Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population

versus Standard of Care (SoC)
durvalumab alone vs. Standard of Care (SoC) 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Dermatitis acneiform TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral 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)

suggested 55 % decrease in AE (any grade) but the degree if certainty is unassessable

suggested 71 % decrease in TRAE (any grade) but the degree if certainty is unassessable

suggested 65 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 96 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 96 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable

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mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative

mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive