For patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
RECIST 1.1 = Response Evaluation Criteria In Solid Tumors v1.1
aTumor MSI status was determined using a polymerase chain reaction (PCR) test and tumor MMR status was determined using an immunohistochemistry test.
Median Age: 66 years (62% aged 65 or older)
48.9% (n=46) endometrioid adenocarcinoma
35.1% (n=33) serous adenocarcinoma
5.3% (n=5) clear cell adenocarcinoma
1.1% (n=1) adenocarcinoma, not otherwise specified
9.6% (n=9) otherb
Prior Systemic Therapy
bPredominantly mixed histology.4
ECOG PS = Eastern Cooperative Oncology Group performance status.
aDOR was assesed by independent review.
CI = confidence interval; CR = complete response; PR = partial response.
The safety of KEYTRUDA in combination with LENVIMA was evaluated in KEYNOTE‑146/Study 111, a single-arm, multicenter, open-label trial in 94 patients with endometrial carcinoma whose tumors had progressed following at least one line of systemic therapy and were not MSI-H or dMMR.
|Most common adverse reactions (≥2%) that led to interruption of KEYTRUDA (%)|
|Increased blood alkaline phosphatase||3|
|Most common adverse reactions (≥5%) that resulted in dose reduction or interruption of LENVIMA (%)|
aIncludes asthenia, fatigue, and malaise
bIncludes arthralgia, arthritis, back pain, breast pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, pain in extremity
cIncludes essential hypertension, hypertension, and hypertensive encephalopathy
dIncludes catheter site bruise, contusion, epistaxis, gastrointestinal hemorrhage, hematemesis, hematuria, hemorrhage intracranial, injection site hemorrhage, intraventricular hemorrhage, large intestinal hemorrhage, metrorrhagia, mouth hemorrhage, uterine hemorrhage, and vaginal hemorrhage
eIncludes diarrhea, gastroenteritis, gastrointestinal viral infection, and viral diarrhea
fIncludes glossitis, mouth ulceration, oral discomfort, oral mucosal blistering, oropharyngeal pain, and stomatitis
gIncludes abdominal discomfort, abdominal pain, lower abdominal pain, and upper abdominal pain
hIncludes decreased appetite and early satiety
iIncludes increased blood thyroid stimulating hormone and hypothyroidism
jIncludes cystitis and urinary tract infection
kIncludes dyspnea and exertional dyspnea
lIncludes rash, rash generalized, rash macular, and rash maculo-papular
Selected Safety Information for
Selected Safety Information for
Perform an oral examination prior to treatment with LENVIMA and periodically during LENVIMA treatment. Advise patients regarding good oral hygiene practices and to consider having preventive dentistry performed prior to treatment with LENVIMA and throughout treatment with LENVIMA.
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.
Adverse reactions led to dose reduction or interruption in 88% of patients receiving LENVIMA. The most common adverse reactions (≥5%) resulting in dose reduction or interruption of LENVIMA were fatigue (32%), hypertension (26%), diarrhea (18%), nausea (13%), palmar-plantar erythrodysesthesia (13%), vomiting (13%), decreased appetite (12%), musculoskeletal pain (11%), stomatitis (9%), abdominal pain (7%), hemorrhages (7%), renal impairment (6%), decreased weight (6%), rash (5%), headache (5%), increased lipase (5%), and proteinuria (5%).
Fatal adverse reactions occurred in 3% of patients receiving LENVIMA + KEYTRUDA, including gastrointestinal perforation, RPLS with intraventricular hemorrhage, and intracranial hemorrhage.
Serious adverse reactions occurred in 52% of patients receiving LENVIMA + KEYTRUDA. Serious adverse reactions in ≥3% of patients were hypertension (9%), abdominal pain (6%), musculoskeletal pain (5%), hemorrhage (4%), fatigue (4%), nausea (4%), confusional state (4%), pleural effusion (4%), adrenal insufficiency (3%), colitis (3%), dyspnea (3%), and pyrexia (3%).
Permanent discontinuation due to adverse reaction (grade 1-4) occurred in 21% of patients who received LENVIMA + KEYTRUDA. The most common adverse reactions (>2%) resulting in discontinuation of LENVIMA were gastrointestinal perforation or fistula (2%), muscular weakness (2%), and pancreatitis (2%).
QTc = corrected QT interval; MRI = magnetic resonance imaging; CNS = central nervous system.
Before prescribing LENVIMA® (lenvatinib), please read the accompanying Prescribing Information and Patient Information.