KEYTRUDA

What it is

Keytruda is a concentrated injection containing pembrolizumab , a monoclonal antibody that is a PD-1 receptor blocking antibody . It works by blocking the programmed death receptor 1 (PD-1) pathway to enable immune responses against cancer cells.

Approved indications

— Monotherapy for the treatment of unresectable or metastatic melanoma in adults. — Adjuvant treatment of adult and adolescent (12 years and older) patients with Stage IIB, IIC, or III melanoma who have undergone complete resection. — In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. — In combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous NSCLC. — As monotherapy for the first-line treatment of patients with NSCLC expressing PD-L1 [tumour proportion score (TPS) ≥ 1%] at stage III (where patients are not candidates for surgical resection or definitive chemoradiation) or metastatic, with no EGFR or ALK genomic tumour aberrations. — As monotherapy for the treatment of patients with advanced NSCLC whose tumours express PD-L1 with a ≥1% TPS and who have received platinum-containing chemotherapy. — As monotherapy for the adjuvant treatment of patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy. — In combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of patients with resectable Stage II, IIIA, or IIIB (T3-4N2) NSCLC. — In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). — For the treatment of adult patients with resectable locally advanced head and neck squamous cell cancer (HNSCC) whose tumours express PD-L1 with a CPS ≥1, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin and then as a single agent. — As monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC whose tumours express PD-L1 [Combined Positive Score (CPS) ≥ 1]. — As monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy whose tumours express PD-L1 [Combined Positive Score (CPS) ≥ 1]. — As monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin Lymphoma (cHL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. — For the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. — In combination with enfortumab vedotin, for the first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). — As monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. — As monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy. — 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 tumours who are ineligible for or have elected not to undergo cystectomy. — For the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options. — For the treatment of patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test. — In combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC). — In combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. — In combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. — In combination with chemoradiotherapy (CRT), for the treatment of patients with high-risk, locally advanced cervical cancer (FIGO 2014 Stage IB2-IIB and node-positive, or Stage III-IVA). — In combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1]. — As monotherapy for the treatment of adult and adolescent (12 years and older) patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). — In combination with axitinib, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). — In combination with lenvatinib (LENVIMA), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). — As monotherapy for the adjuvant treatment of patients with RCC with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. — As monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. — In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GOJ) adenocarcinoma that is not HER2-positive. — In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GOJ) adenocarcinoma, whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1]. — In combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2-negative gastroesophageal junction (GOJ) adenocarcinoma that is not amenable to surgical resection or definitive chemoradiation. — For the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. — For the treatment of 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. — In combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) and who have not received prior chemotherapy for metastatic disease.

Dosing overview

Keytruda is administered as an intravenous (IV) infusion over 30 minutes. For most monotherapy indications in adults, the recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks. For paediatric patients, dosing is 2 mg/kg every 3 weeks (up to a maximum of 200 mg). Treatment continues until disease progression, unacceptable toxicity, or up to 12 months for adjuvant treatment or up to 24 months for other indications, depending on the specific indication. No dose reductions of Keytruda are recommended.

Key safety warnings

Immune-mediated adverse reactions, including severe and fatal cases, have occurred in patients receiving Keytruda, and in clinical trials most occurred during treatment, were reversible and managed with interruptions of Keytruda, administration of corticosteroids