Explore KEYTRUDA® patient profiles

 

For advanced or metastatic HNSCC, in the first-line setting

Meet André†

A patient with unresectable recurrent HNSCC

Background info

  • Age: 52 years old
  • Factory general manager
  • Married, 2 children
  • Heavy smoker (~25 cigarettes/day)
  • Moderate alcohol use (1–2 drinks/day)

André’s† clinical presentation

Imaging/biopsy and results

  • Pulmonary lesions identified through CT scan; biopsy confirms lesions as distant metastases (Stage IVC)
  • Exam reveals large lesion on oropharynx and several enlarged lymph nodes
  • CT confirms the invasion of surrounding structures/encroachment of left internal carotid artery 
  • Complete resection was determined unfeasible
  • Persistent hoarseness, dysphagia, presence of an asymptomatic neck mass

Clinical notes

  • Initially diagnosed with resectable, locally advanced Stage III laryngeal SCC
  • He was treated with external beam radiotherapy plus concurrent administration of platinum chemotherapy and is now in remission for 10 months
  • HPV-negative
  • PD-L1 CPS: 10
  • ECOG PS: 1

Diagnosis: Unresectable, recurrent Stage IVC HNSCC

Explore efficacy and safety profile results for KEYTRUDA® in the first-line setting for unresectable recurrent or metastatic HNSCC

Discover results from the KEYNOTE-048 trial

Meet Marianne†

A patient with unresectable recurrent HNSCC

Background info

  • Age: 65 years old
  • Retired teacher, enjoys gardening
  • Married, 3 children and 2 grandsons
  • Moderate alcohol use (1 drink/day)

Marianne’s† clinical presentation

Imaging/biopsy and results

  • CT scan identified locoregional recurrence in the oral cavity with extensive invasion of local structures 
    • A multidisciplinary tumour board determined lesion to be unresectable
  • Lymph node dissection confirms 1 cervical node involved without extranodal extension (Stage IVA)

Clinical notes

  • Initially diagnosed with Stage III oral cavity SCC
  • Underwent surgery to remove primary tumour and resection of ipsilateral lymph nodes; then received radiotherapy/cisplatin following surgery and was in remission after definitive treatment
  • HPV-positive
  • PD-L1 CPS: 26
  • ECOG PS: 1

Diagnosis: Unresectable, recurrent stage IVA oral cavity SCC

Explore efficacy and safety profile results for KEYTRUDA® in the first-line setting for unresectable recurrent or metastatic HNSCC

Discover results from the KEYNOTE-048 trial

Meet Robert†

A patient with metastatic HNSCC

Background info

  • Age: 48 years old
  • General contractor
  • Married, no children
  • Occasional alcohol use
  • Quit smoking 3 years ago
  • Patient referred by family physician for evaluation

Robert’s† clinical presentation

Imaging/biopsy and results

  • 5.5 cm lesion identified on left soft palate
  • Multiple metastatic lesions in lung, liver and surrounding bone

Clinical notes

  • HPV-negative
  • PD-L1 CPS: <1
  • ECOG PS: 1

Diagnosis: Metastatic stage IVC HNSCC

Explore efficacy and safety profile results for KEYTRUDA® in the first-line setting for unresectable recurrent or metastatic HNSCC

Discover results from the KEYNOTE-048 trial

Meet William†

A patient with metastatic HNSCC

Background info

  • Age: 67 years old
  • Parole officer
  • Divorced, 2 children and 5 grandchildren
  • Quit smoking 17 years ago
  • Quit drinking 3 years ago

William’s† clinical presentation

Imaging/biopsy and results

  • Patient referred for a focused examination of the head and neck with white light endoscopy and further testing as required
  • Endoscopy revealed 3 cm lesion identified on left tonsil;
  • 2 metastatic lesions to left-lower lung

Clinical notes

  • HPV-positive
  • PD-L1 CPS: 1
  • ECOG PS: 1

Diagnosis: Metastatic stage IVC HNSCC

Explore efficacy and safety profile results for KEYTRUDA® in the first-line setting for unresectable recurrent or metastatic HNSCC

Discover results from the KEYNOTE-048 trial
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CPS=combined positive score; CT=computed tomography; ECOG PS=Eastern Cooperative Oncology Group performance status; FU=fluorouracil; HNSCC=head and neck squamous cell carcinoma; HPV=human papillomavirus; PD-L1=programmed death-ligand 1; SCC=squamous cell carcinomas.
†Fictitious patient profile. May not be reflective of all patients.

References:

1. Merck Canada Inc. KEYTRUDA® Product Monograph. April 19, 2023.

2. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Head and Neck Cancers, version 2. 2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf

 

CA-OHN-00038

Safety

Important safety information

KEYTRUDA® has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization.

KEYTRUDA® is indicated for:

  • Treatment, as monotherapy, of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), or who are not candidates for multi-agent salvage chemotherapy and ASCT. An improvement in overall survival has not yet been established.
  • Treatment, as monotherapy, of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more lines of therapy. An improvement in survival or disease-related symptoms has not been established.
  • Treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, or in adults who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. An improvement in survival or disease-related symptoms has not been established. 
  • Treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy. The indication is authorized based on tumour complete response rate and durability of response.
  • Treatment, as monotherapy, of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) for:
    • colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; or
    • endometrial cancer that has progressed following prior therapy and who have no satisfactory alternative treatment options.
  • Treatment of adult patients in combination with lenvatinib 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.

KEYTRUDA® has been issued marketing authorization without conditions for: 

  • Treatment of adult patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy.
  • Treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.
  • Adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
  • Adjuvant treatment of adult patients with stage III melanoma with lymph node involvement who have undergone complete resection.
  • First-line treatment, as monotherapy, of adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS ≥1%)] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations. 
  • Treatment of adult patients with metastatic non-squamous NSCLC in combination with pemetrexed and platinum chemotherapy, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.
  • Treatment of adult patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel, with no prior systemic chemotherapy treatment for metastatic NSCLC.
  • Treatment of adult patients with metastatic NSCLC as monotherapy, whose tumours express PD-L1 [(Tumour Proportion Score (TPS) ≥1%)] as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received authorized therapy for these aberrations prior to receiving KEYTRUDA®.
  • Adjuvant treatment of adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC whohave undergone complete resection and platinum-based chemotherapy.
  • Treatment of adult patients with locally advanced or metastatic urothelial carcinoma, as monotherapy, who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum-containing chemotherapy.
  • Treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) in combination with axitinib, with no prior systemic therapy for metastatic RCC. 
  • 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.
  • Adjuvant treatment, as monotherapy, of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 
  • First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression [Combined Positive Score (CPS) ≥ 1] as determined by a validated test.
  • First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) chemotherapy, in adult patients. 
  • First-line treatment of adult patients with metastatic MSI-H or dMMR colorectal cancer (CRC). 
  • First-line treatment, in combination with platinum and fluoropyrimidine based chemotherapy, of adult patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2 negative adenocarcinoma of the esophagogastric junction (tumour centre 1 to 5 centimetres above the gastric cardia). 
  • Treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test, in combination with chemotherapy with or without bevacizumab.
  • Treatment of adult patients with high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
  • Treatment of adult patients in combination with chemotherapy with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by a validated test 

 

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). 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
  • 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 hematopoietic stem cell transplant after and before treatment
  • Severe infusion-related reactions
  • Teratogenic risk toxicity 
  • 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.