Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous: 100 mg/4 mL [25 mg/mL]) |
| Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with unresectable or metastatic melanoma.
- Indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.
- Indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
- Indicated in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
- Indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: -Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or -metastatic.
- Indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
- Indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
- Indicated as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
- Indicated in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell cancer (HNSCC).
- Indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
- Indicated as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
- Indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
- Indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
- Indicated for the treatment of adult and pediatric patients with refractory primary eediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
- Limitations of Use: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
- Indicated in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
- Indicated as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: -are not eligible for any platinum-containing chemotherapy, or -who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- Indicated as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
- Indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
- Indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.
- Indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
- Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- Indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: -in combination with platinum- and fluoropyrimidine-based chemotherapy, or -as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
- Indicated in combination with chemoradiotherapy, for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.
- Indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
- Indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
- Indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD1/PD-L1-containing regimen.
- Indicated in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
- Indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
- Indicated in combination with axitinib, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
- Indicated in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
- Indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
- Indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
- Indicated as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
- Indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
- Limitations of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
- Indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinomac (SCC) or locally advanced cSCC that is not curable by surgery or radiation.
- Indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
- Indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
- Indicated for use at an additional recommended dosage of 400 mg every 6 weeks for Classical Hodgkin Lymphoma and Primary Mediastinal Large B-Cell Lymphoma in adults.
Summary
- Pembrolizumab (Keytruda) is indicated for the treatment of various conditions including unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), and others. It can be used as a single agent or in combination with other therapies.
- A total of 105 studies were reviewed to gather information about pembrolizumab's safety and effectiveness across different indications.
- Compared to chemotherapy alone, immune checkpoint inhibitors like pembrolizumab generally improved overall survival and progression-free survival in patients with advanced NSCLC. PD-L1 expression greater than or equal to 1% was found to be a significant predictor of improved outcomes.
- When combined with chemotherapy, pembrolizumab showed superior efficacy compared to its use as monotherapy for advanced NSCLC patients who have a PD-L1 Tumor Proportion Score greater than or equal to 50%.
- For metastatic melanoma treatment, pembrolizumab, along with other immune checkpoint inhibitors, demonstrated significant survival benefits. However, combining nivolumab and ipilimumab could potentially offer better overall survival but may lead to higher incidences of treatment-related adverse events.
- The risk profile associated with using pembrolizumab varied across studies; it appeared that factors such as the level of PD-L1 expression, histological subtype, e.g., nonsquamous vs squamous NSCLC, influenced this risk profile significantly.
- Pembrolizumab has been identified as an effective first-line therapy when combined with chemotherapy for treating advanced NSLC, irrespective of their levels on PD-L1 expressions, especially those suffering from non-squamous carcinomas.
- In cases where metastatic melanoma was diagnosed, different immune checkpoint inhibitors displayed varying degrees of efficacies and safety profiles. Pembrolizumab was generally well-tolerated and effective, especially in patients with higher PD-L1 expression.
- The combination of pembrolizumab with other agents has demonstrated significant efficacy across various cancer types, particularly in specific patient subgroups defined by PD-L1 expression and histological subtype. This represents a shift towards more personalized and effective cancer therapies.
- The comparative risk of treatment-related adverse events (TRAEs), particularly with combination therapies, necessitates careful patient selection and monitoring. Further research into optimal combination strategies remains critical to enhancing outcomes while managing adverse effects effectively.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Keytruda (pembrolizumab) prescribing information. | 2024 | Merck & Co., Whitehouse Station, NJ |