuria occurred in 31% of patients receiving LENVIMA + everolimus (8% Grade 3). Monitor for proteinuria prior to initiation and periodically during treatment. If urine dipstick proteinuria ≥2+ is detected, obtain a 24-hour urine protein. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Diarrhea. In DTC and HCC, diarrhea occurred in 49% of LENVIMA-treated patients (6% Grade 3). In RCC, diarrhea occurred in 81% of LENVIMA + everolimus–treated patients (19% Grade 3). Diarrhea was the most frequent cause of dose interruption/reduction, and diarrhea recurred despite dose reduction. Promptly initiate management of diarrhea. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Fistula Formation and Gastrointestinal Perforation. In patients treated with LENVIMA or LENVIMA + everolimus in DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred in 2%. Permanently discontinue in patients who develop gastrointestinal perforation of any severity or Grade 3-4 fistula.

QTc Interval Prolongation. In DTC, QT/QTc interval prolongation occurred in 9% of LENVIMA-treated patients and QTc interval prolongation of >500 ms occurred in 2%. In RCC, QTc interval increases of >60 ms occurred in 11% of patients receiving LENVIMA + everolimus and QTc interval >500 ms occurred in 6%. In HCC, QTc interval increases of >60 ms occurred in 8% of LENVIMA-treated patients and QTc interval >500 ms occurred in 2%.

Monitor and correct electrolyte abnormalities at baseline and periodically during treatment. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those who are taking drugs known to prolong the QTc interval. Withhold and resume at reduced dose upon recovery based on severity.

Hypocalcemia. In DTC, Grade 3-4 hypocalcemia occurred in 9% of LENVIMA-treated patients. In 65% of cases, hypocalcemia improved or resolved following calcium supplementation with or without dose interruption or dose reduction. In RCC, Grade 3-4 hypocalcemia occurred in 6% of LENVIMA + everolimus–treated patients. In HCC, Grade 3 hypocalcemia occurred in 0.8% of LENVIMA-treated patients. Monitor blood calcium levels at least monthly and replace calcium as necessary during treatment. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS). In patients who received LENVIMA as a single agent, RPLS occurred in 0.3%. Confirm diagnosis of RPLS with MRI. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity and persistence of neurologic symptoms.

Hemorrhagic Events. Serious including fatal hemorrhagic events can occur with LENVIMA. In DTC, RCC, and HCC, hemorrhagic events, of any grade, occurred in 29% of patients treated with LENVIMA as a single agent or in combination with everolimus. The most frequently reported hemorrhagic events (≥5%) were epistaxis and hematuria. In DTC, Grade 3-5 hemorrhage occurred in 2% of LENVIMA-treated patients, including 1 fatal intracranial hemorrhage among 16 patients with CNS metastases at baseline. In RCC, Grade 3-5 hemorrhage occurred in 8% of LENVIMA + everolimus–treated patients, including 1 fatal cerebral hemorrhage. In HCC, Grade 3-5 hemorrhage occurred in 5% of LENVIMA-treated patients, including 7 fatal hemorrhagic events. Serious tumor-related bleeds, including fatal hemorrhagic events, occurred in LENVIMA-treated patients in clinical trials and in the postmarketing setting. In postmarketing surveillance, serious and fatal carotid artery hemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than other tumors. Safety and effectiveness of LENVIMA in ATC have not been established.

Consider the risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (eg, carotid artery). Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction. LENVIMA impairs exogenous thyroid suppression. In DTC, 88% of patients had baseline thyroid stimulating hormone (TSH) level ≤0.5 mU/L. In patients with normal TSH at baseline, elevation of TSH level >0.5 mU/L was observed post baseline in 57% of LENVIMA-treated patients. In RCC and HCC, Grade 1 or 2 hypothyroidism occurred in 24% of LENVIMA + everolimus–treated patients and 21% of LENVIMA-treated patients, respectively. In patients with normal or low TSH at baseline, elevation of TSH was observed post baseline in 70% of LENVIMA-treated patients in HCC and 60% of LENVIMA + everolimus–treated patients in RCC.

Monitor thyroid function prior to initiation and at least monthly during treatment. Treat hypothyroidism according to standard medical practice.

Impaired Wound Healing. Impaired wound healing has been reported in patients who received LENVIMA. Withhold LENVIMA for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of LENVIMA after resolution of wound healing complications has not been established.

Osteonecrosis of the Jaw (ONJ). ONJ has been reported in patients receiving LENVIMA. Concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease or invasive dental procedures, may increase the risk of ONJ.

Perform an oral examination prior to treatment with LENVIMA and periodically during treatment. Advise patients regarding good oral hygiene practices.

Avoid invasive dental procedures, if possible, while on LENVIMA treatment, particularly in patients at higher risk. Withhold LENVIMA for at least 1 week prior to scheduled dental surgery or invasive dental procedures, if possible. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk of ONJ.  

Withhold LENVIMA if ONJ develops and restart based on clinical judgement of adequate resolution.

Embryo-Fetal Toxicity. Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to pregnant women. In animal reproduction studies, oral administration of LENVIMA during organogenesis at doses below the recommended clinical doses resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats and rabbits. Advise pregnant women of the potential risk to a fetus; and advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for 30 days after the last dose.

Adverse Reactions

In DTC, the most common adverse reactions (≥30%) observed in LENVIMA-treated patients were hypertension (73%), fatigue, diarrhea (67% each), arthralgia/myalgia (62%), decreased appetite (54%), decreased weight (51%), nausea (47%), stomatitis (41%), headache (38%), vomiting (36%), proteinuria (34%), palmar-plantar erythrodysesthesia syndrome (32%), abdominal pain, and dysphonia (31% each). The most common serious adverse reactions (≥2%) were pneumonia (4%), hypertension, and dehydration (3% each). Adverse reactions led to dose reductions in 68% of LENVIMA-treated patients; 18% discontinued LENVIMA. The most common adverse reactions (≥10%) resulting in dose reductions were hypertension (13%), proteinuria (11%), decreased appetite, and diarrhea (10% each); the most common adverse reactions (≥1%) resulting in discontinuation of LENVIMA were hypertension and asthenia (1% each).

In RCC, the most common adverse reactions (≥20%) observed in LENVIMA + KEYTRUDA–treated patients were fatigue (63%), diarrhea (62%), musculoskeletal pain (58%), hypothyroidism (57%), hypertension (56%), stomatitis (43%), decreased appetite (41%), rash (37%), nausea (36%), decreased weight, dysphonia, proteinuria (30% each), palmar-plantar erythrodysesthesia syndrome (29%), abdominal pain, hemorrhagic events (27% each), vomiting (26%), constipation, hepatotoxicity (25% each), headache (23%), and acute kidney injury (21%).

Fatal adverse reactions occurred in 4.3% of patients receiving LENVIMA + KEYTRUDA, including cardio-respiratory arrest (0.9%), sepsis (0.9%), and one case (0.3%) each of arrhythmia, autoimmune hepatitis, dyspnea, hypertensive crisis, increased blood creatinine, multiple organ dysfunction syndrome, myasthenic syndrome, myocarditis, nephritis, pneumonitis, ruptured aneurysm and subarachnoid hemorrhage.

Serious adverse reactions occurred in 51% of patients receiving LENVIMA + KEYTRUDA; the most common (≥2%) were hemorrhagic events (5%), diarrhea (4%), hypertension, myocardial infarction, pneumonitis, vomiting (3% each), acute kidney injury, adrenal insufficiency, dyspnea, and pneumonia (2% each).

Permanent discontinuation of LENVIMA, KEYTRUDA, or both due to an adverse reaction occurred in 37% of patients; 26% LENVIMA only, 29% KEYTRUDA only, and 13% both. The most common adverse reactions (≥2%) leading to permanent discontinuation of LENVIMA, KEYTRUDA, or both were pneumonitis, myocardial infarction, hepatotoxicity, acute kidney injury, rash (3% each), and diarrhea (2%).

Dose interruptions of LENVIMA, KEYTRUDA, or both due to an adverse reaction occurred in 78% of patients receiving LENVIMA + KEYTRUDA. LENVIMA was interrupted in 73% of patients and both drugs were interrupted in 39% of patients. LENVIMA was dose reduced in 69% of patients. The most common adverse reactions (≥5%) resulting in dose reduction or interruption of LENVIMA were diarrhea (26%), fatigue (18%), hypertension (17%), proteinuria (13%), decreased appetite (12%), palmar-plantar erythrodysesthesia (11%), nausea, stomatitis (9% each), musculoskeletal pain, rash (8% each), increased lipase (7%), abdominal pain and vomiting (6% each), increased ALT, and increased amylase (5% each).

In RCC, the most common (≥25%) adverse reactions, that occurred in patients who received LENVIMA + WELIREG were anemia (70%), fatigue (68%), hypertension (60%), musculoskeletal pain (55%), diarrhea (54%), nausea, hypothyroidism, (42% each), decreased appetite (41%), proteinuria (38%), rash (33%), vomiting (32%), decreased weight (29%), constipation (27%), abdominal pain (26%), and stomatitis (25%).

Fatal adverse reactions occurred in 5% of patients who received LENVIMA + WELIREG, including sepsis (0.8%), pneumonia, pneumonitis, respiratory failure (0.5% each), and one case (0.3%) each of acute cholecystitis, acute respiratory distress syndrome, pulmonary edema, embolic cerebral infarction, hemorrhage, postoperative wound complication, thrombotic microangiopathy, and upper respiratory tract infection.

Serious adverse reactions occurred in 54% of patients. Serious adverse reactions (≥2%) included hypoxia (6%), pneumonia (5%), hyponatremia (3.2%), acute kidney injury (3%), hemorrhage, anemia (2.7% each), cardiac failure, and diarrhea (2.4% each).

Permanent discontinuation of LENVIMA due to an adverse reaction occurred in 23% of patients. Adverse reactions which resulted in permanent discontinuation of LENVIMA in (>0.5%) of patients included fatigue (1.6%), cardiac failure, hyponatremia, pneumonia (1.1% each), decreased ejection fraction, increased lipase, pneumonitis, proteinuria, and rash (0.8% each).

Dosage interruptions of LENVIMA due to an adverse reaction occurred in 72% of patients. The most common adverse reactions requiring dose interruption (>3%) were fatigue (15%), hypertension (14%), diarrhea (13%), nausea, vomiting (10% each), anemia (8%), proteinuria (7%), decreased appetite (6%), COVID-19 (5%), musculoskeletal pain, abdominal pain, rash (4.3% each), pneumonia, stomatitis (3.5% each), and hemorrhage (3.2%).

Dose reductions of LENVIMA due to an adverse reaction occurred in 67% of patients. The most common adverse reactions which required dose reductions (>2%) were fatigue (20%), diarrhea (13%), hypertension (12%), proteinuria (9%), decreased appetite (8%), nausea, rash (6% each), vomiting (4.1%), anemia, decreased weight (3.5% each), abdominal pain (3%), increased ALT, stomatitis (2.7% each), musculoskeletal pain (2.4%), and hypothyroidism (2.2%).

In RCC, the most common adverse reactions (≥30%) observed in LENVIMA + everolimus-treated patients were diarrhea (81%), fatigue (73%), arthralgia/myalgia (55%), decreased appetite (53%), vomiting (48%), nausea (45%), stomatitis (44%), hypertension, peripheral edema (42% each), cough, abdominal pain (37% each), dyspnea, rash (35% each), decreased weight (34%), hemorrhagic events (32%), and proteinuria (31%). The most common serious adverse reactions (≥5%) were renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia, diarrhea, vomiting, and dyspnea (5% each). Adverse reactions led to dose reductions or interruption in 89% of patients. The most common adverse reactions (≥5%) resulting in dose reductions were diarrhea (21%), fatigue (8%), thrombocytopenia, vomiting (6% each), nausea, and proteinuria (5% each). Treatment discontinuation due to an adverse reaction occurred in 29% of patients.

In HCC, the most common adverse reactions (≥20%) observed in LENVIMA-treated patients were hypertension (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%), arthralgia/myalgia, decreased weight (31% each), abdominal pain (30%), palmar-plantar erythrodysesthesia syndrome (27%), proteinuria (26%), dysphonia (24%), hemorrhagic events (23%), hypothyroidism (21%), and nausea (20%). The most common serious adverse reactions (≥2%) were hepatic encephalopathy (5%), hepatic failure, ascites (3% each), and decreased appetite (2%). Adverse reactions led to dose reductions or interruption in 62% of patients. The most common adverse reactions (≥5%) resulting in dose reductions or interruptions were fatigue (9%), decreased appetite, diarrhea (8% each), proteinuria (7%), hypertension (6%), and palmar-plantar erythrodysesthesia syndrome (5%). Treatment discontinuation due to an adverse reaction occurred in 20% of patients. The most common adverse reactions (≥1%) resulting in discontinuation of LENVIMA were hepatic encephalopathy (2%), fatigue (1%), hyperbilirubinemia, and hepatic failure (1% each).

In EC, the most common adverse reactions (≥20%) observed in LENVIMA + KEYTRUDA–treated patients were hypothyroidism, hypertension (67% each), fatigue (58%), diarrhea (55%), musculoskeletal disorders (53%), nausea (49%), decreased appetite (44%), vomiting (37%), stomatitis (35%), decreased weight, abdominal pain (34% each), urinary tract infection (31%), proteinuria (29%), constipation (27%), headache (26%), hemorrhagic events (25%), palmar‐plantar erythrodysesthesia (23%), dysphonia (22%), and rash (20%).

Fatal adverse reactions among these patients occurred in 4.7% of those treated with LENVIMA and KEYTRUDA, including 2 cases of pneumonia, and 1 case of the following: acute kidney injury, acute myocardial infarction, colitis, decreased appetite, intestinal perforation, lower gastrointestinal hemorrhage, malignant gastrointestinal obstruction, multiple organ dysfunction syndrome, myelodysplastic syndrome, pulmonary embolism, and right ventricular dysfunction.

Serious adverse reactions occurred in 50% of these patients receiving LENVIMA and KEYTRUDA. Serious adverse reactions with frequency ≥3% were hypertension (4.4%), and urinary tract infection (3.2%).

Discontinuation of LENVIMA due to an adverse reaction occurred in 26% of these patients. The most common (≥1%) adverse reactions leading to discontinuation of LENVIMA were hypertension (2%), asthenia (1.8%), diarrhea, decreased appetite, proteinuria, and vomiting (1.2% each).

Dose reductions of LENVIMA due to adverse reactions occurred in 67% of patients. The most common (≥5%) adverse reactions resulting in dose reduction of LENVIMA were hypertension (18%), diarrhea (11%), palmar-plantar erythrodysesthesia syndrome (9%), proteinuria, fatigue (7% each), decreased appetite (6%), asthenia, and weight decreased (5% each).

Dose interruptions of LENVIMA due to an adverse reaction occurred in 58% of these patients. The most common (≥2%) adverse reactions leading to interruption of LENVIMA were hypertension, diarrhea (11% each), proteinuria (6%), decreased appetite, vomiting (5% each), increased alanine aminotransferase, fatigue, nausea (3.5% each), abdominal pain (2.9%), weight decreased, urinary tract infection (2.6% each), increased aspartate aminotransferase, asthenia (2.3% each), and palmar-plantar erythrodysesthesia (2%).

Use in Specific Populations

Because of the potential for serious adverse reactions in breastfed children, advise women to discontinue breastfeeding during treatment and for 1 week after last dose.

Verify the pregnancy status of females of reproductive potential prior to initiating LENVIMA.

LENVIMA may impair fertility in males and females of reproductive potential.

No dose adjustment is recommended for patients with mild (creatinine clearance [CLcr] 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment. LENVIMA concentrations may increase in patients with DTC, RCC, or EC and severe (CLcr 15-29 mL/min) renal impairment. Reduce the dose for patients with DTC, RCC, or EC and severe renal impairment. There is no recommended dose for patients with HCC and severe renal impairment. LENVIMA has not been studied in patients with end stage renal disease.

No dose adjustment is recommended for patients with HCC and mild hepatic impairment (Child-Pugh A). There is no recommended dose for patients with HCC with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. No dose adjustment is recommended for patients with DTC, RCC, or EC and mild or moderate hepatic impairment. LENVIMA concentrations may increase in patients with DTC, RCC, or EC and severe hepatic impairment. Reduce the dose for patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment.

For more information about LENVIMA, please see available full Prescribing Information.

About the Eisai and Merck Strategic Collaboration
In March 2018, Eisai and Merck, known as MSD outside of the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, and HIF-2α inhibitor, WELIREG.

About Eisai 
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia, and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).

LENVIMA^® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

©2026 Eisai Inc. All Rights Reserved.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.

WELIREG^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.

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