KEYTRUDA® in RCC

Explore KEYTRUDA^® indications

KEYTRUDA^® is indicated for:

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.
Treatment of adult patients with advanced or metastatic 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 LENVIMA^®, with no prior systemic therapy for metastatic RCC.

Kidney Cancer Research Network of Canada (KCRNC) 2021 consensus statement

In untreated patients with advanced clear cell RCC with favourable, intermediate, or poor risk (IMDC), pembrolizumab + axitinib is recommended as a preferred treatment option.

See the complete KCRNC Guideline recommendation

Clinical Studies

KEYNOTE-564 (KEYTRUDA^® as adjuvant treatment of RCC post-nephrectomy)

KEYNOTE-426 (KEYTRUDA^® for the treatment of advanced or metastatic RCC)

NED=no evidence of disease; RCC=renal cell carcinoma.

References:

1. Merck Canada Inc. KEYTRUDA^® Product Monograph. February 6, 2024.
2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Kidney Cancer. Version 1.2024. © National Comprehensive Cancer Network, Inc. 2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf.
3. Ljungberg B et al. EAU Guidelines on Renal Cell Carcinoma. © European Association of Urology 2023. March 2023. Available at: https://uroweb.org/guidelines/renal-cell-carcinoma.
4. Choueiri TK et al. Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma. NEJM. 2021;385: 683‒94.
5. 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.

CA-RCC-00170

Consider KEYTRUDA^® for your patients with advanced or metastatic RCC

Learn more by reviewing our patient profiles

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.