Keytruda

Pembrolizumab

Unresectable or metastatic melanoma. Adults & ped ≥12 yr w/ stage IIB or IIC melanoma who have undergone complete resection. Adjuvant treatment of patients w/ melanoma w/ lymph node involvement who have undergone complete resection. In combination w/ pemetrexed & platinum chemotherapy for 1st-line treatment of patients w/ metastatic non-squamous NSCLC w/ no EGFR or ALK genomic tumor aberrations. In combination w/ carboplatin & either paclitaxel or nab-paclitaxel for 1st-line treatment of patients w/ metastatic squamous NSCLC. Monotherapy for 1st-line treatment of patients w/ locally advanced or metastatic NSCLC whose tumors express PD-L1 w/ ≥1% tumor proportion score (TPS) w/ no EGFR or ALK genomic tumor aberrations. Monotherapy for advanced NSCLC whose tumors express PD-L1 w/ ≥1% TPS & who have received platinum-containing chemotherapy. Monotherapy for adjuvant treatment of patients w/ stage IB (T2a ≥4 cm), II, or IIIA NSCLC who have undergone complete resection. Monotherapy or in combination w/ platinum & 5-fluorouracil chemotherapy for 1st-line treatment of metastatic or unresectable recurrent head & neck squamous cell carcinoma (HNSCC). Monotherapy for metastatic or unresectable recurrent HNSCC w/ disease progression on or after platinum-containing chemotherapy. Adult & ped patients w/ relapsed or refractory classical Hodgkin's lymphoma (cHL); refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after ≥2 prior lines of therapy. Locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy & whose tumors express PD-L1 [combined +ve score (CPS) ≥10] or ineligible for any platinum-containing chemotherapy regardless of PD- L1 status; w/ prior platinum-containing chemotherapy. BCG-unresponsive, high risk, non-muscle invasive bladder cancer w/ carcinoma in-situ (CIS) w/ or w/o papillary tumors who are ineligible for or have elected not to undergo cystectomy. Hepatocellular carcinoma (HCC) previously treated w/ anti-angiogenic tyrosine kinase inhibitor or oxaliplatin-based chemotherapy. In combination w/ axitinib or lenvatinib for 1st-line treatment of advanced renal cell carcinoma (RCC). Monotherapy for adjuvant treatment of RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy & resection of metastatic lesions. Advanced microsatellite instability-high (MSI-H), including mismatch repair deficient (dMMR) cancer, who have received prior therapy. In combination w/ platinum & fluoropyrimidine based chemotherapy for 1st-line treatment of locally advanced unresectable or metastatic carcinoma of esophagus or gastroesophageal junction. Monotherapy for treatment of recurrent locally advanced or metastatic esophageal cancer whose tumors express PD-L1 (CPS ≥10) & who have received 1 prior line of systemic therapy. Monotherapy for recurrent locally advanced or metastatic esophageal cancer & received ≥2 prior lines of systemic therapy. In combination w/ chemotherapy w/ or w/o bevacizumab for persistent, recurrent, or metastatic cervical cancer. Monotherapy for recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) w/ disease progression on or after chemotherapy. In combination w/ lenvatinib for advanced endometrial carcinoma w/ disease progression following prior systemic therapy & not candidate for curative surgery or radiation. Monotherapy for advanced endometrial carcinoma that is MSI-H or dMMR, w/ disease progression following prior systemic therapy & not candidates for curative surgery or radiation. In combination w/ trastuzumab, fluoropyrimidine- & platinum-containing chemotherapy for 1st-line treatment of locally advanced unresectable or metastatic HER2 +ve gastric or gastroesophageal junction adenocarcinoma. 1st-line treatment of unresectable or metastatic MSI-H or dMMR CRC. Adult & ped patients w/ unresectable or metastatic tumor mutational burden high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors that have progressed following prior treatment & have no satisfactory alternative treatment options. In combination w/ chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment after surgery in patients w/ high-risk early-stage triple -ve breast cancer (TNBC). In combination w/ chemotherapy for locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10).

IV infusion Administer over 30 min. If administered as part of combination w/ IV chemotherapy, administer Keytruda 1st. Adult Head & neck cancer, cHL, PMBCL, urothelial carcinoma, gastric cancer, MSI-H cancer, esophageal cancer, HCC, RCC, cervical cancer, endometrial carcinoma, CRC, TMB-H cancer, TNBC, previously untreated NSCLC, adjuvant treatment of melanoma 200 mg every 3 wk or 400 mg every 6 wk. Adjuvant treatment of melanoma, NSCLC, RCC Administer up to 1 yr or until disease recurrence or unacceptable toxicity. Melanoma, previously treated NSCLC 2 mg/kg every 3 wk. RCC In combination w/ axitinib: May consider dose escalation of axitinib above initial 5 mg dose at ≥6 wk interval. Endometrial carcinoma & RCC In combination w/ lenvatinib: Initially oral lenvatinib 20 mg once daily until disease progression or unacceptable toxicity. Patient w/ high-risk early-stage TNBC Neoadjuvant & adjuvant therapy in combination w/ chemotherapy: 8 doses of 200 mg every 3 wk or 4 doses of 400 mg every 6 wk, followed by adjuvant treatment as monotherapy for 9 doses of 200 mg every 3 wk or 5 doses of 400 mg every 6 wk or until disease recurrence or unacceptable toxicity. Ped patients Melanoma, cHL, PMBCL, TMB-H cancer 2 mg/kg (up to max of 200 mg) every 3 wk. Severe renal & hepatic impairment RCC & endometrial carcinoma Lenvatinib 10 mg orally once daily.

Discontinue if severe infusion & skin reactions; severe, life-threatening or recurrent moderate pneumonitis; life-threatening colitis; hepatitis; severe or life-threatening nephritis, adrenal insufficiency or hypophysitis, & hyperthyroidism; confirmed SJS & TEN occur. Severe infusion reactions, including hypersensitivity & anaphylaxis. Increased risk of rejection in solid organ transplant recipients. Patients w/ history of allogeneic hematopoietic stem cell transplant. Immune-mediated adverse & skin reactions, pneumonitis, colitis, hepatitis, nephritis; primary & secondary adrenal insufficiency; hypophysitis; type 1 DM including diabetic ketoacidosis; thyroid disorders including hyperthyroidism, hypothyroidism & thyroiditis; uveitis, myositis, Guillain-Barré syndrome, pancreatitis encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (including exacerbation), myelitis, vasculitis, & hypoparathyroidism; myocarditis & sclerosing cholangitis. Monitor patients for signs & symptoms of pneumonitis, colitis, adrenal insufficiency & hypophysitis including hypopituitarism; suspected severe skin reactions; changes in liver & thyroid function at the start of treatment, periodically during treatment & as indicated; changes in renal function; hyperglycemia or other signs & symptoms of diabetes. Monitor liver enzymes before initiation of & periodically throughout treatment. Closely monitor patients w/ mild or moderate infusion reaction & consider premed w/ antipyretic & antihistamine. Not recommended in combination w/ thalidomide analogue + dexamethasone in patients w/ multiple myeloma w/ PD-1 or PD-L1 blocking Ab. Severe renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 4 mth after last dose. Not recommended during pregnancy. Lactation.

Hypothyroidism, hyperthyroidism, pneumonitis, colitis, adrenal insufficiency, hepatitis, hypophysitis, nephritis, type 1 DM. Arthralgia, back pain; cough, dyspnea, dysphonia; vitiligo, pruritus, rash, palmar-plantar erythrodysaesthesia syndrome; abdominal pain, diarrhea, nausea, vomiting, constipation; hyponatremia, decreased wt; fatigue, asthenia; neutropenia; hypothyroidism; HTN; proteinuria; headache; increased ALT; UTI. Arthritis; Vogt-Koyanagi-Harada syndrome; hemophagocytic lymphohistiocytosis; optic neuritis.

Potential interference w/ pharmacodynamic activity & efficacy w/ systemic corticosteroids or immunosuppressants.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF02 - pembrolizumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

S