Explore KEYTRUDA® patient profiles

For patients with high-risk, early-stage, triple-negative breast cancer For patients with locally recurrent unresectable or metastatic TNBC

Meet Julie†

A patient with high-risk, early-stage, triple-negative breast cancer

Background info

  • 65 years old
  • Married with 2 children
  • Entrepreneur
  • Caucasian
  • BMI: 32 kg/m2
  • Family history of breast cancer; diabetic

Julie’s† clinical presentation

Symptoms

  • Complaint of painless lump in left breast.

Imaging/biopsy and results

  • Diagnostic bilateral mammogram: 2.1-cm spiculated mass lesion in the upper outer quadrant of the right breast corresponding to palpable mass lesion
  • Ultrasound: 2.1-cm, irregularly shaped solid mass lesion corresponding to mammographic abnormality without nodal involvement
  • Core needle biopsy of the tumour: Grade 3 invasive ductal carcinoma
  • Positron emission tomography/computed tomography (PET/CT) scan: negative for distant metastases

Other assessments

  • Biomarker results: ER/PR-negative, HER2-negative
  • ECOG PS: 1

Diagnosis: TNBC, Stage 0 – Tis(CIS)N0M0

Explore efficacy and safety profile results for KEYTRUDA® for the neoadjuvant and adjuvant treatment of adults with high-risk, early-stage TNBC

Discover results from the KEYNOTE-522 trial

Meet Sarah†

A patient with high-risk, early-stage, triple-negative breast cancer

Background info

  • 52 years old
  • Married with no children
  • Lawyer
  • Caucasian
  • Menarche at age 10
  • BMI: 23 kg/m2
  • Post-menopausal

Sarah’s† clinical presentation

Imaging/biopsy and results

  • Physical exam revealed a palpable mass in the right breast
  • Diagnostic mammogram of right breast showed suspicious lesion in area of palpable abnormality.
  • No radiographic evidence of distant metastases

Other assessments

  • HER2-negative, ER-negative, and PR-negative status

Diagnosis: TNBC, Stage IIA – T1N1miM0

Explore efficacy and safety profile results for KEYTRUDA® for the neoadjuvant and adjuvant treatment of adults with high-risk, early-stage TNBC

Discover results from the KEYNOTE-522 trial

Meet Justine†

A patient with high-risk, early-stage, triple-negative breast cancer

Background info

  • 39 years old
  • Married with 3 children
  • Executive assistant
  • African-American
  • BMI: 29 kg/m2
  • Pre-menopausal; no family history of breast cancer

Justine’s† clinical presentation

Imaging/biopsy and results

  • Exam revealed T2 primary tumour, dimensions of 30mm, with N0 nodal involvement and no distant metastases
  • Biomarker results:
    • Estrogen-negative
    • Progesterone-negative
    • HER2-negative

Other assessments

  • ECOG PS: 0

Diagnosis: Stage IIA – T2N0M0

Explore efficacy and safety profile results for KEYTRUDA® for the neoadjuvant and adjuvant treatment of adults with high-risk, early-stage TNBC

Discover results from the KEYNOTE-522 trial

Meet Ariel†

A patient with locally recurrent, Stage IV triple-negative breast cancer

Background info

  • 65 years old
  • Married with 1 child
  • Janitor
  • Caucasian

Ariel’s† clinical presentation

Clinical notes

  • Complaint of pain in right chest/axillary region
  • Previous diagnosis of triple-negative breast cancer 3 years ago; disease-free for 3 years
  • Previous neoadjuvant/adjuvant chemotherapy: Yes, taxanes
  • BMI: 33 kg/m2
  • Post-menopausal; family history of breast cancer; diabetic

Imaging/biopsy and results

  • Positron emission tomography/computed tomography (PET/CT) scan: positive for distant metastases
    • Number of metastatic sites: 2
    • Location(s) of metastasis: lymph nodes and lung
  • Biomarker results from metastatic region : ER/PR-negative, HER2-negative
  • Ultrasound: 2.9 cm, irregularly shaped solid mass lesion in right (ipsilateral) infraclavicular lymph node and 1.1 cm mass lesion in right lung
  • Core needle biopsy of the tumour: Grade 3
  • IHC pathologic classification: pN3a (metastases to the infraclavicular (level III axillary lymph) nodes)
  • ECOG PS: 0

Diagnosis: Metastatic, locally recurrent TNBC, Stage IV – T2N3aM1

Explore efficacy and safety profile results for KEYTRUDA® for the treatment of adults with locally recurrent unresectable or metastatic TNBC

Discover results from the KEYNOTE-355 trial

Meet Christine†

A patient with metastatic, Stage IV triple-negative breast cancer

Background info

  • 27 years old
  • 1 child
  • Yoga instructor
  • Asian

Christine’s† clinical presentation

Clinical notes

  • Tenderness in left upper arm with swelling and redness
  • Previous diagnosis of triple-negative breast cancer 18 months ago
  • Previous neoadjuvant/adjuvant chemotherapy: Yes, taxanes
  • BMI: 18.4 kg/m2
  • Pre-menopausal

Imaging/biopsy and results

  • Positron emission tomography/computed tomography (PET/CT) scan: positive for distant metastases
    • Number of metastatic sites: 1
    • Location(s) of metastasis: de novo metastasis: bone, left humerus
  • Biomarker results from metastatic region : ER/PR-negative, HER2-negative
  • Ultrasound: 4.1 cm, irregularly shaped solid mass lesion in left humerus
  • Core needle biopsy of the tumour: Grade 3
  • IHC pathologic classification: pN0(i−) (no regional lymph node metastases histologically, negative IHC)
  • ECOG PS: 0

Diagnosis: Metastatic TNBC, Stage IV – T2N0M1

Explore efficacy and safety profile results for KEYTRUDA® for the treatment of adults with locally recurrent unresectable or metastatic TNBC

Discover results from the KEYNOTE-355 trial

Meet Michelle†

A patient with unresectable, Stage III triple-negative breast cancer

Background info

  • 37 years old
  • 1 child
  • Crossing guard

Michelle’s† clinical presentation

Clinical notes

  • Asymptomatic, suspicious lumps found in the axilla during physical exam
  • Previous diagnosis of triple-negative breast cancer 3.5 years ago
  • Previous neoadjuvant/adjuvant chemotherapy: Yes, taxanes
  • BMI: 22.4 kg/m2
  • Pre-menopausal

Imaging/biopsy and results

  • Positron emission tomography/computed tomography (PET/CT) scan: positive for metastases in 7 axillary lymph nodes
    • Number of metastatic sites: 0 – localized to lymph nodes only
  • Biomarker results from metastatic region : ER/PR-negative, HER2-negative
  • Ultrasound: Tumours of varying sizes: 2.1 cm – 4.9 cm (multiple tumours across 7 axillary lymph nodes matted to one another)
  • Core needle biopsy of the tumour: Grade 3
  • IHC pathologic classification: pN2a – multiple lymph node metastasis (Metastases in 4–9 axillary lymph nodes (at least one tumour deposit greater than 2.0 mm)
  • ECOG PS: 0

Diagnosis: Locally recurrent unresectable TNBC, Stage IIIC – T2N2aM0

Explore efficacy and safety profile results for KEYTRUDA® for the treatment of adults with locally recurrent unresectable or metastatic TNBC

Discover results from the KEYNOTE-355 trial
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†Fictitious patient profile. May not be representative of all patients.

AJCC=American Joint Committee on Cancer; BMI=body mass index; CT=computed tomography; ER=estrogen receptor; DCIS=ductal carcinoma in situ; ECOG PS=Eastern Cooperative Oncology Group performance status; HER2=human epidermal growth factor receptor 2; IHC=immunohistochemistry; PR=progesterone receptor; PET=positron emission tomography; TNBC=triple-negative breast cancer.

References:

1. KEYTRUDA® Product Monograph. Merck Canada Inc. February 6, 2024.
2. American Joint Committee on Cancer (AJCC). Cancer Staging Manual 8th edition. doi:10.1007/978-3-319-40618-3.
3. Dent R, et al. Pattern of metastatic spread in triple-negative breast cancer. Breast Cancer Res Treat. 2009;115:423–428. doi:10.1007/s10549-008-0086-2.
4. Cortes J, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020;396:1817–28

CA-OBR-00005

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.