Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

laHNSCC - 1st line (L1) locally advanced (laHNSCC) laHNSCC - 1st line (L1)

mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population

mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive

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

versus Standard of Care (SoC)
durvalumab plus tremelimumab vs. Standard of Care (SoC) 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DCR; 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); Alopecia TRAE (grade 3-4); Anaemia 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 66 % decrease in TRAE (any grade) but the degree if certainty is unassessable

suggested 39 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 92 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable

-

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

versus durvalumab alone
durvalumab plus tremelimumab vs. durvalumab alone 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE leading to treatment discontinuation (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4)--
versus tremelimumab
durvalumab plus tremelimumab vs. tremelimumab 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE leading to treatment discontinuation (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4)

suggested 9.4-fold increase in DCR but the degree if certainty is unassessable

-

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