| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. Standard of Care (SoC) | 3 | none | inconclusive results for: deaths (OS); deaths (OS) (extension); DOR; DOR (extension); objective responses (ORR); objective responses (ORR) (extension); AE (any grade); AE leading to death (grade 5); SAE (any grade); TRAE leading to death (grade 5); Colitis TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); Asthenia 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); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Leucopenia AE (grade 3-4); Nausea AE (grade 3-4); Pancytopenia (AE grade 3-4); Pneumonia AE (grade 3-4); Pyrexia AE (grade 3-4); Sepsis AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 28 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 23 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 61 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 50 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 73 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 81 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| cemiplimab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: DOR | suggested 43 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 46 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 2.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade) | suggested 62 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 79 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 64 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Standard of Care (SoC) | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); STRAE (any grade); STRAE (grade 3-4); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral oedema 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) ; Stomatitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Increase AST AE (grade 3-4) | suggested 80 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 79 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Leucopenia 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 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 4 | statistically conclusive 26 % decrease in deaths (OS) suggested 28 % decrease in deaths (OS) (extension) statistically conclusive 26 % decrease in progression or deaths (PFS) suggested 78 % decrease in TRAE (any grade) suggested 70 % decrease in TRAE (grade 3-4) suggested 94 % decrease in Anaemia TRAE (grade 3-4) suggested 90 % decrease in Nausea TRAE (grade 3-4) suggested 98 % decrease in Neutropenia TRAE (grade 3-4) suggested 92 % decrease in Thrombocytopenia TRAE (grade 3-4) | inconclusive results for: PFS (extension); DOR; DOR (extension); objective responses (ORR); objective responses (ORR) (extension); 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); 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); Dysgeusia 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); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 95 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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