summary
GRADE
treatment
patients
risk of bias
overview
deaths (OS) deaths (OS) (extension) DOR DOR (extension) objective responses (ORR) objective responses (ORR) (extension) pCR PFS (extension) progression or deaths (PFS) AE (any grade) AE (grade 3-4) SAE (grade 3-4) STRAE (any grade) STRAE (grade 3-4) TRAE (any grade) TRAE (grade 3-4) TRAE leading to death (grade 5) TRAE leading to discontinuation (any grade) TRAE leading to discontinuation (grade 3-4) Abdominal pain TRAE (grade 3-4) Acute kidney injury TRAE (grade 3-4) Alopecia TRAE (grade 3-4) Anaemia TRAE (grade 3-4) Arthralgia TRAE (grade 3-4) Asthenia TRAE (grade 3-4) Blood creatinine increased TRAE (grade 3-4) Colitis TRAE (grade 3-4) Constipation TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Diabetes TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Dizziness TRAE (grade 3-4) Dysgeusia TRAE (grade 3-4) Eczema TRAE (grade 3-4) Endocrine disorders TRAE (grade 3-4) Erythema TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Gastrointestinal disorders TRAE (grade 3-4) Hepatobiliary disorders TRAE (grade 3-4) Hypersensitivity TRAE (grade 3-4) Hyperthyroidism TRAE (grade 3-4) Hypothyroidism TRAE (grade 3-4) Increase AST TRAE (grade 3-4) Increased ALT TRAE (grade 3-4) Increased lacrimation (TRAE grade 3-4) Infusion-related reactions TRAE (grade 3-4) Leucopenia TRAE (grade 3-4) Maculopapular rash TRAE (grade 3-4) Mucosal inflammation TRAE (grade 3-4) Myalgia TRAE (grade 3-4) Nausea TRAE (grade 3-4) Neutropenia TRAE (grade 3-4) Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) Paraesthesia TRAE (grade 3-4) Peripheral neuropathy TRAE (grade 3-4) Peripheral oedema TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Pruritic rash TRAE (grade 3-4) Pruritus generalised TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Pyrexia TRAE (grade 3-4) Rash TRAE (grade 3-4) Renal and urinary disorders TRAE (grade 3-4) Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) Skin and subcutaneous tissue disorders TRAE (grade 3-4) Skin exfoliation TRAE (grade 3-4) Stomatitis TRAE (grade 3-4) Thrombocytopenia TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Urticaria TRAE (grade 3-4) Vitiligo TRAE (grade 3-4) Vomiting TRAE (grade 3-4) Abdominal pain AE (grade 3-4) Alopecia AE (grade 3-4) Anaemia AE (grade 3-4) Arthralgia AE (grade 3-4) Asthenia AE (grade 3-4) Back pain AE (grade 3-4) Constipation AE (grade 3-4) Cough AE (grade 3-4) Decreased appetite AE (grade 3-4) Diarrhoea AE (grade 3-4) Dizziness AE (grade 3-4) Dry skin AE (grade 3-4) Dysgeusia AE (grade 3-4) Dyspnoea AE (grade 3-4) Erythema AE (grade 3-4) Fatigue AE (grade 3-4) Febrile neutropenia AE (grade 3-4) Headache AE (grade 3-4) Hypothyroidism AE (grade 3-4) Increase AST AE (grade 3-4) Increased ALT AE (grade 3-4) Lacrimation increased AE (grade 3-4) Leucopenia AE (grade 3-4) Mucosal inflammation AE (grade 3-4) Myalgia AE (grade 3-4) Nausea AE (grade 3-4) Neutropenia AE (grade 3-4) Oropharyngeal pain AE (grade 3-4) Paraesthesia AE (grade 3-4) Peripheral neuropathy AE (grade 3-4) Peripheral oedema AE (grade 3-4) Pneumonia AE (grade 3-4) Pruritus AE (grade 3-4) Pyrexia AE (grade 3-4) Rash AE (grade 3-4) Stomatitis AE (grade 3-4) Vomiting AE (grade 3-4) Weight decreased AE (grade 3-4)
numeric
bar chart
forest plot
medians
frequency on treatment
benefit risk analysis
Study
study type
Pathology T1 T0 Patients sample sizes ROB
Results
CheckMate 816, 2022 NCT02998528 RCT laNSCLC - NA - all population nivolumab plus platinum doublet placebo plus platinum doublet patients with stage IB to IIIA resectable NSCLC, before surgery 179 / 179 NA suggested suggested 12.9-fold increase in pCR (PE) The results show that the Opdivo/chemotherapy treatment met the primary endpoint of pathologic complete response (pCR), with significantly more patients treated with the combination therapy showing no evidence of cancer cells in their resected tissue compared with the placebo arm CheckMate 227 (NC vs C ; PDL1<1%), 2018 NCT02477826 RCT mNSCLC - L1 - PDL1 negative nivolumab plus pemetrexed plus platine platinum based chemotherapy (pemetrexed plus platine) patients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and TMB > 10mut/Mb 177 / 186 some concern conclusif demonstrated 27 % decrease in progression or deaths (PFS) (PE) CheckMate 026 (PDL1>5%), 2016 NCT02041533 RCT mNSCLC - L1 - PDL1 positive Nivolumab platinum-based chemotherapy patients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC PD-L1 at >1% 211 / 212 some concern inconclusive inconclusive 15 % increase in progression or deaths (PFS) (PE) CheckMate 026 (PDL1>1%), 2016 NCT02041533 RCT mNSCLC - L1 - PDL1 positive Nivolumab platinium doublet chemotherapy patients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC with PD-L1 >1% 271 / 270 some concern inconclusive no statistically significant result CheckMate 078, 2019 NCT02613507 RCT mNSCLC - L2 - all population nivolumab docetaxel Patients with stage IIIB or IV or recurrent squamous or nonsquamous NSCLC progressing during or after one previous platinumbased doublet chemotherapy regimen. (predominantly Chinese patient) 338 / 166 some concern conclusif demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 23 % decrease in progression or deaths (PFS) (PE) suggested 25 % decrease in deaths (OS) (extension) suggested 21 % decrease in PFS (extension) more... CheckMate 057, 2015 NCT01673867 RCT non squamous - mNSCLC - L2 - all population nivolumab docetaxel Patients with advanced (stage IIIb or IV or recurrent) nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy 292 / 290 some concern conclusif demonstrated 27 % decrease in deaths (OS) (PE) demonstrated 70 % increase in objective responses (ORR) (PE) CheckMate 017, 2015 NCT01642004 RCT squamous - mNSCLC - L2 - all population Nivolumab Docetaxel Patients with stage IIIB or IV squamous-cell NSCLC who had disease recurrence after only one prior platinum-containing regimen 135 / 137 some concern conclusif demonstrated 41 % decrease in deaths (OS) (PE) demonstrated 38 % decrease in progression or deaths (PFS) (PE) suggested 69 % decrease in deaths (OS) (extension) suggested 52 % decrease in PFS (extension) more... CheckMate 816, 2022 NCT02998528 RCT laNSCLC - NA - all population nivolumab plus platinum doublet placebo plus platinum doublet patients with stage IB to IIIA resectable NSCLC, before surgery 179 / 179 NA suggested suggested 12.9-fold increase in pCR (PE) The results show that the Opdivo/chemotherapy treatment met the primary endpoint of pathologic complete response (pCR), with significantly more patients treated with the combination therapy showing no evidence of cancer cells in their resected tissue compared with the placebo arm