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LENVIMA® for first-line unresectable hepatocellular carcinoma

Adverse reactions observed in the REFLECT trial

Most common serious ARs (≥2%) in the LENVIMA arm of the REFLECT trial1

Most common serious ARs (≥2%) in the LENVIMA arm of the REFLECT trial Most common serious ARs (≥2%) in the LENVIMA arm of the REFLECT trial mobile

REFLECT=A Multicenter, Randomized, Open-label, Phase 3 Trial to Compare the EFficacy and Safety of LEnvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With UnreseCtable HepaTocellular Carcinoma; AR=adverse reaction.

REFLECT was not designed to demonstrate a statistically significant reduction in AR rates for LENVIMA vs sorafenib.1

Most common grade 3-4 ARs (≥5%) in either arm1

Most common grade 3-4 adverse reactions (≥5%) in the REFLECT trial

No grade 4 hypertension, proteinuria, decreased appetite, or diarrhea were reported in REFLECT.2

REFLECT was not designed to demonstrate a statistically significant reduction in AR rates for LENVIMA vs sorafenib.1

REFLECT=A Multicenter, Randomized, Open-label, Phase 3 Trial to Compare the EFficacy and Safety of LEnvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With UnreseCtable HepaTocellular Carcinoma; AR=adverse reaction.

  1. aIncludes increased diastolic blood pressure, increased blood pressure, hypertension, and orthostatic hypertension.
  2. bIncludes asthenia, fatigue, lethargy, and malaise.
  3. cIncludes proteinuria, increased urine protein, and protein urine present.

ARs occurring in ≥10% of patients in the LENVIMA arm1

Adverse reactions occurring in ≥10% of patients in the LENVIMA arm of the REFLECT trial Adverse reactions occurring in ≥10% of patients in the LENVIMA arm of the REFLECT trial mobile

REFLECT was not designed to demonstrate a statistically significant reduction in AR rates for LENVIMA vs sorafenib.1

REFLECT=A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the EFficacy and Safety of LEnvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With UnreseCtable HepaTocellular Carcinoma; HCC=hepatocellular carcinoma; AR=adverse reaction.

  1. aIncludes hypothyroidism and blood thyroid-stimulating hormone increased.
  2. bIncludes abdominal discomfort, abdominal pain, abdominal tenderness, epigastric discomfort, gastrointestinal pain, lower abdominal pain, and upper abdominal pain.
  3. cIncludes ascites and malignant ascites.
  4. dIncludes aphthous ulcer, gingival erosion, gingival ulceration, glossitis, mouth ulceration, oral mucosal blistering, and stomatitis.
  5. eIncludes asthenia, fatigue, lethargy, and malaise.
  6. fIncludes increased body temperature and pyrexia.
  7. gIncludes arthralgia, back pain, extremity pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, and myalgia.
  8. hIncludes proteinuria, increased urine protein, and protein urine present.
  9. iIncludes erythema, erythematous rash, exfoliative rash, genital rash, macular rash, maculo-papular rash, papular rash, pruritic rash, pustular rash, and rash.
  10. jIncludes increased diastolic blood pressure, increased blood pressure, hypertension, and orthostatic hypertension.
  11. kIncludes all hemorrhage terms. Hemorrhage terms that occurred in 5 or more subjects in either treatment group include: epistaxis, hematuria, gingival bleeding, hemoptysis, esophageal varices hemorrhage, hemorrhoidal hemorrhage, mouth hemorrhage, rectal hemorrhage and upper gastrointestinal hemorrhage.

Post hoc analysis of time to first onset of select ARs2

Identify points in treatment when select ARs emerged with LENVIMA in the REFLECT trial

Median weeks; AR (n=476)*

Post hoc analysis of time to first onset of select adverse reactions with LENVIMA when they emerged in the REFLECT trial Post hoc analysis of time to first onset of select adverse reactions with LENVIMA when they emerged in the REFLECT trial mobile

Median weeks; AR (n=476)*

  • Monitor your patients for ARs throughout treatment with LENVIMA

Limitation: This is a post hoc exploratory analysis for descriptive purposes only; no conclusions can be drawn.

AR=adverse reaction.

*The bar represents the time to first onset of select ARs for the middle 50% of the patients who experienced that AR from quartile 1 to 3.

Learn about dosing and dose modifications with LENVIMA
Exploratory Subgroup Analysis Dosing and Administration