Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sintillimab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DCR; DOR; AE (any grade); AE (grade 3-4); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); Diarrhoea 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); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Nausea AE (grade 3-4); Pyrexia AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 39 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 2.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 69 % decrease in AE leading to death (grade 5) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
cemiplimab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: DOR; AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Hepatitis 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); Maculopapular rash TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); hepatitis (Autoimmune) AE (grade 3-4); Acute kidney injury AE (grade 3-4); Alopecia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Blood creatinine increased AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Increased Lipase Level AE (grade 3-4); myocarditis AE (grade 3-4); Nausea AE (grade 3-4); Pancytopenia (AE grade 3-4); Peripheral neuropathy AE (grade 3-4); Peripheral sensory neuropathy AE (grade 3-4); Pneumonia AE (grade 3-4); Pneumonitis AE (grade 3-4); Rash AE (grade 3-4); Rash maculopapular AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 32 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 82 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 81 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in Leucopenia AE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
durvalumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia 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); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Alopecia 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); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Nausea AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 44 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 52 % decrease in STRAE (grade 3-4) but the degree if certainty is unassessable suggested 76 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 66 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 88 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 84 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 93 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
durvalumab plus tremelimumab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia 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); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Alopecia 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); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Nausea AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 49 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 45 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 88 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
nivolumab plus ipilimumab plus SoC vs. Standard of Care (SoC) | 1 | none | inconclusive results for: DOR; 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); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | statistically conclusive 31 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 34 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 32 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 63 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable | - |