Study 1108 Flashcards
How many patients in total were studied in 1108?
408
In the general population, which % of patients experienced any drug-related AE? Any drug-related Grade 3/4 AE?
Any drug-related AE–46%
Grade 3/4–7%
What was the optimal dose used in 1108?
Durva 10mg/kg q2W
What were the most common drug-related AE seen in the general population?
Fatigue–16%
Diarrhea–6%
Vomiting–6%
In the general cohort, what was the ORR for PD-L1+ patients? PD-L1- patients? Overall?
Do we have this data??
Overall ORR is 10%
In the general cohort, what % of responses were ongoing?
88%
How many patients in the SCCHN cohort?
62
In the SCCHN cohort, how many patients experienced a drug-related AE? Grade 3/4 drug-related AE?
Drug-related AE, any grade–??
Drug-related Grade 3/4 event–10%
What were the most common drug-related AE seen in the SCCHN cohort?
Hypothyroidism—3, or 5%
Diarrhea–5, or 8%
Various rashes/skin conditions–various, around 5-7%
In the SCCHN cohort, what was the ORR for PD-L1+ patients? PD-L1- patients? Overall?
ORR PD-L1+—18%
ORR PD-L1- —8%
Overall 11%
In the SCCHN cohort, what % of responses were ongoing?
71%, 5/7
