Tevimbra

In combination w/ pemetrexed & platinum-containing chemotherapy for the 1st line treatment of non-squamous NSCLC in adults whose tumours have PD-L1 expression on ≥50% of tumour cells w/ no EGFR or ALK +ve mutations & who have: locally advanced NSCLC & are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. In combination w/ carboplatin & either paclitaxel or nab-paclitaxel for the 1st line treatment of squamous NSCLC in adults who have: locally advanced NSCLC & are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Monotherapy for the treatment of locally advanced or metastatic NSCLC in adults after prior platinum-based therapy (patients w/ EGFR mutant or ALK +ve NSCLC should also have received targeted therapies before receiving tislelizumab). In combination w/ platinum & fluoropyrimidine-based chemotherapy for the 1st line treatment of HER-2 -ve locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 w/ tumour area positivity (TAP) score ≥5%. In combination w/ platinum-based chemotherapy for the 1st line treatment of unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) in adults whose tumours express PD-L1 w/ TAP score ≥5%. Monotherapy for the treatment of unresectable, locally advanced or metastatic OSCC in adults after prior platinum-based chemotherapy.

IV Administer 1st infusion over a period of 60 min. If well tolerated, administer subsequent infusions over a period of 30 min. Monotherapy 200 mg infusion once every 3 wk. Combination therapy 200 mg infusion once every 3 wk, in combination w/ chemotherapy. Administer Tevimbra before chemotherapy when co-administered on the same day.

Hypersensitivity.

Must not be administered as IV push or single bolus inj. Must not be mixed or co-administered w/ other medicinal products through the same infusion line. Choose a well-validated methodology to minimise false -ve or false +ve determinations when assessing PD-L1 status of tumour. Reports of immune-related adverse reactions. W/hold treatment for the following immune-related adverse reactions: grade 2 pneumonitis; hepatitis (ALT or AST >3 to 8 x ULN or total bilirubin >1.5 to 3 x ULN); grade 3 rash; suspected severe cutaneous adverse reactions (SCARs), including SJS or TEN; grade 2 or 3 colitis; grade 2 or 3 myositis/rhabdomyolysis; grade 3 or 4 hyperthyroidism; grade 3 or 4 adrenal insufficiency; grade 3 or 4 hypophysitis; type 1 DM associated w/ grade ≥3 hyperglycaemia (glucose >250 mg/dL or >13.9 mmol/L) or associated w/ ketoacidosis; grade 2 nephritis w/ renal dysfunction (creatinine >1.5 to 3 x baseline or >1.5 to 3 x ULN); grade 2 neurological toxicities; grade 3 pancreatitis, or grade 3 or 4 serum amylase or lipase levels increased (>2 x ULN). Permanently discontinue treatment for the following immune-related adverse reactions: grade 3 or 4, or recurrent grade 2 pneumonitis; hepatitis (ALT or AST >8 x ULN or total bilirubin >3 x ULN); grade 4 rash; confirmed SCARs, including SJS or TEN; grade 4 or recurrent grade 3 colitis; grade 4 or recurrent grade 3 myositis/rhabdomyolysis; grade 3 (creatinine >3 x baseline or >3 to 6 x ULN) or 4 (creatinine >6 x ULN) nephritis w/ renal dysfunction; grade 2, 3 or 4 myocarditis; grade 3 or 4 neurological toxicities; grade 4 pancreatitis. Consider withholding treatment for the following immune-related adverse reactions until controlled by HRT: grade 2 adrenal insufficiency; grade 2 hypophysitis. Grade 2, 3 or 4 immune-related hypothyroidism may be managed w/ HRT w/o treatment interruption. Reports of other clinically important immune-related adverse reactions: myositis, myocarditis, arthritis, polymyalgia rheumatica, pericarditis, immune thrombocytopenia, encephalitis, myasthenia gravis, Sjögren's syndrome, Guillain-Barré syndrome. Increased risk of rejection in solid organ transplant recipients. W/hold treatment for other grade 3 immune-related adverse reactions. Permanently discontinue treatment for other grade 4 or recurrent grade 3 immune-related adverse reactions. Reports of severe infusion-related reactions. Consider pre-medication for grade 1 infusion-related reactions. Interrupt infusion for grade 2 infusion-related reactions. Permanently discontinue treatment for grade 3 or 4 infusion-related reactions. Caution in patient populations excluded from clinical studies: baseline ECOG performance status ≥2; active brain or leptomeningeal metastases; active autoimmune disease or history of autoimmune disease that may relapse; any condition requiring systemic treatment w/ either corticosteroids (>10 mg/day prednisone or equiv) or other immunosuppressants w/in 14 days prior to study treatment; active or untreated HIV; untreated hepatitis B or C carriers; history of ILD; administration of live vaccine w/in 14 days prior to study treatment; infection requiring systemic therapy w/in 14 days prior to study treatment; history of severe hypersensitivity to another monoclonal Ab. Contains 16 mg Na per 10 mL vial, equiv to 0.8% of WHO-recommended max daily intake of 2 g Na for an adult. Minor influence on the ability to drive & use machines. Limited data in patients w/ severe renal or severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 4 mth following the last dose. Can cause foetal harm when administered to a pregnant woman. Should not be used during pregnancy unless clinical condition of woman requires treatment. Women should not breast-feed during treatment & for at least 4 mth after the last dose. Safety & efficacy in patients <18 yr have not been established.

Monotherapy: Anaemia, fatigue, increased AST. Combination therapy: Neutropenia, anaemia, thrombocytopenia, nausea, fatigue, decreased appetite, increased AST/ALT, diarrhoea, rash.

Avoid use of systemic corticosteroids & other immunosuppressants at baseline, before starting tislelizumab, except for low doses of systemic corticosteroid (10 mg/day prednisone or equiv), because of their potential interference w/ pharmacodynamic activity & efficacy of tislelizumab.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF09 - tislelizumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

P₁S₁S₃