Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mGC or mGEJC - L1 - HER2 neg/PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - HER2 neg/PDL1 positive

versus Standard of Care (SoC)
nivolumab plus SoC vs. Standard of Care (SoC) 2 noneinconclusive results for: DOR; objective responses (ORR)

statistically conclusive 29 % decrease in deaths (OS) but the degree if certainty is unassessable

statistically conclusive 32 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable

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mGC or mGEJC - L1 - HER2 negative metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - HER2 negative

versus Standard of Care (SoC)
nivolumab plus SoC vs. Standard of Care (SoC) 1 noneinconclusive 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); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy 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) ; Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4)

statistically conclusive 20 % decrease in deaths (OS) but the degree if certainty is unassessable

suggested 23 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable

suggested 63 % increase in objective responses (ORR) but the degree if certainty is unassessable

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mGC or mGEJC - L1 - PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - PDL1 positive

versus placebo plus SoC
pembrolizumab alone vs. placebo plus SoC 1 noneinconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR)

suggested 31 % decrease in deaths (OS) but the degree if certainty is unassessable

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pembrolizumab plus SoC vs. placebo plus SoC 2 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); TRAE (any grade); Alopecia TRAE (grade 3-4); Anaemia 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); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4)

suggested 60 % increase in objective responses (ORR) but the degree if certainty is unassessable

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versus Standard of Care (SoC)
pembrolizumab alone vs. Standard of Care (SoC) 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE leading to death (grade 5); Alopecia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Weight decreased TRAE (grade 3-4)

suggested 91 % decrease in AE (grade 3-4) but the degree if certainty is unassessable

suggested 81 % decrease in AE leading to treatment discontinuation (any grade) but the degree if certainty is unassessable

suggested 89 % decrease in TRAE (any grade) but the degree if certainty is unassessable

suggested 90 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 91 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 84 % decrease in Decreased appetite TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 80 % decrease in Diarrhoea TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 94 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Mucosal inflammation TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 95 % decrease in Nausea 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 95 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Vomiting TRAE (grade 3-4) but the degree if certainty is unassessable

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