Study 006 Flashcards
1
Q
How many patients overall? In relevant T1 D10-20 cohort?
A
102 overall
56 in relevant cohort.
2
Q
In relevant cohort, what was the % of AEs? Grade 3/4 AEs? Discontinuation and death?
A
Drug related AEs–63%
Drug-related Grade 3/4 AEs–29%
Discontinuation due to AE–7%
Death due to AE–1 person, 2%
3
Q
Study Design Details
A
Phase 1b, non-randomized, multicentre open-label with standard dose escalation (3+3) followed by an expansion phase in immunotherapy naive patients.
Advanced NSCLC patients, either treatment naive, or failure to respond/relapsed after prior treatment(s)
4
Q
ADA evidence from 006
A
From ALPS study protocol, 4/60 patients had either anti treme or durva antibodies, the PK of durva was affected in 2 of these patients.
