Tecentriq

Atezolizumab

Monotherapy in adult patients w/ locally advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy, or who are considered cisplatin ineligible & whose tumours have PD-L1 expression ≥5%. Monotherapy as adjuvant treatment following complete resection & platinum-based chemotherapy for adult patients w/ NSCLC w/ high risk of recurrence whose tumours have PD-L1 expression ≥50% tumour cells & who do not have EGFR mutant or ALK +ve NSCLC. In combination w/ bevacizumab, paclitaxel & carboplatin as 1st-line treatment of adult patients w/ metastatic NSCLC; indicated only after failure of appropriate targeted therapies in patients w/ EGFR mutant or ALK +ve NSCLC. In combination w/ nab-paclitaxel & carboplatin as 1st-line treatment of adult patients w/ metastatic non-squamous NSCLC who do not have EGFR mutant or ALK +ve NSCLC. Monotherapy as 1st-line treatment of adult patients w/ metastatic NSCLC whose tumours have a PD-L1 expression ≥50% tumour cells or ≥10% tumour-infiltrating immune cells & who do not have EGFR mutant or ALK +ve NSCLC. Monotherapy in adult patients w/ locally advanced or metastatic NSCLC after prior chemotherapy; patients w/ EGFR mutant or ALK +ve NSCLC should also have received targeted therapies before receiving Tecentriq. In combination w/ carboplatin & etoposide as 1st-line treatment of adult patients w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ nab-paclitaxel for the treatment of adult patients w/ unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥1% & who have not received prior chemotherapy for metastatic disease. In combination w/ bevacizumab for the treatment of adult patients w/ advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

IV Initial dose must be administered over 60 min. If well tolerated, all subsequent infusions may be administered over 30 min. Monotherapy: 1st-line urothelial carcinoma 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until disease progression or unmanageable toxicity. Early-stage NSCLC 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, for 1 yr unless disease recurrence or unacceptable toxicity. 2nd-line urothelial carcinoma 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until loss of clinical benefit or unmanageable toxicity. 2nd-line NSCLC 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until loss of clinical benefit or unmanageable toxicity. Combination therapy: 1st-line non-squamous NSCLC w/ bevacizumab, paclitaxel, & carboplatin Induction & maintenance phases: 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until disease progression or unmanageable toxicity. Tecentriq should be administered 1st when given on the same day. Induction phase for combination partners (4 or 6 cycles): Bevacizumab, paclitaxel, & then carboplatin are administered every 3 wk. Maintenance phase (w/o chemotherapy): Bevacizumab every 3 wk. 1st-line non-squamous NSCLC w/ nab-paclitaxel & carboplatin Induction & maintenance phases: 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until disease progression or unmanageable toxicity. Tecentriq should be administered 1st when given on the same day. Induction phase for combination partners (4 or 6 cycles): Nab-paclitaxel & carboplatin are administered on day 1; in addition, nab-paclitaxel is administered on days 8 & 15 of each 3-wkly cycle. 1st-line ES-SCLC w/ carboplatin & etoposide Induction & maintenance phases: 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until disease progression or unmanageable toxicity. Tecentriq should be administered 1st when given on the same day. Induction phase for combination partners (4 cycles): Carboplatin & then etoposide are administered on day 1; etoposide is also administered on days 2 & 3 of each 3-wkly cycle. 1st-line unresectable locally advanced or metastatic TNBC w/ nab-paclitaxel 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until disease progression or unmanageable toxicity. Tecentriq should be administered prior to nab-paclitaxel when given on the same day. Nab-paclitaxel should be administered at 100 mg/m² on days 1, 8, & 15 of each 28-day cycle. Advanced or unresectable HCC w/ bevacizumab 840 mg every 2 wk, or 1,200 mg every 3 wk, or 1,680 mg every 4 wk, until loss of clinical benefit or unmanageable toxicity. Tecentriq should be administered prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 wk.

Hypersensitivity.

Immune-related adverse reactions: Pneumonitis; hepatitis; diarrhoea or colitis; hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis & type 1 DM including diabetic ketoacidosis; meningoencephalitis; myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome; pancreatitis including increased serum amylase & lipase levels; myocarditis; nephritis; myositis; severe cutaneous adverse reactions, including SJS & TEN. Monitor patients for signs & symptoms of immune-related adverse reactions, & based on severity of the reaction, manage w/ treatment modifications & corticosteroids as clinically indicated. Permanently discontinue for any Grade 3 immune-related adverse reaction that recurs & for any Grade 4 immune-related adverse reactions, except for endocrinopathies that are controlled w/ replacement hormone. Infusion-related reactions. Can cause autoimmune hemolytic anemia. Carefully consider the combined risks of the 4-drug regimen of atezolizumab, bevacizumab, paclitaxel, & carboplatin before initiating treatment for metastatic non-squamous NSCLC. Occurrence of neutropenia & peripheral neuropathies when combined w/ nab-paclitaxel in metastatic TNBC. Excluded from clinical trials: Patients w/ history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, HBV or HCV infection (for non-HCC patients); significant CV disease; inadequate hematologic & end-organ function; patients who were administered a live, attenuated vaccine w/in 28 days prior to enrolment; systemic immunostimulatory agents w/in 4 wk or systemic immunosuppressive medicinal products w/in 2 wk prior to study entry; therapeutic oral or IV antibiotics w/in 2 wk prior to study treatment initiation; patients w/ ECOG performance status ≥2; patients w/ NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions. Use in combination w/ bevacizumab, paclitaxel & carboplatin in EGFR+ patients w/ NSCLC who have previously progressed on erlotinib + bevacizumab. Use in urothelial carcinoma for previously untreated patients who are considered cisplatin ineligible. Risk of DM & increased risk of haemorrhage when combined w/ bevacizumab for HCC therapy. Consider the delayed onset of atezolizumab effect before initiating 1st-line treatment as monotherapy in patients w/ NSCLC. Minor influence on the ability to drive & use machines. Patients w/ severe renal impairment or severe hepatic impairment. HCC patients w/ Child-Pugh B or C liver disease. Women of childbearing potential must use effective contraception during & for 5 mth after treatment. Pregnancy & lactation. Safety & efficacy in childn & adolescents <18 yr have not been established.

Fatigue, decreased appetite, nausea, rash, diarrhoea. Monotherapy: Pyrexia, cough, dyspnoea, arthralgia, asthenia, back pain, vomiting, UTI, headache. Combination therapy: Anaemia, neutropenia, alopecia, thrombocytopenia, constipation, peripheral neuropathy.

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

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF05 - atezolizumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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