Explore patient profiles for KEYTRUDA® in combination with LENVIMA®

Meet Julia†

A patient with metastatic RCC

Background info

  • 58 years of age
  • Widow; 3 children
  • Non-smoker
  • No prior systemic therapy for RCC

Julia’s† clinical presentation

Blood work and results4

  • Normal CBC
    • WBC: 5.4 x 109/L [normal: 3.5–10.5 × 109/L4]
    • Hemoglobin: 129 g/L [normal (female): 115–155 g/L4]
    • Platelets: 230 x 109/L [normal: 130–380 × 109/L4]
  • Normal corrected calcium
    • Albumin: 36 g/L [normal: 34–50 g/L4]
    • Calcium: 2.29 mmol/L [normal: 2.12–2.52 mmol/L4]

Imaging/biopsy and results

  • CT showed a large right-sided primary tumour, maximum diameter 17 cm, multiple lung metastases up to 5 cm, multiple lymph node metastases in mediastinum and retroperitoneum, no brain metastases and no scintigraphic evidence of bone metastases
  • Kidney biopsy revealed RCC

Other assessments

  • Karnofsky Performance Status 70%
  • MSKCC risk: intermediate

Diagnosis: metastatic RCC

Explore efficacy and safety profile results for KEYTRUDA® in combination with LENVIMA® in the first-line setting for advanced or metastatic RCC.

Discover results from the KEYNOTE-581/CLEAR trial

Meet James†

A patient with metastatic RCC

Background info

  • 65 years of age
  • Hypertension, dyslipidemia, coronary artery disease (bypass surgery 7 years ago)
  • Non-smoker

James’s† clinical presentation

Blood work and results4

  • Hemoglobin: 104 g/L [normal (male): 125–170 g/L4]
  • Platelets: >ULN (436 x 109/L) [normal: 130–380 × 109/L4]
  • WBC: Within normal limits (6.5 x 109/L) [normal: 3.5–10.5 × 109/L4]
  • Creatinine: >ULN (134 µmol/L) [normal (male): 49–93 µmol/L4]
  • Corrected calcium: Within normal limits (2.5 mmol/L) [normal: 2.12–2.52 mmol/L4]
  • Neutrophils: Within normal limits (4.1 x 109/L) [normal: 2.0–7.5 × 109/L4]

Imaging/biopsy and results

  • CT showed 6.5 cm in primary right kidney, multiple metastatic lymph nodes, multiple lung metastases
  • Kidney biopsy shows RCC

Other assessments

  • Karnofsky Performance Status 70%
  • Time since diagnosis <1 year (synchronous metastases)
  • MSKCC risk: poor

Diagnosis: metastatic RCC


Serious cases of artery dissection, some fatal, have been reported with or without hypertension.
Blood pressure should be well controlled prior to treatment. Monitor blood pressure while on
treatment. Blood pressure should be monitored after 1 week of treatment with LENVIMA®, then
every 2 weeks for the first 2 months and then monthly thereafter while on treatment. If a patient
develops systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg active management is recommended. Early detection and management of hypertension are important to minimize dose interruptions and reductions. Withhold LENVIMA® for Grade 3 hypertension that persists despite optimal antihypertensive therapy; discontinue for life-threatening hypertension. Cardiac failure, including fatal cases, have been reported. Monitor for symptoms or signs of cardiac decompensation. Withhold LENVIMA® for Grade 3 cardiac dysfunction until improvement to ≤Grade 1 or baseline; discontinue for Grade 4 cardiac dysfunction.

Explore efficacy and safety profile results for KEYTRUDA® in combination with LENVIMA® in the first-line setting for advanced or metastatic RCC.

Discover results from the KEYNOTE-581/CLEAR trial

Meet Henry†

A patient with metastatic RCC

Background info

  • 76 years of age
  • Retired salesperson
  • Married; no children
  • Very active
  • Hypertension; lifelong non-smoker

Henry’s† clinical presentation

Blood work and results4

  • WBC: 7.5 x 109/L [normal: 3.5–10.5 × 109/L4]
  • Hemoglobin: 145 g/L [normal (male): 125–170 g/L4]
  • Corrected calcium: Within normal range (albumin 42 g/L, calcium 2.29 mmol/L) [normal: 34–50 g/L and 2.12–2.52 mmol/L, respectively4]
  • Platelets: 280 x 109/L [normal: 130–380 × 109/L4]
  • Neutrophils: 4.9 x 109/L [normal: 2.0–7.5 × 109/L4]

Previous therapy

  • Nephrectomy 5 years ago: RCC, Fuhrman grade 3/4 vascular invasion, TNM stage pT3a NX M0
  • Early last year: adrenal metastasis and solitary lung lesion, both treated with resection; pathology consistent with metastatic RCC
  • Late last year: progression with lymph node, soft tissue and adrenal metastases

Imaging/biopsy and results

  • CT early last year: growing mediastinal and axillary lymph nodes, enlarging adrenal lesion, pathologic fracture right humerus
  • Growing soft tissue nodules
  • Bone scan showed solitary right humerus lesion

Other assessments

  • Karnofsky Performance Status 90%
  • MSKCC risk: favorable 

Diagnosis: metastatic RCC

Explore efficacy and safety profile results for KEYTRUDA® in combination with LENVIMA® in the first-line setting for advanced or metastatic RCC.

Discover results from the KEYNOTE-581/CLEAR trial
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CBC=complete blood count; CT=computed tomography; MSKCC=Memorial Sloan Kettering Cancer Center; TNM=primary tumour, regional lymph nodes, distant metastasis; ULN=upper limit of normal; WBC=white blood cells.

† Fictitious patient profile. May not be representative of all patients.

References:

  1. Merck Canada Inc. KEYTRUDA® Product Monograph. March 21, 2024.
  2. Eisai Limited. LENVIMA® Product Monograph. July 19, 2023.
  3. Canil C et al. Management of advanced kidney cancer: Kidney Cancer Research Network of Canada (KCRNC) consensus update 2021. Can Urol Assoc J. 2021;15(4):84‒97.
  4. Medical Council of Canada. Clinical laboratory tests: Adult normal values. Available at: https://mcc.ca/examinations-assessments/resources-to-help-with-exam-prep/normal-lab-values/. Last accessed April 19, 2023.
  5. NCCN Clinical Practice Guidelines in Oncology. Kidney Cancer, Version 2.2024.
  6. Motzer R et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021;384(14):1289-1300. doi: 10.1056/NEJMoa2035716

CA-KLH-00054

Safety

Important safety information

KEYTRUDA® IMPORTANT SAFETY INFORMATION

KEYTRUDA® has been issued marketing authorization without conditions for:

  • Treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC in combination with lenvatinib with no prior systemic therapy for metastatic RCC.
  • Treatment of adult patients with advanced endometrial carcinoma, in combination with lenvatinib, that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy and are not candidates for curative surgery or radiation.

 

Clinical use:

The safety and efficacy of KEYTRUDA® has not been established for pediatric patients with conditions other than relapsed or refractory cHL, or relapsed or refractory PMBCL, or melanoma (Stage IIB or IIC).

Geriatrics (>65 years of age): No overall differences in safety or efficacy were reported between elderly patients (65 years and over) and younger patients (less than 65 years) for KEYTRUDA® monotherapy. No overall differences in efficacy were reported between elderly patients (65 years and over) and younger patients (less than 65 years) for KEYTRUDA® combination therapy. Limited safety and efficacy information is available for KEYTRUDA® in cHL ≥ 65 years of age (n=20).

Relevant warnings and precautions:

  • Immune-mediated adverse reactions, including severe and fatal cases:
    • Pneumonitis
    • Colitis
    • Hepatitis
    • Nephritis and renal dysfunction
    • Endocrinopathies including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus and thyroid disorders
    • Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Other immune-mediated adverse events including uveitis, arthritis, myositis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis, vasculitis, Guillain-Barré syndrome, hemolytic anemia, pancreatitis, myelitis, myocarditis, hypoparathyroidism, sclerosing cholangitis, aplastic anemia, gastritis
  • Solid organ transplant rejection
  • Elevated liver enzymes when used in combination with axitinib for RCC
  • Increased mortality when used with thalidomide analogue and dexamethasone in multiple myeloma
  • Allogeneic stem cell transplant after and before treatment
  • Severe infusion-related reactions
  • Teratogenic risk
  • Women should avoid pregnancy and breastfeeding during treatment and for at least 4 months after it
  • Patients with hepatic impairment
  • Renal impairment
  • Driving and operating machinery
  • Monitoring requirements
  • Pediatrics <18 years of age
  • Geriatrics

 

For more information:

Please consult the Product Monograph for important information regarding adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.

The Product Monograph is also available by calling us at 1-800-567-2594 or by email at medinfocanada@merck.com.

PD-L1=programmed death-ligand 1.

 

LENVIMA® IMPORTANT SAFETY INFORMATION

LENVIMA® (lenvatinib capsules) is indicated:

  • Renal Cell Carcinoma (RCC) in combination with pembrolizumab, for the treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC with no prior systemic therapy for metastatic RCC.
  • Endometrial Carcinoma (EC) in combination with pembrolizumab, for the treatment of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation.

 

Clinical use:

  • The safety and efficacy of LENVIMA® have not been established in patients < 18 years of age
  • LENVIMA® in combination with KEYTRUDA® showed a higher incidence of adverse events (Grade ≥ 3) and discontinuation in RCC patients ≥ 65 years of age than in patient <65 years of age

 

Most serious warnings & precautions:

Hypertension and its complications, including fatal artery dissection

Cardiovascular: Cardiac failure, including fatal cases

Arterial thromboembolism (ATE), including fatal cases

Gastrointestinal perforation and fistula formation, including reactions leading to death

Hepatic/Biliary/Pancreatic: Hepatotoxicity/hepatic failure, including fatal cases

Renal: Renal failure and impairment, including fatal cases. The primary risk factor identified was dehydration/hypovolemia due to diarrhea and vomiting

Hematologic: Hemorrhage, including fatal cases

Neurologic: Posterior reversible encephalopathy syndrome (PRES)

Other relevant warnings and precautions:

  • Prior anticancer treatments
  • QTc prolongation; correct electrolyte abnormalities in all patients. Avoid use with electrolyte-disrupting drugs
  • Hypocalcemia
  • Impairment of thyroid stimulating hormone suppression/thyroid dysfunction
  • Diarrhea: Initiate prompt medical management
  • Osteonecrosis of the jaw (ONJ): Consider a dental examination and preventative dentistry prior to initiating LENVIMA®. If possible, avoid invasive dental procedures. Caution is advised with agents associated with ONJ such as bisphosphonates and denosumab
  • Wound healing complications
  • Proteinuria
  • Fertility
  • Men and women of reproductive potential should use contraception
  • Caution in patients with body weight <60 kg
  • Caution in Asian and Caucasian patients
  • Monitor complete blood cell count (CBC)
  • Pregnancy: LENVIMA® should not be used during pregnancy unless necessary and based on a benefit/risk assessment of the mother and fetus
  • Breastfeeding: LENVIMA® should not be used during breastfeeding
  • Not recommended for patients with end-stage renal disease
  • Incidence of side effects may vary by gender
  • Monitoring and laboratory tests
  • When LENVIMA® is used in combination with KEYTRUDA®, see the KEYTRUDA® Product Monograph

 

For more information:

Please consult the LENVIMA® Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information that has not been discussed in this piece.

The Product Monograph is also available by calling Eisai Limited at 1-877-873-4724.